Division of Infectious Diseases and Global Public Health, University of California San Diego (UCSD), San Diego, CA.
Department of Psychiatry, University of California San Diego (UCSD), San Diego, CA.
J Acquir Immune Defic Syndr. 2019 Jun 1;81(2):166-174. doi: 10.1097/QAI.0000000000002003.
Efficacy of HIV pre-exposure prophylaxis (PrEP) among men who have sex with men is well documented in randomized trials. After trial completion, participants are challenged with acquiring PrEP on their own and remaining adherent.
This was a follow-up study of the TAPIR randomized controlled multicenter PrEP trial. Participants were contacted after their last TAPIR visit (ie, after study-provided PrEP was discontinued) to attend observational posttrial visits 24 and 48 weeks later. Adherence during TAPIR and posttrial visits was estimated by dried blood spot intracellular tenofovir diphosphate levels (adequate adherence defined as tenofovir diphosphate levels >719 fmol/punch). Binary logistic regression analysis assessed predictors of completing posttrial visits and PrEP adherence among participants completing ≥1 visit.
Of 395 TAPIR participants who were on PrEP as part of the TAPIR trial for a median of 597 days (range 3-757 days), 122 (31%) completed ≥1 posttrial visit (57% of University of California San Diego participants completed posttrial visits, whereas this was 13% or lower for other study sites). Among participants who completed ≥1 posttrial visit, 57% had adequate adherence posttrial. Significant predictors of adequate adherence posttrial were less problematic substance use, higher risk behavior, and adequate adherence in year 1 of TAPIR.
More than half of PrEP users followed after trial completion had successfully acquired PrEP and showed adequate adherence. Additional adherence monitoring and intervention measures may be needed for those with low PrEP adherence and problematic substance use during the first year of trial.
在随机试验中,已充分证明男男性行为者使用 HIV 暴露前预防(PrEP)的疗效。试验完成后,参与者面临自行获取 PrEP 并保持依从性的挑战。
这是 TAPIR 随机对照多中心 PrEP 试验的随访研究。在最后一次 TAPIR 访视(即研究提供的 PrEP 停止后)后,联系参与者参加 24 周和 48 周后的观察性试验后访视。通过干血斑细胞内替诺福韦二磷酸水平(定义为替诺福韦二磷酸水平>719 fmol/打孔)估计 TAPIR 访视和试验后访视期间的依从性。二元逻辑回归分析评估了完成试验后访视和参与者在完成≥1 次访视时坚持 PrEP 的预测因素。
在 395 名作为 TAPIR 试验一部分接受 PrEP 的 TAPIR 参与者中,中位随访时间为 597 天(范围 3-757 天),122 名(31%)完成了≥1 次试验后访视(加利福尼亚大学圣地亚哥分校参与者中有 57%完成了试验后访视,而其他研究地点的这一比例为 13%或更低)。在完成≥1 次试验后访视的参与者中,57%在试验后有足够的依从性。试验第一年的较少问题性物质使用、更高的风险行为和足够的依从性是试验后足够依从性的显著预测因素。
在试验完成后随访的 PrEP 使用者中,超过一半成功获得了 PrEP 并表现出足够的依从性。对于在试验第一年物质使用有问题且 PrEP 依从性低的人,可能需要额外的依从性监测和干预措施。