NCT03052010

The Partners Scale-Up Project

Completed Phase 4 Last updated 19 October 2021

What this trial tests

Phase 4 trial testing Integrated PrEP as a bridge to ART HIV-1 prevention strategy in HIV-1-infection in 4,898 participants. Completed in 30 April 2021.

Timeline

6 February 2017

Primary endpoint
15 December 2020

30 April 2021

Quick facts

Lead sponsor	University of Washington
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	4,898
Start date	6 February 2017
Primary completion	15 December 2020
Estimated completion	30 April 2021
Sites	2 locations across Kenya

Drugs / interventions tested

• Integrated PrEP as a bridge to ART HIV-1 prevention strategy
• PrEP — full drug profile →
• ART — full drug profile →

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

University of Washington

Who can join

18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial.
   Irungu EM, Mugwanya KK, Mugo NR, Bukusi EA, et al · · 2021 · cited 38× · PMID 34798031 · DOI 10.1016/s2214-109x(21)00391-0
2. Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya.
   Mugwanya KK, Irungu E, Bukusi E, Mugo NR, et al · · 2018 · cited 31× · PMID 30180860 · DOI 10.1186/s13012-018-0809-7
3. Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector.
   Peebles K, Mugwanya KK, Irungu E, Odoyo J, et al · · 2021 · cited 18× · PMID 34399736 · DOI 10.1186/s12913-021-06832-3
4. Integrating PrEP into HIV care clinics could improve partner testing services and reinforce mutual support among couples: provider views from a PrEP implementation project in Kenya.
   Odoyo JB, Morton JF, Ngure K, O'Malley G, et al · · 2019 · cited 17× · PMID 31321911 · DOI 10.1002/jia2.25303
5. Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics.
   Irungu EM, Odoyo J, Wamoni E, Bukusi EA, et al · · 2021 · cited 15× · PMID 34496148 · DOI 10.1002/jia2.25799
6. Training health care providers to provide PrEP for HIV serodiscordant couples attending public health facilities in Kenya.
   Irungu EM, Ngure K, Mugwanya K, Mugo N, et al · · 2019 · cited 12× · PMID 30871413 · DOI 10.1080/17441692.2019.1588908
7. Patterns of PrEP continuation and coverage in the first year of use: a latent class analysis of a programmatic PrEP trial in Kenya.
   Mugwanya KK, Palayew A, Schaafsma T, Irungu EM, et al · · 2023 · cited 8× · PMID 37403405 · DOI 10.1002/jia2.26137
8. Using an on-site modular training approach to amplify prep service delivery in public health facilities in Kenya.
   Irungu EM, Musau M, Nyerere B, Dollah A, et al · · 2022 · cited 4× · PMID 36962311 · DOI 10.1371/journal.pgph.0000092