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A Mobile Gaming App to Improve ART Adherence for Youth

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ClinicalTrials.gov Identifier: NCT03760211
Recruitment Status : Enrolling by invitation
First Posted : November 30, 2018
Last Update Posted : November 5, 2019
Sponsor:
Collaborators:
University of Mississippi Medical Center
Boston Medical Center
Information provided by (Responsible Party):
Laura Whiteley, Rhode Island Hospital

Brief Summary:
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 and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.

Condition or disease Intervention/treatment Phase
Medication Adherence HIV/AIDS Behavioral: Multilevel Gaming Adherence Intervention Behavioral: Treatment as Usual + Not Applicable

Detailed Description:
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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).
Behavioral: Multilevel Gaming Adherence Intervention
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

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.
Behavioral: Treatment as Usual +
Combination of electronic medication monitoring device and non-HIV related mobile gaming application




Primary Outcome Measures :
  1. Change from Baseline HIV-1 Viral Load at 48 weeks [ Time Frame: 48 weeks ]
    Assessing change from Baseline HIV-1 viral load (copies/mL)


Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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



Other Outcome Measures:
  1. 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


  2. Antiretroviral Therapy Treatment Knowledge [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

    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


  3. Motivation for Adherence [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

    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


  4. Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

    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


  5. Medication Adherence Barriers [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

    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


  6. Social Support [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

    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


  7. HIV Treatment Self-Efficacy [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760211


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
University of Mississippi Medical Center
Boston Medical Center
Investigators
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Study Director: Leandro Mena, MD University of Mississippi Medical Center
Study Director: Rachel Epstein, MD Boston Medical Center
Study Director: Stephen Pelton, MD Boston Medical Center
Study Director: Larry Brown, MD Rhode Island Hospital
Principal Investigator: Laura Whiteley, MD Rhode Island Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laura Whiteley, Assistant Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03760211    
Other Study ID Numbers: 217318
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases