open-label extension study

  • 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.

  • HIV Prevention Trials Terms: An Advocates Guide

    This fact sheet explains some of the terms used to talk about trials designed to test new HIV prevention tools.

  • 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.