An interventional study of REMIT intervention package in HIV, sponsored by University of California, Los Angeles. Recruiting at 1 site in Malawi. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Health services research
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:
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.
RATIONALE FOR RESEARCH: While Malawi has made tremendous progress towards ending the HIV epidemic - nearly reaching UNAIDS' 95-95-95 target goals (95% of people living with HIV know their status, 95% of people living with HIV have initiated ART, and 95% of those on ART reach viral suppression) - certain sub-groups of people living with HIV continue to face challenges remaining in care. One key issue that perpetuates this cycle of interruption, re-initiation, and re-interruption is mobility, or temporary travel, which is the number one reason for interruption in treatment (IIT) across several of our recent studies. Mobile people living with HIV require additional interventions to stay in care and reduce IIT. In the REMIT study (Reducing Mobility-associated Interruption in HIV Treatment), we will pilot a package of interventions that have been co-created with ART clients, healthcare workers (HCWs), and community and national stakeholders. The REMIT intervention package will include: enhanced counselling at initiation or re-initiation; a toll-free line for mobile clients and HCWs; and trainings for HCWs on the benefits of multi-month dispensing (MMD).
Study design and rationale: We propose a cluster-randomized control trial to pilot these interventions at three facilities, comparing results with three control facilities (total n=6 facilities). This cluster-randomized design is appropriate for testing interventions that are offered to healthcare workers (specifically training on an enhanced counselling curriculum and the benefits of MMD); each intervention facility will receive the full intervention package.
Population: The study population will include ART clients (≥15 years) who are initiating or re-initiating ART >28 days after a missed appointment. We will enrol n=400 men and women attending ART clinic for their own care.
We will randomly select a subset of participants from intervention facilities for additional in-depth interviews. We will also conduct focus group discussions with healthcare workers working in the ART clinic at intervention facilities.
People living with HIV and health care providers will be included in the study. Participants will be in good health so that they are feeling well and able to participate in the study. Participants will not be excluded if they are experiencing minor illness symptoms.
We will not exclude pregnant women who are otherwise eligible for the study, because they may benefit from our interventions and our interventions pose no additional risk to pregnant women relative to the general population. We will include minors aged 15-17 if they are receiving care in the general ART clinic because they may also benefit from our interventions; their participation will require parent/guardian consent and participant assent.
Research assistants will recruit participants from facilities on ART clinic days, working with facility HCWs to identify potentially eligible participants and conducting screening, consent, eligibility, and baseline survey procedures during waiting time or after the facility visit has concluded.
Interventions: Our intervention package includes three components:
Research procedures:
Baseline survey: All enrolled participants will complete a baseline survey including modules on sociodemographic characteristics and economic indicators, ART and other health history, ART knowledge, HIV stigma and disclosure status, mobility history and patterns, and other risk factors for treatment interruption including depression and alcohol use.
Implementation data: We will collect data on the implementation of the intervention, including counselling recordings, counselling progress notes, a register of calls to the hotline and call recordings, and facility-level data on MMD.
Medical chart reviews: We will conduct medical chart reviews to determine ART retention outcomes and exposure to MMD for all enrolled participants.
Follow-up survey: For all participants with chart-review evidence of treatment interruption and a subset of matched controls, we will conduct community tracing to administer a follow-up survey including updated socioeconomic and ART risk factor characteristics, verification of chart review outcomes, satisfaction with services and interventions, adverse events, and mobility during trial.
IDIs: We will conduct in-depth interviews with a subset of participants to assess intervention acceptability.
FGDs: We will conduct focus group discussions with healthcare workers to assess intervention acceptability and feasibility.
Attending ART clinic to initiate OR re-initiate care:
Exclusion Criteria:
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
Half of facilities will be randomized to control status and will administer standard of care with no additional interventions offered.
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.
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.
Time frame: 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).
Time frame: From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled
Preliminary estimate of efficacy
We will use medical chart reviews and follow-up tracing surveys to determine rates of interruption in treatment (IIT, defined as missing an ART refill appointment by \>28 days; of note, obtaining an emergency refill at another facility within 28 days of missing the appointment at a home facility will not be considered an IIT) among all participants.
Time frame: From day of enrollment to 6 months after enrollment
Plan to share: Yes — Fully de-identified data (including baseline surveys conducted at enrollment, medical chart reviews, endline surveys conducted after 6-month follow-up, and summaries of in-depth interviews and focus group discussions), will be uploaded to the NIMH Data Archive.
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University of California, Los Angeles