Integrating PrEP delivery in family planning clinics in Kenya

摘要 艾滋病毒高负担环境中的妇女是艾滋病毒预防的优先人群，因为她们携带 新感染艾滋病毒的比例高得不成比例。最近在四个非洲国家进行的一项大型临床研究(ECHO研究) 各国发现，在渴望避孕的女性中，艾滋病毒感染率高得令人无法接受。 平均为3.8%。这些结果正确地激起了关于需要加强艾滋病毒整合的讨论 预防和性生殖健康服务。口服暴露前预防(PrEP)是一个有吸引力的用户- 受控的艾滋病毒预防战略，鉴于其高效和安全。整合艾滋病毒预防服务， 将PrEP规定纳入妇女信任和常规获得的护理环境中可能会提供一个有效的平台 为高危妇女提供艾滋病毒预防服务。在最近的一项初步研究中，我们证明了 将计划生育诊所的PrEP规定与专注于计划的工作人员整合在一起。然而，这种做法也突显了 需要与现有员工有效集成以实现可持续性的交付模式。具有多学科的 团队并从试点工作中吸取经验教训，我们建议催化扩大针对风险的PrEP拨备 肯尼亚基苏木的妇女在FP诊所就诊--该地区年轻人中艾滋病毒感染率高达28% 女人。我们的目标是在计划生育诊所实现可持续、制度化和低成本、高效率的PrEP交付。 我们假设，计划生育诊所将为PrEP和FP服务提供以妇女为中心的一站式位置， 可以解决妇女在获得艾滋病毒预防服务方面面临的障碍，包括缺乏时间、成本和耻辱 参观一个仅用于艾滋病毒预防的设施。我们将进行阶梯式整群随机试验，以测试 在12个计划生育诊所(n=3600名妇女)实施多方面的战略，目标如下：在目标1，我们将 在公共卫生计划生育诊所分阶段开展预防接种，落实和优化艾滋病预防服务 提供现有的计划生育诊所工作人员。我们将严格评估计划覆盖范围、有效性、采用率 使用RE-AIM框架的实施、维护和影响。多方面的实施 将PrEP整合到计划生育诊所的战略将包括：1)提供者培训；2)促进艾滋病毒检测，合作伙伴艾滋病毒 艾滋病毒和性传播疾病风险的检测、筛查和提供预防预防措施；3)持续的技术援助；4)审计和反馈 以优化交付；5)工作流图；以及6)简化数据和PrEP供应系统。在目标2中，引导 按组织实施变革的准备情况和实施的综合框架 科学研究，我们将评估实施准备情况、保真度、对当前服务的影响、促进者和 在计划生育临床背景下提供PrEP的整合障碍。在目标3中，我们将评估方案成本、预算 肯尼亚计划生育诊所整合PrEP交付的影响和可负担性。成本将在5年内进行估算 考虑付款人的视角以及社会视角来考虑客户机会和 财务成本。该项目的成果将为更大规模的口服PrEP和下一步- 不仅在肯尼亚，而且在全球其他资源有限的环境中，在计划生育诊所生成PrEP配方。

ABSTRACT Women in HIV high burden settings are a priority population for HIV prevention, because they carry disproportionately high fraction of new HIV infections. A recent large clinical study (ECHO Study) in four African countries found that incident HIV infections were unacceptably high among women desiring contraception– an average of 3.8%. These results have rightly spurred discussions about the need to strengthen integration of HIV prevention and sexual reproductive health services. Oral pre-exposure prophylaxis (PrEP) is an attractive user- controlled HIV prevention strategy, given its high effectiveness and safety. Integrating HIV prevention services, including PrEP provision into care settings that women trust and access routinely may offer an efficient platform to reach at-risk women for HIV prevention. In a recent pilot study, we demonstrated that it was feasible to integrate PrEP provision in FP clinics with program-dedicated staff. However, that approach also highlighted the need for delivery models that integrate efficiently with existing staff for sustainability. With a multidisciplinary team and drawing from lessons from the pilot work, we propose to catalyze scale up PrEP provision for at-risk women accessing FP clinics in Kisumu, Kenya – a region with an HIV prevalence of up to 28% among young women. We will aim for a sustainable, institutionalized, and cost- and time-efficient PrEP delivery in FP clinics. We hypothesize that FP clinics will provide woman-centered ‘one-stop’ location for PrEP and FP services that could address barriers women face to access HIV prevention services, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. We will conduct a step-wedged cluster-randomized trial to test a multifaceted implementation strategy in 12 FP clinics (n=3600 women) with the following Aims: In Aim 1, we will deliver PrEP in public health FP clinics in staged fashion, implementing and optimizing HIV prevention service provision with existing FP clinic staffing. We will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using the RE-AIM framework. The multifaceted implementation strategy to integrate PrEP in FP clinics will include: 1) provider training; 2) promotion of HIV testing, partner HIV testing, screening for HIV and STIs risk and offer of PrEP; 3) ongoing technical assistance; 4) Audit and feedback to optimize delivery; 5) work-flow mapping; and 6) streamlined data and PrEP supply systems. In Aim 2, guided by the Organizational Readiness for Implementing Change and the Consolidated Framework for Implementation Science Research, we will assess readiness to implement, fidelity, impact on current services, facilitators, and barriers to integration PrEP provision in FP clinic context. In Aim 3, we will assess programmatic cost, budget impact, and affordability of integrating PrEP delivery in FP clinics in Kenya. Costs will be estimated over a 5 year horizon considering the payer’s perspective as well as societal perspective to account for client opportunity and financial costs. The results of this project will lay the ground for wider scale delivery of oral PrEP and next- generation PrEP formulations in FP clinics, not only in Kenya but in other resource-limited settings globally.