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Medication AdherenceNCT03760211

A Mobile Gaming App to Improve ART Adherence for Youth

A study testing Multilevel Gaming Adherence Intervention and Treatment as Usual + in people with Medication Adherence and HIV/AIDS, run by Rhode Island Hospital at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 30 years
Conditions the study is for
Medication Adherence, HIV/AIDS
What is being tested?
Multilevel Gaming Adherence Intervention and Treatment as Usual +
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
4 sitesUnited States
Study dates
1 Nov 2019to 17 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: A Multisite Randomized Trial of Battle Viro: 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.

Read the 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, 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.

Being tested
Multilevel Gaming Adherence Intervention, Treatment as Usual +
Medical subject headings
Medication Adherence, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multilevel Gaming Adherence InterventionBehavioural

    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 +Behavioural

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

Study groups in NCT03760211
Study groupRoleWhat they receive
Multilevel Gaming AdherenceExperimentalParticipants 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).
Receives: Behavioral: Multilevel Gaming Adherence Intervention
Treatment as Usual +Active comparatorTAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game and an electronic pill monitoring device.
Receives: Behavioral: Treatment as Usual +

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline HIV-1 Viral Load at 48 weeks

    Assessing change from Baseline HIV-1 viral load (copies/mL)

    Measured: 48 weeks

Secondary outcomes (3)

  1. Self-reported Medication Adherence

    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

    Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

  2. Self-reported Missed ARV Doses (1 Month)

    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

    Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

  3. Self-reported Missed ARV Doses (1 week)

    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

    Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study start1 Nov 2019
  3. Primary completion17 Oct 2024
  4. Study completion17 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760211
Sponsor's protocol ID
217318
Status last verified
Apr 2024
First submitted
19 Nov 2018
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PubMed 32779730

Questions about this trial

What is this clinical trial studying?

A study testing Multilevel Gaming Adherence Intervention and Treatment as Usual + in people with Medication Adherence and HIV/AIDS, run by Rhode Island Hospital at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline HIV-1 Viral Load at 48 weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03760211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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