The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa-study protocol.
The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa-study protocol.
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DOI：
10.1186/s13063-021-05402-6
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发表时间：
2021-07-26
期刊：
影响因子：
2.5
通讯作者：
Bekker LG
中科院分区：
文献类型：
--
作者：
Medina-Marino A;Bezuidenhout D;Hosek S;Barnabas RV;Atujuna M;Bezuidenhout C;Ngwepe P;Peters RPH;Little F;Celum CL;Daniels J;Bekker LG
南非少女和年轻妇女（AGYW）的艾滋病毒感染率仍然很高，但可以通过高效的暴露前预防（PrEP）来降低。遗憾的是，青年协会报告说，在诊所提供性健康和生殖健康服务方面存在重大障碍。即使AGYW将PrEP作为一种艾滋病毒预防方法，预防有效性差的使用也是实现其最佳艾滋病毒预防效益的严重障碍。需要确定以社区为基础的平台的可接受性和可行性，以增加AGYW获得PrEP的机会，并评估行为干预措施，以改善PrEP的预防有效使用。我们建议在南非东开普省年龄在16-25岁的AGYW中进行混合方法研究。在第一部分中，一项横断面研究将评估利用基于社区的艾滋病毒咨询和检测（CBCT）平台将艾滋病毒阴性，有风险的AGYW转介到非诊所的当天PrEP启动服务的可接受性和可行性。在第二部分中，我们将通过我们的CBCT平台招募480名AGYW启动PrEP进入一项三臂（1：1：1）随机对照试验（RCT），该试验将评估依从性支持干预措施的有效性，以改善PrEP的预防有效使用。依从性将通过二磷酸替诺福韦血药浓度水平在24个月内测量。定性调查将探讨与基于社区的PrEP服务，依从性支持活动，研究实施和社区意识相关的参与者，工作人员和社区经验。将评估服务平台和干预措施的成本和可扩展性。这将是第一项评估利用CBCT平台识别并将有风险的AGYW转介到基于社区的当天PrEP启动服务的可接受性和可行性的研究。它还将提供定量和定性结果，为促进AGYW预防有效使用PrEP的坚持支持活动和服务提供信息。通过应用实施科学，行为科学和卫生经济学研究的原则，我们的目标是为AGYW提供战略，以改善获得和预防有效使用PrEP。ClinicalTrials.govNCT03977181.于2019年6月6日注册-追溯注册。
HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. ClinicalTrials.govNCT03977181. Registered on 6 June 2019—retrospectively registered.
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