Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya

Abstract

Background 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. Methods 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. Discussion 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

Patterns of PrEP continuation and coverage in the first year of use: a latent class analysis of a programmatic PrEP trial in Kenya

“…We found that individuals having partners living with HIV and those with sexual behaviours likely to put them at elevated risk for HIV were more likely to exhibit high continuation and persistence patterns on PrEP. Consistent with previous studies [ 28 , 29 , 30 , 31 ], these findings indicate that individuals continue reasonably well on PrEP when they perceive to be at risk for HIV—like having a partner living with HIV. Thus, efforts to identify strategies that support the recognition of HIV risk and normalization of PrEP use are needed to help persons navigate their decisions about PrEP use and HIV prevention preferences.…”

Preparing for long‐acting PrEP delivery: building on lessons from oral PrEP

“…PrEP was initially delivered in HIV clinics, which worked well to increase PrEP uptake among HIV‐uninfected partners in HIV serodifferent couples through integrated care programmes delivering both ART and PrEP [ 30 , 31 ]. Increasingly, PrEP is being integrated into other service points to cater for different populations, such as in antenatal clinics [ 32 , 33 ], family planning clinics [ 33 ], post‐abortion care [ 34 ] and STI clinics [ 35 ].…”

Factors associated with retention on pre-exposure prophylaxis among female sex workers in Kigali, Rwanda

“…The desire to stay healthy HIV free and bare HIV negative children has been noted as motivator to be retained on PrEP [ 38 ].Relatedly, the desire to stay healthy and maintain earning potential so as to take care of their children has also been cited as a motivator to being retained on PrEP [ 39 ]. This further emphasizes the need to integrate PrEP into sexual and reproductive health services [ 40 ]. FSW on PrEP that come to clinics for contraceptive counseling or for their next dose of injectable contraceptives get an opportunity to hear PrEP reinforcing messages [ 39 ].…”