Mugwanya Kenneth K, Matemo Daniel, Scoville Caitlin W, Beima-Sofie Kristin M, Meisner Allison, Onyango Dickens, Mugambi Mary, Feutz Erika, Grabow Cole, Barnabas Ruanne, Weiner Bryan, Baeten Jared M, Kinuthia John
Departments of Global Health and Epidemiology, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Research & Programs, Kenyatta National Hospital, Nairobi, Kenya.
Implement Sci Commun. 2021 Dec 11;2(1):135. doi: 10.1186/s43058-021-00228-4.
Adolescent girls and young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including provision of pre-exposure prophylaxis (PrEP). Anchoring PrEP delivery to care settings like family planning (FP) services that women already access routinely may offer an efficient platform to reach HIV at-risk women. However, context-specific implementation science evaluation is needed.
The Family Planning Plus Project is a prospective, pragmatic implementation evaluation, designed as a stepped wedge, cluster randomized trial, at 12 clinics in Kenya. In collaboration with the Kenya Ministry of Health and Kisumu County Department of Health, we will introduce integration of HIV risk screening and PrEP delivery in public health FP clinics. The core multifaceted implementation strategies to integrate PrEP in FP clinics will include: (1) PrEP delivery by existing FP clinic staff, (2) health provider training, (3) PrEP technical assistance to coach and mentor providers, (4) joint supervision with Kisumu County health officials, and (5) stakeholder engagement. All core components of PrEP delivery-including screening for HIV risk, HIV testing, dispensing, adherence and risk reduction counseling, assessment of side effects, and provision of refills, or safety assessment-will be conducted by existing FP clinic staff as part of a standard care service package. The goal is to catalyze sustainable scale-up within existing infrastructures beyond the project. We will rigorously evaluate implementation outcomes and impact, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, and we will use Organizational Readiness for Implementing Change (ORIC) and the Consolidated Framework for Implementation Science Research (CFIR) to assess readiness to implement and contextual enablers and barriers of implementation, including how clinics innovate efficient delivery systems.
Anchoring PrEP delivery to existing FP systems and staffing has tremendous potential to address barriers that women face in accessing HIV prevention and PrEP care, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. The FP Plus Project will initiate preparation for full-scale and sustainable model of integration of comprehensive HIV prevention services, including PrEP implementation, in public health FP clinics in low-income settings. Trial registration Registered with ClinicalTrials.gov on December 14, 2020: NCT04666792.
在非洲，青少年女孩和年轻女性在新增艾滋病毒感染病例中所占比例过高，是艾滋病毒预防的重点人群，包括提供暴露前预防（PrEP）。将PrEP服务与女性常规使用的计划生育（FP）等医疗服务相结合，可能为接触艾滋病毒高危女性提供一个有效的平台。然而，需要针对具体情况进行实施科学评估。
计划生育增强项目是一项前瞻性、务实的实施评估，设计为阶梯式楔形整群随机试验，在肯尼亚的12家诊所开展。我们将与肯尼亚卫生部和基苏木县卫生部合作，在公共卫生FP诊所引入艾滋病毒风险筛查和PrEP服务的整合。在FP诊所整合PrEP的核心多方面实施策略将包括：（1）由现有的FP诊所工作人员提供PrEP；（2）对医疗服务提供者进行培训；（3）为指导和辅导提供者提供PrEP技术援助；（4）与基苏木县卫生官员联合监督；（5）让利益相关者参与。PrEP服务的所有核心组成部分，包括艾滋病毒风险筛查、艾滋病毒检测、配药、依从性和降低风险咨询、副作用评估、提供续方或安全性评估，将由现有的FP诊所工作人员作为标准护理服务包的一部分进行。目标是在项目之外的现有基础设施内推动可持续扩大规模。我们将使用RE-AIM（覆盖范围、有效性、采用率、实施情况、维持情况）框架严格评估实施结果和影响，并将使用实施变革的组织准备情况（ORIC）和实施科学研究综合框架（CFIR）来评估实施准备情况以及实施的背景促进因素和障碍，包括诊所如何创新高效的服务提供系统。
将PrEP服务与现有的FP系统和人员配置相结合，对于解决女性在获得艾滋病毒预防和PrEP护理方面面临的障碍具有巨大潜力，这些障碍包括时间不足、成本以及仅为艾滋病毒预防而去医疗机构就诊所带来的耻辱感。计划生育增强项目将启动准备工作，以建立在低收入环境下的公共卫生FP诊所全面整合艾滋病毒预防服务（包括实施PrEP）的全面且可持续的模式。试验注册于2020年12月14日在ClinicalTrials.gov上注册：NCT04666792。
