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COMMIT HIV Trial Nepal

COMMIT HIV Acceptability and Feasibility Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04462679
Enrollment
86
Registered
2020-07-08
Start date
2020-02-25
Completion date
2021-07-01
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

low- and middle-income countries, mHealth, human-centered design and engineering, digital tools, Nepal, motivational interviewing, non-physician healthcare workers, community health workers, HIV

Brief summary

Community Healthcare Workers (CHWs), who live in the communities they serve, have the potential to reach patients who poorly engage in their care. Motivational Interviewing (MI) is a special type of interactional approach that focuses on improving the person's motivation to engage in healthy behaviors, such as keeping their clinic appointments and regularly taking medications. In this study, we will develop a mobile health tool that will assist CHWs in two tasks while they utilize MI to assist patients' engagement in care: 1) follow prompts on the mobile device to deliver MI; and 2) record consented conversations between CHWs and patients so that MI specialists can review the audiotape and provide feedback to maintain the MI skills.

Interventions

We will develop Community-based mHealth Motivational Interviewing Tool (COMMIT) using iterative design and testing with frequent, structured input from the key stakeholders: community health workers (CHWs), their supervisors and youth living with HIV (YLWH).The tool will be used by community CHWs in Achham, Nepal to: 1) obtain decision-support to deliver motivational interviewing (MI) for patients in their communities, and 2) capture consented audio recordings of client interactions for review and feedback by their supervisors, allowing CHWs to maintain MI skills beyond the initial training period.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Francisco
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health
CollaboratorUNKNOWN
Nyaya Health Nepal
CollaboratorUNKNOWN
Ministry of Health and Population, Nepal
CollaboratorOTHER_GOV
Possible
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Inclusion criteria for patient population: 1) having a documented HIV diagnosis, 2) living in the community health worker catchment area at the Nepal research site and , 3) having poor adherence (missed a clinic visit by more than 2 weeks, \<95% adherence from visual analogue scale and/ or failed to refill their antiretroviral medications 1 week past the expected date) 2. Inclusion criteria for community health worker or a community health worker supervisor: living/working at the Nepal research site who has received motivational interviewing training as part of the intervention, and are involved directly in program implementation process.

Exclusion criteria

1.

Design outcomes

Primary

MeasureTime frameDescription
CD4 count9 monthsIndividual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold
HIV viral load9 monthsIndividual HIV viral load count, measured at baseline and endline, with viral load suppression or \>2 log drop in viral load as binary suppressed/not threshold
Self-reported HIV treatment adherence9 monthsIndividual ART medication adherence over past month as measured by the self-reported HIV visual analogue scale (scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to a stronger outcome; patients asked to self-report what proportion of prescribed medications did the patient take over the past month).

Secondary

MeasureTime frameDescription
Application access and completion percentage9 monthsFrequency of community health worker accessing mobile application during study (number of times mobile application is accessed/data are entered and completed as a proportion of patients assigned for follow-up)
Patient encounter duration9 monthsTotal amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)
Application error/crash percentage9 monthsFrequency of mobile application displaying error messages or crashing while in use by community health workers during patient encounters (proportion of all patient encounters where an error message/application crashes occurs)

Countries

Nepal

Contacts

Primary ContactBibhav Acharya, MD
Bibhav.Acharya@ucsf.edu9176539358
Backup ContactDuncan Maru, MD, PhD
duncan.maru@mssm.edu2128247950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026