<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04462679</url>
  </required_header>
  <id_info>
    <org_study_id>COMMITHIVNyaya</org_study_id>
    <secondary_id>1R34MH118049-01</secondary_id>
    <nct_id>NCT04462679</nct_id>
  </id_info>
  <brief_title>COMMIT HIV Trial Nepal</brief_title>
  <official_title>COMMIT HIV Acceptability and Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Possible</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nyaya Health Nepal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health and Population, Nepal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Possible</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Community Healthcare Workers (CHWs), who live in the communities they serve, have the&#xD;
      potential to reach patients who poorly engage in their care. Motivational Interviewing (MI)&#xD;
      is a special type of interactional approach that focuses on improving the person's motivation&#xD;
      to engage in healthy behaviors, such as keeping their clinic appointments and regularly&#xD;
      taking medications. In this study, we will develop a mobile health tool that will assist CHWs&#xD;
      in two tasks while they utilize MI to assist patients' engagement in care: 1) follow prompts&#xD;
      on the mobile device to deliver MI; and 2) record consented conversations between CHWs and&#xD;
      patients so that MI specialists can review the audiotape and provide feedback to maintain the&#xD;
      MI skills.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 25, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD4 count</measure>
    <time_frame>9 months</time_frame>
    <description>Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV viral load</measure>
    <time_frame>9 months</time_frame>
    <description>Individual HIV viral load count, measured at baseline and endline, with viral load suppression or &gt;2 log drop in viral load as binary suppressed/not threshold</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported HIV treatment adherence</measure>
    <time_frame>9 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Application access and completion percentage</measure>
    <time_frame>9 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient encounter duration</measure>
    <time_frame>9 months</time_frame>
    <description>Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Application error/crash percentage</measure>
    <time_frame>9 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Hiv</condition>
  <arm_group>
    <arm_group_label>Pilot arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COMMIT mHealth application</intervention_name>
    <description>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.</description>
    <arm_group_label>Pilot arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inclusion criteria for patient population: 1) having a documented HIV diagnosis, 2)&#xD;
             living in the community health worker catchment area at the Nepal research site and ,&#xD;
             3) having poor adherence (missed a clinic visit by more than 2 weeks, &lt;95% adherence&#xD;
             from visual analogue scale and/ or failed to refill their antiretroviral medications 1&#xD;
             week past the expected date)&#xD;
&#xD;
          2. Inclusion criteria for community health worker or a community health worker&#xD;
             supervisor: living/working at the Nepal research site who has received motivational&#xD;
             interviewing training as part of the intervention, and are involved directly in&#xD;
             program implementation process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Exclusion criteria for patient population: includes decision from the patient to not&#xD;
             receive care delivered by care provider at the Nepal research site or not to&#xD;
             participate in the study&#xD;
&#xD;
          2. Exclusion criteria for a community health worker or a community health worker&#xD;
             supervisor: includes decision not to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bibhav Acharya, MD</last_name>
    <phone>9176539358</phone>
    <email>Bibhav.Acharya@ucsf.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Duncan Maru, MD, PhD</last_name>
    <phone>2128247950</phone>
    <email>duncan.maru@mssm.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bayalpata Hospital</name>
      <address>
        <city>Sanfebagar-10</city>
        <state>Achham/Province 7</state>
        <country>Nepal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabitri Sapkota, PhD, MPH</last_name>
      <phone>+977 14100597</phone>
      <email>sabitri.sapkota@nyayahealthnepal.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>low- and middle-income countries</keyword>
  <keyword>mHealth</keyword>
  <keyword>human-centered design and engineering</keyword>
  <keyword>digital tools</keyword>
  <keyword>Nepal</keyword>
  <keyword>motivational interviewing</keyword>
  <keyword>non-physician healthcare workers</keyword>
  <keyword>community health workers</keyword>
  <keyword>HIV</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT04462679/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462679
org study id: COMMITHIVNyaya
secondary id: 1R34MH118049-01
nct id: NCT04462679
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: CD4 count
time frame: 9 months
description: Individual CD4 count, measured at baseline and endline, with 350 (cells/cubic ml) as binary low/high threshold
measure: HIV viral load
time frame: 9 months
description: 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
measure: Self-reported HIV treatment adherence
time frame: 9 months
description: 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).
measure: Application access and completion percentage
time frame: 9 months
description: 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)
measure: Patient encounter duration
time frame: 9 months
description: Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)
measure: Application error/crash percentage
time frame: 9 months
description: 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)
arm group label: Pilot arm
arm group type: Experimental
description: Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application
intervention type: Other
intervention name: COMMIT mHealth application
description: 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.
arm group label: Pilot arm
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Bibhav Acharya, MD
phone: 9176539358
email: Bibhav.Acharya@ucsf.edu
last name: Duncan Maru, MD, PhD
phone: 2128247950
email: duncan.maru@mssm.edu
facility: 
status: Recruiting
contact: 
country: Nepal
responsible party type: Sponsor
sharing ipd: No
provided document: 