COMMIT HIV Trial Nepal

Sponsor

Possible (Other)

Overall Status

Unknown status

CT.gov ID

NCT04462679

Collaborator

National Institute of Mental Health (NIMH) (NIH), University of California, San Francisco (Other), Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health (Other), Nyaya Health Nepal (Other), Ministry of Health and Population, Nepal (Other)

Enrollment

Location

Arm

16.2

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Other: COMMIT mHealth application	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

COMMIT HIV Acceptability and Feasibility Trial

Actual Study Start Date :

Feb 25, 2020

Anticipated Primary Completion Date :

Nov 25, 2020

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pilot arm Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application	Other: COMMIT mHealth application 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.

Arm

Intervention/Treatment

Experimental: Pilot arm

Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application

Other: COMMIT mHealth application

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.

Outcome Measures

Primary Outcome Measures

CD4 count [9 months]
Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold
HIV viral load [9 months]
Individual 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 adherence [9 months]
Individual 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 Outcome Measures

Application access and completion percentage [9 months]
Frequency 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 duration [9 months]
Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)
Application error/crash percentage [9 months]
Frequency 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 ,

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)

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:

Exclusion criteria for patient population: includes decision from the patient to not receive care delivered by care provider at the Nepal research site or not to participate in the study
Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bayalpata Hospital	Sanfebagar-10	Achham/Province 7	Nepal

Sponsors and Collaborators

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