COMMIT HIV Trial Nepal

Hiv Clinical Trial

Official title:

COMMIT HIV Acceptability and Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462679
• Other study ID #: COMMITHIVNyaya
• Secondary ID: 1R34MH118049-01
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2020
• Source: Possible
• Contact: Bibhav Acharya, MD
• Phone: 9176539358
• Email: Bibhav.Acharya[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: July 1, 2021
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
Nepal	Bayalpata Hospital	Sanfebagar-10	Achham/Province 7

Sponsors (6)

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

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 count	Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold	9 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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