COMMIT HIV Trial Nepal

NCT ID: NCT04462679

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-25
• Study Completion Date: 2021-07-01

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.

Conditions

Hiv

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pilot arm

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

Group Type: EXPERIMENTAL

COMMIT mHealth application

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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. 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

2. Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health

UNKNOWN

Sponsor Role: collaborator

Nyaya Health Nepal

UNKNOWN

Sponsor Role: collaborator

Ministry of Health and Population, Nepal

OTHER_GOV

Sponsor Role: collaborator

Possible

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bayalpata Hospital

Sanfebagar-10, Achham/Province 7, Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Bibhav Acharya, MD

Role: CONTACT

Bibhav.Acharya@ucsf.edu

9176539358

Duncan Maru, MD, PhD

Role: CONTACT

duncan.maru@mssm.edu

2128247950

Facility Contacts

Sabitri Sapkota, PhD, MPH

Role: primary

sabitri.sapkota@nyayahealthnepal.org

+977 14100597

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34MH118049-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

COMMITHIVNyaya

Identifier Type: -

Identifier Source: org_study_id