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HivNCT04462679

COMMIT HIV Trial Nepal

A study testing COMMIT mHealth application in people with Hiv, run by Possible at 1 site in Nepal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Hiv
What is being tested?
COMMIT mHealth application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteNepal
Study dates
25 Feb 2020to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Bibhav Acharya, MD contact

9176539358

Bibhav.Acharya@ucsf.edu

Duncan Maru, MD, PhD contact

2128247950

duncan.maru@mssm.edu

Nepal1 site, 1 recruiting

  • Bayalpata Hospital

    Sanfebagar-10, Achham/Province 7

    Sabitri Sapkota, PhD, MPH, +977 14100597, sabitri.sapkota@nyayahealthnepal.org

    Recruiting

Other trials in Nepal

About this study

Official title: COMMIT HIV Acceptability and Feasibility Trial

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.

Conditions
Hiv
Being tested
COMMIT mHealth application
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
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04462679
Study groupRoleWhat they receive
Pilot armExperimentalMixed methods, acceptability and feasibility pilot of the COMMIT mHealth application
Receives: Other: COMMIT mHealth application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD4 count

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

    Measured: 9 months

  2. 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

    Measured: 9 months

  3. 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).

    Measured: 9 months

Secondary outcomes (3)

  1. 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)

    Measured: 9 months

  2. 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)

    Measured: 9 months

  3. 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)

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start25 Feb 2020
  3. Primary completion25 Nov 2020 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04462679
Sponsor's protocol ID
COMMITHIVNyaya
Other IDs
1R34MH118049-01
Status last verified
Jul 2020
First submitted
2 Jul 2020
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing COMMIT mHealth application in people with Hiv, run by Possible at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bibhav Acharya, MD (9176539358, Bibhav.Acharya@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4 count (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04462679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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