Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi

NCT07220278 | Recruiting DMC

• 1 other identifier: R01MH139452
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

client empowerment; HIV services; HIV treatment interruption; Malawi; eastern and southern Africa

Outcome Measures

Primary Outcomes (1)

• Proportion of clients with viral suppression at 12-months (<1,000 copies/ML)

  Test the effectiveness of CHOICE versus SOC on 12-month viral suppression among TI clients. Primary outcome is viral suppression at 12-months (\<1,000 copies/ML).

  12 months after enrollment

Secondary Outcomes (5)

• Viral suppression at 24 months

  24 months after enrollment

• Advanced HIV at 12 and 24 months

  at 12 and 24 months after enrollment

• ART re-initiation

  3 months after enrollment

• Repeat treatment interuption

  6, 12, and 24 months after enrollment.

• Adverse Events

  Ongoing after enrollment to 24 months

Study Arms (2)

CHOICE

EXPERIMENTAL

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.

Behavioral: CHOICE

Standard of Care

NO INTERVENTION

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.

Interventions

CHOICE BEHAVIORAL

Routine HIV counselors will provide person-centered counseling and guide clients through a facilitated choice process to select DSDs and other support services routinely available to participating facilities. ART providers will review client preferences alongside client clinical assessments, resulting in a shared decision making of what DSD and support services is clinical safe and preferred for the client. Clients can change their preferred choice at any point throughout study enrollment. Ongoing, dynamic choice of available DSD models is a feasible and likely safe way to optimize the benefits of choice and provide responsive services for TI clients.

CHOICE

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• pregnant women because the ART/antenatal care (ANC) programs are integrated and require additional considerations and linkages with antenatal services.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator
• Partners in Hope, Inc.: collaborator
• Boston University: collaborator

Study Sites (1)

Partners in Hope

Lilongwe, Malawi

RECRUITING

Study Officials

• Kathryn L Dovel, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Augustine Choko, PhD

  Partners in Hope, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn L Dovel, PhD

CONTACT

310-267-5844; kdovel@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 23, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

MA (1)