印度男男性行为者和跨性别女性人群口服 TDF 含 PREP 的示范项目：研究方案。
Demonstration project of oral TDF-containing PrEP, administered, once-daily orally to men having sex with men (MSM) and transgender women (TGW) in India: Study protocol.
机构信息
ICMR-National AIDS Research Institute, Division of Social and Behavioral Sciences, Pune, India.
ICMR-National AIDS Research Institute, Division of Epidemiology and Biostatistics, Pune, India.
出版信息
PLoS One. 2023 Jun 23;18(6):e0287454. doi: 10.1371/journal.pone.0287454. eCollection 2023.
BACKGROUND
India has successfully reduced Human Immuno-deficiency Virus (HIV) incidence, with a 66% decline since the year 2000 has been seen; however, control among Men having sex with Men (MSM) and transgender women (TGW) remains a critical challenge. Oral Pre-Exposure Prophylaxis (PrEP) may help close a critical HIV prevention gap for MSM and TGW in India; however, no studies to date have evaluated the feasibility of oral PrEP among MSM and TGW in India.
METHODS
The proposed study aims at understanding the implementation of the provision of daily oral-Tenofovir (TDF) containing PrEP among MSM and TGW through the clinic and community-based delivery models in Pune, Maharashtra, and Jalandhar, Punjab respectively in India. The study aims at estimating PrEP adherence, facilitators, and barriers to PrEP use, retention, acceptability, and willingness to pay for PrEP. After the screening, eligible participants (n = 600) will receive PrEP medicines and will be monitored quarterly for HIV, STIs, and renal and liver toxicity for 12 months as per the schedule of events. The primary outcomes of interest are PrEP acceptability, PrEP adherence, retention rate, adverse medical events, and sexual behavioural changes with PrEP use and breakthrough infections while on PrEP. The study will assess the feasibility of two service delivery models; however, the data from the two service delivery models will be analyzed independently and will not be compared for feasibility and other outcome indicators. The study has been initiated after obtaining appropriate regulatory approvals.
DISCUSSION
PrEP is efficacious in preventing HIV among high-risk population however there are scarce data on providing PrEP to MSM and TGW. The study will provide critical evidence to programs and policymakers on the implementation of PrEP in a "real world" setting, among MSM and TGW in India including identifying populations that can benefit most from this additional HIV prevention intervention along with acceptable delivery strategies and means of support for adherence.
TRIAL REGISTRATION
Not applicable being a demonstration project. Efficacy is already proven.
背景
印度已成功降低艾滋病毒（HIV）发病率，自 2000 年以来，发病率下降了 66%；然而，男男性行为者（MSM）和跨性别女性（TGW）的控制仍然是一个关键挑战。口服暴露前预防（PrEP）可能有助于缩小印度 MSM 和 TGW 在 HIV 预防方面的关键差距；然而，迄今为止，尚无研究评估印度 MSM 和 TGW 中口服 PrEP 的可行性。
方法
拟议的研究旨在了解在印度浦那马哈拉施特拉邦和贾朗达尔旁遮普邦，通过诊所和社区为 MSM 和 TGW 提供每日含替诺福韦（TDF）的 PrEP 的实施情况。该研究旨在评估 PrEP 的依从性、使用 PrEP 的促进因素和障碍、保留率、可接受性以及对 PrEP 的支付意愿。在筛选后，符合条件的参与者（n=600）将接受 PrEP 药物，并将根据事件时间表每季度监测 12 个月的 HIV、性传播感染以及肾脏和肝脏毒性。主要的研究结果是 PrEP 的可接受性、PrEP 的依从性、保留率、不良医疗事件以及 PrEP 使用后的性行为变化和突破性感染。该研究将评估两种服务提供模式的可行性；然而，两种服务提供模式的数据将分别进行分析，不会对可行性和其他结果指标进行比较。在获得适当的监管批准后，该研究已启动。
讨论
PrEP 在预防高危人群中的 HIV 方面是有效的，但在为 MSM 和 TGW 提供 PrEP 方面数据很少。该研究将为方案和决策者提供在印度 MSM 和 TGW 中实施 PrEP 的重要证据，包括确定最能从这一额外 HIV 预防干预措施中受益的人群，以及可接受的提供策略和支持依从性的方法。
试验注册
不适用，因为这是一个示范项目。疗效已经得到证实。
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