Integrating oral pre-exposure prophylaxis delivery in primary care family planning clinics: a pragmatic, stepped-wedge, cluster-randomised trial.

Background: Integrating pre-exposure prophylaxis (PrEP) delivery in family planning (FP) settings may offer an efficient platform to reach women at elevated risk for HIV. Methods: We conducted a stepped-wedge cluster randomized trial to integrate systematic screening for HIV risk and PrEP delivery in twelve public FP clinics in Kisumu County, Kenya. Clients were HIV-negative women 15-49 years accessing the participating clinics. Each clinic represented a cluster, and four clinics sequentially transitioned from usual care (control) to the intervention period in a randomized staged order every three-month interval. The intervention included provider training and technical support to build FP clinic staff capacity to deliver PrEP as part of the standard of care. There was no masking. Oral PrEP was free to clients. A subset of women assessed to be at elevated HIV risk including those who declined PrEP were enrolled in nested cohort and followed quarterly up to 24 months to measure HIV incidence. The primary outcomes were the proportion of women screened for oral PrEP among those attending FP clinics and PrEP initiation among women screened and assessed to be eligible for PrEP. Analysis was intention-to-treat, with all women not known to be living with HIV at the first clinic visit encounter included in the analysis for the HIV risk and PrEP screening outcome. This trial is registered with ClinicalTrials.gov., NCT04666792 and completed. Results: Between March 1, 2021 and December 31, 2022, 25457 HIV-negative women visited twelve FP clinics contributing 7386 woman-encounters during control period and 21343 woman-encounters during the intervention period. Median age was 27 (IQR 23-31) years. The proportion of woman-encounters screened for PrEP significantly increased from 2.9% (213/7386) to 91.6% (19560/21343) (relative risk: 20·5, 95%CI 3·5-120.4; p=0·0008). Oral PrEP initiation among women assessed to be at elevated HIV risk increased from 3.9% (5/120) to 40.6% (985/2429) (relative risk: 50·1, 95%CI 2·8-913.4; p=0·0082). Five HIV infections occurred during 833·4 women-years of cohort follow-up (incidence 0.60 95%CI 0.19-1.40 per 100 woman-years). All infections were in women who either declined PrEP (n=3) or had undetectable tenofovir diphosphate in dried blood spots at multiple visits prior to seroconversion (n=2). Interpretation: An implementation intervention package to build capacity of public clinic FP healthcare providers successfully led to integration of oral PrEP delivery in real-world FP clinics in Kenya. These findings could help inform similar strategies in FP clinics in other African settings.