MedPath

COMMIT HIV Trial Nepal

Not Applicable
Conditions
Hiv
Interventions
Other: COMMIT mHealth application
Registration Number
NCT04462679
Lead Sponsor
Possible
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
86
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pilot armCOMMIT mHealth applicationMixed methods, acceptability and feasibility pilot of the COMMIT mHealth application
Primary Outcome Measures
NameTimeMethod
CD4 count9 months

Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold

HIV viral load9 months

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

Self-reported HIV treatment adherence9 months

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).

Secondary Outcome Measures
NameTimeMethod
Application error/crash percentage9 months

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)

Application access and completion percentage9 months

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)

Patient encounter duration9 months

Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)

Trial Locations

Locations (1)

Bayalpata Hospital

🇳🇵

Sanfebagar-10, Achham/Province 7, Nepal

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