RecruitingNot ApplicableNCT07329166

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

Sponsor

University of California, Los Angeles

Enrollment

400 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

HIV

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

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new support approach to help people living with HIV in Malawi stay on their HIV medication (antiretroviral therapy, or ART), especially those who have recently missed appointments or moved around frequently. Mobility and life disruptions are common reasons people fall off treatment, and this study aims to address that. **You may be eligible if...** - You are 15 years or older - You are living with HIV - You are visiting an ART clinic to start HIV treatment for the first time, OR returning after missing an appointment by more than 28 days **You may NOT be eligible if...** - You are visiting the clinic to pick up medication on behalf of someone else - You are only there for an emergency refill - You are attending for a routine refill without any prior gap in treatment - You are transferring from another clinic without a prior treatment interruption Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALREMIT intervention package

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.