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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH123267 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Kenyatta National Hospital | OTHER_GOV |
| Kenya National AIDS & STI Control Programme | OTHER |
| Kisumu County Government |
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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.
Investigators will conduct a stepped-wedge cluster-randomized programmatic project to integrate PrEP provision within a combination HIV prevention package in 12 family planning clinics in Kisumu, Kenya- a region with an HIV prevalence of up to 28% among young women. The project will optimize and sustain PrEP delivery with existing family planning staff, supported through training and ongoing technical assistance. The investigators will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using validated implementation science frameworks and how clinics build new efficient delivery systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP for HIV-1 uninfected for women accessing family planning | Other | Women accessing family planning will be assessed for HIV risk and PrEP eligibility. If eligible and willing to initiate PrEP, they will be provided PrEP in accordance with national guidelines as part of their standard of care at the family planning clinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP | Drug | A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women accessing family planning services who are screened for HIV risk | Measure HIV risk screening completion among women receiving family planning services | up to 24 months |
| Proportion of women accessing family planning services who uptake PrEP for HIV prevention | Measure PrEP initiation among women receiving family planning services | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP adherence quantified by tenofovir drug levels in blood | Measure PrEP adherence among women who initiate PrEP | up to 24 months |
| Proportion of women who remain HIV-negative | Assess HIV status of women receiving family planning services |
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Inclusion Criteria:
Exclusion Criteria:
- Otherwise not eligible based on the above inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Mugwanya, MBChB, MS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenyatta National Hospital | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42232582 | Derived | 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. | |
| 41802176 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2026 | |
| Reset | May 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2026 | May 15, 2026 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| UNKNOWN |
This a programmatic stepped-Wedge cluster randomized trial
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| up to 24 months |
| Proportion of family planning clinics that implement PrEP provision | Measure number of clinics that provide PrEP | up to 36 months |
| Proportion of targeted providers who are trained and provide PrEP | Measure number of providers in family planning clinics who implement PrEP | up to 24 months |
| Proportion of core PrEP delivery components delivered per protocol | Measure fidelity to PrEP delivery procedures in family planning clinics | up to 24 months |
| Facilitators and barriers to PrEP implementation | Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol | up to 24 months |
| Programmatic costs of providing PrEP in family planning clinics | Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing PrEP in family planning clinics | up to 24 months |
| Develop data tools to expand and support delivery of family planning and HIV prevention services | Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation | up to 24 months |
| 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. |
| 34895357 | Derived | 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. |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |