Clinical trial NCT04462679: COMMIT HIV Trial Nepal
Official title: COMMIT HIV Acceptability and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Francisco
name: Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health
name: Nyaya Health Nepal
name: Ministry of Health and Population, Nepal
First posted: 2020-07-08
Enrollment: 86
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: CD4 count
timeFrame: 9 months
measure: HIV viral load
timeFrame: 9 months
measure: Self-reported HIV treatment adherence
timeFrame: 9 months
Secondary outcomes:
measure: Application access and completion percentage
timeFrame: 9 months
measure: Patient encounter duration
timeFrame: 9 months
measure: Application error/crash percentage
timeFrame: 9 months
Other outcomes:
Locations:
city: Sanfebagar-10
country: Nepal
facility: Bayalpata Hospital
state: Achham/Province 7
Study officials:
References: