drugset / Trial / NCT03052010
The Partners Scale-Up Project
Phase 4
Completed
4898 enrolled
University of Washington
Bill and Melinda Gates Foundation · collabKenya Medical Research Institute · collabKenya National AIDS & STI Control Programme · collabNational Institute of Mental Health (NIMH) · collab
NaSingle-groupOpen-labelPrevention
Summary
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.
Timeline
- Start
- 2017-02-06
- Primary completion
- 2020-12-15
- Completion
- 2021-04-30
Publications
- Irungu EM, Mugwanya KK, Mugo NR, Bukusi EA, Donnell D, Odoyo J, Wamoni E, Peacock S, Morton JF, Ngure K, Mugambi M, Mukui I, O'Malley G, Baeten JM; Partners Scale-Up Project Team. Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial. Lancet Glob Health. 2021 Dec;9(12):e1730-e1739. doi: 10.1016/S2214-109X(21)00391-0.
- Irungu EM, Odoyo J, Wamoni E, Bukusi EA, Mugo NR, Ngure K, Morton JF, Mugwanya KK, Baeten JM, O'Malley G; Partners Scale-Up Project Team. Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics. J Int AIDS Soc. 2021 Sep;24(9):e25799. doi: 10.1002/jia2.25799.
- Peebles K, Mugwanya KK, Irungu E, Odoyo J, Wamoni E, Morton JF, Ngure K, Bukusi EA, Mugo NR, Masyuko S, Mukui I, Baeten JM, Barnabas RV; Partners Scale-Up Project Team. Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector. BMC Health Serv Res. 2021 Aug 16;21(1):823. doi: 10.1186/s12913-021-06832-3.
- Irungu EM, Ngure K, Mugwanya K, Mugo N, Bukusi E, Wamoni E, Odoyo J, Morton JF, Bernabee G, Mambo B, Masyuko S, Mukui I, O'Malley G, Baeten JM. Training health care providers to provide PrEP for HIV serodiscordant couples attending public health facilities in Kenya. Glob Public Health. 2019 Oct;14(10):1524-1534. doi: 10.1080/17441692.2019.1588908. Epub 2019 Mar 14.
- Mugwanya KK, Irungu E, Bukusi E, Mugo NR, Odoyo J, Wamoni E, Ngure K, Morton JF, Peebles K, Masyuko S, Barnabee G, Donnell D, Barnabas R, Haberer J, O'Malley G, Baeten JM; Partners Scale Up Team. Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya. Implement Sci. 2018 Sep 4;13(1):118. doi: 10.1186/s13012-018-0809-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Subject | emtricitabine | Other / unclassified | — | Oral |