The Community PrEP Study

项目摘要 2015年，全球约有190万人感染艾滋病毒，其中大多数居住在南部和南部。 东非。在南非，15-24岁女性青年的艾滋病毒感染率（2.5%）是 较男性（0.6%）为高。最近在南非进行的艾滋病毒预防试验记录了发病率 15-24岁少女和年轻妇女的发病率为每年5-6%（AGYW）。鉴于这种高发病率 实施有效的艾滋病毒预防战略--包括PrEP --对全球控制艾滋病毒至关重要。 这项拟议的研究利用了南非现有的基于社区的艾滋病咨询和检测平台 并使用混合方法评估基于社区的预防有效的PrEP依从性 AGYW计划，同时优化PrEP级联。这项研究将在马梅洛迪市进行， 普罗旺斯豪登镇和姆普马兰加省农村戈万姆贝基分区，这两个地区都是 艾滋病传播率很高的地区。已经描述了许多延迟或阻止AGYW的障碍 获得诊所保健服务，特别是生殖健康和艾滋病毒检测及预防服务。 因此，要大规模地向青少年妇女提供艾滋病毒预防服务，卫生系统就必须思考 在诊所以外的平台上。以社区为基础的咨询和检测项目 显示出最大的覆盖面和潜力，以实现艾滋病毒血清状况的高水平知识和联系， 艾滋病毒护理。使用基于社区的咨询和测试计划，该提案将提供PrEP作为 人口水平的综合预防计划，这是必要的，以大幅降低艾滋病毒的发病率。 我们建议通过以下具体目标来回答我们的关键研究问题：1）评估青少年 通过大规模社区艾滋病毒咨询提供的女孩和年轻妇女对PrEP的吸收 2）评估基于社区的可扩展的 干预措施，以实现预防有效坚持PrEP之间AGYW，和3）测量差异， PrEP接受者、非接受者和延迟启动者的风险状况。为了实现目标1，我们将利用 我们正在进行的大规模CBCT计划和平台（移动的单元和系统的家庭测试），以识别 并将AGYW与社区PrEP启动服务联系起来。为了实现目标2，我们将执行三臂 随机对照试验，受试者随机分配至以下组之一：组1）基于组的 社区健康俱乐部，类似于ART依从性俱乐部;组2）一对一依从性咨询和支持; 第三类：社区药房。最后，虽然PrEP接受者正在被纳入 作为目标1的一部分，516名拒绝PrEP的个体将被招募为对照组，以（a）测量 PrEP接受者和非接受者中STI和HIV感染的发生率，（B）：评估性行为和自我 接受和不接受PrEP的人的感知风险，以及（c）：确定 延迟PrEP启动，并描述延迟启动的原因。

PROJECT ABSTRACT Worldwide, about 1.9 million people became infected with HIV in 2015, most of whom live in Southern and Eastern Africa. In South Africa, the HIV incidence rate among female youth aged 15-24 (2.5%) is four times higher than their male counterparts (0.6%). Recent HIV prevention trials in South Africa documented incidence rates of 5-6% per year in 15-24 year old adolescent girls and young women (AGYW). Given this high incidence of HIV, implementing effective HIV prevention strategies – including PrEP – is crucial to controlling HIV globally. The proposed study leverages existing community-based HIV counseling and testing platforms in South Africa and evaluates, using a mixed methods approach, a community-based prevention-effective PrEP adherence program in AGYW whilst optimizing the PrEP cascade. This study will take place in the urban Mamelodi Township in Gauteng Provence and rural Govan Mbeki sub-district in Mpumalanga Province, both of which are very high HIV transmission areas. Numerous barriers have been described that delay or block AGYW from accessing clinic-based health services, especially reproductive health and HIV testing and prevention services. Consequently, reaching AGYW at large scale with HIV prevention services requires the health system to think of delivery platforms outside of clinic-based facilities. Community-based counseling and testing programs have shown the greatest coverage and potential to achieve high levels of knowledge of HIV serostatus and linkage to HIV care. Using community-based counseling and testing programs, this proposal will deliver PrEP as part of a population-level combination prevention program which is necessary to substantially reduce HIV incidence. We propose to answer our key research questions through the following Specific Aims: 1) Assess adolescent girls and young women's uptake of PrEP when delivered through large- scale community-based HIV counseling and testing (CBCT) platforms in urban and rural settings in South Africa, 2) Evaluate community-based scalable interventions to achieve prevention-effective adherence to PrEP among AGYW, and 3) Measure differences in risk profiles of PrEP acceptors, non-acceptors and delayed initiators. In order to achieve Aim 1, we will leverage our on-going, at-scale CBCT program and platforms (mobile unit and systematic home-based testing) to identify and link AGYW to community-based PrEP initiation services. In order to achieve Aim 2, we will perform a 3-arm randomized control trial, with participants randomised to one of the following arms: Arm 1) a group-based community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling and support; Arm 3) community-based medication dispensary. And finally, while PrEP acceptors are being enrolled into the study as part of Aim 1, 516 individuals that decline PrEP will be enrolled as a control group to (a) measure the incidence of STI and HIV infections in PrEP acceptors and non-acceptors, (b): assess sexual behaviors and self- perception risk in those that accept and did not accept PrEP, and (c): determine the proportion of individuals that delay PrEP initiation and describe their reasons for delayed initiation.