drugset / Trial / NCT04666792
PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
Phase 4
Completed
25457 enrolled
University of Washington
Kenya National AIDS & STI Control Programme · collabKenyatta National Hospital · collabKisumu County Government · collabNational Institute of Mental Health (NIMH) · collab
NaSingle-groupOpen-labelPrevention
Summary
This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Outcome
Met primary endpoint
paper The proportion of woman-encounters screened for PrEP significantly increased from 2.9% (213/7386) to 91.6% (19560/21343) PMID 42232582 ↗
paper Oral PrEP initiation among women assessed to be at elevated HIV risk increased from 3.9% (5/120) to 40.6% (985/2429) PMID 42232582 ↗
Publications
- Mugwanya KK, Matemo D, Meisner A, Schaafsma T, Morton J, Wandera C, Kemunto V, Cherotich I, Odhiambo S, Bii M, Oduor B, Achieng E, Oyombra T, Owaga D, Beima-Sofie KM, Baeten JM, Kinuthia J. Integrating oral pre-exposure prophylaxis delivery in primary care family planning clinics: a pragmatic, stepped-wedge, cluster-randomised trial. Lancet Prim Care. 2025 Nov;1(5):100057. doi: 10.1016/j.lanprc.2025.100057. Epub 2025 Nov 21.
- Mukasa D, Kinuthia J, Meisner A, Matemo D, Schaafsma T, Morton J, Wandera C, Budiawan E, Kemuto V, Irine C, Odhiambo S, Bii M, Oduor B, Achieng E, Oyombra T, Ukah UV, Mugwanya KK; FP Plus Project Team. Oral preexposure prophylaxis use and the risk of bacterial sexually transmitted infections and HIV among African women: A prospective observational cohort study. PLoS Med. 2026 Mar 9;23(3):e1004962. doi: 10.1371/journal.pmed.1004962. eCollection 2026 Mar.
- Mugwanya KK, Matemo D, Scoville CW, Beima-Sofie KM, Meisner A, Onyango D, Mugambi M, Feutz E, Grabow C, Barnabas R, Weiner B, Baeten JM, Kinuthia J; FP Plus Team. Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya. Implement Sci Commun. 2021 Dec 11;2(1):135. doi: 10.1186/s43058-021-00228-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Subject | emtricitabine | Other / unclassified | — | Oral |