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Clinical Trials/NCT04462679
NCT04462679
Unknown
Not Applicable

COMMIT HIV Acceptability and Feasibility Trial

Possible1 site in 1 country86 target enrollmentFebruary 25, 2020
ConditionsHiv

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hiv
Sponsor
Possible
Enrollment
86
Locations
1
Primary Endpoint
CD4 count
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2020
End Date
July 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Possible
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)
  • 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

  • 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
  • Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

Outcomes

Primary Outcomes

CD4 count

Time Frame: 9 months

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

HIV viral load

Time Frame: 9 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 adherence

Time Frame: 9 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 Outcomes

  • Application error/crash percentage(9 months)
  • Application access and completion percentage(9 months)
  • Patient encounter duration(9 months)

Study Sites (1)

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