| Study Objectives: |
Primary Objective
To compare the risks of HIV acquisition between women randomised to DMPA, LNG implant, and copper IUDs
Secondary Objectives
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To compare pregnancy rates among women randomised to DMPA, LNG implant, and copper IUDs
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To compare rates of serious adverse events among women randomised to DMPA, LNG implant, and copper IUDs
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To compare rates ofadverse events that lead tomethod discontinuation among women randomised to DMPA, LNG implant, and copper IUDs
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To compare contraceptive method continuation rates among women randomisedto DMPA, LNG implant, and copper IUDs
Tertiary Objectives
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To evaluate whether age modifies the hormonal contraception and HIV acquisition relationship
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To evaluate whether HSV-2 status modifies the hormonal contraception and HIV acquisition relationship
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To evaluate early HIV disease progression among seroconvertersrandomisedto DMPA, LNG implant, and copper IUDs
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| Abstract of Study: |
Abstract (300 words):
Introduction: Hormonal forms of contraception, are used by >150 million women worldwide. Some epidemiologic studies conducted in a variety of contexts have suggested that women using some types of hormonal contraceptives may be at increased risk of HIV acquisition; however, the results across multiple studies have been mixed, with some studies demonstrating increased HIV risk but others not showing increased HIV risk. The best way to address this uncertainty and provide clear policy guidance is with evidence from a large, well designed, randomised clinical trial.
Objectives: The main objective of this study is to compare the risks of HIV acquisition between women randomised to depot medroxyprogesterone acetate (DMPA), levonorgestrel (LNG) implant, and copper intrauterine device (IUD).
Methods: We aim to conduct an open-label, 3 armed randomised clinical trial in 12 sites across east and southern Africa comparing DMPA, LNG implant, and copper IUDs. This research design will greatly reduce many of the important limitations to the current body of observational evidence, including selection bias and many confounding factors whether known or unknown. In East Africa, the only site will be the KEMRI-RCTP study centre at Lumumba health centre in Kisumu County. The Lumumba study site will enrol approximately 1000 sexually active, HIV-negative women, 16-35 years old, seeking effective contraception, willing to be randomised to any of the study arms, and not desiring pregnancy for the duration of study participation. Participants will be randomly allocated to one of three study arms in a 1:1:1 ratio: DMPA, LNG implant, copper IUD. Participants will be followed for upto 18 months per woman or until closure of the study or study site
Anticipated results: This study has the potential to address the hormonal contraceptive uncertainty among senior policy makers in countries that are highly dependent on injectable progestins and have high HIV prevalence. Results from this study will permit clear guidance for policymakers and programs, clearly formulated counselling messages, and ultimately allow women to make informed choices. Failure to undertake this research will leave a critical public health question unanswered.
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