Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi

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

Interventions

BEHAVIORAL

CHOICE

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Partners in Hope, Inc.

  collaborator INDUSTRY

• Boston University

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Kathryn L Dovel, PhD · University of California, Los Angeles

• Augustine Choko, PhD · Partners in Hope, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-17

Primary Completion

2028-07-01

Completion

2029-07-01

Countries

• Malawi

Study Locations