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dc.contributor.authorHofmeyr, G. Justus
dc.contributor.authorMorrison, Charles S.
dc.contributor.authorBaeten, Jared
dc.contributor.authorChipato, Tsungai
dc.contributor.authorDonnell, Deborah
dc.contributor.authorGichangi, Peter
dc.contributor.authorMugo, Nelly
dc.contributor.authorNanda, Kavita
dc.contributor.authorRees, Helen
dc.contributor.authorSteyn, Petrus
dc.contributor.authorTaylor, Douglas
dc.date.accessioned2021-06-08T11:46:04Z
dc.date.available2021-06-08T11:46:04Z
dc.date.issued2017-12-29
dc.identifier.urihttps://ir.tum.ac.ke/handle/123456789/17418
dc.description.abstractBackground: 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.en_US
dc.language.isoenen_US
dc.publisherGates foundationen_US
dc.subjectcontraceptionen_US
dc.subjectHIV acquisitionen_US
dc.subjecteffectivenessen_US
dc.subjectrandomized trialen_US
dc.subjectDMPAen_US
dc.subjectIUDen_US
dc.subjectimplantsen_US
dc.titleRationale 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) [version 1; peer review: 2 approved]en_US
dc.typeArticleen_US


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