Peer-led DCP Study:
Title: Peer-led Dynamic Choice HIV Prevention for Women at Elevated HIV Risk in Uganda: The Peer-led DCP Study.
Study period: August, 2024-April, 2029
Study synopsis: This study is in two phases. In Aim 1, we refined and pilot tested the Peer-led Dynamic Choice HIV Prevention (DCP) intervention in a single-arm pilot trial in Ibanda district to test the hypothesis that the Peer-led Dynamic Choice HIV Prevention intervention will be feasible, acceptable, and increase biomedical HIV prevention coverage in the 6 months after receipt of the Peer-led DCP intervention compared to the standard of care in the 6 months prior to intervention implementation. Aim 2 is a Hybrid Type 1 cluster-randomised trial to test the Peer-led DCP intervention against the standard of care. The trial will include 14 clusters, each within the catchment area of a government health centre that offers standard-of-care HIV prevention services. The trial population will include approximately 560 HIV-noninfected women with a PrEP indication or at elevated risk of HIV exposure followed for up to 96 weeks.
Objectives:
Aim 1 Primary Objective: To refine and pilot test a Peer-led Dynamic Choice HIV Prevention intervention for women at elevated HIV risk in southwestern Uganda
Aim 2 Primary Objective: To test the effectiveness and implementation outcomes of a Peer-led Dynamic Choice HIV Prevention intervention for women in Western and South-central Uganda
Study site: Western and South-central Uganda.
Collaborators: Infectious Diseases Research Collaboration (IDRC), Makerere University College of Health Sciences, University of California San Francisco, University of California, Berkeley.
Principle investigators: Dr Jane Kabami, Dr Catherine A. Koss.
Co-investigators: Prof Moses R. Kamya, Dr Laura B. Balzer, Dr Cecilia Akatukwasa, Dr Carol Camlin, Dr Diane V. Havlir, Dr Elijah Kakande, Dr Starley Shade.
Study sponsor: University of California, San Francisco (UCSF).
Study funder: National Institute of Mental Health, R01MH137799.
