Format

Send to

Choose Destination
Gates Open Res. 2017 Dec 29;1:17. doi: 10.12688/gatesopenres.12775.1.

Rationale and design of a multi-center, open-label, randomised clinical trial comparing HIV incidence and contraceptive benefits in women using three commonly-used contraceptive methods (the ECHO study).

Author information

1
Effective Care Research Unit, Universities of Witwatersrand and Fort Hare, Eastern Cape Department of Health, East London, South Africa.
2
Global Health, Population and Nutrition, FHI 360, Durham, NC, USA.
3
Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.
4
Department of Obstetrics and Gynaecology, University of Zimbabwe, Harare, Zimbabwe.
5
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
6
University of Nairobi, Nairobi, Kenya.
7
Ghent University, Ghent, Belgium.
8
International Centre for Reproductive Health (ICRH), Mombasa, Kenya.
9
Kenya Medical Research Institute, Nairobi, Kenya.
10
Department of Global Health, University of Washington, Seattle, WA, USA.
11
Wits RHI, University of the Witwatersrand, Johannesburg, South Africa.
12
World Health Organization, Geneva, Switzerland.
#
Contributed equally

Abstract

BACKGROUND:

In vitro, animal, biological and observational clinical studies suggest that some hormonal methods, particularly depot medroxyprogesterone acetate - DMPA, may increase women's risk of HIV acquisition. DMPA is the most common contraceptive used in many countries worst affected by the HIV epidemic. To provide robust evidence for contraceptive decision-making among women, clinicians and planners, we are conducting the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study in four countries with high HIV incidence and DMPA use: Kenya, South Africa, Swaziland, and Zambia (Clinical Trials.gov identifier NCT02550067).

STUDY DESIGN:

We randomized HIV negative, sexually active women 16-35 years old requesting effective contraception and agreeing to participate to either DMPA, the copper T 380A intrauterine device or levonorgestrel implant. Participants attend a contraception support visit after 1 month and quarterly visits thereafter for 12 to 18 months. Participants receive a standard HIV prevention package and contraceptive side-effect management at each visit. The primary outcome is HIV seroconversion. Secondary outcomes include pregnancy, serious adverse events and method discontinuation. The sample size of 7800 women provides 80% power to detect a 50% difference in HIV risk between any of the three method pairs, assuming 250 incident infections per comparison. Ethical considerations: Several WHO consultations have concluded that current evidence on HIV risk associated with DMPA is inconclusive and that a randomized trial is needed to guide policy, counselling and choice. Previous studies suggest that women without a specific contraceptive preference are willing to accept randomization to different contraceptive methods. Stringent performance standards are monitored by an independent data and safety monitoring board approximately every 6 months. The study has been conducted with extensive stakeholder engagement.

CONCLUSIONS:

The ECHO study is designed to provide robust evidence on the relative risks (HIV acquisition) and benefits (pregnancy prevention) between three effective contraceptive methods.

KEYWORDS:

DMPA; HIV acquisition; IUD; contraception; effectiveness; implants; randomized trial

Supplemental Content

Full text links

Icon for PubMed Central
Loading ...
Support Center