Reducing Mobility-associated Interruption in HIV Treatment in Malawi
Reducing Mobility-associated Interruption in HIV Treatment in Malawi (REMIT): Pilot Trial to Assess Acceptability and Feasibility of a Mobility-specific Intervention Package
University of California, Los Angeles
400 participants
Dec 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria4
- 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
Interventions
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.
Locations(1)
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NCT07329166