Evaluation of Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
What is HPTN 082?
HPTN 082 is a sub-Saharan-based research study designed to assess the number of and characteristics of young women who accept versus decline pre-exposure prophylaxis (PrEP) at enrollment. The study is also comparing adherence to PrEP between women who are randomized to receive standard adherence support and those receiving enhanced adherence support.
Who is participating in the study?
Approximately 400 HIV-uninfected women ages 16-25 who accept PrEP at enrollment and up to 200 who decline PrEP at enrollment will be recruited at two sites in South Africa (Cape Town and Johannesburg) and one site in Harare, Zimbabwe.
Why is HPTN 082 important?
Young African women are an important population for PrEP implementation, representing three of the four million young people living with HIV in sub-Saharan Africa, and with high annual HIV incidence rates of 5-6% in recent HIV prevention trials. Oral PrEP has the potential to significantly reduce HIV incidence among young African women, if delivered with clear information about its efficacy and the importance of high-level adherence; counseling and risk assessments to determine women’s perceived risks and benefits of PrEP; and tailored cognitive behavioral counseling with short message service (SMS) reminders adapted to this specific population.
What happens during the study?
Participants will be offered open-label PrEP and followed for up to one year. Participants who accept PrEP will be randomly assigned in a 1:1 ratio to receive standard adherence support (counseling, two-way SMS communication), and peer support through adherence support clubs or enhanced adherence support with counseling based on feedback from drug levels in addition to the standard adherence support (counseling, two-way SMS communication, and peer support through adherence support clubs). A subset of up to 25 women per site (up to 75 total women), including PrEP decliners and late accepters, will also be recruited to participate in interviews, to explore why a woman decides to use PrEP in the first three months after PrEP acceptance. Up to 200 additional women may be enrolled who are interested in PrEP and are eligible for the study, but decline to accept oral PrEP at enrollment. These women will continue to be offered PrEP during follow up visits to determine the proportion who subsequently accept PrEP (late acceptors), and the characteristics of early vs. delayed PrEP accepters and those who do not accept PrEP during follow up.
HPTN 082 Version 1.0
- HPTN 082 Protocol V1.0 - 8 Dec 2015
- Clarification Memo #1- 7 March 2016
- Letter of Amendment #1 - 9 March 2017
- Letter of Amendment #2 - 19 July 2017
- Letter of Amendment #3 - 15 October 2017