Adaptation and optimization of the Friendship Bench mental health intervention for adolescent girls and young women in South African PrEP delivery settings

摘要 非洲少女和年轻妇女(AGYW)面临艾滋病毒和常见精神疾病的高比率。艾滋病病毒 暴露前预防(PrEP)是一种高效的艾滋病毒预防方法，正在南方推广 非洲。然而，常见精神障碍的症状是PrEP使用的重大障碍。有效心理 健康治疗，如问题解决疗法(PST)，有可能与PrEP交付相结合 应对心理健康挑战和PrEP使用的可修改障碍，并提高PrEP的遵从性 AGYW。友谊长椅是AGYW在PrEP环境下基于证据的PST干预方案 鉴于它是为在繁忙的艾滋病毒诊所提供而开发的，目前正在南非扩大规模，以及 初步数据表明，可以对其进行调整，以提高非洲妇女对艾滋病毒治疗的依从性。 需要研究来评估其对心理健康和PrEP坚持结果的有效性，并确定 AGYW在PrEP交付环境中的实施战略。在之前的K99研究(K99 MH123369)中，Velloza博士 她的团队进行了以人为中心的设计工作，以了解围绕综合心理健康和 准备实施干预措施，并调整友谊板凳干预措施和实施战略。这个 当前R00研究(R00 MH123369)的总体目标是测试和优化适用于 非洲AGYW正在进行PrEP交付。具体目标是进行第二类混合执行--有效性 青年友谊长椅SA对PrEP依从性和心理健康的初步效果评价 同时针对PrEP交付中的成本限制优化实施(目标1)，并确定以下主题 干预措施的可接受性、适当性和可行性(目标2)。为了准备这项工作的目标2，我们 对可接受性指标进行了系统审查，并会见了艾滋病毒和实施方面的主要领导人 科学领域讨论这些早期执行成果的衡量方法。我们发现 在高质量可接受性、适当性和可行性指标方面存在重大差距，并且缺乏标准化 这些结构如何在艾滋病毒相关研究和实施领域中运作 更广泛地说，科学。这些差距使我们无法进行目标2的数据收集和分析。这 12个月的补充申请建议通过确定和验证现有的父项目来增强现有的父项目 可接受性、适当性和可行性衡量标准，以便为母研究的目标2提供信息。我们建议利用 我们当前的R00研究旨在：1)开发可接受性、适当性和可行性的“最佳实践”工具包 向父母R00的目标2通报情况并协调艾滋病毒预防方面的实施科学努力的措施 实地；以及2)在我们的PrEP的背景下验证可接受性、适当性和可行性措施 约翰内斯堡的实施试验。我们完全有能力实施这些新提出的研究 活动，这将支持和加强最初批准的R00研究。我们的发现也有 在更广泛的艾滋病毒预防领域推进实施科学建设措施的潜力。

ABSTRACT African adolescent girls and young women (AGYW) face high rates of HIV and common mental disorders. HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention approach which is being scaled up in South Africa. However, symptoms of common mental disorders are significant barriers to PrEP use. Effective mental health treatment, such as problem-solving therapy (PST), has the potential to be integrated with PrEP delivery to address mental health challenges and modifiable barriers to PrEP use and improve PrEP adherence for AGYW. The Friendship Bench is a promising evidence-based PST intervention option for AGYW in PrEP settings given that it was developed for delivery in busy HIV clinics, is currently being scaled-up in South Africa, and preliminary data suggests it can be adapted to improve HIV treatment adherence among African women. Research is needed to evaluate its effectiveness on mental health and PrEP adherence outcomes and identify implementation strategies for AGYW in PrEP delivery settings. In a prior K99 study (K99 MH123369), Dr. Velloza and her team conducted human-centered design work to understand needs around integrated mental health and PrEP intervention delivery and to adapt the Friendship Bench intervention and implementation strategies. The overall goal of the current R00 study (R00 MH123369) is to test and optimize the adapted Friendship Bench for African AGYW in PrEP delivery. The Specific Aims are to conduct a hybrid Type II implementation-effectiveness trial to assess preliminary effectiveness of Youth Friendship Bench SA on PrEP adherence and mental health while optimizing implementation for cost constraints in PrEP delivery (Aim 1) and identify themes around intervention acceptability, appropriateness, and feasibility (Aim 2). In preparation for Aim 2 of this work, we conducted a systematic review of acceptability metrics and met with key leaders in the HIV and implementation science fields to discuss measurement approaches for these early implementation outcomes. We found significant gaps in high quality acceptability, appropriateness, and feasibility metrics and a lack of standardization in how these constructs are operationalized in HIV-related research specifically and the field of implementation science more broadly. These gaps have prevented us from conducting Aim 2 data collection and analyses. This 12-month supplement application proposes to enhance the existing parent project by identifying and validating acceptability, appropriateness, and feasibility metrics to inform Aim 2 of the parent study. We propose to leverage our current R00 study to: 1) develop a toolkit of “best practice” acceptability, appropriateness, and feasibility measures to inform Aim 2 of the parent R00 and harmonize implementation science efforts in the HIV prevention field; and 2) validate acceptability, appropriateness, and feasibility measures in the context of our PrEP implementation trial in Johannesburg. We are well-positioned to implement these newly proposed research activities, which will support and strengthen the originally approved R00 research. Our findings also have the potential to advance implementation science construct measurement in the HIV prevention field more broadly.