Reducing mobility-related treatment interruptions for people with HIV 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
This pilot tests a package of enhanced counseling, a toll-free helpline, and provider training to help people with HIV in Malawi who travel stay on antiretroviral treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT07329166 on ClinicalTrials.gov |
What this trial studies
This pilot uses a cluster-randomized design at six facilities (three intervention, three control) to test a co-created intervention package aimed at reducing mobility-associated interruptions in ART. The package includes enhanced counseling at initiation or re-initiation, a toll-free line for mobile clients and healthcare workers, and trainings to promote multi-month dispensing. Eligible participants (age ≥15) are people living with HIV who are initiating ART or returning to care after missing a refill by 28 days or more; participants complete enrollment surveys and some will have in-depth interviews after six months. The trial will measure feasibility and acceptability among clients and healthcare workers and compare 6-month ART retention between arms to provide a preliminary estimate of efficacy and identify operational barriers to scale-up.
Who should consider this trial
Good fit: People aged 15 or older living with HIV in Malawi who are initiating ART for the first time or returning to care after missing a refill by 28 days or more at participating clinics.
Not a fit: Those attending on behalf of someone else, seeking only an emergency refill, transferring in without a recent interruption, or already stable on routine refills without a recent interruption are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce treatment interruptions among mobile people with HIV, improving ART retention and long-term viral suppression.
How similar studies have performed: Enhanced counseling and multi-month dispensing have improved retention in other sub-Saharan African programs, while toll-free helplines and mobility-focused packages have been less widely tested but show promising, mixed results in mobile-support interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 15 years of age or older 2. Living with HIV 3. Attending ART clinic to initiate OR re-initiate care: 1. Initiate: initiating ART for the first time, per self-report 2. Re-initiate: returning to care after missing a refill appointment by \>28 days Exclusion Criteria: 1. Attending ART clinic on behalf of someone else (i.e. guardian) 2. Attending ART clinic only to obtain emergency refill 3. Attending ART clinic for a routine refill without a recent \>=28 days interruption in treatment 4. Transferring in to study facility without a preceding interruption in treatment of \>=28 days
Where this trial is running
Lilongwe
- Partners in Hope — Lilongwe, Malawi (Recruiting)
Study contacts
- Study coordinator: Marguerite Thorp, MD, MPA/ID
- Email: mthorp@mednet.ucla.edu
- Phone: (310) 267-5844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.