Abstract
BackgroundAdolescent 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.MethodsThe 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.DiscussionAnchoring 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 registrationRegistered with ClinicalTrials.gov on December 14, 2020: NCT04666792
Highlights
MethodsThe Family Planning Plus Project is a prospective, pragmatic implementation evaluation, designed as a stepped wedge, cluster randomized trial, at 12 clinics in Kenya
Adolescent girls and young women account for a disproportionate fraction of new Human immunodeficiency virus (HIV) infections in Africa and are a priority population for HIV prevention, including provision of pre-exposure prophylaxis (PrEP)
Young African women are a priority for HIV prevention including PrEP provision because they account for a disproportionate percentage of new HIV infections
Summary
TAs will conduct structured periodic visits to each clinic to engage with the health care providers and observe and document PrEP implementation processes, with a specific focus on delivery modifications over time to understand integration optimization within and between facilities. We will use unannounced standardized patient actors to measure fidelity of the implementation of comprehensive HIV prevention services, including PrEP delivery (i.e., counseling and screening for HIV risk factors, HIV testing, PrEP provision). Cohort participants will complete visits at one month and quarterly after enrollment for up to 24 months with HIV testing and a brief questionnaire on sexual behaviors, FP and prevention methods use, HIV and STI risk, partner relationship, stigma, mental health, and for women initiated on PrEP, dried blood spots will be collected for objective assessment of adherence. Project status The project activated in March 2021 and implementation is currently ongoing and expected to end in 2024
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