COMMIT HIV Trial Nepal

COMMIT HIV Acceptability and Feasibility Trial

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.

Study Overview

• Status: Unknown
• Conditions: Hiv
• Intervention / Treatment: Other: COMMIT mHealth application

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Achham/Province 7
    • Sanfebagar-10, Achham/Province 7, Nepal
      • Recruiting
      • Bayalpata Hospital
      • Contact: Sabitri Sapkota, PhD, MPH; Phone Number: +977 14100597; Email: sabitri.sapkota@nyayahealthnepal.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4 count	Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold	9 months
HIV viral load	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	9 months
Self-reported HIV treatment adherence	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).	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Application access and completion percentage	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)	9 months
Patient encounter duration	Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)	9 months
Application error/crash percentage	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)	9 months

Collaborators and Investigators

• Sponsor: Possible
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Anticipated): November 25, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HIV; mHealth; motivational interviewing; Nepal; low- and middle-income countries; human-centered design and engineering; digital tools; non-physician healthcare workers; community health workers
• Other Study ID Numbers: COMMITHIVNyaya; 1R34MH118049-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No