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Chou R, Cantor A, Bougatsos C, et al. Screening for HIV in Pregnant Women: Systematic Review to Update the U.S. Preventive Services Task Force Recommendation [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. (Evidence Syntheses, No. 96.)

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Screening for HIV in Pregnant Women: Systematic Review to Update the U.S. Preventive Services Task Force Recommendation [Internet].

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APPENDIX ADETAILED METHODS

Appendix A1. Search Strategies

All Key Questions

Database: EBM Reviews - Cochrane Database of Systematic Reviews

  1. hiv.ti.
  2. limit 1 to full systematic reviews
  3. antiretroviral.mp. [mp=title, short title, abstract, full text, keywords, caption text]
  4. haart.mp. [mp=title, short title, abstract, full text, keywords, caption text]
  5. 3 or 4
  6. 2 and 5
  7. screen$.mp. [mp=title, short title, abstract, full text, keywords, caption text]
  8. 2 and 7
  9. test$.mp. [mp=title, short title, abstract, full text, keywords, caption text]
  10. 2 and 9
  11. 6 or 8 or 10
  12. limit 11 to last 8 years
  13. pregnan$.mp. [mp=title, short title, abstract, full text, keywords, caption text]
  14. 12 and 13

Key Questions 1, 2a, and 2b

Database: Ovid MEDLINE(R) without Revisions

  1. exp AIDS Serodiagnosis/
  2. exp HIV Seronegativity/
  3. exp HIV Antigens/
  4. exp HIV/
  5. exp HIV Seroprevalence/
  6. exp HIV Seropositivity/
  7. exp HIV Antibodies/
  8. or/2–7
  9. exp Mass Screening/
  10. 8 and 9
  11. 1 or 10
  12. (hiv adj1 screen$).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  13. 11 or 12
  14. 13 and (200406$ or 200407$ or 200408$ or 200409$ or 20041$ or 2005$ or 2006$ or 2007$ or 2008$ or 2009$ or 2010$ or 2011$).ed.
  15. limit 14 to English language
  16. limit 14 to abstracts
  17. 15 or 16
  18. limit 17 to humans
  19. Pregnancy/
  20. pregnan$.mp.
  21. 19 or 20
  22. 18 and 21

Database: EBM Reviews - Cochrane Central Register of Controlled Trials

  1. exp AIDS Serodiagnosis/
  2. exp HIV Seronegativity/
  3. exp HIV Antigens/
  4. exp HIV/
  5. exp HIV Seroprevalence/
  6. exp HIV Seropositivity/
  7. exp HIV Antibodies/
  8. or/2–7
  9. exp Mass Screening/
  10. 8 and 9
  11. 1 or 10
  12. (hiv adj1 screen$).mp. [mp=title, original title, abstract, mesh headings, heading words, keyword]
  13. 11 or 12
  14. limit 13 to yr=“2004 -Current”
  15. Pregnancy/
  16. 14 and 15

Key Question 3a

Database: Ovid MEDLINE(R) without Revisions

  1. Antiretroviral Therapy, Highly Active/
  2. haart.mp.
  3. 1 or 2
  4. Anti-HIV Agents/
  5. 3 or 4
  6. Infectious Disease Transmission, Vertical/
  7. HIV Infections/tm [Transmission]
  8. 6 or 7
  9. 5 and 8
  10. Pregnancy/
  11. 9 and 10
  12. limit 11 to English language
  13. limit 11 to abstracts
  14. 12 or 13
  15. limit 14 to yr=“2004 -Current”

Database: EBM Reviews - Cochrane Central Register of Controlled Trials

  1. Antiretroviral Therapy, Highly Active/
  2. haart.mp.
  3. 1 or 2
  4. Anti-HIV Agents/
  5. 3 or 4
  6. Infectious Disease Transmission, Vertical/
  7. HIV Infections/tm [Transmission]
  8. 6 or 7
  9. 5 and 8
  10. Pregnancy/
  11. 9 and 10
  12. limit 11 to yr=“2004 -Current”

Key Question 3b and 3c

Database: Ovid MEDLINE(R) without Revisions

  1. Antiretroviral Therapy, Highly Active/
  2. Anti-HIV Agents/
  3. haart.mp.
  4. or/1–3
  5. Pregnancy/
  6. 4 and 5
  7. limit 6 to yr=“2004 - Current”
  8. limit 7 to English language
  9. limit 7 to abstracts
  10. 8 or 9
  11. 10 not (letter or editorial or comment or case reports).pt.

Database: EBM Reviews - Cochrane Central Register of Controlled Trials

  1. Antiretroviral Therapy, Highly Active/
  2. Anti-HIV Agents/
  3. haart.mp.
  4. or/1–3
  5. Pregnancy/
  6. 4 and 5
  7. limit 6 to yr= “2004 -Current”

Appendix A2. Inclusion and Exclusion Criteria per Key Question

IncludeExclude
All Key Questions
SettingsPrimary care or other settings generalizable to primary care (e.g., family planning clinics, school-based health clinics), other health care settings in which screening is commonly performed (e.g., emergency room or urgent care). Focus on studies conducted in the United States and other developed countries, except for randomized trials of antiretroviral therapies (Africa).Developing countries, unless fair- or good-quality trials and studies in the United States are lacking
Key Question 1: What are the benefits of HIV screening vs. no screening in asymptomatic pregnant women on maternal or child morbidity, mortality, or quality of life or rates of mother-to-child transmission?
PopulationsAsymptomatic pregnant women; neonates, infants, and children who were exposed to ART in uteroKnown HIV infection, on dialysis, post-transplant, occupational exposure
InterventionsRapid or standard HIV testing
ComparisonsHIV screening versus no screening
OutcomesMother-to-child transmission rates of HIV, mortality related to HIV infection, and quality of life for mothers and their newbornsPharmacokinetics
Study designsRandomized, controlled trials and controlled observational studiesModeling studies
Key Question 2a: What is the yield of repeat HIV screening in asymptomatic pregnant women?
PopulationsAsymptomatic pregnant womenKnown HIV infection, on dialysis, post-transplant, occupational exposure
InterventionsRapid or standard HIV testing
ComparisonsRepeat HIV screening during pregnancy versus one-time screening, or screening at one interval versus another interval
OutcomesNumber of positive test results
Study designsRandomized, controlled trials and controlled observational studiesModeling studies
Key Question 2b: What are the adverse effects (including false-positive results and anxiety) of rapid vs. standard HIV testing in asymptomatic pregnant women?
PopulationsAsymptomatic pregnant womenKnown HIV infection, on dialysis, post-transplant, occupational exposure
InterventionsRapid or standard HIV testing
ComparisonsRapid versus standard HIV testing
OutcomesFalse-positive results, anxiety, and effects of labeling; partner discord, abuse, or violence
Study designsRandomized, controlled trials and comparative observational studiesModeling studies
Key Question 3a: What is the effectiveness of newer antiretroviral regimens for reducing mother-to-child transmission?
PopulationsPregnant women with HIV; neonates and infants who were exposed to antiretroviral regimens in uteroWomen already or previously on ART prior to pregnancy; acute HIV or HIV subtypes
InterventionsNewer antiretroviral regimensDiscontinuing ART during pregnancy; treatment interruption
ComparisonsNewer antiretroviral regimens versus placebo, older antiretroviral regimens, or one another
OutcomesMother-to-child transmission rates of HIV
Study designsRandomized, controlled trials and controlled observational studiesModeling studies
Key Question 3b: What are the effects of antiretroviral regimens in pregnant, HIV-positive women on long-term maternal morbidity, mortality, or quality of life?
PopulationsWomen who were on antiretroviral regimens while pregnantWomen already or previously on ART prior to pregnancy; acute HIV or HIV subtypes
InterventionsNewer antiretroviral regimensDiscontinuing ART during pregnancy; treatment interruption
ComparisonsNewer antiretroviral regimens versus placebo, older antiretroviral regimens, or one another
OutcomesLong-term maternal morbidity, mortality, or quality of lifePharmacokinetics
Study designsAny
TimingOne or more years after giving birthLess than 1 year after giving birth
Key Question 3c: What are the harms (including longer-term harms) to the mother or child associated with antiretroviral therapy during pregnancy?
PopulationsWomen who were on antiretroviral regimens while pregnant; neonates, infants, and children who were exposed to antiretroviral therapy in uteroWomen already or previously on antiretroviral therapy prior to pregnancy; acute HIV or HIV subtypes
InterventionsNewer antiretroviral regimensDiscontinuing antiretroviral therapy during pregnancy; treatment interruption
ComparisonsNewer antiretroviral regimens versus placebo, older antiretroviral regimens, or one another
OutcomesHarmful effects on pregnancy outcomes, neonatal outcomes, or effects on exposed children; long-term cardiovascular and metabolic maternal outcomesPharmacokinetics
Study designsAny
TimingAny

Appendix A3. Literature Flow Diagram

Appendix A3 is a flow chart that summarizes the search and selection of articles related to HIV screening in pregnant women. Citations were identified through bibliographic databases, including MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews, as well as through other sources, including experts and reference lists. There were 1,636 abstracts of potentially relevant articles reviewed. After excluding 1,249 abstracts and titles and articles from other sources that were not relevant to key questions, 387 full-text articles were retrieved for further review. A total of 344 full-text articles were excluded for the following reasons: wrong population (69), wrong intervention (32), wrong outcome (84), wrong study design for key question (30), no original data (106), out of scope (10), sample size too small (8), and systematic review, not directly included (5). For key question 1, no studies were included. For key question 2a, no studies were included. For key question 2b, 2 studies were included. For key question 3a, 10 studies were included. For key question 3b, no studies were included. For key question 3c, 27 studies were included, specifically 11 studies on preterm/other birth outcomes, 3 studies on mitochrondrial effects, 4 studies on congenital abnormalities, 2 studies on infant neurodevelopment, 5 studies on other infant harms, and 2 studies on maternal harms.

* Cochrane databases include the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews.

Other sources include reference lists, suggestions from peer reviewers.

Some articles are included for more than one key question.

Appendix A4. Excluded Studies List

Wrong Population

  • Alrajhi A, Edathodu J, Halim M, Dahham M. Mother-to-child transmission of HIV: experience at a referral hospital in Saudi Arabia. Ann Saudi Med. 2010;30:15–7. [PMC free article: PMC2850177] [PubMed: 20103953]
  • Aluisio A, Richardson BA, Bosire R, John-Stewart G, Mbori-Ngacha D, Farquhar C. Male antenatal attendance and HIV testing are associated with decreased infant HIV infection and increased HIV-free survival. J Acquir Immune Defic Syndr. 2011;56(1):76–82. [PMC free article: PMC3005193] [PubMed: 21084999]
  • Asavapiriyanont S, Kasiwat S. Prevalence of low birthweight infants in HIV-infected women delivered in Rajavithi Hospital. J Med Assoc Thai. 2011;94(Suppl 2):S66–70. [PubMed: 21717881]
  • Azcoaga-Lorenzo A, Ferreyra C, Alvarez A, Palma PP, Velilla E, del Amo J. Effectiveness of a PMTCT programme in rural Western Kenya. AIDS Care. 2011;23(3):274–80. [PubMed: 21347890]
  • Becker S, Mlay R, Schwandt HM, Lyamuya E. Comparing couples’ and individual voluntary counseling and testing for HIV at antenatal clinics in Tanzania: a randomized trial. AIDS Behav. 2010;14(3):558–66. [PubMed: 19763813]
  • Betancourt TS, Abrams EJ, McBain R, Fawzi MC. Family-centred approaches to the prevention of mother to child transmission of HIV. J Int AIDS Soc. 2010;13(2) [PMC free article: PMC2890971] [PubMed: 20573284]
  • Black V, Hoffman RM, Sugar CA, Menon P, Venter F, Currier JS, et al. Safety and efficacy of initiating highly active antiretroviral therapy in an integrated antenatal and HIV clinic in Johannesburg, South Africa. J Acquir Immune Defic Syndr. 2008;49(3):276–81. [PMC free article: PMC2893046] [PubMed: 18845949]
  • Black V, von Mollendorf CE, Moyes JA, Scott LE, Puren A, Stevens WS. Poor sensitivity of field rapid HIV testing: implications for mother-to-child transmission programme. BJOG. 2009;116(13):1805–8. [PubMed: 19781042]
  • Boer K, Nellen JF, Patel D, Timmermans S, Tempelman C, Wibaut M, et al. The AmRo study: pregnancy outcome in HIV-1-infected women under effective highly active antiretroviral therapy and a policy of vaginal delivery. BJOG. 2007;114(2):148–55. [PubMed: 17305888]
  • Bracher L, Valerius NH, Rosenfeldt V, Herlin T, Fisker N, Nielsen H, et al. Long-term effectiveness of highly active antiretroviral therapy (HAART) in perinatally HIV-infected children in Denmark. Scand J Infect Dis. 2007;39(9):799–804. [PubMed: 17701719]
  • Briand N, Le Coeur S, Traisathit P, Karnchanamayul V, Hansudewechakul R, Ngampiyasakul C, et al. Growth of human immunodeficiency virus-uninfected children exposed to perinatal zidovudine for the prevention of mother-to-child human immunodeficiency virus transmission. Pediatr Infect Dis J. 2006;25(4):325–32. [PubMed: 16567984]
  • Bussmann H, Wester CW, Wester CN, Lekoko B, Okezie O, Thomas AM, et al. Pregnancy rates and birth outcomes among women on efavirenz-containing highly active antiretroviral therapy in Botswana. J Acquir Immune Defic Syndr. 2007;45(3):269–73. [PubMed: 17450102]
  • Casula M, Bosboom-Dobbelaer I, Smolders K, Otto S, Bakker M, de Baar MP, et al. Infection with HIV-1 induces a decrease in mtDNA. J Infect Dis. 2005;191(9):1468–71. [PubMed: 15809905]
  • Casula M, Weverling GJ, Wit FW, Timmermans EC, Stek M, Lange JM, et al. Mitochondrial DNA and RNA increase in peripheral blood mononuclear cells from HIV-1-infected patients randomized to receive stavudine-containing or stavudine-sparing combination therapy. J Infect Dis. 2005;192(10):1794–800. [PubMed: 16235179]
  • Chama C, Gashau W, Oguche S. The value of highly active antiretroviral therapy in the prevention of mother-to-child transmission of HIV. J Obstet Gynaecol. 2007;27(2):134–7. [PubMed: 17454457]
  • Chatterjee A, Bosch RJ, Kupka R, Hunter DJ, Msamanga GI, Fawzi WW. Predictors and consequences of anaemia among antiretroviral-naive HIV-infected and HIV-uninfected children in Tanzania. Public Health Nutr. 2010;13(2):289–96. [PMC free article: PMC3775572] [PubMed: 19650963]
  • Chi BH, Sinkala M, Stringer EM, Cantrell RA, Mtonga V, Bulterys M, et al. Early clinical and immune response to NNRTI-based antiretroviral therapy among women with prior exposure to single-dose nevirapine. AIDS. 2007;21(8):957–64. [PMC free article: PMC2745970] [PubMed: 17457089]
  • Ching N, Deville JG, Nielsen KA, Ank B, Wei LS, Sim MS, et al. Cellular and humoral immune responses to a tetanus toxoid booster in perinatally HIV-1-infected children and adolescents receiving highly active antiretroviral therapy (HAART) Eur J Pediatr. 2007;166(1):51–6. [PubMed: 16868780]
  • Ciaranello AL, Perez F, Maruva M, Chu J, Engelsmann B, Keatinge J, et al. WHO 2010 guidelines for prevention of mother-to-child HIV transmission in Zimbabwe: modeling clinical outcomes in infants and mothers. PLoS One. 2011;6(6):e20224. [PMC free article: PMC3107213] [PubMed: 21655097]
  • Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, et al. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor–based viral suppression. JAMA. 2010;304(10):1082–90. [PMC free article: PMC4540068] [PubMed: 20823434]
  • Coovadia HM, Brown ER, Fowler MG, Chipato T, Moodley D, Manji K, et al. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. Lancet. 2012;379(9812):221–8. [PMC free article: PMC3539769] [PubMed: 22196945]
  • Dabis F, Elenga N, Meda N, Leroy V, Viho I, Manigart O, et al. 18-Month mortality and perinatal exposure to zidovudine in West Africa. AIDS. 2001;15(6):771–9. [PubMed: 11371692]
  • Danel C, Moh R, Anzian A, Abo Y, Chenal H, Guehi C, et al. Tolerance and acceptability of an efavirenz-based regimen in 740 adults (predominantly women) in West Africa. J Acquir Immune Defic Syndr. 2006;42(1):29–35. [PubMed: 16763490]
  • Darin N, Oldfors A, Moslemi A-R, Holme E, Tulinius M. The incidence of mitochondrial encephalomyopathies in childhood: Clinical features and morphological, biochemical, and DNA abnormalities. Ann Neurol. 2001;49(3):377–83. [PubMed: 11261513]
  • Davies MA, Moultrie H, Eley B, Rabie H, Van Cutsem G, Giddy J, et al. Virologic failure and second-line antiretroviral therapy in children in South Africa--the IeDEA Southern Africa collaboration. J Acquir Immune Defic Syndr. 2011;56(3):270–8. [PMC free article: PMC3104241] [PubMed: 21107266]
  • Dryden-Peterson S, Shapiro RL, Hughes MD, Powis K, Ogwu A, Moffat C, et al. Increased risk of severe infant anemia after exposure to maternal HAART, Botswana. J Acquir Immune Defic Syndr. 2011;56(5):428–36. [PMC free article: PMC3112252] [PubMed: 21266910]
  • Ekouevi DK, Coffie PA, Becquet R, Tonwe-Gold B, Horo A, Thiebaut R, et al. Antiretroviral therapy in pregnant women with advanced HIV disease and pregnancy outcomes in Abidjan, Cote d’Ivoire. AIDS. 2008;22(14):1815–20. [PubMed: 18753864]
  • Ekouevi DK, Coffie PA, Ouattara E, Moh R, Amani-Bosse C, Messou E, et al. Pregnancy outcomes in women exposed to efavirenz and nevirapine: an appraisal of the IeDEA West Africa and ANRS Databases, Abidjan, Cote d’Ivoire. J Acquir Immune Defic Syndr. 2011;56(2):183–7. [PMC free article: PMC3045727] [PubMed: 21084995]
  • Farquhar C, Kiarie JN, Richardson BA, Kabura MN, John FN, Nduati RW, et al. Antenatal couple counseling increases uptake of interventions to prevent HIV-1 transmission. J Acquir Immune Defic Syndr. 2004;37(5):1620–6. [PMC free article: PMC3384734] [PubMed: 15577420]
  • Geddes R, Giddy J, Butler LM, Van Wyk E, Crankshaw T, Esterhuizen TM, et al. Dual and triple therapy to prevent mother-to-child transmission of HIV in a resource-limited setting--lessons from a South African programme. S Afr Med J. 2011;101(9):651–4. [PubMed: 21920158]
  • Gumbo FZ, Kandawasvika GQ, Duri K, Mapingure MP, Kurewa NE, Nathoo K, et al. Reduced HIV transmission at subsequent pregnancy in a resource-poor setting. Trop Doct. 2011;41(3):132–5. [PMC free article: PMC3128383] [PubMed: 21576348]
  • Herman JS, Easterbrook PJ. The metabolic toxicities of antiretroviral therapy. Int J STD AIDS. 2001;12(9):555–64. [PubMed: 11516363]
  • Hernandez S, Moren C, Lopez M, Coll O, Cardellach F, Gratacos E, et al. Perinatal outcomes, mitochondrial toxicity and apoptosis in HIV-treated pregnant women and in-utero-exposed newborn. AIDS. 2012;26(4):419–28. [PubMed: 22156962]
  • Hughes CA, Zuk D, Foisy M, Robinson J, Singh AE, Houston S. Prenatal screening and perinatal HIV transmission in Northern Alberta, 1999–2006. Am J Public Health. 2009;99(2) [PMC free article: PMC4504366] [PubMed: 19372528]
  • Jackson JB, Musoke P, Fleming T, Guay LA, Bagenda D, Allen M, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003;362(9387):859–68. [PubMed: 13678973]
  • Jao J, Palmer D, Leus I, Tih P, Baweja M, Klotman M, et al. Prevalence and predictors of proteinuria in HIV-infected and uninfected pregnant women in Cameroon. Nephrol Dial Transplant. 2011;26(9):3051–3. [PubMed: 21719713]
  • Joseph O, Biodun O, Michael E. Pregnancy outcome among HIV positive women receiving antenatal HAART versus untreated maternal HIV infection. J Coll Physicians Surg Pak. 2011;21(6):356–9. [PubMed: 21711992]
  • Jungmann EM, Mercey D, DeRuiter A, Edwards S, Donoghue S, Booth T, et al. Is first trimester exposure to the combination of antiretroviral therapy and folate antagonists a risk factor for congenital abnormalities? Sex Transm Infect. 2001;77(6):441–3. [PMC free article: PMC1744398] [PubMed: 11714944]
  • Khalsa A, Karim R, Mack W, Minkoff H, Cohen M, Young M, et al. Hypertension in HIV-infected Women Related to HAART: Women’s Interagency HIV Study. 11th Conference on Retroviruses and Opportunistic Infections; 2004. Abstract 741.
  • Kiarie JN, Kreiss JK, Richardson BA, John-Stewart GC. Compliance with antiretroviral regimens to prevent perinatal HIV-1 transmission in Kenya. AIDS. 2003;17(1):65–71. [PMC free article: PMC3387271] [PubMed: 12478070]
  • Leroy V, Karon JM, Alioum A, Ekpini ER, van de Perre P, Greenberg AE, et al. Postnatal transmission of HIV-1 after a maternal short-course zidovudine peripartum regimen in West Africa. AIDS. 2003;17(10):1493–501. [PubMed: 12824787]
  • Lindsey JC, Malee KM, Brouwers P, Hughes MD. Neurodevelopmental functioning in HIV-infected infants and young children before and after the introduction of protease inhibitor-based highly active antiretroviral therapy. Pediatrics. 2007;119(3):e681–93. [PubMed: 17296781]
  • Lopez-Vilchez MA, Guxens Junyent M, Mur Mila E, Mur Sierra A. HIV-mother-to-child transmission in a tertiary hospital in the era of generalization of preventive interventions [Spanish] Med Clin (Barc) 2009;132(13):487–94. [PubMed: 19345962]
  • Machado ES, Hofer CB, Costa TT, Nogueira SA, Oliveira RH, Abreu TF, et al. Pregnancy outcome in women infected with HIV-1 receiving combination antiretroviral therapy before versus after conception. Sex Transm Infect. 2009;85:82–7. [PMC free article: PMC2864649] [PubMed: 18987014]
  • Matida LH, Santos NJS, Ramos AN Jr, Gianna MC, da Silva MH, Domingues CSB, et al. Eliminating vertical transmission of HIV in Sao Paulo, Brazil: progress and challenges. J Acquir Immune Defic Syndr. 2011;57(Suppl 3):S164–70. [PubMed: 21857313]
  • Miura T, Goto M, Hosoya N, Odawara T, Kitamura Y, Nakamura T, et al. Depletion of mitochondrial DNA in HIV-1-infected patients and its amelioration by antiretroviral therapy. J Med Virol. 2003;70(4):497–505. [PubMed: 12794710]
  • Moodley D, Esterhuizen TM, Pather T, Chetty V, Ngaleka L. High HIV incidence during pregnancy: compelling reason for repeat HIV testing. AIDS. 2009;23(10):1255–9. [PubMed: 19455017]
  • Myers JJ, Modica C, Dufour MS, Bernstein C, McNamara K. Routine rapid HIV screening in six community health centers serving populations at risk. J Gen Intern Med. 2009;24(12):1269–74. [PMC free article: PMC2787931] [PubMed: 19655204]
  • Ndirangu J, Newell ML, Tanser F, Herbst AJ, Bland R. Decline in early life mortality in a high HIV prevalence rural area of South Africa: evidence of HIV prevention or treatment impact? AIDS. 2010;24(4):593–602. [PMC free article: PMC4239477] [PubMed: 20071975]
  • Onyeador N, Patel D, Lyall H. Renal tubular dysfunctionassociated wiht tenofovir-based HAART in perinatally acquired HIV: the need for paediatric formulations and pharmacokinetic studies. HIV Med. 2008;9(Supplement 1):26 (P61).
  • Ouyang DW, Shapiro DE, Lu M, Brogly SB, French AL, Leighty RM, et al. Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure. AIDS. 2009;23(18):2425–30. [PMC free article: PMC2783653] [PubMed: 19617813]
  • Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, et al. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010;363(16):1510–20. [PMC free article: PMC3021781] [PubMed: 20942667]
  • Parekh N, Ribaudo H, Souda S, Chen J, Mmalane M, Powis K, et al. Risk factors for very preterm delivery and delivery of very-small-for-gestational-age infants among HIV-exposed and HIV-unexposed infants in Botswana. Int J Gynaecol Obstet. 2011;115(1):20–5. [PubMed: 21767835]
  • Patel K, Ming X, Williams PL, Robertson KR, Oleske JM, Seage GR 3rd, et al. Impact of HAART and CNS-penetrating antiretroviral regimens on HIV encephalopathy among perinatally infected children and adolescents. AIDS. 2009;23(14):1893–901. [PMC free article: PMC2821205] [PubMed: 19644348]
  • Peixoto MF, Pilotto JH, Stoszek SK, Kreitchmann R, Mussi-Pinhata MM, Melo VH, et al. Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities. Braz J Infect Dis. 2011;15(3):253–61. [PubMed: 21670927]
  • Phanuphak N, Apornpong T, Intarasuk S, Teeratakulpisarn S, Phanuphak P. Toxicities from nevirapine in HIV-infected males and females, including pregnant females with various CD4 cell counts. 12th Conference on Retroviruses and Opportunistic Infections; 2005. Abstract 21.
  • Powis KM, Smeaton L, Ogwu A, Lockman S, Dryden-Peterson S, van Widenfelt E, et al. Effects of in utero antiretroviral exposure on longitudinal growth of HIV-exposed uninfected infants in Botswana. J Acquir Immune Defic Syndr. 2011;56(2):131–8. [PMC free article: PMC3023002] [PubMed: 21124227]
  • Ramautarsing RA, van der Lugt J, Gorowara M, Kerr SJ, Burger D, Ruxrungtham K, et al. Thai HIV-1-infected women do not require a dose increase of lopinavir/ritonavir during the third trimester of pregnancy. AIDS. 2011;25(10):1299–303. [PubMed: 21516029]
  • Semrau K, Kuhn L, Vwalika C, Kasonde P, Sinkala M, Kankasa C, et al. Women in couples antenatal HIV counseling and testing are not more likely to report adverse social events. AIDS. 2005;19(6):603–9. [PMC free article: PMC1201374] [PubMed: 15802979]
  • Singh HK, Gupte N, Kinikar A, Bharadwaj R, Sastry J, Suryavanshi N, et al. High rates of all-cause and gastroenteritis-related hospitalization morbidity and mortality among HIV-exposed Indian infants. BMC Infect Dis. 2011;11:193. [PMC free article: PMC3161884] [PubMed: 21762502]
  • Szyld E, Warley E, Freimanis L, Gonin R, Cahn P, Calvet GA, et al. Maternal antiretroviral drugs during pregnancy and infant low birth weight and preterm birth. AIDS. 2006;20:2345–53. [PubMed: 17117021]
  • Theron GB, Shapiro DE, Van Dyke R, Cababasay MP, Louw J, Watts DH, et al. Rapid intrapartum or postpartum HIV testing at a midwife obstetric unit and a district hospital in South Africa. Int J Gynaecol Obstet. 2011;113(1):44–9. [PMC free article: PMC3087603] [PubMed: 21251654]
  • Uusimaa J, Remes AM, Rantala H, Vainionpaa L, Herva R, Vuopala K, et al. Childhood encephalopathies and myopathies: a prospective study in a defined population to assess the frequency of mitochondrial disorders. Pediatrics. 2000;105(3):598–603. [PubMed: 10699115]
  • van der Merwe K, Hoffman R, Black V, Chersich M, Coovadia A, Rees H. Birth outcomes in South African women receiving highly active antiretroviral therapy: a retrospective observational study. J Int AIDS Soc. 2011;14:42. [PMC free article: PMC3163172] [PubMed: 21843356]
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Wrong Intervention

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  • Bae WH, Wester C, Smeaton LM, Shapiro RL, Lockman S, Onyait K, et al. Hematologic and hepatic toxicities associated with antenatal and postnatal exposure to maternal highly active antiretroviral therapy among infants. AIDS. 2008;22(13):1633–40. [PMC free article: PMC2664540] [PubMed: 18670224]
  • Baroncelli S, Pinnetti C, Genovese O, Tamburrini E, Floridia M. Hematological effects of zidovudine prophylaxis in newborn infants with and without prenatal exposure to zidovudine. J Med Virol. 2011;83(3):551–6. [PubMed: 21264878]
  • Boer K, Smit C, van der Flier M, de Wolf F. group Acs. The comparison of the performance of two screening strategies identifying newly-diagnosed HIV during pregnancy. Eur J Public Health. 2011;21(5):632–7. [PubMed: 21051473]
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  • Chibwesha CJ, Giganti MJ, Putta N, Chintu N, Mulindwa J, Dorton BJ, et al. Optimal time on HAART for prevention of mother-to-child transmission of HIV. J Acquir Immune Defic Syndr. 2011;58(2):224–8. [PMC free article: PMC3605973] [PubMed: 21709566]
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  • European Collaborative Study. Bailey H, Townsend C, Cortina-Borja M, Thorne C. Insufficient antiretroviral therapy in pregnancy: missed opportunities for prevention of mother-to-child transmission of HIV in Europe. Antivir Ther. 2011;16(6):895–903. [PMC free article: PMC3428867] [PubMed: 21900722]
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  • McIntyre JA, Martinson N, Grey GE, Team TI. Single-dose nevirapine combined with a short course of combivir for prevention of mother to child transmission of HIV-1 can significantly decrease the subsequent development of maternal and infant resistant virus. Antivir Ther. 2005;10(Suppl 1):S4.
  • Money DM, Khoo D, MacDonald G. A comparison of toxicity in nevirapine vs protease inhibitor-containing HAART regimens in pregnant women. 12th Conference on Retroviruses and Opportunistic Infections; 2005. Abstract 784.
  • Omer SB. Six Week Extended Dose Nevirapine Study T. Twelve-month follow-up of six week extended dose nevirapine randomized controlled trials: differential impact of extended-dose nevirapine on mother-to-child transmission and infant death by maternal CD4 cell count. AIDS. 2011;25(6):767–76. [PubMed: 21330912]
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Wrong Outcome

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  • Beitune PE, Duarte G, Foss MC, Montenegro RM, Spara P, Quintana SM, et al. Effect of antiretroviral agents on carbohydrate metabolism in HIV-1 infected pregnant women. Diabetes Metab Res Rev. 2006;22(1):59–63. [PubMed: 16021650]
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Wrong Study Design for Key Question

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No Original Data

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Out of Scope

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Sample Size Too Small

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Systematic Review, Not Directly Used

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Appendix A5. U.S. Preventive Services Task Force Quality Rating Criteria

Diagnostic Accuracy Studies

Criteria

  • Screening test relevant, available for primary care, adequately described
  • Study uses a credible reference standard, performed regardless of test results
  • Reference standard interpreted independently of screening test
  • Handles indeterminate results in a reasonable manner
  • Spectrum of patients included in study
  • Sample size
  • Administration of reliable screening test
  • Random or consecutive selection of patients
  • Screening cutoff pre-determined
  • All patients undergo the reference standard

Definition of ratings based on above criteria

Good:Evaluates relevant available screening test; uses a credible reference standard; interprets reference standard independently of screening test; reliability of test assessed; has few or handles indeterminate results in a reasonable manner; includes large number (more than 100) broad-spectrum patients with and without disease; study attempts to enroll a random or consecutive sample of patients who meet inclusion criteria screening cutoffs pre-stated.
Fair:Evaluates relevant available screening test; uses reasonable although not best standard; interprets reference standard independent of screening test; moderate sample size (50 to 100 subjects) and a “medium” spectrum of patients (i.e. applicable to most screening settings).
Poor:Has important limitation such as: uses inappropriate reference standard; screening test improperly administered; biased ascertainment of reference standard; very small sample size of very narrow selected spectrum of patients.

Randomized Controlled Trials (RCTs) and Cohort Studies

Criteria

  • Initial assembly of comparable groups: RCTs—adequate randomization, including concealment and whether potential confounders were distributed equally among groups; cohort studies—consideration of potential confounders with either restriction or measurement for adjustment in the analysis; consideration of inception cohorts
  • Maintenance of comparable groups (includes attrition, cross-overs, adherence, contamination)
  • Important differential loss to followup or overall high loss to followup
  • Measurements: equal, reliable, and valid (includes masking of outcome assessment)
  • Clear definition of interventions
  • Important outcomes considered
  • Analysis: adjustment for potential confounders for cohort studies, or intention-to-treat analysis for RCTs; for cluster RCTs, correction for correlation coefficient

Definition of ratings based on above criteria

Good:Meets all criteria: Comparable groups are assembled initially and maintained throughout the study (followup at least 80 percent); reliable and valid measurement instruments are used and applied equally to the groups; interventions are spelled out clearly; important outcomes are considered; and appropriate attention to confounders in analysis.
Fair:Studies will be graded “fair” if any or all of the following problems occur, without the important limitations noted in the “poor” category below: Generally comparable groups are assembled initially but some question remains whether some (although not major) differences occurred in followup; measurement instruments are acceptable (although not the best) and generally applied equally; some but not all important outcomes are considered; and some but not all potential confounders are accounted for.
Poor:Studies will be graded “poor” if any of the following major limitations exists: Groups assembled initially are not close to being comparable or maintained throughout the study; unreliable or invalid measurement instruments are used or not applied at all equally among groups (including not masking outcome assessment); and key confounders are given little or no attention.

Source: Harris R, Helfand M, Woolf SH, et al. Current methods of the U.S. Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20(3S):21–35.

Appendix A6. Expert Reviewers of the Draft Report

Marc Bulterys, MD, MPH, PhD

Director, Centers for Disease Control and Prevention, Global AIDS Program - China

Timothy Dondero, MD

Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention

Laurie Zephyrin, MD

National Director for Reproductive Health, Department of Veterans Affairs

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