- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03760211
A Mobile Gaming App to Improve ART Adherence for Youth
A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Living with HIV
- English speaking
- Have started antiretroviral therapy (ART) in the last three months or restarted ART in the last three months after not taking ART for approximately six months
- Have access to a smartphone for the duration of the study
- Not involved with another HIV prevention or adherence related study
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment
- Detectable viral load
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multilevel Gaming Adherence
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).
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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
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Active Comparator: Treatment as Usual +
TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game and an electronic pill monitoring device.
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Combination of electronic medication monitoring device and non-HIV related mobile gaming application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline HIV-1 Viral Load at 48 weeks
Time Frame: 48 weeks
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Assessing change from Baseline HIV-1 viral load (copies/mL)
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Medication Adherence
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
|
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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Self-reported Missed ARV Doses (1 Month)
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
|
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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Self-reported Missed ARV Doses (1 week)
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
|
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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Treatment Knowledge Scale
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
|
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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Antiretroviral Therapy Treatment Knowledge
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Motivation for Adherence
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Medication Adherence Barriers
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Social Support
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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HIV Treatment Self-Efficacy
Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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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 |
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Larry K Brown, MD, Rhode Island Hospital
- Study Director: Andres Camacho-Gonzalez, MD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 217318
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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