NCT04462679

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 2, 2020

Last Update Submit

July 10, 2020

Conditions

Hiv

Keywords

low- and middle-income countriesmHealthhuman-centered design and engineeringdigital toolsNepalmotivational interviewingnon-physician healthcare workerscommunity health workersHIV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Application access and completion percentage

    9 months

  • Patient encounter duration

    9 months

  • Application error/crash percentage

    9 months

Study Arms (1)

Pilot arm

EXPERIMENTAL

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

Other: COMMIT mHealth application

Interventions

COMMIT mHealth applicationOTHER

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.

Pilot arm

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayalpata Hospital

Sanfebagar-10, Achham/Province 7, Nepal

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Bibhav Acharya, MD

CONTACT

9176539358Bibhav.Acharya@ucsf.edu

Duncan Maru, MD, PhD

CONTACT

2128247950duncan.maru@mssm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

February 25, 2020

Primary Completion

November 25, 2020

Study Completion

July 1, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)