open-label

  • Rolling Out Tenofovir Gel in Family Planning Clinics: The CAPRISA 008 Implementation Trial (Abstract)

    CAPRISA 008 was a two-arm, open-label, randomized controlled, non-inferiority implementation trial that provided participants from CAPRISA 004 with post-trial access to tenofovir gel while generating evidence that could be used for future implementation of topical pre-exposure prophylaxis (PrEP) among women. Its findings on the delivery of a microbicide containing tenofovir gel in family planning clinics are reported in this chapter of a book about HIV prevention and treatment trials conducted by the Centre for the AIDS Programme of Research in South Africa.

  • Social Context of Adherence in an Open-Label 1% Tenofovir Gel Trial: Gender Dynamics and Disclosure in KwaZulu-Natal, South Africa

    CAPRISA 008, an open-label extension study of tenofovir vaginal gel with coitally related dosing, provided an opportunity to explore the relationship between product adherence and gender dynamics in a context where women knew they were receiving an active product with evidence of HIV prevention effectiveness. Interviews with 63 study participants and 13 male partners in KwaZulu-Natal, South Africa, highlighted that the process of negotiating gel use was determined in part by relationship dynamics.

  • HOPE and Beyond: Next Steps and Planned Studies of the Dapivirine Vaginal Ring

    The HIV Open-Label Extension (HOPE) study offers former participants in the ASPIRE study of the dapivirine vaginal ring the opportunity to use the ring in the context of a study while researchers collect additional data on safety and adherence. This Q&A document provides information about HOPE and other studies of the dapivirine ring, including REACH, which will evaluate how adolescent girls and young women use the monthly ring and daily oral pre-exposure prophylaxis.

  • After The Ring Study: DREAM

    A follow-on to The Ring Study of a dapivirine ring, the Dapivirine Ring Extended Access and Monitoring (DREAM) open-label extension study is providing the active ring to former Ring Study participants — and young women using the ring for the first time — while the product is under regulatory review for licensure.