Reducing Mobility-associated Interruption in HIV Treatment in Malawi (REMIT)

January 8, 2026 updated by: Marguerite Thorp, MD, MPA/ID, University of California, Los Angeles

Reducing Mobility-associated Interruption in HIV Treatment in Malawi (REMIT): Pilot Trial to Assess Acceptability and Feasibility of a Mobility-specific Intervention Package

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  1. Enhanced counseling: at facilities supported by Partners in Hope, routine care counselling is offered to clients including those initiating and re-initiating care, and covers topics such as HIV basics, disclosure, and adherence. We will be training counselors (PIH Treatment Supporters) to provide intervention counselling 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. This hotline is not part of standard of care; however, the hotline staff will provide assistance to any caller, regardless of whether they are enrolled participants or working in an intervention facility or not.
  3. Training on MMD: in an effort to increase rates of MMD offered to mobile clients, we will conduct a training for HCWs at intervention facilities 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.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of REMIT intervention package
Time Frame: From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled
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
Time Frame: From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preliminary estimate of efficacy
Time Frame: From day of enrollment to 6 months after enrollment
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.
From day of enrollment to 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Partners in Hope, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K01MH138243 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

By the time of publication of primary results for a minimum of 5 years.

IPD Sharing Access Criteria

Access managed via NIMH Data Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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