Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi

Repeat and prolonged treatment interruption (TI) is common and the major threat to HIV epidemic control in eastern and southern Africa. The proposed project will test an innovative long-term dynamic choice intervention for ART clients experiencing TI in Malawi. Findings will provide essential information on how to improve sustained retention among TI client, a critical step to curbing the HIV epidemic. TI clients need long-term, responsive interventions. There are no one-size fits all intervention to support long-term care for TI clients because clients experience vastly different and changing barriers to care. While health facilities do have limited capacity for adding new services, existing services can be packaged differently to meet clients' needs. Long-term, dynamic choice of services is one way to provide responsive services and promotes client ownership over care. The investigators propose to give TI clients long-term, dynamic choice of what services they receive and how they receive it (drawing from key building blocks of DSD). Long-term, dynamic choice puts clients in the driver's seat and may be the best practical strategy to provide long-term and responsive TI interventions that are tailored to clients' evolving life circumstances. Dynamic choice is frequently used for HIV prevention and family planning products, whereby clients select the type of health product that works best for them (i.e., condoms, injectables, etc.). Choice of these services is strongly associated with improved outcomes. The goal of this clinical trial is to determine if CHOICE can improve outcomes in TI clients, compared to standard of care (SOC). Participants will be randomly assigned to either the CHOICE or SOC group, and follow them for 12 months. The primary outcome will be viral suppression at 12 months.

NCT Number	NCT07220278
Lead Sponsor	University of California, Los Angeles Collaborators: National Institute of Mental Health (NIMH), Partners in Hope, Inc., Boston University
Conditions	HIV
Enrollment	800 participants
Start Date	2025-11-17
Primary Completion	2028-07-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-18