Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, The University of Arizona, Tucson, Arizona, United States of America.
Department of Behavioural Sciences, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.
PLoS One. 2024 Jun 27;19(6):e0304077. doi: 10.1371/journal.pone.0304077. eCollection 2024.
Pre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in preventing HIV infection. Female Bar Workers (FBWs) often act as informal sex workers, placing them at risk of HIV infection. Despite expressing interest in PrEP, FBWs face barriers to accessing public-sector clinics where PrEP is delivered. We developed a study to compare the effectiveness of workplace-based PrEP provision to standard-of-care facility-based provision for PrEP initiation, retention and adherence among FBWs.
In this double-randomized intervention study, FBWs aged 15 years and above will be screened, consented and initiated on PrEP (emtricitabine/tenofovir disoproxil), and followed for six months. Participants will be randomized at the bar level and offered PrEP at their workplace or at a health facility. Those who are initiated will be independently individually randomized to either receive or not receive an omni-channel PrEP champion intervention (support from an experienced PrEP user) to improve PrEP adherence. We expect to screen 1,205 FBWs to enroll at least 160 HIV negative women in the study. Follow-up visits will be scheduled monthly. HIV testing will be performed at baseline, month 1, 4 and 6; and TDF testing at months 2 and 6. Primary outcomes for this trial are: (1) initiation on PrEP (proportion of those offered PrEP directly observed to initiate PrEP); and (2) adherence to PrEP (detectable urine TDF drug level at 6-months post-enrollment). The primary outcomes will be analyzed using Intention-to-Treat (ITT) analyses.
Using a randomized trial design, we will evaluate two interventions aiming to reduce barriers to uptake and retention on PrEP among FBWs, a vulnerable population at risk of HIV acquisition and onward transmission. If these interventions prove effective in promoting PrEP among FBWs, they could assist in abating the HIV epidemic in Africa.
Registered with German Clinical Trials Register (www.drks.de) on 29 April 2020; Registration number DRKS00018101.
暴露前预防（PrEP）已被证明可有效预防 HIV 感染。女性酒吧工作者（FBWs）经常充当非正式性工作者，使她们面临 HIV 感染的风险。尽管对 PrEP 表现出兴趣，但 FBWs 在获得提供 PrEP 的公共部门诊所方面面临障碍。我们开展了一项研究，以比较基于工作场所的 PrEP 提供与基于标准护理的医疗机构提供 PrEP 对 FBWs 中 PrEP 起始、保留和依从性的效果。
在这项双随机干预研究中，将对年龄在 15 岁及以上的 FBWs 进行筛查、同意并开始接受 PrEP（恩曲他滨/替诺福韦二吡呋酯）治疗，并随访 6 个月。参与者将在酒吧层面进行随机分组，并在工作场所或医疗机构提供 PrEP。那些开始接受 PrEP 的人将被独立随机分组，接受或不接受全渠道 PrEP 冠军干预（由经验丰富的 PrEP 用户提供支持），以提高 PrEP 的依从性。我们预计将筛选 1,205 名 FBWs，以招募至少 160 名 HIV 阴性女性参加该研究。随访预约将每月安排一次。基线、第 1、4 和 6 个月进行 HIV 检测；第 2 和 6 个月进行 TDF 检测。该试验的主要结局为：（1）开始接受 PrEP（直接观察到接受 PrEP 的人中开始接受 PrEP 的比例）；（2）接受 PrEP 的依从性（入组后 6 个月时可检测到尿液 TDF 药物水平）。主要结局将使用意向治疗（ITT）分析进行分析。
我们将使用随机试验设计，评估旨在减少 FBWs 中 PrEP 获得和保留障碍的两种干预措施，FBWs 是一个面临 HIV 获得和传播风险的脆弱人群。如果这些干预措施在促进 FBWs 中 PrEP 的使用方面证明有效，它们可以帮助遏制非洲的 HIV 流行。
于 2020 年 4 月 29 日在德国临床试验注册中心（www.drks.de）注册；注册号 DRKS00018101。
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