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Completed

NCT Number: NCT03760211

A Mobile Gaming App to Improve ART Adherence for Youth

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.

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Key information

Conditions

Medication Adherence Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multilevel Gaming Adherence Intervention

Behavioral

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

Treatment as Usual +

Behavioral

Combination of electronic medication monitoring device and non-HIV related mobile gaming application

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Boston Medical Center
  • Emory University
  • University of Mississippi Medical Center

Registry information

Official study title

A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2018
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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