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过高。最近在四个非洲国家进行的大型临床研究（ECHO研究） 一些国家发现，希望避孕的妇女中艾滋病毒感染率高得令人无法接受， 平均3.8%。这些结果正确地激发了关于加强艾滋病毒/艾滋病一体化的必要性的讨论， 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- 控制艾滋病毒预防战略，因为它的高效率和安全性。整合艾滋病毒预防服务， 将PrEP提供纳入妇女信任和经常获得的护理环境中可能会提供一个有效的平台 向高危妇女提供艾滋病毒预防服务。在最近的一项试点研究中，我们证明， 在计划生育诊所与专门负责计划的工作人员整合PrEP供应。然而，这种做法也突出了 需要与现有工作人员有效整合的交付模式，以实现可持续性。种用多学科 团队和吸取试点工作的经验教训，我们建议催化扩大PrEP提供风险 在肯尼亚基苏穆-一个年轻人艾滋病毒感染率高达28%的地区-前往计划生育诊所的妇女 妇女我们的目标是在FP诊所提供可持续的，制度化的，具有成本和时间效益的PrEP。 我们假设FP诊所将为PrEP和FP服务提供以女性为中心的“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、费用和耻辱感 去一个专门预防艾滋病的机构我们将进行一项逐步楔入的随机分组试验， 在12个计划生育诊所（n= 3 600名妇女）实施多方面的实施战略，目标如下：在目标1中，我们将 在公共卫生计划生育诊所分阶段提供PrEP，实施和优化艾滋病毒预防服务 与现有的FP诊所人员配置一起提供。我们将严格评估项目的覆盖范围、有效性、采用率， 使用RE-AIM框架的实施、维护和影响。多方面执行 将PrEP纳入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， 检测、筛查艾滋病毒和性传播感染风险并提供PrEP; 3）持续的技术援助; 4）审计和反馈 优化交付; 5）工作流程图; 6）简化数据和PrEP供应系统。在目标2中， 实施变革的准备情况和综合实施框架 科学研究，我们将评估准备实施，保真度，对当前服务的影响，促进者， 在FP诊所背景下提供PrEP的整合障碍。在目标3中，我们将评估方案成本、预算 在肯尼亚计划生育诊所整合PrEP提供的影响和可负担性。费用将在5年内估算 考虑付款人的观点以及社会观点，以考虑客户机会， 财务费用。该项目的结果将为更大规模的口服PrEP和下一个- 在计划生育诊所中使用PrEP制剂，不仅在肯尼亚，而且在全球其他资源有限的环境中。

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.