<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/NCT03760211</url>
  </required_header>
  <id_info>
    <org_study_id>217318</org_study_id>
    <nct_id>NCT03760211</nct_id>
  </id_info>
  <brief_title>A Mobile Gaming App to Improve ART Adherence for Youth</brief_title>
  <official_title>A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island 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>
      Despite the need for consistent adherence to medical care, youth living with HIV have low&#xD;
      rates of adherence to medications and treatment. There are few interventions to improve&#xD;
      adherence to HIV medications and treatment for youth, and there is a great need for novel&#xD;
      approaches that are engaging for this age group. The investigators developed an intervention&#xD;
      that includes a mobile gaming app that is integrated with a 7-day electronic medication&#xD;
      device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small&#xD;
      previous project found that the intervention helped youth who were newly starting medications&#xD;
      for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This&#xD;
      proposed project will test the intervention with larger number of youth (100) who are newly&#xD;
      starting HIV treatment and medications in New England, Georgia, and in Mississippi. The&#xD;
      investigators want to determine if adherence is improved and viral load is reduced in this&#xD;
      larger sample.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have low&#xD;
      rates of adherence and retention in care, and are at great risk for being lost to&#xD;
      follow-up.(5,16-18) There is a great need for adherence interventions that are novel and&#xD;
      appealing for YLWH.(7,8,14) The investigators developed, and preliminarily examined, a&#xD;
      multi-level technology that integrates a 7-day smart medication device WITH an immersive and&#xD;
      appealing smartphone app/game that is attractive and engaging for YLWH.(82,83) During&#xD;
      gameplay, YLWH fight HIV in colorful and immersive organ systems, and receive adherence&#xD;
      related text messages with game graphics. Electronic medication monitoring device openings&#xD;
      guide game-related text messages. The investigators tested the Multilevel Gaming Intervention&#xD;
      in a developmental trial. The impact of the intervention was greatest among those who had&#xD;
      newly begun ART. In participants who had newly begun ART, the intervention decreased viral&#xD;
      load and improved ART adherence. Those newly starting ART in the intervention, compared to&#xD;
      those newly starting ART in the control, experienced a 0.96 log viral load greater decrease&#xD;
      and evidenced a large effect size for improved adherence as measured by an electronic&#xD;
      medication monitoring device (d=1.18, 71% vs. 48% adherence at post-test). These interactions&#xD;
      between intervention and newly starting ART were significant in ANCOVAs, accounting for&#xD;
      baseline values (viral load: F=4.33, p=0.04, adherence: F=3.20, p=0.05). For this next&#xD;
      proposed stage of research, the investigators will further test the Multilevel Gaming&#xD;
      Intervention with YLWH who are newly starting ART at clinical sites in New England, Georgia,&#xD;
      and in Mississippi. A multisite randomized controlled study (48 weeks) among 100 YLWH newly&#xD;
      starting ART will test the efficacy of the intervention compared to a control condition (who&#xD;
      receive a non-HIV game and the electronic medication monitoring device) on behavioral and&#xD;
      biological measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline HIV-1 Viral Load at 48 weeks</measure>
    <time_frame>48 weeks</time_frame>
    <description>Assessing change from Baseline HIV-1 viral load (copies/mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported Medication Adherence</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>Proportion of doses taken correctly via electronic pill monitoring device. The proportion of days with correct openings each month will be calculated: (correct openings) / (total number of days in month)&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Missed ARV Doses (1 Month)</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month)&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Missed ARV Doses (1 week)</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>Proportion of days with missed doses via self-report: (reported missed doses in past 7 days) / 7&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HIV Treatment Knowledge Scale</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>Balfour L, Kowal J, Tasca GA, et al. Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care. 2007;19(9):1141-1148.&#xD;
The HIV Treatment Knowledge scale is a 21-item scale that assesses knowledge about complex HIV treatment issues such as co-occurring illnesses and drug resistance. Response options include &quot;True&quot;, &quot;False&quot;, and &quot;Do not know&quot;. Cronbach's alpha was 0.90 in a population of HIV-infected adults. Higher scores indicate greater HIV treatment knowledge.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Antiretroviral Therapy Treatment Knowledge</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.&#xD;
Antiretroviral therapy treatment knowledge will be assessed with the &quot;Information&quot; subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. The Information subscale includes 19 Likert-style items. Response options include &quot;Strongly Disagree&quot;, &quot;Somewhat Agree&quot;, &quot;Neither Agree nor Disagree&quot;, &quot;Somewhat Agree&quot;, and &quot;Strongly Agree&quot;. Cronbach's alpha was 0.60 in a sample of youth living with HIV. Higher scores indicate greater knowledge of ART treatment.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Motivation for Adherence</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.&#xD;
Motivation for adherence will be assessed with the &quot;Motivation&quot; subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. The &quot;Motivation&quot; subscale includes 10 Likert-style items that assess personal and social motivations for ART adherence. Cronbach's alpha was 0.75 in a sample of youth living with HIV. Higher scores indicate greater motivation towards adherence.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.&#xD;
The &quot;Behavioral Skills&quot; subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire assesses perceived ability to perform necessary ART skills. This subscale includes 14 Likert-style items. Response options range from &quot;Very Hard&quot; to &quot;Very Easy&quot;. Cronbach's alpha was 0.90 in a sample of youth living with HIV. Higher scores indicate greater motivation towards adherence.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication Adherence Barriers</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>Simoni JM, Kurth AE, Pearson CR, Pantalone DW, Merrill JO, Frick PA. Self-report measures of antiretroviral therapy adherence: a review with recommendations for HIV research and clinical management. AIDS Behav. 2006; 10(3):227-245. doi: 10.1007/s10461-006-9078-6. PMID: 16783535. PMCID: PMC4083461.&#xD;
This 26-item checklist was developed for use by the Adolescent AIDS Trials Network (ATN). This measure assesses common barriers to taking antiretrovirals (ARV) as prescribed and common reasons for stopping ARV.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Social Support</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>Martinez J, Harper G, Carleton RA, et al. The Impact of Stigma on Medication Adherence Among HIV-Positive Adolescent and Young Adult Females and the Moderating Effects of Coping and Satisfaction with Health Care. AIDS Patient Care and STDs. 2012;26(2):108-115. doi:10.1089/apc.2011.0178.&#xD;
Six Likert-style items assess social support for taking medications, going to medical appointments, and other tasks related to adherence. Responses options range from &quot;Strongly disagree&quot; to &quot;Strongly agree&quot;. Cronbach's alpha for this scale is 0.91. Higher scores indicate greater perceived social support.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>HIV Treatment Self-Efficacy</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</time_frame>
    <description>MacDonell KE, Naar-King S, Murphy DA, Parsons JT, Harper GW. Predictors of Medication Adherence in High Risk Youth of Color Living with HIV. Journal of Pediatric Psychology. 2010;35(6):593-601. doi:10.1093/jpepsy/jsp080.&#xD;
This six-item, Likert-style scale includes three items that assess self-efficacy for taking medication and three items that assess self-efficacy for adherence to medical appointments. Response options range from &quot;Very Sure I Can&quot; to &quot;Very Sure I Cannot&quot;. Higher scores indicate greater self-efficacy for medication and appointment adherence. Cronbach's alpha is 0.92 for this scale.&#xD;
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Medication Adherence</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Multilevel Gaming Adherence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Battle Viro on their mobile phones, an electronic pill monitoring device, and, for 24 weeks, game-related text messages guided by medication adherence data (collected from an electronic pill monitoring device).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual +</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game and an electronic pill monitoring device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multilevel Gaming Adherence Intervention</intervention_name>
    <description>Combination of electronic medication monitoring device with Information-Motivation-Behavior based mobile gaming application tailored for those living with HIV and adherence-based text messages</description>
    <arm_group_label>Multilevel Gaming Adherence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual +</intervention_name>
    <description>Combination of electronic medication monitoring device and non-HIV related mobile gaming application</description>
    <arm_group_label>Treatment as Usual +</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living with HIV&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Have started antiretroviral therapy (ART) in the last three months or restarted ART in&#xD;
             the last three months after not taking ART for approximately six months&#xD;
&#xD;
          -  Have access to a smartphone for the duration of the study&#xD;
&#xD;
          -  Not involved with another HIV prevention or adherence related study&#xD;
&#xD;
          -  Able to give consent/assent and not impaired by cognitive or medical limitations as&#xD;
             per clinical assessment&#xD;
&#xD;
          -  Detectable viral load&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James B Brock, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachel Epstein, MD</last_name>
    <role>Study Director</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Pelton, MD</last_name>
    <role>Study Director</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Larry K Brown, MD</last_name>
    <role>Study Director</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Whiteley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andres Camacho-Gonzalez, MD</last_name>
    <role>Study Director</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Laura Whiteley</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT03760211
org study id: 217318
nct id: NCT03760211
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite the need for consistent adherence to medical care, youth living with HIV have low
      rates of adherence to medications and treatment. There are few interventions to improve
      adherence to HIV medications and treatment for youth, and there is a great need for novel
      approaches that are engaging for this age group. The investigators developed an intervention
      that includes a mobile gaming app that is integrated with a 7-day electronic medication
      device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small
      previous project found that the intervention helped youth who were newly starting medications
      for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This
      proposed project will test the intervention with larger number of youth (100) who are newly
      starting HIV treatment and medications in New England, Georgia, and in Mississippi. The
      investigators want to determine if adherence is improved and viral load is reduced in this
      larger sample.
Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have low
      rates of adherence and retention in care, and are at great risk for being lost to
      follow-up.(5,16-18) There is a great need for adherence interventions that are novel and
      appealing for YLWH.(7,8,14) The investigators developed, and preliminarily examined, a
      multi-level technology that integrates a 7-day smart medication device WITH an immersive and
      appealing smartphone app/game that is attractive and engaging for YLWH.(82,83) During
      gameplay, YLWH fight HIV in colorful and immersive organ systems, and receive adherence
      related text messages with game graphics. Electronic medication monitoring device openings
      guide game-related text messages. The investigators tested the Multilevel Gaming Intervention
      in a developmental trial. The impact of the intervention was greatest among those who had
      newly begun ART. In participants who had newly begun ART, the intervention decreased viral
      load and improved ART adherence. Those newly starting ART in the intervention, compared to
      those newly starting ART in the control, experienced a 0.96 log viral load greater decrease
      and evidenced a large effect size for improved adherence as measured by an electronic
      medication monitoring device (d=1.18, 71% vs. 48% adherence at post-test). These interactions
      between intervention and newly starting ART were significant in ANCOVAs, accounting for
      baseline values (viral load: F=4.33, p=0.04, adherence: F=3.20, p=0.05). For this next
      proposed stage of research, the investigators will further test the Multilevel Gaming
      Intervention with YLWH who are newly starting ART at clinical sites in New England, Georgia,
      and in Mississippi. A multisite randomized controlled study (48 weeks) among 100 YLWH newly
      starting ART will test the efficacy of the intervention compared to a control condition (who
      receive a non-HIV game and the electronic medication monitoring device) on behavioral and
      biological measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change from Baseline HIV-1 Viral Load at 48 weeks
time frame: 48 weeks
description: Assessing change from Baseline HIV-1 viral load (copies/mL)
measure: Self-reported Medication Adherence
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: Proportion of doses taken correctly via electronic pill monitoring device. The proportion of days with correct openings each month will be calculated: (correct openings) / (total number of days in month)
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Self-reported Missed ARV Doses (1 Month)
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month)
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Self-reported Missed ARV Doses (1 week)
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: Proportion of days with missed doses via self-report: (reported missed doses in past 7 days) / 7
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: HIV Treatment Knowledge Scale
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: Balfour L, Kowal J, Tasca GA, et al. Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care. 2007;19(9):1141-1148.
The HIV Treatment Knowledge scale is a 21-item scale that assesses knowledge about complex HIV treatment issues such as co-occurring illnesses and drug resistance. Response options include "True", "False", and "Do not know". Cronbach's alpha was 0.90 in a population of HIV-infected adults. Higher scores indicate greater HIV treatment knowledge.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Antiretroviral Therapy Treatment Knowledge
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.
Antiretroviral therapy treatment knowledge will be assessed with the "Information" subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. The Information subscale includes 19 Likert-style items. Response options include "Strongly Disagree", "Somewhat Agree", "Neither Agree nor Disagree", "Somewhat Agree", and "Strongly Agree". Cronbach's alpha was 0.60 in a sample of youth living with HIV. Higher scores indicate greater knowledge of ART treatment.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Motivation for Adherence
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.
Motivation for adherence will be assessed with the "Motivation" subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. The "Motivation" subscale includes 10 Likert-style items that assess personal and social motivations for ART adherence. Cronbach's alpha was 0.75 in a sample of youth living with HIV. Higher scores indicate greater motivation towards adherence.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.
The "Behavioral Skills" subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire assesses perceived ability to perform necessary ART skills. This subscale includes 14 Likert-style items. Response options range from "Very Hard" to "Very Easy". Cronbach's alpha was 0.90 in a sample of youth living with HIV. Higher scores indicate greater motivation towards adherence.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Medication Adherence Barriers
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: Simoni JM, Kurth AE, Pearson CR, Pantalone DW, Merrill JO, Frick PA. Self-report measures of antiretroviral therapy adherence: a review with recommendations for HIV research and clinical management. AIDS Behav. 2006; 10(3):227-245. doi: 10.1007/s10461-006-9078-6. PMID: 16783535. PMCID: PMC4083461.
This 26-item checklist was developed for use by the Adolescent AIDS Trials Network (ATN). This measure assesses common barriers to taking antiretrovirals (ARV) as prescribed and common reasons for stopping ARV.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Social Support
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: Martinez J, Harper G, Carleton RA, et al. The Impact of Stigma on Medication Adherence Among HIV-Positive Adolescent and Young Adult Females and the Moderating Effects of Coping and Satisfaction with Health Care. AIDS Patient Care and STDs. 2012;26(2):108-115. doi:10.1089/apc.2011.0178.
Six Likert-style items assess social support for taking medications, going to medical appointments, and other tasks related to adherence. Responses options range from "Strongly disagree" to "Strongly agree". Cronbach's alpha for this scale is 0.91. Higher scores indicate greater perceived social support.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: HIV Treatment Self-Efficacy
time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
description: MacDonell KE, Naar-King S, Murphy DA, Parsons JT, Harper GW. Predictors of Medication Adherence in High Risk Youth of Color Living with HIV. Journal of Pediatric Psychology. 2010;35(6):593-601. doi:10.1093/jpepsy/jsp080.
This six-item, Likert-style scale includes three items that assess self-efficacy for taking medication and three items that assess self-efficacy for adherence to medical appointments. Response options range from "Very Sure I Can" to "Very Sure I Cannot". Higher scores indicate greater self-efficacy for medication and appointment adherence. Cronbach's alpha is 0.92 for this scale.
Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
arm group label: Multilevel Gaming Adherence
arm group type: Experimental
description: Participants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Battle Viro on their mobile phones, an electronic pill monitoring device, and, for 24 weeks, game-related text messages guided by medication adherence data (collected from an electronic pill monitoring device).
arm group label: Treatment as Usual +
arm group type: Active Comparator
description: TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game and an electronic pill monitoring device.
intervention type: Behavioral
intervention name: Multilevel Gaming Adherence Intervention
description: Combination of electronic medication monitoring device with Information-Motivation-Behavior based mobile gaming application tailored for those living with HIV and adherence-based text messages
arm group label: Multilevel Gaming Adherence
intervention type: Behavioral
intervention name: Treatment as Usual +
description: Combination of electronic medication monitoring device and non-HIV related mobile gaming application
arm group label: Treatment as Usual +
criteria: 
gender: All
minimum age: 15 Years
maximum age: 30 Years
healthy volunteers: No
last name: James B Brock, MD
role: Study Director
affiliation: University of Mississippi Medical Center
last name: Rachel Epstein, MD
role: Study Director
affiliation: Boston Medical Center
last name: Stephen Pelton, MD
role: Study Director
affiliation: Boston Medical Center
last name: Larry K Brown, MD
role: Study Director
affiliation: Rhode Island Hospital
last name: Laura Whiteley, MD
role: Principal Investigator
affiliation: Rhode Island Hospital
last name: Andres Camacho-Gonzalez, MD
role: Study Director
affiliation: Emory University
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Laura Whiteley
investigator title: Assistant Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections