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 up 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% relative increasein 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.
Highlights
Women living in sub Saharan Africa (SSA) face an unacceptably high risk of maternal mortality, with an estimated mortality ratio of >500 per 100,000 live births[1,2]
Several recent meta-analyses have found 40–50% increased risks of HIV acquisition among women using DMPA IM compared to women not using hormonal contraception[5,6]; sparse data are available for other methods including implants and IUDs
The World Health Organization (WHO) recently changed its guidance for women at high risk of HIV infection using injectable progestogens from a medical eligibility criteria (MEC) category 1 to a MEC category 27
Summary
Women living in sub Saharan Africa (SSA) face an unacceptably high risk of maternal mortality, with an estimated mortality ratio of >500 per 100,000 live births[1,2]. These women are at substantial risk of HIV infection. An increasing number of in vitro, animal, biological and observational clinical studies have raised the possibility that hormonal contraception ( DMPA IM) may increase a woman’s risk of HIV acquisition. Animal, biological and observational clinical studies suggest that some hormonal methods, depot medroxyprogesterone acetate – DMPA, may increase women’s risk of HIV acquisition.
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