drugset / Trial / NCT02732730
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
Phase 4
Completed
451 enrolled
HIV Prevention Trials Network
Gilead Sciences · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
Timeline
- Start
- 2016-10-12
- Primary completion
- 2018-10-25
- Completion
- 2018-10-25
Publications
- Magongo M, Mhlanga N, Nobanda S, Chasakara C, Yola N, Hinson K, Bryan M, Mzizi P, Essien T, Hastings N, Ndimande-Khoza MN, Bekker LG, Mgodi N, Celum C, Delany-Moretlwe S. Engagement of adolescent girls and young women into an early oral PrEP open-label study in Southern Africa: lessons learned from HPTN 082. BMC Public Health. 2025 Nov 17;25(1):3982. doi: 10.1186/s12889-025-24890-8.
- Ssemambo PK, Burton M, Mirembe BG, Nakabiito C, Donnell D, Beauchamp G, Delany-Moretlwe S, Celum C, Velloza J. Correlates of long-acting reversible contraceptive (LARC) use among young women in Southern Africa: a secondary analysis from HPTN 082. medRxiv [Preprint]. 2025 Sep 18:2025.09.16.25335943. doi: 10.1101/2025.09.16.25335943.
- Magongo M, Mhlanga N, Nobanda S, Chasakara C, Yola N, Hinson K, Bryan M, Mzizi P, Essien T, Hastings N, Ndimande-Khoza MN, Bekker LG, Mgodi N, Celum C, Delany-Moretlwe S. Recruitment of Adolescent Girls and Young Women into an Early Oral PrEP Open- Label Study in Southern Africa: Lessons Learned from HPTN 082. Res Sq [Preprint]. 2025 Mar 28:rs.3.rs-5084642. doi: 10.21203/rs.3.rs-5084642/v1.
- Beauchamp G, Hosek S, Donnell D, Chan KCG, Anderson PL, Dye BJ, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study team. The Effect of Disclosure of PrEP Use on Adherence Among African Young Women in an Open-Label PrEP Study: Findings from HPTN 082. AIDS Behav. 2024 May;28(5):1512-1521. doi: 10.1007/s10461-023-04175-0. Epub 2023 Sep 28.
- Beauchamp G, Donnell D, Hosek S, Anderson PL, Chan KCG, Dye BJ, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C. Trust in the provider and accurate self-reported PrEP adherence among adolescent girls and young women in South Africa and Zimbabwe: HPTN 082 study. BMC Womens Health. 2023 May 19;23(1):276. doi: 10.1186/s12905-023-02418-9.
- Delany-Moretlwe S, Mgodi N, Bekker LG, Baeten JM, Li C, Donnell D, Agyei Y, Lennon D, Rose SM, Mokgatle M, Kassim S, Mukaka S, Adeyeye A, Celum C. High prevalence and incidence of gonorrhoea and chlamydia in young women eligible for HIV pre-exposure prophylaxis in South Africa and Zimbabwe: results from the HPTN 082 trial. Sex Transm Infect. 2023 Nov;99(7):433-439. doi: 10.1136/sextrans-2022-055696. Epub 2023 Mar 8.
- Beauchamp G, Hosek S, Donnell DJ, Chan KCG, Flaherty BP, Anderson PL, Dye BJ, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study team. Development of a tool to assess HIV prevention readiness of adolescent girls and young women in HPTN 082 study. PLoS One. 2023 Feb 24;18(2):e0281728. doi: 10.1371/journal.pone.0281728. eCollection 2023.
- Velloza J, Donnell D, Hosek S, Anderson PL, Chirenje ZM, Mgodi N, Bekker LG, Marzinke MA, Delany-Moretlwe S, Celum C. Alignment of PrEP adherence with periods of HIV risk among adolescent girls and young women in South Africa and Zimbabwe: a secondary analysis of the HPTN 082 randomised controlled trial. Lancet HIV. 2022 Oct;9(10):e680-e689. doi: 10.1016/S2352-3018(22)00195-3. Epub 2022 Sep 7.
- Velloza J, Hosek S, Donnell D, Anderson PL, Chirenje M, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study group. Assessing longitudinal patterns of depressive symptoms and the influence of symptom trajectories on HIV pre-exposure prophylaxis adherence among adolescent girls in the HPTN 082 randomized controlled trial. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25731. doi: 10.1002/jia2.25731.
- Celum C, Hosek S, Tsholwana M, Kassim S, Mukaka S, Dye BJ, Pathak S, Mgodi N, Bekker LG, Donnell DJ, Wilson E, Yuha K, Anderson PL, Agyei Y, Noble H, Rose SM, Baeten JM, Fogel JM, Adeyeye A, Wiesner L, Rooney J, Delany-Moretlwe S. PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: Results from HPTN 082, a randomized controlled trial. PLoS Med. 2021 Jun 18;18(6):e1003670. doi: 10.1371/journal.pmed.1003670. eCollection 2021 Jun.
- Velloza J, Khoza N, Scorgie F, Chitukuta M, Mutero P, Mutiti K, Mangxilana N, Nobula L, Bulterys MA, Atujuna M, Hosek S, Heffron R, Bekker LG, Mgodi N, Chirenje M, Celum C, Delany-Moretlwe S; HPTN 082 study group. The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study. J Int AIDS Soc. 2020 Mar;23(3):e25463. doi: 10.1002/jia2.25463.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir | Small molecule | — | Oral |