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Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi (CHOICE)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:

• 15 years of age or older

• living with HIV;

• initiated ART for the first time\>3-months ago (i.e., not a new initiate);

• non-pregnant;

• experienced Treatment Interuptions during their most recent ARTappointment (\>28 days late).

Locations
Other Locations
Malawi
Partners in Hope
RECRUITING
Lilongwe
Contact Information
Primary
Kathryn L Dovel, PhD
kdovel@mednet.ucla.edu
310-267-5844
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 800
Treatments
Experimental: CHOICE
The CHOICE intervention will provide long-term person-centered counseling + long-term, dynamic choice of DSD services to TI clients in Malawi over a 24-month period.
No_intervention: Standard of Care
TI clients will be offered long-term person-centered counseling tailored to TI clients. The Malawi Ministry of Health adopted findings from previous trials and is incorporating short-term person-centered counseling into standard of care (SOC) for TI clients. This will be the SOC control condition.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Boston University, National Institute of Mental Health (NIMH), Partners in Hope, Inc.

This content was sourced from clinicaltrials.gov