{"doi":"10.1016/j.lanprc.2025.100057","title":"Integrating oral pre-exposure prophylaxis delivery in primary care family planning clinics: a pragmatic, stepped-wedge, cluster-randomised trial","abstract":"Background Integrating pre-exposure prophylaxis (PrEP) delivery in family planning settings might offer an efficient platform to reach women at increased risk for HIV. This study aimed to prospectively assess the effectiveness of a health-care provider capacity-building intervention on the integration of oral PrEP delivery in family planning clinics in Kenya. Methods We conducted a stepped-wedge cluster-randomised trial in 12 public family planning clinics in Kisumu County, Kenya. Clients were female, HIV-negative, aged 15–49 years, and accessed the participating clinics. Each clinic represented a cluster, and the clinics were randomly assigned to three groups of four clinics, which were then randomly assigned to the order that they sequentially transitioned from the usual-care period to the intervention period (with the randomisation sequence based on a web-based wheel-of-fortune program) every 3 months. The intervention included provider training and technical support to build family planning clinic staff capacity to deliver oral PrEP as part of the standard of care. There was no masking. A subset of clients assessed to be at increased risk of HIV, including among those who declined oral PrEP, were enrolled in a nested cohort and followed up every 3 months up to 24 months to measure HIV incidence. The primary outcomes were the proportion of women without HIV who were screened for oral PrEP among those attending family planning clinics and the proportion of women who initiated PrEP among those screened and determined to be eligible for PrEP. The primary analysis was done per intention to treat, which included all women not known to have HIV at the first clinic encounter. This trial is registered with ClinicalTrials.gov (NCT04666792) and is complete. Findings Between March 1, 2021, and Dec 31, 2022, 25 457 women negative for HIV visited the family planning clinics, contributing 7386 encounters from 7058 women during the usual-care period and 21 343 encounters from 18 399 women during the intervention period. Median age was 27 years (IQR 23–31). The proportion of women encountered screened for PrEP significantly increased from 2·9% (213 of 7386 encounters) in the usual-care period to 91·6% (19 560 of 21 343) in the intervention period (relative risk 20·5 [95% CI 3·5–120·4]; p=0·0008). Oral PrEP initiation among women assessed to be eligible for PrEP increased from 4·2% (five of 120) to 40·6% (985 of 2429; relative risk 50·1 [95% CI 2·8–913·4]; p=0·0082). In the nested cohort (n=650), five new HIV infections occurred during 833·4 woman-years of follow-up (incidence 0·60 cases per 100 woman-years [95% CI 0·19–1·40]). All HIV infections were in women who either declined PrEP (n=3) or had undetectable tenofovir diphosphate in dried blood spot samples at multiple visits before seroconversion (n=2). Interpretation An implementation intervention package to build the capacity of public family planning health-care providers successfully led to integration of oral PrEP delivery in real-world family planning clinics in Kenya. These findings could help inform similar strategies in family planning clinics in other African settings. Funding National Institute of Mental Health.","journal":"The Lancet Primary Care","year":2025,"id":554511,"datarank":0.10397207708399181,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.0,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":1,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9538,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04666792"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":445175,"name":"Daniel Matemo","orcid":"0000-0002-7209-1648","position":1,"is_corresponding":false},{"id":562260,"name":"Allison Meisner","orcid":"0000-0001-5177-7635","position":2,"is_corresponding":false},{"id":547276,"name":"Torin Schaafsma","orcid":null,"position":3,"is_corresponding":false},{"id":505088,"name":"Jennifer F. 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Baeten","orcid":"0000-0001-8242-8438","position":15,"is_corresponding":false},{"id":299054,"name":"John Kinuthia","orcid":"0000-0001-6571-8927","position":16,"is_corresponding":false},{"id":323802,"name":"Kenneth K. Mugwanya","orcid":"0000-0001-5208-7468","position":0,"is_corresponding":true}],"reference_count":21,"raw_metadata":null,"created_at":"2026-07-19T02:54:50.112989Z","pmid":"42232582","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}