Burden of Disease Research Unit, South African Medical Research Council, Cape Town, South Africa.
Division of Health Systems and Public Health, Stellenbosch University, Cape Town, South Africa.
PLoS One. 2022 Mar 17;17(3):e0264808. doi: 10.1371/journal.pone.0264808. eCollection 2022.
Pre-exposure prophylaxis (PrEP) is an effective prevention intervention that can be used to control HIV incidence especially among people who are at increased risk for HIV such as adolescent girls and young women (AGYW) and adolescent boys and young men (ABYM). In South Africa, various approaches of delivering PrEP have been adopted at different service delivery points (facility-based only, school-based only, community-based only and hybrid school-facility and community-facility models) to overcome challenges associated with individual, structural, and health systems related barriers that may hinder access to and uptake of PrEP among these populations. However, little is known about how to optimize PrEP implementation and operational strategies to achieve high sustained uptake of good quality services for AGYW and ABYM. This study aims to identify effective and feasible PrEP models of care for improving PrEP uptake, continuation, and adherence among AGYW and ABYM.
A sequential explanatory mixed-methods study will be conducted in 22 service delivery points (SDPs) in uMgungundlovu district, KwaZulu-Natal, South Africa. We will recruit 600 HIV negative, sexually active, high risk, AGYW (aged 15-24 years) and ABYM (aged 15-35 years). Enrolled participants will be followed up at 1-, 4- and 7-months to determine continuation and adherence to PrEP. We will conduct two focus group discussions (with 8 participants in each group) across four groups (i. Initiated PrEP within 1 month, ii. Did not initiate PrEP within 1 month, iii. Continued PrEP at 4/7 months and iv. Did not continue PrEP at 4/7 months) and 48 in-depth interviews from each of the four groups (12 per group). Twelve key informant interviews with stakeholders working in HIV programs will also be conducted. Associations between demographic characteristics stratified by PrEP initiation and by various service-delivery models will be assessed using Chi-square/Fishers exact tests or t-test/Mann Whitney test. A general inductive approach will be used to analyze the qualitative data.
The protocol was approved by the South African Medical Research Council Health Research Ethics Committee (EC051-11/2020). Findings from the study will be communicated to the study population and results will be presented to stakeholders and at appropriate local and international conferences. Outputs will also include a policy brief, peer-reviewed journal articles and research capacity building through research degrees.
暴露前预防（PrEP）是一种有效的预防干预措施，可用于控制艾滋病毒的发病率，特别是在艾滋病毒感染风险较高的人群中，如少女和年轻妇女（AGYW）以及青少年男孩和年轻男子（ABYM）。在南非，为了克服与个人、结构和卫生系统相关的障碍相关的挑战，这些障碍可能阻碍这些人群获得和接受 PrEP，已经在不同的服务提供点（仅在机构内、仅在学校内、仅在社区内以及混合学校-机构和社区-机构模型）采用了各种提供 PrEP 的方法。然而，对于如何优化 PrEP 的实施和运营策略以实现高质量服务的高持续使用率，以便为 AGYW 和 ABYM 提供服务，人们知之甚少。本研究旨在确定有效的 PrEP 护理模式，以提高 AGYW 和 ABYM 对 PrEP 的接受率、持续性和坚持性。
本研究将在南非夸祖鲁-纳塔尔省乌姆古伦多夫区的 22 个服务提供点（SDP）进行一项序贯解释性混合方法研究。我们将招募 600 名 HIV 阴性、性活跃、高风险的 AGYW（年龄 15-24 岁）和 ABYM（年龄 15-35 岁）。入组参与者将在 1、4 和 7 个月时进行随访，以确定 PrEP 的持续性和坚持性。我们将进行两次焦点小组讨论（每组 8 名参与者），并从四个组（i.在 1 个月内开始 PrEP，ii.在 1 个月内未开始 PrEP，iii.在 4/7 个月时继续 PrEP，iv.在 4/7 个月时未继续 PrEP）和每组 12 名（共 48 名）深度访谈参与者中进行。还将对在艾滋病毒规划中工作的 12 名利益攸关方进行关键知情人访谈。将使用卡方检验/Fisher 精确检验或 t 检验/Mann-Whitney 检验评估按 PrEP 启动分层和按各种服务提供模式分层的人口统计学特征之间的关联。将采用一般归纳方法对定性数据进行分析。
该方案已获得南非医学研究理事会健康研究伦理委员会（EC051-11/2020）的批准。研究结果将与研究人群进行沟通，并将结果提交给利益攸关方，并在适当的地方和国际会议上进行介绍。研究结果还将包括政策简报、同行评议的期刊文章和通过研究学位进行研究能力建设。
