Reducing Mobility-associated Interruption in HIV Treatment in Malawi

NCT07329166 | Recruiting

• 1 other identifier: K01MH138243
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to assess the feasibility and acceptability of an intervention package designed to reduce mobility-associated interruptions in HIV treatment in people living with HIV in Malawi who are initiating or returning to antiretroviral treatment (ART) after interruption. The main questions it aims to answer are:

• Is the intervention acceptable to healthcare workers and ART clients?
• Is the intervention feasible in the context of Malawi's health system, and what are the major operational challenges, resource requirements, and implementation barriers? In addition, researchers will compare HIV treatment outcomes (specifically ART retention rates) between intervention and control groups to establish a preliminary estimate of the intervention's efficacy. Participants will complete a survey on the day of enrollment and some participants will complete an in-depth interview and/or a survey after completion of the 6-month follow-up period. Facilities assigned to the intervention group will receive the full package of interventions (training on mobility-specific counseling for counsellors, access to a toll-free hotline for clients and healthcare workers, and training on multi-month dispensing for providers), while facilities assigned to the control group will provide standard of care.

Conditions

HIV

Keywords

mobility; antiretroviral therapy; HIV treatment interruption; ART retention; sub-Saharan Africa; Malawi; ART interruption

Outcome Measures

Primary Outcomes (2)

• Acceptability of REMIT intervention package

  To assess acceptability, we will analyse qualitative data from participant IDIs and HCW FGDs. We will code data from all IDIs and FGDs in Atlas.ti using inductive and deductive codes. Coded text will be analysed using grounded theory and guided by Human Centered Design principles.

  From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled

• Feasibility of REMIT intervention package

  To assess feasibility, we will analyse qualitative data from participant IDIs and HCW FGDs. We will code data from all IDIs and FGDs in Atlas.ti using inductive and deductive codes. Coded text will be analysed using grounded theory and guided by Human Centered Design principles. We will also review process implementation data, such as counselling recordings (fidelity of implementation and quality of counselling), the hotline register and recordings (number of calls, fidelity of implementation, and quality of counselling), and rates of MMD (compared between control and intervention facilities to assess the effectiveness of our MMD training, a component of fidelity of implementation).

  From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled

Secondary Outcomes (1)

• Preliminary estimate of efficacy

  From day of enrollment to 6 months after enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

Half of facilities will be randomized to intervention status and will receive the full package of interventions, including training on mobility-specific counseling for counsellors, access to a toll-free hotline for clients and healthcare workers, and training on multi-month dispensing for providers.

Behavioral: REMIT intervention package

Control

NO INTERVENTION

Half of facilities will be randomized to control status and will administer standard of care with no additional interventions offered.

Interventions

REMIT intervention package BEHAVIORAL

Intervention package includes three components: 1. Enhanced counseling: Counselors (PIH Treatment Supporters) will be trained to provide intervention counseling on mobility topics including how to prepare for travel and options for obtaining a refill while traveling. 2. Hotline: clients and HCWs at intervention facilities will receive information about a toll-free "hotline" staffed by a treatment supporter trained in mobility-related topics. The staffer will offer advice and coordination to support mobile clients and HCWs caring for them. 3. Training on MMD: HCWs at intervention facilities will be trained on the benefits of MMD especially for mobile clients. The MMD prescribing guidelines will be aligned with routine care and national ART guidelines, but this additional training on the benefits of MMD and its applicability to mobility will be only offered at intervention facilities.

Intervention

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
• Attending ART clinic to initiate OR re-initiate care:
• Initiate: initiating ART for the first time, per self-report
• Re-initiate: returning to care after missing a refill appointment by \>28 days

You may not qualify if:

• Attending ART clinic on behalf of someone else (i.e. guardian)
• Attending ART clinic only to obtain emergency refill
• Attending ART clinic for a routine refill without a recent \>=28 days interruption in treatment
• Transferring in to study facility without a preceding interruption in treatment of \>=28 days

Sponsors & Collaborators

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

Study Sites (1)

Partners in Hope

Lilongwe, Malawi

RECRUITING

Central Study Contacts

Marguerite Thorp, MD, MPA/ID

CONTACT

(310) 267-5844; mthorp@mednet.ucla.edu

Kathryn Dovel, PhD, MPH

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: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 9, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: By the time of publication of primary results for a minimum of 5 years.
• Access Criteria: Access managed via NIMH Data Archive.

Locations

MA (1)