<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/NCT03825952</url>
  </required_header>
  <id_info>
    <org_study_id>K24MH114732</org_study_id>
    <nct_id>NCT03825952</nct_id>
  </id_info>
  <brief_title>Optimizing mHealth for Adherence Monitoring and Intervention</brief_title>
  <acronym>OAsIS</acronym>
  <official_title>Optimizing mHealth for Adherence Monitoring and Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      High and sustained adherence is critical for achieving the individual and public health&#xD;
      benefits of HIV antiretroviral therapy (ART). Electronic adherence monitors provide a&#xD;
      detailed understanding of adherence and enable real-time interventions. Research has shown&#xD;
      the benefit of these monitors and low-cost models have recently become available; however,&#xD;
      their use to date has largely been confined to the research context.&#xD;
&#xD;
      This study is an implementation science-driven assessment of strategies to improve uptake of&#xD;
      electronic adherence monitoring and associated interventions for routine, clinical delivery&#xD;
      of ART in Uganda. The study consists of two aims. In Aim 1, the investigators will conduct&#xD;
      multi-level formative interviews to design a preliminary implementation strategy. In Aim 2,&#xD;
      the investigators will use an iterative approach to optimize the implementation strategy. All&#xD;
      work will be guided by the Consolidated Framework for Research Implementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: Prospective mixed-method assessment with iterative improvements for program&#xD;
      implementation&#xD;
&#xD;
      Populations: 1) Health care administrators and clinicians and 2) individuals taking ART&#xD;
&#xD;
      Study site: Kabwohe Clinical Research Centre (KCRC)&#xD;
&#xD;
      Approach The electronic adherence monitors to be assessed in this study are pill containers&#xD;
      that record each opening as a proxy for pill taking behavior. They provide day-to-day&#xD;
      information about adherence that can be used to provide informed counseling at clinic visits,&#xD;
      as well as SMS reminders and notifications for missed or late doses. For Aim 1, the study&#xD;
      team will recruit up to 35 health care administrators and clinicians from various levels of&#xD;
      the Ugandan health care system (Health Center IV to the national hospital level), as well as&#xD;
      15 individuals taking ART at the KCRC. Research assistants will conduct individual, in depth&#xD;
      qualitative interviews to define a preliminary implementation strategy for these electronic&#xD;
      adherence monitors to be used in routine HIV clinical care. In Aim 2 (iteration 1),&#xD;
      investigators will deploy the electronic adherence monitors and associated interventions per&#xD;
      the strategy identified in Aim 1 among 30 individuals taking ART at the KCRC. Study staff&#xD;
      will monitor their adherence for 3 months, during which time they will quantify multiple&#xD;
      metrics of the deployment. The investigators will review these metrics with the same health&#xD;
      care administrators and clinicians from Aim 1, as well as up to 15 individuals who used the&#xD;
      adherence monitors in the Aim 2 deployment. Research assistants will then interview both&#xD;
      groups to develop an improved implementation strategy for deployment in a second iteration.&#xD;
      In Aim 2 (iteration 2), study staff will utilize the revised implementation strategy to&#xD;
      deploy the electronic adherence monitors and associated interventions among a new cohort of&#xD;
      30 individuals taking ART at the KCRC. The study team will then repeat the assessment of the&#xD;
      implementation strategy with the same health care administrators and clinicians from Aims 1&#xD;
      and 2 (iteration 1), as well as up to 15 individuals who used the adherence monitors in the&#xD;
      Aim 2 (iteration 2) deployment. The investigators will conclude the study with&#xD;
      recommendations for wide-scale uptake of this technology in routine HIV clinical care.&#xD;
&#xD;
      Aims Aim 1. Define a preliminary implementation strategy for real-time electronic adherence&#xD;
      monitoring plus associated interventions for routine HIV clinical care in Uganda&#xD;
&#xD;
      Aim 2. Deploy and optimize an implementation strategy for real-time electronic ART adherence&#xD;
      monitoring plus associated interventions in routine HIV clinical care in Uganda&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Actual">August 5, 2022</completion_date>
  <primary_completion_date type="Actual">August 5, 2022</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>Adherence to ART</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Participants using MERM device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use an electronic medication monitor to measure their adherence to ART in routine clinical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MERM - medication event reminder monitor</intervention_name>
    <description>The MERM will help measure adherence to ART in routine clinical care.</description>
    <arm_group_label>Participants using MERM device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  engagement in HIV care&#xD;
&#xD;
          -  For individuals taking ART:&#xD;
&#xD;
          -  HIV infection per clinic records&#xD;
&#xD;
          -  own a cellular phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwillingness or inability to provide informed consent&#xD;
&#xD;
          -  intention to move &gt;100 km away from KCRC during the three-month study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Haberer, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kabwohe Clinical Research Center</name>
      <address>
        <city>Kabwohe</city>
        <state>Sheema District</state>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jessica Haberer, MD</investigator_full_name>
    <investigator_title>Director of Research</investigator_title>
  </responsible_party>
  <keyword>adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT03825952
org study id: K24MH114732
nct id: NCT03825952
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
High and sustained adherence is critical for achieving the individual and public health
      benefits of HIV antiretroviral therapy (ART). Electronic adherence monitors provide a
      detailed understanding of adherence and enable real-time interventions. Research has shown
      the benefit of these monitors and low-cost models have recently become available; however,
      their use to date has largely been confined to the research context.

      This study is an implementation science-driven assessment of strategies to improve uptake of
      electronic adherence monitoring and associated interventions for routine, clinical delivery
      of ART in Uganda. The study consists of two aims. In Aim 1, the investigators will conduct
      multi-level formative interviews to design a preliminary implementation strategy. In Aim 2,
      the investigators will use an iterative approach to optimize the implementation strategy. All
      work will be guided by the Consolidated Framework for Research Implementation.
Design: Prospective mixed-method assessment with iterative improvements for program
      implementation

      Populations: 1) Health care administrators and clinicians and 2) individuals taking ART

      Study site: Kabwohe Clinical Research Centre (KCRC)

      Approach The electronic adherence monitors to be assessed in this study are pill containers
      that record each opening as a proxy for pill taking behavior. They provide day-to-day
      information about adherence that can be used to provide informed counseling at clinic visits,
      as well as SMS reminders and notifications for missed or late doses. For Aim 1, the study
      team will recruit up to 35 health care administrators and clinicians from various levels of
      the Ugandan health care system (Health Center IV to the national hospital level), as well as
      15 individuals taking ART at the KCRC. Research assistants will conduct individual, in depth
      qualitative interviews to define a preliminary implementation strategy for these electronic
      adherence monitors to be used in routine HIV clinical care. In Aim 2 (iteration 1),
      investigators will deploy the electronic adherence monitors and associated interventions per
      the strategy identified in Aim 1 among 30 individuals taking ART at the KCRC. Study staff
      will monitor their adherence for 3 months, during which time they will quantify multiple
      metrics of the deployment. The investigators will review these metrics with the same health
      care administrators and clinicians from Aim 1, as well as up to 15 individuals who used the
      adherence monitors in the Aim 2 deployment. Research assistants will then interview both
      groups to develop an improved implementation strategy for deployment in a second iteration.
      In Aim 2 (iteration 2), study staff will utilize the revised implementation strategy to
      deploy the electronic adherence monitors and associated interventions among a new cohort of
      30 individuals taking ART at the KCRC. The study team will then repeat the assessment of the
      implementation strategy with the same health care administrators and clinicians from Aims 1
      and 2 (iteration 1), as well as up to 15 individuals who used the adherence monitors in the
      Aim 2 (iteration 2) deployment. The investigators will conclude the study with
      recommendations for wide-scale uptake of this technology in routine HIV clinical care.

      Aims Aim 1. Define a preliminary implementation strategy for real-time electronic adherence
      monitoring plus associated interventions for routine HIV clinical care in Uganda

      Aim 2. Deploy and optimize an implementation strategy for real-time electronic ART adherence
      monitoring plus associated interventions in routine HIV clinical care in Uganda
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Adherence to ART
time frame: 3 months
arm group label: Participants using MERM device
arm group type: Experimental
description: Participants will use an electronic medication monitor to measure their adherence to ART in routine clinical care.
intervention type: Device
intervention name: MERM - medication event reminder monitor
description: The MERM will help measure adherence to ART in routine clinical care.
arm group label: Participants using MERM device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica Haberer, MD, MS
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jessica Haberer, MD
investigator title: Director of Research
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections