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WHO Consolidated Guideline on Self-Care Interventions for Health: Sexual and Reproductive Health and Rights. Geneva: World Health Organization; 2019.

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WHO Consolidated Guideline on Self-Care Interventions for Health: Sexual and Reproductive Health and Rights.

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4Recommendations

This chapter summarizes the evidence and considerations for existing and new recommendations as identified throughout the development of this document.

Recommendations:

The following steps were taken, and the subsequent findings were compiled and reported in further detail in this chapter:

  • Evidence and considerations are summarized
  • Certainty of the evidence is assessed
  • Rationale for the strength and direction of the recommendation is given
  • An estimate of the resource use required
  • Feasibility is determined
  • Impact on equity and human rights are analysed
  • Acceptability of the intervention is assessed.

“In implementing these globally relevant recommendations, WHO regions and countries can adapt them to the local context, taking into account the economic conditions and the existing health services and health-care facilities.”

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4.1. Improving Antenatal Care, Delivery, Postpartum and Newborn Care

4.1.1. Existing recommendations on self-care during antenatal care and delivery

Existing recommendations on non-clinical interventions to reduce unnecessary caesarean sections

REC 1.

Health education for women is an essential component of antenatal care. The following educational interventions and support programmes are recommended to reduce caesarean births only with targeted monitoring and evaluation.

(context-specific recommendation, low-certainty evidence)

REC 1a.

Childbirth training workshops (content includes sessions about childbirth fear and pain, pharmacological pain-relief techniques and their effects, non-pharmacological pain-relief methods, advantages and disadvantages of caesarean sections and vaginal delivery, indications and contraindications of caesarean sections, among others).

REC 1b.

Nurse-led applied relaxation training programme (content includes group discussion of anxiety and stress-related issues in pregnancy and purpose of applied relaxation, deep breathing techniques, among other relaxation techniques).

REC 1c.

Psychosocial couple-based prevention programme (content includes emotional self-management, conflict management, problem solving, communication and mutual support strategies that foster positive joint parenting of an infant). “Couple” in this recommendation includes couples, people in a primary relationship or other close people.

REC 1d.

Psychoeducation (to address fear of pain; comprising information about fear and anxiety, fear of childbirth, normalization of individual reactions, stages of labour, hospital routines, birth process, and pain relief [led by a therapist and midwife], among other topics).

REC 2.

When considering the educational interventions and support programmes, no specific format (e.g. pamphlet, videos, role play education) is recommended as more effective.

(low- to moderate-certainty evidence)

Remarks

Existing recommendations on antenatal care for a positive pregnancy experience – self-administered interventions for common physiological symptoms

Interventions for nausea and vomiting:

REC 3.

Ginger, chamomile, vitamin B6 and/or acupuncture are recommended for the relief of nausea in early pregnancy, based on a woman’s preferences and available options.

Interventions for heartburn:

REC 4.

Advice on diet and lifestyle is recommended to prevent and relieve heartburn in pregnancy. Antacid preparations can be offered to women with troublesome symptoms that are not relieved by lifestyle modification.

Interventions for leg cramps:

REC 5.

Magnesium, calcium or non-pharmacological treatment options can be used for the relief of leg cramps in pregnancy, based on a woman’s preferences and available options.

Interventions for low back and pelvic pain:

REC 6.

Regular exercise throughout pregnancy is recommended to prevent low back and pelvic pain. There are a number of different treatment options that can be used, such as physiotherapy, support belts and acupuncture, based on a woman’s preferences and available options.

Interventions for constipation:

REC 7.

Wheat bran or other fibre supplements can be used to relieve constipation in pregnancy if the condition fails to respond to dietary modification, based on a woman’s preferences and available options.

Interventions for varicose veins and oedema:

REC 8.

Non-pharmacological options, such as compression stockings, leg elevation and water immersion, can be used for the management of varicose veins and oedema in pregnancy based on a woman’s preferences and available options.

Remarks

Existing recommendation on self-administered pain relief for prevention of delay in the first stage of labour

REC 9.

Pain relief for preventing delay and reducing the use of augmentation in labour is not recommended.

(weak recommendation, very low-quality evidence)

Remarks

  • This existing recommendation was integrated into this guideline from the 2014 publication, WHO recommendations for augmentation of labour (3).
  • This recommendation looked at evidence on: relaxation techniques in labour, yoga in labour, music in labour, acupuncture and acupressure in labour, hypnosis (including self-hypnosis), aromatherapy and biofeedback.
  • Further information can be found in the original publication, available at: https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/augmentation-labour/en/

i. Background

Focused or goal-oriented antenatal (ANC) services provide specific, evidence-based interventions to be carried out at certain critical times during all pregnancies. This includes a package of interventions including advice and support for clients and their family members for developing healthy home behaviours and a birth and emergency-preparedness plan to increase awareness of maternal and newborn health needs and self-care during pregnancy and the postnatal period, including the need for social support during and after pregnancy (4).

4.1.2. Additional existing guidance on self-care for prevention of postpartum haemorrhage (PPH)

Although self-care was reviewed by WHO in relation to uterotonics for the prevention of PPH for a guideline published in 2012, the GDG at that time concluded that there was insufficient evidence to recommend the antenatal distribution of misoprostol for self-administration during the third stage of labour for the prevention of PPH. Therefore, further research is needed on this topic.

Further information can be found in the original guideline, WHO recommendations for the prevention and treatment of postpartum haemorrhage (2012), available at: https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241548502/en/ (5).

4.2. Providing High-Quality Services for Family Planning, Including Infertility Services

4.2.1. New recommendations on self-care in family planning and fertility management

New recommendation on self-administration of injectable contraception

REC 10 (NEW)

Self-administered injectable contraception should be made available as an additional approach to deliver injectable contraception for individuals of reproductive age.

(strong recommendation, moderate-certainty evidence)

Remarks

  • Medical eligibility for the injectable contraceptive method should be verified according to the WHO Medical eligibility criteria for contraceptive use (MEC) (6), and providers should advise end-users of precautions and be available to discuss potential side-effects.
  • This recommendation refers to depot medroxyprogesterone acetate in its subcutaneous form (DMPA-SC).
  • Instructions on how to self-inject are available in the WHO global handbook for family planning providers (7).
  • Note: For additional existing guidance on self-administration of injectable contraception, see the end of section 4.2.3.

i. Background

Injectable contraception is widely used globally. One form of injectable contraception, depot medroxyprogesterone acetate (DMPA), which contains only progestogen and no estrogen, is widely used in its intramuscular form (DMPA-IM). Recently, a subcutaneous form (DMPA-SC) has been developed which can be injected relatively easily and is safe and efficacious (8, 9). DMPA-SC is being produced and marketed as a prefilled needle and drug combination, which has regulatory approval in more than 40 countries (10, 11) and is currently available in at least 20 Family Planning 2020 (FP2020)1 countries. Providing the option to self-inject DMPA may improve DMPA continuation by removing barriers, such as the need to return to a health-care facility every three months for a repeat injection. Self-administration of DMPA-SC, or other injectable contraceptives, could potentially expand access to contraception for those facing challenges in accessing health-care settings regularly, and in places where there are shortages of health-care providers.

ii. Summary of evidence and considerations for the new recommendation

The WHO Guideline Steering Group (SG) determined to examine self-administration of injectable contraception as an additional approach to delivering injectable contraception. The PICO question was: For individuals of reproductive age using injectable contraception, should self-administration be made available as an additional approach to deliver injectable contraception? A systematic review was conducted of peer-reviewed journal publications in any location or language. The included studies on people using injectable contraception compared those who had the option of self-administration with those who did not have that option (i.e. the latter all received provider-administered injectable contraception). The studies measured one or more of the following outcomes: unintended pregnancy; side-effects or adverse events (e.g. bleeding, skin-site reactions, mental health); uptake of injectable contraception (initial use); continuation rate of injectable contraception (or, conversely, discontinuation); self-efficacy, knowledge and empowerment; and social harms (e.g. coercion, violence, psychosocial harm, self-harm), and whether these harms were corrected or had redress available (see Annex 6 for further details on the PICOs). More information on the review methods and findings can be found in the published review (12).

Results

The systematic review included six studies, published between 2012 and 2019, with a combined total of 3851 participants: three randomized controlled trials (RCTs) and three controlled cohort studies. Locations included Malawi, Scotland, Senegal, Uganda (one study each) and the United States of America (USA; two studies). Self-injection of DMPA-SC was compared to provider-administered DMPA-SC (three studies) or provider-administered DMPA-IM (three studies), with injections being every three months (12–13 weeks), with some leeway for early and late injections. All the studies followed the participants through 12 months of contraceptive coverage and measured continuation (or discontinuation) of injectable contraception.

Meta-analysis reported in the review found higher rates of continuation with self-administration of injectable contraception compared with provider administration both in the three RCTs (RR: 1.27, 95% CI: 1.16–1.39) and in the three controlled cohort studies (RR: 1.18, 95% CI: 1.10–1.26). Four studies reported pregnancies: meta-analysis showed no difference in this outcome across study arms. Four studies reported side-effects/adverse events: two controlled cohort studies showed increased injection-site reactions with self-administration, but no other side-effects increased with self-administration. One study reported no difference in social harms. No studies measured the outcomes of initial uptake or self-efficacy/empowerment.

Overall, moderate-certainty evidence from the three RCTs indicates that self-administration of injectable contraceptives probably increases continuation of injectable contraception, but is probably equivalent with respect to rates of unintended pregnancy, side-effects/adverse events (except perhaps injection-site pain or irritation) and social harms. Evidence from the three observational studies was consistent with these findings. There were no clear differences in outcomes for different populations (12).

Certainty of the evidence for the recommendation

The available evidence was of moderate certainty overall.

Rationale for the strength and direction of the recommendation

A strong recommendation was made in favour of the intervention, with every GDG member who offered an opinion saying that benefits outweighed any potential harms. The GDG emphasized in the wording of this recommendation that the intervention should be made available as an additional approach, because nobody should have to self-inject due to having no access to provider-administered injections.

Resource use

There was evidence that longer-term contraceptive use is cost-effective for the end-user, but higher initial investment by the health system is required for the provision of training and support/supervision. A study in Uganda reported incremental costs at the start, leading to higher continuation rates and lower rates of unintended pregnancy, indicating that the intervention was quite cost-effective, and would also be cost-saving (13, 14).

Feasibility

All GDG members agreed that this recommendation is feasible.

Equity and human rights

The GDG agreed that, despite insufficient information, there is potential for this self-care intervention to improve equity if implemented in the context of an enabling environment. An enabling environment, however, may be lacking if literacy levels are low and there are barriers to education that may decrease access to the intervention. The GDG noted that the need for contact with a health-care provider before using this intervention means that there may still be a risk of discrimination. More information and evidence is needed on structural and regulatory issues, and on how best to implement this intervention without increasing inequity.

Acceptability of the intervention: values and preferences of end-users and health-care providers

A review was conducted to gather evidence on values and preferences related to this intervention as input for the development of a recommendation on this intervention for this guideline. The review included 14 studies: three used qualitative methods and 11 used quantitative or mixed methods. Two of the included studies were among adolescents and 12 were among the general female population; no studies were found on the values and preferences of providers or other stakeholders. Among the 14 studies, six took place in high-income countries (two in Scotland; four in the USA), one in an upper-middle-income country (Brazil), and seven in low-income countries (one in the Democratic Republic of the Congo; one in Ethiopia; two in Malawi; one in Senegal; two in Uganda). The evidence suggested that women generally like self-administration, find it easy to use, and often prefer it to provider administration. Benefits included saving time and money, ease of administration, and convenience. Barriers included fear of needles, fear of incorrect administration, or preference for seeing a health-care professional.

As described in Chapter 1, section 1.9, a Global Values and Preferences Survey (GVPS) was also conducted among health-care providers and potential end-users on their values and preferences in relation to this and other interventions covered by new recommendations in this guideline. The relevant findings from the GVPS are presented in the box below. Overall, more than 60% of potential users said they had heard of this intervention, and many reported that convenience, access and privacy would be reasons for using it. Most said they would go to a doctor/clinic to obtain supplies for self-administration. The top two concerns reported by health-care providers were safety (e.g. side-effects) and incorrect use by patients.

The GDG reviewed the evidence on values and preferences of potential end-users, and noted that convenience of access was important to them, but there was insufficient evidence from potential users from a range of different subgroups (i.e. vulnerable individuals, different age groups). The GDG concluded that the values and preferences of the potential end-users were variable, and that the nature of the barriers may be easy to overcome.

The GDG noted that while there were limited data on health-care providers’ perspectives, providers generally aim to offer the best possible care to their patients. Health-care providers in low-resource settings may find the option to task-shift the administration of injectable contraception to clients themselves acceptable, as long as effective training can be provided and the safety of users can be assured. Private-sector health-care practitioners, however, may be resistant to self-care interventions due in part to possible financial loss. Acceptability to health-care providers likely also differs by provider age, and level of confidence and/or training. In summary, the GDG concluded that acceptability to health-care providers was uncertain, noting reticence, but also noting that task shifting is achievable with training.

Global Values and Preferences Survey (GVPS) Findings on Self-Administration of Injectable Contraception

End-users and potential end-users

Respondents were asked about their knowledge and use of self-injectable long-acting contraceptives. While more than half of respondents (62.8%, n=486) reported knowing what self-injectable long-acting contraceptives were, less than 5% of respondents reported that they or their partner had ever used this intervention. Among participants who responded to a question on factors that would be important in choosing to use self-injectable long-acting contraceptives (n=420), respondents selected factors including: convenience (51.9%), accessibility (47.6%) and privacy and confidentiality (40.5%). Not feeling judged (23.6%) and feeling empowered (24.8%) were also identified as important factors in choosing to use self-injectable long acting contraceptives. There were no statistically significant differences by residing in the Global North/Global South with regard to awareness of self-injectable long-acting contraceptives. However, participants in the Global North were significantly more likely to report accessing this intervention from a doctor or at a health clinic than those in the Global South. Participants below 50 years old were more likely to have heard of and used self-injectable long-acting contraceptives than those aged 50 and above. Furthermore, the qualitative findings from responses to the open-ended questions highlight acceptability of self-injectable long-acting contraceptives along with the need to provide users with information and guidance.

The largest proportion of respondents 47.7% (n=297 out of 622 responding about this intervention) indicated that they would go to the doctor or health clinic to access supplies for self-administration of injectable contraception. Other respondents reported that they would access it a pharmacy (17.7%; n=110), that they did not know where to get this (12.7%; n=79), that they would buy it online (1.6%; n=10), and that they did not need this intervention (30.2%; n=188). For those who responded about where they accessed information on self-injectable long-acting contraceptives (n=436), 64% (n=279) asked their doctor or health-care provider, 40.8% (n=178) went online, 15.4% (n=67) asked friends or community members, and 17.7% (n=77) reported not having received information on this intervention.

Health-care providers

When the health-care provider respondents of the GVPS were asked whether they had ever provided a referral for self-injectable contraceptives, of those who responded (n=325), more than one-third (41.2%, n=127) indicated they had, 28.2% (n=87) had not, 11% (n=34) responded that the intervention is not available where they live, and 20.8% (n=64) reported that it was not related to their job. When asked about their level of confidence and knowledge on self-injectable long-acting contraceptives, of those who replied (n=296), more than half of respondents (52.4%; n=155) felt confident and informed. One-third (33.1%, n=98) needed more information and one-fifth (21.3%, n=63) needed training to provide this service.

Among participants who reported concerns regarding this intervention (n=229), 52% (n=119) indicated safety concerns, 47.2% (n=108) indicated concerns of misuse by patients, 40.2% (n=92) reported concerns that a patient would not access needed health care, and 21% (n=48) indicated concerns about the quality of products. Of those who responded about benefits of self-injectable contraceptives (n=224), 68.8% (n=154) indicated the benefit of convenience, 48.2% (n=108) indicated it is empowering, 44.6% (n=100) indicated reduction of health care workload, 35.3% (n=79) indicated removal of barriers, and 30.8% (n=69) indicated that it is cheaper for the client.

New recommendation on self-management of contraceptive use with over-the-counter oral contraceptive pills (OTC OCPs)

REC 11 (NEW)

Over-the-counter oral contraceptive pills (OCPs) should be made available without a prescription for individuals using OCPs.

(strong recommendation, very low-certainty evidence)

Remarks

  • Medical eligibility screening before initiation of OCPs is preferable.

i. Background

Oral contraceptive pills (OCPs), including both combined oral contraceptives (COCs) and progestogen-only pills (POPs), are widely used, safe and effective methods of birth control. Access to OCPs, however, varies around the world. In some countries, OCPs are available over the counter (OTC) – meaning without the need for a prescription; OTC includes (a) “off the shelf” availability with no screening and (b) “behind the counter” pharmacy access requiring eligibility screening by trained pharmacy staff before dispensation. In other countries, there is no OTC access to OCPs at all, such that a prescription from a health-care provider is required. A review of contraceptive access across 147 countries, published in 2015, found that 35 countries had OCPs legally available OTC, 56 countries had OCPs informally available OTC, 11 countries had OCPs available OTC but only after eligibility screening by trained pharmacy staff, and 45 countries required a prescription to obtain OCPs (no OTC access) (15). Given that, globally, an estimated 44% of pregnancies are unintended (16), making OCPs easier to access in more settings by making them available OTC (either “off the shelf” or “behind the counter”) could contribute to increasing OCP use and reducing unintended pregnancies.

ii. Summary of evidence and considerations for the new recommendation

The SG determined that OTC availability of OCPs should be reviewed as one of the topic areas for the development of new recommendations; therefore, a systematic review was conducted on the PICO question: For individuals using oral contraceptive pills (OCPs), should OCPs be made available over-the-counter (OTC), i.e. without a prescription? Peer-reviewed articles published through 30 November 2018 were included if they compared either full OTC (“off the shelf”) or pharmacist dispensation (“behind the counter”) to prescription-only availability of OCPs and measured at least one of the selected outcomes of interest: uptake of OCPs (initial use); continuation of OCPs (or, conversely, discontinuation); adherence to OCPs (correct use); comprehension of instructions (product label); unintended pregnancy, side-effects, adverse events, or use of OCPs despite contraindications; social harms (e.g. coercion, violence, psychosocial harm, self-harm), and whether these harms were corrected or had redress available; and client satisfaction (see Annex 6 for further details on the PICOs). The focus was on daily OCP use for routine pregnancy prevention and so studies examining pills specifically for emergency contraception were not included. Meta-analysis was not conducted due to the small number of included studies (17).

Results

The effectiveness review included four observational studies with a total of 5197 participants, reported in six articles. Two of these studies were published in the 2000s, written up in four articles. One of these was the Border Contraceptive Access Study (a longitudinal cohort study from Texas, USA, which used convenience sampling and was reported in three articles), and the other was the 2000 Mexican National Health Survey (a cross-sectional comparison study, which was reported in one article). Both of these studies compared women who obtained OCPs OTC in Mexico to women who obtained OCPs from providers in either Mexico or the USA. The two other studies were from Bogota, Colombia (1974 Fertility and Contraceptive Use Survey), and from Mexico (1979 Mexico National Fertility and Mortality Study), and were published in the 1970s, providing cross-sectional comparisons of women using OCPs obtained OTC or from a private-sector or national health-care provider. All studies included mainly women using COCs, rather than POPs (with differing pill formulations). The included studies reported on four of the seven outcomes of interest: continuation of OCPs, use of OCPs despite contraindications, side-effects and client satisfaction (17).

With a small evidence base, evidence from one observational study (the Border Contraceptive Access Study) indicated that women who get OCPs OTC may have higher OCP continuation rates over nine months of follow-up compared with women who get them from a clinic (adjusted hazard ratio: 1.58, 95% CI: 1.11–2.26). The two older studies also examined continuation. The Mexican study found no difference between the three groups (57–60% continuation after 12 months). The Colombian study found that after both 12 and 24 months, OCP continuation was approximately 5% higher for clinic users than OTC users.

Evidence from both of the more recent observational studies showed mixed evidence on whether women who get OCPs OTC are more likely to use OCPs despite contraindications. The Border Contraceptive Access Study found OTC users were more likely to report at least one WHO category 3 contraindication (13.4% versus 8.6%, P = 0.006), but not category 4 contraindications. Meanwhile, the analysis of the 2000 Mexican National Health Survey found no differences in contraindicated use. In the meta-analysis, the pooled effect size from these two studies showed higher odds of using OCPs despite at least one category 3 or 4 contraindication among OTC users (OR: 1.57, 95% CI: 1.18–2.09).

Two studies reported on side-effects of OCP use: the longitudinal Border Contraceptive Access Study reported fewer side-effects among OTC users and the Colombian study reported more side-effects among OTC users.

The longitudinal cohort study (Border Contraceptive Access Study) reported on client satisfaction, finding high patient satisfaction with both OTC and prescription access: “three quarters of clinic users and more than 70% of pharmacy users said they were very satisfied with their source … Only about 4% of each group said they were either somewhat or very unsatisfied with their source” (18).

There were no data on initial uptake, correct use, comprehension of instructions, unintended pregnancy, adverse events, or social harms.

Certainty of the evidence for the recommendation

This recommendation was based on very low-certainty evidence. The GDG also noted the potential for bias with self-reporting of side-effects. Both of the more recent studies included in the systematic review found that women who obtained their OCPs OTC were different in at least some sociodemographic characteristics from those who obtained OCPs from clinics, but both studies used analysis methods to appropriately adjust for confounders to address this discrepancy, which the reviewers judged improved the validity of the effect estimates. Meanwhile, the two studies from the 1970s reported only minor sociodemographic differences between the groups, although neither presented supporting data nor adjusted for confounders. The Border Contraceptive Access Study relied on convenience sampling, but was strengthened by its longitudinal design. Conversely, the other three studies were cross-sectional, but were strengthened by their multi-stage sampling strategies (17).

Rationale for the strength and direction of the recommendation

Despite the very low-quality evidence, after extensive discussion, the GDG agreed that the benefits outweighed the harms and a strong recommendation was made in favour of the intervention. The GDG put the emphasis on equity, which is supported by the increased availability made possible by OTC access, and on high feasibility, given that the intervention is already available in many countries. While contraindications are an important concern, research has indicated that women can self-screen for contraindications fairly well using a simple checklist (19). In many parts of the world where OCPs are already available without a prescription, self-screening tools are provided with the OCP packaging. The GDG noted the preference for eligibility screening before initiation of OCPs.

The GDG also noted the need for regular linkages to the health system. In the 35 countries where OCPs are already legally available OTC, with neither prescription nor pharmacist screening required, locally adapted guidance (e.g. from WHO regional offices) could indicate that this approach should continue. The GDG agreed that since OTC availability is associated with higher continuation rates, this intervention should be available, even where health systems are not strong, but that more research is needed on managing contraindications.

In-country systems need to assess the way that OCPs are being made available without prescriptions; there need to be systems in place to ensure that end-users can be accurately screened for contraindications, whether that means (i) self-screening using a checklist or other tool available at the point of sale, or (ii) being screened by a pharmacist or community health worker. The GDG also noted the need to be aware that many OTC drugs, potentially including OCPs, are counterfeit, off-label and/or contain toxic components. The quality of all drugs needs to be regulated to a high standard, but this issue is beyond the scope of these guidelines.

Resource use

The GDG agreed that this intervention is cheap in many places, noting that government subsidies should be retained if distribution is transferred to an OTC approach. The GDG expressed concerns that the burden of payment may fall to end-users themselves if insurance does not cover OTC availability, thus risking a decrease in accessibility. On the other hand, this intervention could be cost-saving for end-users as they will not have to pay to see a doctor, travel to a clinic or take time off work (and lose wages) for a clinic appointment. The resource implications for this intervention would be context specific, depending on current systems, costs and the burden of payment.

Feasibility

The GDG agreed that the intervention is feasible, given that it is already in use in several countries.

Equity and human rights

The GDG agreed that this intervention is likely to increase access and reduce discrimination (supporting human rights), especially among adolescent girls and young women and sexual and gender minorities, since it may remove the need to see a health-care provider and/or to get third-party authorization from a parent or spouse. Attention to context is important, however, as in some countries OCPs may not be sold to unmarried individuals. Furthermore, increased access could perhaps be accompanied by a decrease in quality of care.

Acceptability of the intervention: values and preferences of end-users and health-care providers

The systematic review for this PICO (17) included a review of 22 quantitative and qualitative studies (reported in 23 articles) on the values and preferences relating to OTC access to OCPs (including behind-the-counter pharmacy access) among current and potential users and women in general (13 articles); health-care providers and pharmacists (eight articles); the general public (one article); and a combination of women and health-care providers (one article). Nearly all the studies were conducted in the USA, while one each was conducted in Canada, France and the Republic of Ireland. Regarding full OTC (off-the-shelf) access to OCPs, the evidence indicated that users/potential users generally favoured this, citing ease of access, convenience, privacy and time saved by avoiding clinic visits for presciptions. Concerns of users included cost, continued use of preventive care/screening (e.g. Pap smears, breast exams, STI screening), and the safety of OTC access, especially for young people. Health-care providers were moderately supportive of full OTC access, expressing concerns including safety, efficacy, correct use and missed examinations for medical contraindications. Regarding OTC pharmacy (behind-the-counter) access, users also generally favoured and were satisfied with this, citing increased access and convenience. Pharmacists were generally very supportive of this approach while physicians were only moderately supportive. In general, providers were also more supportive of providing POPs OTC (behind the counter) compared with COCs. Potential barriers to this OTC pharmacy access included: safety, time constraints, lack of private space in the pharmacy, increased liability, and reimbursement. Overall, support was generally higher for OTC dispensation in pharmacies (behind the counter) compared with full OTC availability (off the shelf).

As described in Chapter 1, section 1.9, a Global Values and Preferences Survey (GVPS) was also conducted among health-care providers and potential end-users on their values and preferences in relation to this and other interventions covered by new recommendations in this guideline. The relevant findings from the GVPS are presented in the box below. Overall, almost all potential end-users who responded said they had heard of this intervention, and the most important factors affecting uptake were access, convenience, and privacy and confidentiality. Most said they would access the intervention through a doctor or health clinic. When responding health-care providers were asked about this intervention, the top two concerns reported were misuse by patients and safety (e.g. side-effects).

The GDG reviewed the evidence from the systematic review and the GVPS and concluded that overall there was minor variability in the values and preferences of potential end-users, and also minor variability in acceptability among health-care providers in relation to the intervention. The GDG noted that the data were from high-income countries where there may be resistance to this intervention due to health system issues surrounding insurance and reimbursement. This intervention is already in practice in many countries around the globe. More data are needed from drug stores and informal pharmacies, as well as from lower-cadre health workers and non-health professionals.

Global Values and Preferences Survey (GVPS) Findings on Access to OCPs

End-users and potential end-users

Of the GVPS respondents who reported whether or not they had heard of OCPs (n=783), 0.9% (n=7) reported not knowing what they are, 3.6% (n=28) reported that they knew what they were but they did not know how to access them, and 95.5% (748) reported that they both knew what they were and where to access them. When asked about their use of OCPs, approximately half of respondents (n=720) indicated that they or their partner had used oral contraceptives: 43.6% (n=314) had used them in the past, 6.8% (n=49) had used them within the past three months, 26.5% (n=191) had not used OCPs, and 23.1% (n=166) did not have a need for contraception. The most important factors related to OCP uptake, as reported by 513 respondents, were access (57.1%, n=293), convenience (56.3%, n=289) and privacy and confidentiality (46.4%, n=238). The possibility that OCPs can reduce the feeling of being judged (24.2%, n=124) and can foster a sense of empowerment (28.8%, n=148) were also listed as important factors associated with uptake.

There were no statistically significant differences in awareness of OCPs between respondents residing in the Global North versus the Global South. However, participants residing in the Global North were more likely to report using OCPs than those in the Global South. Those in the Global South were more likely to report accessing OCPs from a pharmacy, while those in the Global North reported being more likely to access OCPs from a doctor or a health clinic. Participants aged 50 and above were more likely to have heard of OCPs. There were no other differences in responses by place of residence, age or gender.

Participant responses related to OCPs in the open-ended (qualitative) survey responses revealed that OCPs were perceived as simple enough, compared to other interventions (e.g. abortion self-management), that using OCPs would not require the direct assistance of a health-care provider, and that OCPs should be made freely available. Concerns expressed regarding OCPs were focused more on the delivery and availability, as opposed to the intervention itself. Participants also discussed challenges with the care they received from health-care providers when accessing OCPs. Taken together, the qualitative responses reveal great promise for over-the-counter (OTC) access to OCPs in allowing individuals to circumvent health-care providers who may stigmatize certain groups of OCP users. At the same time, providing instructions and contraindications for use of OCPs in an accessible language and format for people of various literacy levels is another implementation consideration.

Among respondents on this topic and for this intervention (n=658), 56.5% (n=372) would access OCPs through a doctor or health clinic and 45.4% (n=299) would access them through a pharmacy. Very few indicated online sources (2.7%; n=18) or not knowing where to get this intervention (0.5%; n=3). Nearly one fifth (18.8%; n=124) indicated not having a need for OCPs. Of the individuals who reported accessing information on OCPs (n=496), 76.2% (n=378) asked a doctor or health-care provider, 51.2% (n=254) went online, 24% (n=119) asked friends and community members, and 4.8% (n=24) have not received information on this.

Health-care providers

When asked about referrals for use of OCPs, of the health-care providers who responded (n=325), about three quarters (74.8%; n=243) reported having provided a referral, 6.8% (n=22) had not, nearly one fifth (18.5%; n=60) indicated it was not relevant to their job and one person (0.3%) indicated it is not available where they live. Out of respondents on this question (n=316), most said they feel confident and informed about OCPs (82.3%; n=260). There were 11.4% (n=36) of health-care providers who replied that they need more information and 9.2% (n=29) indicated that they need more training in order to provide a referral for OCPs. Of those who indicated their concerns regarding OCPs (n=263), most expressed concerns about misuse by patients (58.6%; n=154) and about safety (53.6%; n=141). Others indicated concerns that patients would not access health care when needed (31.6%; n=83) and concerns about the quality of products (27.8%; n=73). Of those respondents who answered regarding the benefits of OCPs (n=267), three quarters (75.7%; n=202) expressed that OCPs are convenient for the patient or client. Next, 49.8% (n=133) reported that OCPs are empowering, 44.2% (n=118) expressed that they will remove barriers like stigma, 40.4% (n=108) expressed that OCPs will reduce health care workload, and 40.1% (n=107) expressed the OCP use will be affordable.

New recommendation on self-screening with ovulation predictor kits (OPKs) for fertility management

REC 12 (NEW)

Home-based ovulation predictor kits (OPKs) should be made available as an additional approach to fertility management for individuals attempting to become pregnant.

(strong recommendation, low-certainty evidence)

i. Background

For couples who are attempting pregnancy through coitus, or individuals who are attempting pregnancy through vaginal insemination, knowing when to do so can be difficult. There is a short window during the menstrual cycle when ovulation occurs and a mature egg or eggs have been released and are able to be fertilized by sperm, with subsequent embryo implantation. Reportedly, up to 85% of women will become pregnant on their own within 12 menstrual cycles (20, 21). However, global estimates indicate that 15–25% are unable to become pregnant despite attempting for at least five years (22, 23). Infertility is typically diagnosed if pregnancy has not been achieved after 12 months of regular intercourse without a condom (24), although this timeframe may vary by age and by presence of anatomical abnormalities or disease (25). Individuals who are diagnosed as infertile may turn to medically assisted reproduction (MAR) using various diagnostics and interventions for fertility care (26). However, some options are unaffordable or inaccessible, especially in resource-constrained settings.

Preventing fertile individuals and couples from assuming a status of infertility, when they may be able to help themselves to become pregnant with better knowledge of their reproductive cycles and fertile window, can be empowering and can avoid high costs, especially if there is an ability to prevent recourse to more expensive assisted reproductive technologies. Use of ovulation predictor kits (OPKs) can support better timing of condom-less intercourse or the self-intravaginal insemination during the fertile window. OPKs are readily available in many settings worldwide without the need for a prescription, including at pharmacies, supermarkets and other shops, as well as from websites found online, which can deliver goods anywhere in the world. OPKs do not actually predict ovulation, but rather they predict the surge of luteinizing hormone that precedes ovulation, while also tracking corresponding oestrogen levels (27). The kits do not directly indicate a peak fertility day, and multiple pregnancy attempts may still be needed within the appropriate timeframe. OPKs increase fertility awareness and may alert individuals to potential menstrual cycle abnormalities. Individuals with HIV serodiscordant partners could use OPKs to time intercourse and limit exposure to condom-less sex in order to reduce the risk of transmission of HIV and other sexually transmitted infections (28, 29). Single individuals, those who wish to observe specific religious or cultural traditions, migrant/irregular workers, or couples in unconsummated marriages (e.g. due to male erectile dysfunction or physical disabilities) might benefit from using OPKs to appropriately time condomless intercourse or attempt self-intravaginal insemination (30).

ii. Summary of evidence and considerations for the new recommendation

The SG determined that the use of home-based OPKs should be reviewed for the development of this guideline. Therefore, WHO commissioned a new systematic review of available evidence of effectiveness and values and preferences surrounding the use of home-based, self-initiated OPKs for fertility management (31). The PICO question was: For individuals attempting to become pregnant, should home-based ovulation predictor kits (OPKs) be made available as an additional approach for fertility management? To be included in the effectiveness review, studies had to compare individuals who managed their fertility using (commercially available) home-based OPKs with those who had clinician-led assessment only, or no ovulation prediction, and they had to be published in a peer-reviewed journal (through 21 November 2018). Included studies also had to report on at least one of the following outcomes of interest: time to pregnancy; pregnancy; live birth; stress/anxiety; social harms or adverse events (e.g. device-related issues, coercion, violence, psychosocial harm, self-harm, suicide, stigma, discrimination), and whether these harms were corrected or had redress available (see Annex 6 for further details on the PICOs). Inclusion was not restricted by location of the study or language of the publication.

OPKs used in the reviewed studies could include both urine-and serum-based kits and any modality (stick, monitor, digital, electronic slip that connects to a phone, etc.). To focus on OPKs as a specific biomedical and biochemical intervention, the review did not include behavioural and non-biochemical methods of ovulation prediction, such as calendar/standard days/fertility awareness methods, basal body temperature monitoring, Billings/cervical mucus monitoring methods, use of fertility beads, etc. (31).

Results

Four studies were included in the effectiveness (PICO) review: three RCTs and one prospective cohort (observational) study. The four studies included a total of 1487 women (or couples), with individual study sample sizes ranging from 117 to 1000, and with participants’ ages ranging from 18 to 43. The articles were published between 1992 and 2013 and reported on studies taking place between 1991 and 2010. All studies were conducted in high-income countries: Australia, Scotland, the United Kingdom and the USA. Two studies recruited women from the general population nationwide, and the other two recruited women undergoing fertility treatment or investigation. All studies measured pregnancy as an outcome (with follow-up periods ranging from two to six menstrual cycles). Two studies measured time to pregnancy and one study reported on stress/anxiety. None of the studies presented comparative data on live births or social harms/adverse events.

All the included studies reported pregnancy rates. A single RCT from the 1990s among couples with unexplained or male-factor infertility provided uncertain results indicating no difference in clinical pregnancy rate (RR: 1.09, 95% CI: 0.51–2.32). Meta-analysis of two more recent RCTs (conducted in 2001–2002 and 2010) among the general population found higher self-reported pregnancy rates among OPK users (pooled RR: 1.40, 95% CI: 1.08–1.80). Meta-analysis of all three RCTs incidated that using a home-based OPK for timing intercourse was associated with higher rates of pregnancy compared with not using an OPK (pooled RR: 1.36, 95% CI: 1.07–1.73). A small observational study published in 1996 found higher rates of pregnancy with laboratory testing versus OPKs among women using donor insemination services (RR: 0.35, 95% CI: 0.15–0.86).

Two RCTs found that there may be no difference in time to pregnancy.

Results for measures of stress from a single RCT showed mixed results. When stress/anxiety was measured with the Perceived Stress Scale after two menstrual cycles using OPKs, results indicated that there may be no appreciable difference in stress/anxiety (mean difference [MD]: 1.98, 95% CI: −0.91 to 4.87). When stress was measured using the Positive and Negative Affect Schedule (PANAS positive affect scale), results showed there may have been an increase in stress in those using OPKs (MD: −4.51, 95% CI: −8.77 to −0.25).

Certainty of the evidence for the recommendation

This recommendation was based on low-certainty evidence, and a lack of data generated within low- and middle-income countries (LMICs). The risk of bias among the RCTs was generally high. Blinding was not possible for this intervention – all participants knew whether they were in the intervention or control group – increasing the risk of performance bias. The outcome “self-reported pregnancy” may have suffered from detection bias, as lack of blinding could lead to greater awareness of fertility, and increased frequency of pregnancy testing, and thus greater rates of positive pregnancy tests. Increased frequency of intercourse by couples using OPKs is also possible, which may have influenced the outcomes of pregnancy and time to pregnancy. There is also a high risk of publication bias, given the small number and small sample size of the included studies. In addition, two studies were funded by the OPK manufacturer and one study had its intervention delivered by the manufacturer; because of the commercial nature of OPKs, there may be some concern that data yielding negative results have not been published.

Rationale for the strength and direction of the recommendation

After extensive discussion, the GDG made a strong positive recommendation in favour of the intervention, despite the low certainty of the evidence and the fact that it was all from high-income countries. A strong recommendation was made because this intervention provides an additional choice and option for those who are concerned that they may not be attempting pregnancy during the appropriate time frame within the menstrual cycle. Another reason for making a strong recommendation, despite the limited evidence, is that this is a low-cost intervention that would be more likely to be needed in the context of LMICs where other fertility services are unaffordable or not available. But the intention of the recommendation is not to say that individuals or couples should use this intervention (e.g. if the cost is beyond their means). The GDG agreed that the benefits outweigh harms, noting that there are few to no harms if this intervention is provided with appropriate instructions. In addition, if an individual or a couple are unable to become pregnant within six months to one year of attempting during the fertile window, it would be suggested that they seek advice from their health-care provider. They may be advised to either continue trying or be assessed for a potential infertility diagnosis. Since there are so many possible reasons for infertility, the GDG expressed concern about the use of OPKs beyond one year, without this additional suggestion. Although a strong recommendation has been made, it should be noted that there is a clear need for more research in LMICs on this topic, and for a larger review comparing this to other interventions for couples seeking to become pregnant. One GDG member wished their reservations to be noted – that a strong recommendation was not supported by the evidence – but agreed to support the consensus decision.

Resource use

The GDG agreed that the intervention may increase costs and that costs may be borne by the user. It was noted that the cost of OPKs differs widely – from one month’s income on the minimum wage in Egypt to half a day’s income on the minimum wage in the Philippines – and that this may not be affordable. The GDG noted that OPKs seem fairly expensive, even in high-income countries.

Feasibility

The GDG agreed that the intervention is feasible.

Equity and human rights

This intervention has the potential to improve equity, but the GDG noted that there is uncertainty surrounding this reproductive health issue. High cost could limit access (depending on who covers these costs), which may increase inequity. Not being able to build a family through pregnancy may be a challenge for individuals, couples and their families. OPKs have the potential to improve human rights, but also the potential to be harmful if appropriate information is not included with this intervention. As with all interventions related to the decision to, or not to, become pregnant, the gender dimension needs to be carefully assessed: Who is blamed for lack of pregnancy? Who can access the intervention? In poor families where individuals and couples are using the intervention, if a pregnancy does not occur, there could be harm to the individuals (usually the woman) or in some societies even to the family. The GDG noted the potential for harm if there is coercion to use an OPK and that this might be minimized through education for individuals and couples on how the OPK could be used effectively with appropriate referral if pregnancy does not occur.

Acceptability of the intervention: values and preferences of end-users and health-care providers

The systematic review conducted for this topic also included a review of evidence on the values and preferences of end-users of OPKs. Seven articles reporting on six studies were included, all of which involved primary data collection, and the results were summarized qualitatively (31). Almost all end-users reported feeling satisfied with OPKs (i.e. they were viewed as easy to use and understand, convenient, accurate), as well as being comfortable and confident in their ability to use OPKs. They appreciated knowing more about their menstrual cycle and timing to attempt pregnancy, which decreased stress and enabled teamwork with their partner. However, those who do not become pregnant within a short time frame could become overdependent on any method of timing intercourse, including the use of OPKs, which could result in only planned coitus, and could foster obsession and doubt – especially if there is a lack of education or lack of referral to a health-care provider after six months or up to one year of trying. Most participants stated that they would use OPKs again in the future.

The GDG reviewed the evidence from the systematic review and concluded that there was minor variability in the available data on values and preferences among users. The GDG considered that from a consumer perspective, the intervention is viewed as empowering and useful.

Regarding acceptability among health-care providers, the GDG considered, based on their experience, that from a pharmacist perspective, a recommendation from WHO would give them more license to provide this intervention. The GDG concluded that there was minor variability in the acceptability of this intervention among health-care providers.

4.2.2. Existing recommendations on self-care with use of condoms and oral contraceptives

Existing recommendation on condoms

REC 13.

Consistent and correct use of male and female condoms is highly effective in preventing the sexual transmission of HIV; reducing the risk of HIV transmission both from men to women and women to men in serodiscordant couples; reducing the risk of acquiring other STIs and associated conditions, including genital warts and cervical cancer; and preventing unintended pregnancy.

Remarks

Existing recommendation on condoms for key populations9

REC 14.

The correct and consistent use of condoms with condom-compatible lubricants is recommended for all key populations to prevent sexual transmission of HIV and STIs.

(strong recommendation, moderate quality of evidence)

Remarks

  • This existing recommendation was integrated into this guideline from the 2014 WHO publication, Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations (33).
  • Other relevant recommendations (non-GRADE) and guidance mentioned in this guideline include:
    -

    Condoms and condom-compatible lubricants are recommended for anal sex.

    -

    Correct and consistent use of condoms and condom-compatible lubricants is recommended for sex workers and their clients.

    -

    It is important that contraceptive services are free, voluntary and non-coercive for all people from key populations.

  • Further information can be found in the original publication, available at: https://www.who.int/hiv/pub/guidelines/keypopulations/en/
9

See definition in Annex 4: Glossary.

Existing recommendations on the number of POP pill packs and COC pill packs that should be provided at initial and return visits

REC 15a.

Provide up to one year’s supply of pills, depending on the woman’s preference and anticipated use.

REC 15b.

Programmes must balance the desirability of giving women maximum access to pills with concerns regarding contraceptive supply and logistics.

REC 15c.

The re-supply system should be flexible, so that the woman can obtain pills easily in the amount and at the time she requires them.

Remarks

  • The GDG concluded that restricting the number of cycles of pills can result in unwanted discontinuation of the method and increased risk of pregnancy.
  • This existing recommendation and remark have been integrated into this guideline from the 2016 WHO publication, Selected practice recommendations for contraceptive use, third edition (34), available at: https://apps.who.int/iris/bitstream/handle/10665/252267/9789241565400-eng.pdf

i. Background

Family planning is essential to promoting the well-being and autonomy of individuals, couples, their families and their communities. Quality of care in family planning is paramount for ensuring progress towards achieving high standards of health for all. As defined in the WHO publication, Ensuring human rights in the provision of contraceptive information and services: guidance and recommendations, five elements of quality of care in family planning include:

  1. choice among a wide range of contraceptive methods;
  2. evidence-based information on the effectiveness, risks and benefits of different methods;
  3. technically competent, trained health workers;
  4. provider–user relationships based on respect for informed choice, privacy and confidentiality; and
  5. the appropriate constellation of services that are available in the same locality (35).

4.2.3. Additional existing guidance on self-care in family planning

Existing guidance on self-administered contraception

The WHO guidance Medical eligibility for contraceptive use (MEC) includes a range of contraceptive methods that are self-administered by users, including the combined contraceptive patch, the combined contraceptive vaginal ring, the progesterone-releasing vaginal ring (PVR) and barrier methods, including condoms (male latex, male polyurethane and female condoms), the diaphragm (with spermicide) and the cervical cap.

Regarding barrier methods, the MEC says:

If there is a risk of sexually transmitted infections (STIs), including HIV, then the correct and consistent use of condoms is recommended. When used correctly and consistently, condoms offer one of the most effective methods of protection against STIs, including HIV. Female condoms are effective and safe, but are not used as widely by national programmes as male condoms (6).

It is further noted that “Women with conditions that make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively higher typical-use failure rates.” The MEC provides further guidance on the use of barrier methods depending on the user’s personal characteristics and reproductive history, cardiovascular disease, rheumatic diseases, neurologic conditions, depressive disorders, reproductive tract infections and disorders, HIV/AIDS, other infections, endocrine conditions, gastrointestinal conditions, anaemias and drug interactions, as well as additional comments.

The MEC includes recommendations on the safety of combined hormonal contraceptives (CHCs, which include combined oral contraceptives, the combined contraceptive patch and the combined contraceptive vaginal ring) for those with particular medical conditions or personal characteristics. The MEC also includes recommendations on the safety of hormonal contraception (including the combined contraceptive patch and the combined contraceptive vaginal ring among others) for women at high risk of HIV infection, women living with HIV, and women living with HIV using antiretroviral therapy (ART) (6).

For further information, see Medical eligibility criteria for contraceptive use, fifth edition (2015), available at: https://www.who.int/reproductivehealth/publications/family_planning/MEC-5/en/

In addition the Selected practice recommendations for contraceptive use, third edition (2016), which provides essential guidance on how to provide family planning/contraception – including how to address user errors and manage side-effects – is available at: https://www.who.int/reproductivehealth/publications/family_planning/SPR-3/en/ (34).

Existing guidance on task sharing to improve access to family planning/contraception

To address the problem of poor access to family planning services due to inadequate numbers of health workers or their uneven distribution, “WHO recommends that family planning services and methods can be safely and effectively provided by different health worker cadres, under specified circumstances”, and this includes “user/self” (i.e. individual, client) among the cadres referred to in task shifting/sharing guidelines (36).

For further information, see Task sharing to improve access to family planning/contraception (2017), available at: https://www.who.int/reproductivehealth/publications/task-sharing-access-fp-contraception/en/ (36).

4.3. Eliminating Unsafe Abortion2

4.3.1. Existing recommendations on self-care in medical abortion and post-abortion contraception

Existing recommendations on self-management of the medical abortion process in the first trimester

Individuals have a role to play in managing their own health and this constitutes another important component of task sharing within health systems. Therefore, the following recommendations for specific components were made related to self-assessment and self-management approaches in contexts where pregnant individuals have access to appropriate information and to health services should they need or want them at any stage of the process.

REC 16.

Self-assessing eligibility [for medical abortion] is recommended in the context of rigorous research.

REC 17.

Managing the mifepristone and misoprostol medication without direct supervision of a health-care provider is recommended in specific circumstances. We recommend this option in circumstances where women have a source of accurate information and access to a health-care provider should they need or want it at any stage of the process.a

REC 18.

Self-assessing completeness of the abortion process using pregnancy testsb and checklists is recommended in specific circumstances. We recommend this option in circumstances where both mifepristone and misoprostol are being used and where women have a source of accurate information and access to a health-care provider should they need or want it at any stage of the process.

Remarks

  • Self-management and self-assessment approaches can be empowering and also represent a way of optimizing available health workforce resources and sharing of tasks.
  • These existing recommendations were integrated into this guideline from the 2015 WHO publication, Health worker roles in providing safe abortion care and post-abortion contraception (37).
  • Further information can be found in the original publication, available at: https://www.who.int/reproductivehealth/publications/unsafe_abortion/abortion-task-shifting/en/

Notes from the 2018 Medical management of abortion guideline:

a

As a general implementation consideration with reference to REC 17: “When using the combination mifepristone and misoprostol regimen, the medical abortion process can be self-managed for pregnancies up to 12 weeks of gestation, including the ability to take the medications at home, without direct supervision of a health-care provider; it should be noted that there was limited evidence for pregnancies beyond 10 weeks” (38).

b

Regarding pregnancy tests mentioned in REC 18: “Pregnancy tests used to self-assess the success of the abortion process are low-sensitivity urine pregnancy tests, which are different from those tests commonly used to diagnose pregnancy” (38).

i. Background on medical abortion and self-management

Medical abortion care encompasses the management of various clinical conditions including spontaneous and induced abortion (both viable and non-viable pregnancies), incomplete abortion and intrauterine fetal demise, as well as post-abortion contraception. Medical management of abortion generally involves either a combination regimen of mifepristone and misoprostol, or a misoprostol-only regimen. Medical abortion care plays a crucial role in providing access to safe, effective and acceptable abortion care. In both high- and low-resource settings, the use of medical methods of abortion have contributed to task shifting and sharing and more efficient use of resources. Moreover, many interventions in medical abortion care, particularly those in early pregnancy, can now be provided at the primary-care level and on an outpatient basis, which further increases access to care. Medical abortion care reduces the need for skilled surgical abortion providers and offers a non-invasive and highly acceptable option to pregnant individuals (38).

Furthermore, self-assessment and self-management approaches, as recommended in REC 16, 17 and 18 above, can be empowering for individuals and help to triage care, leading to a more optimal use of health-care resources.

Based on an updated review of the evidence, recommendations related to the timing, dosage, dosing intervals and routes of administration of medications to manage abortion, and also the timing of contraception initiation following a medical abortion, were published by WHO in 2018 in Medical management of abortion (38). However, the 2015 recommendations (see REC 16, 17 and 18) remain applicable, since the 2018 guideline focuses solely on the medication regimens.

Existing recommendations on post-abortion hormonal contraception initiation

REC 19.

Self-administering injectable contraceptives is recommended in specific circumstances. We recommend this option in contexts where mechanisms to provide the woman with appropriate information and training exist, referral linkages to a health-care provider are strong, and where monitoring and follow-up can be ensured.

REC 20.

For individuals undergoing medical abortion with the combination mifepristone and misoprostol regimen or the misoprostol-only regimen who desire hormonal contraception (oral contraceptive pills, contraceptive patch, contraceptive ring, contraceptive implant or contraceptive injections), we suggest that they be given the option of starting hormonal contraception immediately after the first pill of the medical abortion regimen.

Remarks

i. Background on post-abortion contraception and self-administration

Contraception can be initiated at the time of administration of the first pill of the medical abortion regimen or after assessment of successful medical abortion. All contraceptive options may be used. Criteria laid out in the WHO publications Medical eligibility criteria for contraceptive use and Ensuring human rights in the provision of contraceptive information and services should be adhered to (6, 35).

4.4. Combating Sexually Transmitted Infections (Including HIV), Reproductive Tract Infections, Cervical Cancer and Other Gynaecological Morbidities

4.4.1. New recommendations on self-sampling as part of cervical cancer screening and STI testing

New recommendation on human papillomavirus (HPV) self-sampling as part of cervical cancer screening services

REC 21 (NEW)

HPV self-sampling should be made available as an additional approach to sampling in cervical cancer screening services for individuals aged 30–60 years.

(strong recommendation, moderate-certainty evidence)

i. Background

Globally, cervical cancer is one of the most common types of cancer among women, and in LMICs, it is the leading cause of cancer deaths in women (39, 40). Cervical cancer develops from persistent infection with high-risk types of human papillomavirus (HPV) (41). Although there are vaccines that protect against infection and disease associated with specific types of HPV, many women do not have access to them and women still die of preventable cervical cancer (41). The two- to four-decade lag time between the peak of HPV infection and the peak of cervical cancer incidence provides an opportunity for cancer prevention (41). Secondary prevention measures include early detection and treatment of precancerous lesions. Population-based cervical cancer screening programmes have been successful in reducing cervical cancer incidence and mortality, especially in high-income settings with well organized programmes and good coverage and quality (42, 43). However, these programmes require an available and accessible screening test. Common tests include cervical cytology (Pap smear), visual inspection with acetic acid (VIA), and HPV testing.

Primary high-risk HPV testing is a relatively new method of secondary prevention for cervical cancer, with or without HPV immunization. A 2018 review found that self-collected HPV samples showed reasonably high diagnostic accuracy, compared with clinician samples (44). While HPVSS does not provide a diagnosis of cervical (pre-)cancer, it identifies women who are at higher risk. HPVSS has gained attention for its potential to increase participation in screening, especially due to the privacy afforded by this approach. Self-sampling requires an individual to obtain a kit, collect one’s own (cervico-)vaginal sample, and send the specimen to a laboratory where it is tested and then the results returned to the individual (45). Collection methods include lavage, brush, swab and vaginal patch. Using a kit, self-sampling can be conducted alone in private either at a health-care facility or elsewhere, and can be initiated either by health-care providers or by clients themselves.

ii. Summary of evidence and considerations for the new recommendation

The GDG determined to review the evidence on HPV self-sampling (HPVSS) for the development of this guideline. A systematic review and meta-analysis were conducted including studies that compared adult women using HPVSS with those receiving HPV testing through another modality, those receiving another cervical cancer screening test or those receiving no cervical cancer screening services (no intervention) (46). The PICO question was: For individuals aged 30–60 years, should HPV self-sampling be offered as an additional approach to sampling in cervical cancer screening services? Studies were included in the systematic review if they were published in a peer-reviewed journal (the search included publications in any language through October 2018) and reported on at least one of the following priority outcomes: uptake of cervical cancer screening services; frequency of cervical cancer screening; social harms or adverse events (e.g. device-related issues, coercion, violence, psychosocial harm, self-harm, suicide, stigma, discrimination), and whether these harms were corrected or had redress available; linkage to clinical assessment or treatment of cervical lesions following a positive self-test result (e.g. the percentage of those with a positive result who reach the next stage of management, such as positive diagnosis for HPV by a health-care provider) (see Annex 6 for further details on the PICOs). Inclusion was not restricted by location of the intervention.

Results

Thirty three studies (reported in 34 articles) with 369 017 total participants met the inclusion criteria for the systematic review: 29 RCTs and 4 observational studies (the latter comprised three prospective cohort studies and one cross-sectional study). Individual study sample sizes ranged from 63 to 36 390, with participants’ ages ranging from 18 to 70, but most often in the 30–60 age range. The studies were published between 2007 and 2018. Studies were primarily conducted in high-income countries (one article each in Argentina, Australia, Belgium, Slovenia and Switzerland; two each in England, Finland and Italy; three each in Canada, Denmark, France and the Netherlands; and four each in Sweden and the USA) – accounting for 93% of participants. One study each took place in Mexico, Nigeria and Uganda.

All studies examined HPVSS and the comparison groups used standard care (e.g. clinician-collected HPV testing, Pap smear, VIA). Most studies (n=24) sent HPVSS kits directly to participants’ home addresses, and six studies had health workers/research staff offer the kits door-to-door; with both of these approaches, recipients could simply opt out and not use the kits. Seven studies required participants to opt in to HPVSS by requesting a kit by phone, mail, text message or website, or by picking up a kit from a local pharmacy or health centre. In one study, participants self-collected samples for HPV testing at an HIV clinic. All 33 studies measured cervical cancer screening uptake, but follow-up periods ranged from immediately after being offered screening to 36 months, with half between 6 and 12 months. Five articles reported on linkage to clinical assessment or treatment of cervical lesions. None of the included articles reported comparative data on screening frequency or social harms/adverse events.

Evidence from 29 RCTs suggests HPVSS, especially if implemented using an opt-out strategy, is generally associated with increased uptake of cervical cancer screening services, regardless of country income classification, setting, supervision, socioeconomic status or age. Specifically, meta-analysis of the effect sizes from all 29 RCTs found that women were twice as likely to use cervical cancer screening services through HPVSS compared with standard care (RR: 2.13, 95% CI: 1.89–2.40).

Effect size varied by strategy used to disseminate the HPVSS kits, whether mailed directly to home addresses (RR: 2.27, 95% CI: 1.89–2.71), offered door-to-door (RR: 2.37, 95% CI: 1.12–5.03), or provided upon request (RR: 1.28, 95% CI: 0.90–1.82). Six RCTs using opt-out dissemination methods (mail or door-to-door) reported on linkage to clinical assessment or treatment following a positive test result. Meta-analysis showed that there was probably no difference in this outcome between the intervention and control group participants (RR: 1.12, 95% CI: 0.80–1.57) (46).

Certainty of the evidence for the recommendation

This recommendation is based on moderate-certainty evidence. The risk of bias in the 29 RCTs was generally low. It was not possible to blind participants and personnel to HPVSS versus standard care, but most outcomes were not likely to be influenced by lack of blinding.

Rationale for the strength and direction of the recommendation

The GDG agreed that the benefits of this intervention outweighed harms, and made a strong recommendation in favour of it, by consensus.

Resource use

Total programme costs increase as detection increases (since the intervention reaches a larger number of people), but per cervical lesion detected, it likely reduces hospital treatment costs and improves outcomes, and so the intervention may be cost-effective over time, considering both costs to the health system and to the patient. The kit itself is only part of the cost of the same service if provided at a health-care facility. This intervention significantly reduces the burden on health-care providers in overburdened settings. Cost-effectiveness must be contingent on effective linkage to care; data on this aspect are almost all from high-income countries.

Feasibility

The GDG agreed that the intervention is feasible. Previous research provides some information on this subject. Four systematic reviews of RCTs in the context of population-based screening programmes showed that offering high-risk HPVSS to never- and under-screened women increased participation compared with inviting women to have samples taken by health-care providers (44, 47, 48, 49). Unfortunately, in many countries, standard cervical cancer screening tests are not universally or even widely available: while almost 81% of countries have cervical cancer screening policies and strategies, only 48% have an operational plan with funding (50). The magnitude of this public health problem necessitates innovative approaches to support individuals, families and communities. Reaching more people at risk of cervical cancer with HPV testing, including women living with HIV who have higher risk of HPV infection and cervical cancer, is critical (51).

Equity and human rights

The GDG agreed that this intervention has the potential to improve equity all along the cascade, in particular through targeting and reaching those who are not currently accessing cervical cancer screening services, since access to care is a major factor in increasing equity. The GDG also noted that linkage to care is key – supportive services must be in place. A variety of interventions need to be available to achieve equity (e.g. a strategy of mailing kits to a home address will not work for homeless people; Internet-based strategies will not reach those without access to the Internet). In communities where sex outside of marriage is unacceptable, this intervention will provide a lot of unmarried individuals with a chance to get screened. Engagement in care is critical and more studies are needed on this aspect; clear research is needed on different ways to engage individuals in HPVSS for cervical cancer screening and to link them to appropriate services as required (e.g. door to door, mobile phones), keeping low-resource settings in mind. The GDG noted that the body of research has included women with vulnerabilities. The GDG expressed concerns about quality assurance and accountability, especially with regard to online access or researchers mailing test kits out to people. Also, this intervention could negatively affect equity if it is available online to people in high-income countries but not available to those in low-income countries who lack Internet access. An enabling environment for this intervention is needed to increase equity and to avoid potential unintended consequences.

Acceptability of the intervention: values and preferences of end-users and health-care providers

A review was conducted of the available evidence on values and preferences in relation to HPVSS as a method of cervical cancer screening among end-users and health-care providers, including 75 studies from a variety of countries from all WHO regions and all World Bank income classification categories. Almost all studies were cross-sectional surveys, but study designs also included in-depth interviews and focus groups. The findings indicate high acceptability for HPVSS among women in general, who tended to prefer HPVSS over HPV sampling by a health-care provider, citing privacy, convenience, time and effort saved, cost-effectiveness, ease, comfort (including decreased embarrassment, pain and anxiety), speed, safety and user-friendliness. Some concerns were expressed in relation to accuracy and reliability, but these concerns often diminished after repeated use. Respondents generally found kit directions easy to understand, and were comfortable with multiple devices used for HPVSS. Factors that increased the likelihood of HPVSS use among respondents included previous Pap testing, high perceived risk of cervical cancer, willingness to self-sample for HPV, high HPV knowledge, and giving high value or priority to cost-saving and/or time-saving. A small proportion of respondents preferred clinician-based cervical cancer screening regardless of the benefits of self-sampling, citing trust and confidence in provider services, and concerns about accuracy and reliability of HPVSS. Some generational differences were noted among end-users. Health-care providers saw HPVSS as a mechanism for encouraging more people to return to the health system.

The GDG considered the findings of the review and concluded that there was minor variability in values and preferences among end-users and potential end-users, and also concluded that there was minor variability in acceptability of the intervention among health-care providers.

New recommendation on self-collection of samples for STI testing

REC 22a (NEW)

Self-collection of samples for Neisseria gonorrhoeae and Chlamydia trachomatis should be made available as an additional approach to deliver STI testing services.

(strong recommendation, moderate-certainty evidence)

REC 22b (NEW)

Self-collection of samples for Treponema pallidum (syphilis) and Trichomonas vaginalis may be considered as an additional approach to deliver STI testing services.

(conditional recommendation, low-certainty evidence)

Remarks

  • Please also refer to an existing recommendation below on HIV self-testing (REC 23).

i. Background

Globally, every year, there are an estimated 357 million new infections of four curable sexually transmitted infections (STIs): chlamydia, gonorrhoea, syphilis and trichomoniasis (52, 53). Etiological diagnosis via STI testing is the best way to determine infection status and appropriate treatment (54, 55). While STI diagnostic tests are in use in many high-income countries, they are largely unavailable in LMICs (54, 56, 57, 58), where syndromic management is the primary approach for STI treatment (56, 59). While practical, the syndromic approach has significant limitations (56, 60, 61). Social stigma and a lack of effective policies also affect the uptake of STI testing and treatment worldwide. Low coverage of STI testing and high transmission rates are common among at-risk vulnerable adolescents and key populations, including men who have sex with men (MSM), migrants, sex workers, indigenous and minority populations, and those affected by humanitarian emergencies (60).

Greater efforts are needed to expand STI testing services globally, and self-collection of samples (SCS) is one way to facilitate this. SCS means that individuals take a specimen themselves, either at a health-care facility or elsewhere, and send it to a laboratory for testing (45), and the laboratory returns the result to the individual. Follow-up in the case of positive test results requires linking the individual with the health system. In high-income countries, where laboratory facilities and health care are widely available, research shows that self-collected STI samples are as accurate as clinician-collected samples (62), and that SCS is feasible and acceptable in a variety of populations (63). SCS approaches can also potentially address some barriers that often prevent people from seeking STI testing from a health-care provider or clinic, such as concerns about autonomy, inconvenience, stigma and lack of privacy (56, 64, 65).

ii. Summary of evidence and considerations for the new recommendation

For the development of this guideline, the GDG determined to investigate whether self-collection of samples (SCS) should be made available as an additional approach to deliver STI testing services. A systematic review was conducted, for which the PICO question was: For individuals using STI testing services, should self-collection of samples (SCS) be offered as an additional approach to deliver STI testing services? Studies were included if they compared people using SCS for STI testing with people using another mode of STI sample collection or no STI testing (no intervention), and if they were published in a peer-reviewed journal (in any language, through 18 July 2018), and reported on at least one of the following outcomes of interest: uptake of STI testing services; frequency of STI testing; social harms or adverse events (e.g. device-related issues, coercion, violence, psychosocial harm, self-harm, suicide, stigma, discrimination, frequency of HIV testing), and whether these harms were corrected or had redress available; case-finding (proportion of people who tested positive for an STI); linkage to clinical assessment or STI treatment following a positive test result; and reported sexual risk behaviour (see Annex 6 for further details on the PICOs). No restrictions were placed based on the location of the intervention, but studies were excluded if they compared STI SCS interventions delivered in one location versus another (e.g. SCS at home versus at a clinic) (63).

SCS for STI testing differs from self-testing, where individuals not only take the sample themselves but also perform the test and interpret the test results. Since self-testing is still under development for STIs other than HIV, the review focused on SCS for STIs, though self-testing was included if available. The review assessed SCS for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Treponema pallidum (syphilis) and Trichomonas vaginalis (trichomoniasis or TV). This is in line with ongoing multicountry evaluations of promising point-of-care testing (POCT) interventions to detect these four STIs, as well as the goal of the WHO STI POCT initiative to achieve universal access to reliable and affordable STI testing (66). SCS methods included first-void urine, vaginal flush using saline, and pharyngeal, rectal, urethral and vaginal swabs.

Results

Eleven studies, published in 11 articles between 1998 and 2018, were included in the review (five RCTs and six observational studies, including four serial cross-sectional and two cross-sectional). Ten of the studies were included in the meta-analyses. All 11 studies (with 202 745 participants in total) were conducted in high-income countries: two in Australia, three in Denmark and six in the USA. Three studies focused on NG and CT; two studies on NG, CT and TV; five studies on CT alone; and one study did not specify which bacterial STIs were covered. No studies compared findings for syphilis. The studies varied in location of self-collection (i.e. three clinic-based studies and eight home-based studies) as well as target population (i.e. general population, MSM, people living with HIV, adolescents and young people, detainees, people who inject drugs, sex workers, and partners of CT-positive patients).

All five RCTs and three observational studies reported some measure of uptake of STI testing services. Regarding the secondary outcome, case finding, four RCTs and five observational studies reported comparisons of STI test positivity rate comparing participants who self-collected samples with those whose samples were collected by a clinician. No studies compared the impact of SCS to clinician-collection of samples on the following outcomes: frequency of STI testing, social harms or adverse events, linkage to clinical assessment or STI treatment following a positive test result, and reported sexual risk behaviour.

The meta-analysis of the five RCTs found that programmes offering SCS increased overall uptake of STI testing services by almost three times, compared with clinician collection of samples (RR: 2.941, 95% CI: 1.188–7.281). The findings of the observational studies were similar. Meta-analysis of two observational studies testing for multiple STIs (CT and NG, and NG and TV) found a non-significant relative risk of 2.990. A third observational study, which could not be combined in meta-analysis, found that after implementing an “express clinic” with self-collection of genital and rectal samples at a large sexual health clinic, a total of 5335 patients were seen (at the express and main clinics) compared with 4804 patients seen through the prior routine STI testing services.

With regard to case finding, meta-analysis of four RCTs reporting on this (all of which measured CT only) found effects in opposite directions depending on the sensitivity analysis used. When all enrolled study participants were included in the calculation, meta-analysis found that the likelihood of receiving a positive test result doubled among those using SCS compared with the control group (RR: 2.166, 95% CI: 1.043–4.498). However, when the denominator was limited to only people who ultimately provided samples for STI testing, the association went in the opposite direction (RR: 0.718, 95% CI: 0.585–0.882). The observational studies generally showed no difference in case finding between SCS and clinician-collection groups, regardless of which group was used in the denominator for the meta-analyses, and regardless of which specific STI or combination of STIs were being tested for (63).

Certainty of the evidence for the recommendation

Recommendation 22a was based on moderate-certainty evidence while Recommendation 22b was based on low-certainty evidence. Risk of bias was deemed moderate in the RCTs. With regard to selection bias, one RCT used date of birth to randomize participants, while two did not specify the randomization method used. Given the nature of the intervention, blinding was impossible and may have biased performance. Four RCTs did not report on the blinding of the laboratory personnel conducting the STI testing. The observational studies were judged to have high risk of bias. None of the observational studies clearly controlled for confounders.

Rationale for the strength and direction of the recommendation

The GDG agreed that the benefits of this intervention outweigh the harms, and made a strong recommendation in favour of the intervention.

Resource use

The GDG concluded that this intervention may decrease future costs, but that costs may be borne by users.

Feasibility

The GDG concluded that this intervention is feasible.

Equity and human rights

The GDG agreed that this intervention has the potential to improve equity, but the group cautioned about the potential for coercion.

Acceptability of the intervention: values and preferences of end-users and health-care providers

A literature review on values and preferences related to SCS for STI testing was conducted, including 112 studies, presentations and conference abstracts. STIs assessed included CT, NG, syphilis and trichomoniasis. Study locations included countries in all WHO regions except the Eastern Mediterranean Region, but the location was not specified in 11 articles. The populations studied included females, males and key populations (including young people, MSM, female sex workers and people who inject drugs). Six articles included health-care providers as a study population. Seventy-nine articles used quantitative methods (including one RCT), 20 used qualitative methods and 8 used mixed methods. Findings suggest high acceptability of SCS for STI testing (high satisfaction, comfort, ease, privacy, convenience, and confidence – especially after the experience), though some participants mentioned pain, discomfort and concerns about safety. Pooled data from 36 articles indicated that 85% of patients found the method to be acceptable, and findings were similar in other studies also. Pooled data from 28 articles indicated that 88% of participants found SCS to be “very easy”, “easy” or “not difficult” to perform, and findings were similar in other studies also. Pain and discomfort were each generally reported by approximately 13% of users, regardless of SCS method or gender of user. Privacy and safety were the most common concerns related to SCS. The most common reasons for refusing the intervention were lack of time or inconvenience, discomfort or dislike of the process or method, perception of not being at risk of an STI, having recently been tested, and current menstruation. Prohibitive costs, confidentiality, not wanting to know their STI diagnosis, and general lack of time were also mentioned, as well as a proportion who reported fears without specifying them.

As described in Chapter 1, section 1.9, a Global Values and Preferences Survey (GVPS) was also conducted among health-care providers and potential end-users on their values and preferences in relation to this and other interventions covered by new recommendations in this guideline. The relevant findings from the GVPS are presented in the box below. In summary, the findings were generally similar to the literature review with regard to users’ decision-making factors. However, although over 80% of end-users knew about STI self-sampling, and almost half knew where they could access it, only about 11% had ever used it. Many health-care providers wanted more training or information about this intervention, and their top two concerns about it were incorrect use by patients and worry that the patient will not access health care if/when needed.

The GDG considered the evidence from the literature review and the GVPS and concluded there was minor variability in the evidence on end-users’ values and preferences, as well as minor variability in acceptability among health-care providers.

Global Values and Preferences Survey (GVPS) Findings on Self-Collection of Samples (SCS) for STI Testing

End-users and potential end-users

When asked whether they had heard of self-sampling or self-collection of samples (SCS) for STI testing, 46.5% (n=360 of 775 respondents) knew what this was and where to access it, 36.1% (n=280) knew what it was but did not know how to access it, and 17.4% (n=135) did not know what it was. For those who responded to questions regarding their use or their partner’s use of SCS for STIs (n=708), approximately two thirds (66.7%; n=472) had never used SCS for STI testing, 8.2% (n=58) had previously used it, 3.0% (n=21) had used in the past three months, and 22.2% (n=157) reported not having a need for SCS for STI testing. Among those responding to this question (n=437), the option of privacy and confidentiality was the most important factor (62.9%, n=275), with convenience (45.3%, n=198) and access (45.3%, n=198) as the next most important factors. Not feeling judged (36.2%, n=158) and feeling empowered (27.7%, n=121) were also important factors in choosing to use SCS for STI testing.

Participants in the Global North were significantly more likely to have heard of SCS for STI testing than those in the Global South, and participants in the Global South were more likely to report that this intervention was not relevant for themselves/their partners. Participants who were younger than 50 years old were more likely to report having used the intervention than participants aged 50 and over. There were no gender differences in these responses.

In reviewing all responses to open-ended questions on the topic of SCS for STI testing, there was general support for this intervention, with reasons including convenience, cost-effectiveness and empowerment. The topic of linkage to care frequently came up in discussion of this intervention. As a 41-year-old woman from Kenya stated, “if it is a self-test that is positive, then it would be very important to have a health provider”, with another woman (USA, 52 years old) going as far as to say “if positive, should be an automatic link to a local provider or some sort of affordable access to a provider with an ability to retest and provide treatments (antiretrovirals, abortion, fertility interventions)”. However, there were those who felt that being given the tools to interpret the results for themselves because “having to seek a provider to understand the results negates the advantage of self-testing” explains another 52-year-old woman from the USA. Lastly, concerns about SCS for STI testing arose with respect to existing barriers, with stigma being cited as a major concern about this intervention.

For respondents who indicated that they accessed SCS for STI testing (n=621), 46.5% (n=289) would go to the doctor or health clinic, 18.7% (n=116) would go to the pharmacy, and 6.3% (n=39) would buy it online. In addition, 20.3% of respondents (n=126) indicated not knowing where to get the intervention, and 20.6% (n=128) indicated not needing it. For SCS for STI testing (n=440), 59.8% (n=263) asked their doctor or health care provider, 44.1% (n=194) went online, 13% (n=57) asked friends and community, and 22% (n=97) have not received information on this.

Health-care providers

Of health-care providers who replied to questions regarding SCS for STI testing (n=307), one third (32.6%, n=100) had provided a referral, prescription or information on the intervention, while 35.8% (n=110) had not. For 15.6% (n=48) of respondents, SCS for STI testing is not available where they live, and for 19.5% (n=60), it is not relevant to their job. Regarding their information and confidence levels regarding SCS for STI testing, of those who replied (n=295), one third (34.2%, n=101) felt confident and informed. Nearly half of respondents (49.2%, n= 145) reported needing more information and 21.7% (n=64) reported needing training to provide this service. For those who responded about SCS for STI testing (n=222), 57.2% (n=127) expressed concern about patients not seeking health care if needed, and 53.6% (n=119) expressed concern about misuse by patient. In addition, 25.7% (n=57) had concerns about safety and 24.3% (n=54) indicated concerns about the quality of product.

Among health-care providers responding to questions about the benefits of SCS for STI testing (n=231), more than two thirds (64.1%, n=148) reported convenience, 61.5% (n=142) reported it removed barriers, and 48.5% (n=112) reported it is empowering. Other benefits included reduction of health-care provider workload (44.6%, n=103) and affordability (30.3%, n=70).

4.4.2. Existing recommendations on self-care and self-testing for HIV

Existing recommendation on HIV self-testing

REC 23.

HIV self-testing should be offered as an additional approach to HIV testing services.

(strong recommendation, moderate-quality evidence)

Remarks

Existing recommendation on women living with HIV

REC 24.

For women living with HIV, interventions on self-efficacy and empowerment around sexual and reproductive health and rights should be provided to maximize their health and fulfil their rights.

(strong recommendation, low quality evidence)

Remarks

i. Background

HIV self-testing (HIVST) has been shown to be an empowering, discreet and highly acceptable option for many users, including key populations, men, young people, health workers, pregnant women and their male partners, couples and general population groups. HIVST represents another forward step in line with efforts to increase patient autonomy, decentralize services and create demand for HIV testing among those not reached by existing services (69).

4.5. Promoting Sexual Health

There are no new or existing recommendations in this area in relation to self-care for SRHR. Nevertheless, relevant existing WHO guidance is provided below.

4.5.1. Existing guidance on self-care in relation to intimate partner violence and sexual violence

Information in the Consolidated guideline on sexual and reproductive health and rights of women living with HIV (2017) highlights that self-care can be inhibited by the negative psychological outcomes of violence, and also states the following.

Social norms and taboos related to sexual orientation, sexual identity, gender, sexual health, sexuality and reproductive health create a culture of shame, blame and silence. Women living with HIV in such contexts can feel isolated and may internalize negative perceptions, leading to mental health problems such as depression and the neglect of self-care. In addition, the lack of confidential and non-judgemental health care services is a barrier for women living with HIV to obtain information and commodities, and to feel supported in expressing their SRH needs and concerns. Safe spaces (both within health-care facilities and social services) and confidential and stigma-free environments can encourage women living with HIV to access the services they need (68).

The 2014 WHO guidance, Health care for women subjected to intimate partner violence or sexual violence: a clinical handbook, includes a plan for self-care after sexual assault, including care of injuries and prevention of STIs (see Box 4.1), and guidance for strengthening positive coping methods after a violent event (see Box 4.2) (70).

BOX 4.1Plan for Self-Care after Sexual Assault

Explain your examination findings and treatment

Discuss the examination findings with the survivor of the assault, the health implications, and any treatments provided. Invite any questions and concerns. Respond in detail and check the survivor’s understanding.

Care of injuries

  • Teach the survivor how to care for any injuries.
  • Describe the signs and symptoms of wound infection—warm, red, painful, or swollen wound; blood or pus; bad smell; fever. Recommend a follow-up visit to a health-care provider if these signs develop.
  • Explain the importance of completing the course of any medications given, particularly antibiotics. Discuss any likely side-effects and what to do about them.

Prevention of STIs

  • Discuss the signs and symptoms of STIs, including HIV. Recommend a follow-up visit for treatment if any signs or symptoms occur.
  • Ask the survivor to refrain from sexual intercourse until all treatments or prophylaxis for STIs have finished. Encourage the use of condoms during sexual intercourse, at least until STI/HIV status has been determined at the 3- or 6-month visit.

Follow-up

  • Plan follow-up visits at 2 weeks, 1 month, 3 months and 6 months after the assault.

Source: adapted from WHO, 2014 (70).

BOX 4.2Strengthening Positive Coping Methods after a Violent Event

After a violent event, the survivor may find it difficult to return to a normal routine. Encourage small and simple steps. Talk about her life and activities. Discuss and plan together, giving reassurance that things will likely get better over time.

Encourage survivors to

  • build on strengths and abilities, and coping methods used in difficult situations in the past
  • continue normal activities, especially ones that used to be interesting or pleasurable
  • engage in relaxing activities to reduce anxiety and tension
  • keep a regular sleep schedule and avoid sleeping too much
  • engage in regular physical activity
  • avoid using self-prescribed medications, alcohol or illegal drugs to try to feel better
  • recognize thoughts of self-harm or suicide and come back as soon as possible for help if they occur
  • return for a follow-up visit if these suggestions are not helping.

Source: adapted from WHO, 2014 (70).

The publication also includes a relevant guiding principle: “Self-determination – being entitled to make their own decisions including sexual and reproductive decisions; entitled to refuse medical procedures and/or take legal action”.

Finally, the guidance provides advice for self-care for health-care providers, reminding them that their needs are as important as those of the people they care for, and that they themselves may have strong reactions or emotions when discussing violent incidents with clients, especially if the provider themself has experienced violence or abuse: “Be aware of your emotions and take the opportunity to understand yourself better. Be sure to get the help and support you need for yourself” (70).

4.5.2. Existing guidance on sexuality education

The 2018 UNESCO publication, International technical guidance on sexuality education: an evidence-informed approach, provides a new definition (see Annex 4: Glossary) and description of comprehensive sexuality education (CSE), emphasizing that this is a process to empower children and young people. The guidance presents key considerations for understanding the evolving field of CSE. Taken as a whole, that publication constitutes the recommended set of CSE topics, as well as guidance on effective delivery (71).

The section on delivering effective CSE programmes includes 14 recommendations on effective curriculum development (see summary table on p. 93 of the guidance), 10 recommendations on designing and implementing CSE programmes (see summary table on p. 97), 3 recommendations on monitoring and evaluation of CSE programmes, and 10 key principles for scaling up CSE (see p. 99) (71).

4.5.3. Existing guidance on sexuality

The 2018 WHO publication, Brief sexuality-related communication: recommendations for a public health approach, mentions, but does not provide a recommendation on, assessing self-efficacy/self-esteem.

The key study regarding adolescents that supports this recommendation is a study in Washington DC that used the Awareness, Skills, Self-efficacy/Self-esteem, and Social Support (ASSESS) Programme. It advocates “increasing adolescent awareness about sexual risks, skills to avoid risky sexual situations, self-efficacy (such as a feeling that peer pressure can be resisted), and social support (such that adolescents felt encouraged by the physician)” (72).

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Footnotes

1

Further information available at: http://www​.familyplanning2020.org/

2

To the full extent of the law, safe abortion services should be readily available and affordable to all women. Self-management approaches reflect an active extension of health systems and health care. These recommendations are NOT an endorsement of clandestine self-use by women without access to information or a trained health-care provider/health-care facility as a backup. All women should have access to health services should they want or need it.

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