Acceptability of an annual tenofovir alafenamide implant for HIV prevention in South African women: findings from the CAPRISA 018 Phase I clinical trial

作者：Tanuja N. Gengiah, Craig J. Heck, Lara Lewis, Leila E. Mansoor, Ishana Harkoo, Nqobile Myeni, Marc M. Baum, John A. Moss, James F. Rooney, Catherine Hankins, Bruno Pozzetto, Salim S. Abdool Karim, Quarraisha Abdool Karim · 发表于：Journal of the International AIDS Society · 年份：2025 · DOI：10.1002/jia2.26426 · 被引用次数：6 · 研究领域：HIV/AIDS Research and Interventions、HIV/AIDS drug development and treatment、HIV-related health complications and treatments

INTRODUCTION: Long-acting HIV pre-exposure prophylaxis promises to improve uptake, adherence and persistence challenges experienced with daily oral tablets. We assessed the acceptability of an annual tenofovir alafenamide (TAF) implant in South African women enrolled from 9 July 2020 until 31 May 2022 in a Phase I trial. METHODS: Six women received one TAF implant for 4 weeks (Group 1), after which 30 women were randomized (4:1, TAF to placebo ratio) to receive 1 or 2 TAF or placebo implants for 48 weeks (Group 2), before trial discontinuation. Acceptability assessments were conducted pre- and post-implant removal. Implant attributes (size, quantity, insertion site, palpability, visibility) and physical experiences (insertion/removal procedures, implant site reactions [ISRs]) were rated on a scale of 1 (highly unacceptable) to 6 (highly acceptable), with 4 being the acceptability threshold. The mean (range) of the mean acceptability scores across all pre-removal visits were calculated, including stratification by removal timing (early vs. scheduled). Implant likes and dislikes were also assessed. RESULTS: The median participant age was 26 years. Prior to implant removal, the mean (range) acceptability scores were 5.4 (3.6-6.0) for product attributes and 5.1 (1.7-6.0) for physical experiences. Eleven (31%) participants had early implant removals, occurring on average 19 weeks (range 2-27 weeks) after insertion. The proportion of study visits reporting adherence measure as unac...