Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Institute for Global Health, University College London, London, UK.
BMC Public Health. 2023 Aug 15;23(1):1553. doi: 10.1186/s12889-023-16262-x.
Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN).
We are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15-30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15-30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15-30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention.
The findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care.
ClinicalTrials.gov Identifier-NCT05405582. Registered: 6th June 2022.
通过普遍检测和治疗（UTT）以及艾滋病毒暴露前预防（PrEP），抗逆转录病毒疗法（ART）大大降低了与艾滋病毒相关的死亡率和发病率。由于年轻人的覆盖范围不理想，有效的基于 ART 的预防措施并未转化为南部非洲的人群水平影响。我们旨在研究在夸祖鲁-纳塔尔省（KZN），通过将同伴主导的社会动员纳入分散式综合艾滋病毒和性生殖健康（SRH）服务中，对青少年和年轻成年人进行的同伴主导的社会动员对艾滋病毒和性生殖健康（SRH）服务的有效性、实施情况和成本效益。
我们正在进行 1a 型混合有效性/实施研究，采用集群随机分步楔形试验（SWT）评估有效性和现实过程评估评估实施结果。SWT 将在 45 个月内在夸祖鲁-纳塔尔省的 40 个集群中进行。集群将被随机分配在第 1 期（早期）或第 2 期（延迟）接受干预。1）干预组：每个集群的驻地同伴导航员将接近居住在其集群中的 15-30 岁的年轻男女，进行健康、社会和教育需求评估，并根据心理社会支持和健康促进、同伴指导进行调整，并促进转介到定期访问每个集群的护士主导的移动诊所，提供综合的 SRH 和差异化的艾滋病毒预防（为阳性者提供艾滋病毒检测、UTT，为符合条件且阴性者提供 PrEP）。标准护理是通过初级保健诊所向来自对照集群的 15-30 岁的年轻人提供 UTT 和 PrEP。在对 15-30 岁年轻人进行的横断面调查中，有 3 个主要次要结果：1）干预在降低性传播艾滋病毒流行率方面的有效性；2）普遍风险知情的艾滋病毒预防干预措施的采用率；3）可避免的传染性 HIV 感染的成本。我们将使用现实过程评估来询问干预措施的各个组成部分在支持需求、采用和保留风险差异化生物医学艾滋病毒预防方面的程度。
该试验的结果将为决策者提供信息，以优化普遍差异化艾滋病毒预防的提供，包括通过同伴主导的动员纳入社区为基础的青少年和青年友好型艾滋病毒和性生殖健康护理，提供艾滋病毒暴露前预防。
ClinicalTrials.gov 标识符-NCT05405582。注册日期：2022 年 6 月 6 日。
