Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

Summary

The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.

Timeline

Start

2019-01-14

Primary completion

2021-09-09

Completion

2021-09-09

Publications

• Friedland BA, Browne EN, Roberts ST, Ngure K, Nakalega R, Macdonald P, Mpongo CN, Tenza S, Mhlanga N, Szydlo D, Johnson S, McClure T, Nair G, Celum C, Hillier SL, van der Straten A; MTN-034 REACH clinical trial team. Higher Acceptability of the Monthly Dapivirine Ring Versus Daily Oral Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa in the REACH Trial. J Acquir Immune Defic Syndr. 2025 Dec 15;100(5):415-424. doi: 10.1097/QAI.0000000000003756.
• Shapley-Quinn MK, Tenza S, Jensen D, Tauya T, Mampuru L, Etima J, Kemigisha D, Atujuna M, Soto-Torres L, Johnson S, Mpongo N, Mhlanga N, Ngure K, van der Straten A. Adolescent Girls and Young Women Overcoming Adherence Challenges with Vaginal and Oral PrEP Use: A Longitudinal Qualitative Study from a Crossover Trial in South Africa, Uganda, and Zimbabwe. AIDS Behav. 2024 Dec;28(12):4209-4223. doi: 10.1007/s10461-024-04503-y. Epub 2024 Sep 30.
• Nair G, Celum C, Szydlo D, Brown ER, Akello CA, Nakalega R, Macdonald P, Milan G, Palanee-Phillips T, Reddy K, Tahuringana E, Muhlanga F, Nakabiito C, Bekker LG, Siziba B, Hillier SL, Baeten JM, Garcia M, Johnson S, McClure T, Levy L, Livant E, Jacobson C, Soto-Torres L, van der Straten A, Hosek S, Rooney JF, Steytler J, Bunge K, Parikh U, Hendrix C, Anderson P, Ngure K; REACH Protocol Team. Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial. Lancet HIV. 2023 Dec;10(12):e779-e789. doi: 10.1016/S2352-3018(23)00227-8. Epub 2023 Oct 25.
• Young AM, Mancuso N, Atujuna M, Tenza S, Chitukuta M, Kemigisha D, Ngure K, van der Straten A, Garcia M, Szydlo D, Soto-Torres L, Roberts ST. Adolescent Girls and Young Women's Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis. AIDS Behav. 2023 Dec;27(12):3941-3951. doi: 10.1007/s10461-023-04109-w. Epub 2023 Jul 1.

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Indications