Mobile Gaming App for PrEP Adherence

Recruiting at 2 trial locations

Overseen By James B Brock, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must be taking: PrEP

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile game called Viral Combat to determine if it helps people adhere to their PrEP medication plan, which prevents HIV. The study compares the game's effectiveness and acceptability with a non-HIV-related game among those who have recently started or restarted PrEP. Participants will receive game-related text messages for 24 weeks to support medication adherence. The trial seeks individuals aged 15-34 who are HIV-negative, have started or restarted PrEP in the past month, and speak English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance medication adherence through engaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on participants who are already taking PrEP, so you may continue with your PrEP medication.

What prior data suggests that this mobile gaming app is safe for PrEP adherence?

Research has shown that playing the mobile game "Viral Combat" is safe. The game helps people remember to take their PrEP medication on time. PrEP is a medicine that helps prevent HIV, working best when taken regularly.

The game provides a fun way to remind players to take their medicine. As a digital app, it lacks the side effects that medicines might have. Studies suggest that apps like this can improve medication adherence, which is crucial for maintaining health.

In summary, while the game is safe, its purpose is to help people maximize the health benefits of taking PrEP correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multilevel Gaming Adherence Intervention for PrEP adherence because it uses an innovative mobile gaming app called Viral Combat, which is designed to engage users in a fun and interactive way. Unlike traditional methods that rely on reminders or counseling, this approach incorporates game-related text messages to encourage consistent medication use over 24 weeks. This unique strategy aims to improve adherence by making the process enjoyable and interactive, potentially increasing the effectiveness of PrEP by ensuring users take their medication as prescribed.

What evidence suggests that this mobile gaming app is effective for PrEP adherence?

Research shows that the mobile game app Viral Combat, provided to participants in the Multilevel Gaming Adherence arm of this trial, helps people remember to take their PrEP medication, which prevents HIV. Studies found that this app improved medication adherence and encouraged safer behaviors, especially among young men who have sex with men. Users reported better habits in taking their PrEP, crucial for preventing HIV infection. The game is fun and interactive, making it easier for users to remember their medication. Overall, the app helps people stay on track with their PrEP treatment. ^{2 3 5 6 7}

Who Is on the Research Team?

Larry K Brock, MD

Principal Investigator

Rhode Island Hospital

Sharon Vuppula, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 15-34 who have recently started or restarted PrEP (a medication to prevent HIV) within the last month, are HIV negative, and can consent to participate. There are no specific exclusion criteria.

Inclusion Criteria

I have started or restarted PrEP within the last 30 days after a break of at least 1 month.

I am between 15 and 34 years old.

I am mentally capable of understanding and agreeing to participate in the study.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Evaluation

Conduct formative evaluation interviews with stakeholders to adapt Viral Combat for diverse PrEP patient populations

4 weeks

Treatment

Participants receive the Viral Combat mobile game and game-related text messages for 24 weeks

24 weeks

Summative Evaluation

Conduct summative evaluation interviews to assess the i-PARIHS constructs for future implementation

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multilevel Gaming Adherence Intervention
• Treatment as Usual +

Trial Overview The study is testing 'Viral Combat,' a mobile game designed to improve adherence to PrEP among young people in clinical settings across New England and Mississippi. It's compared with a control group using a non-PrEP related game through a randomized controlled trial.

How Is the Trial Designed?

Group I: Multilevel Gaming Adherence Experimental Treatment 1 Intervention

Participants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Viral Combat on their mobile phones, and, for 24 weeks, game-related text messages guided by self-reported medication adherence.

Group II: Treatment as Usual + Active Control 1 Intervention

TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Published Research Related to This Trial

The mSMART mobile health intervention showed high feasibility and acceptability among 15 Black men who have sex with men (MSM) already prescribed PrEP, with an impressive 82% daily usage rate and positive feedback on user-friendliness.

Participants demonstrated improved PrEP adherence, as indicated by biomarker scores, suggesting that gamified interventions like mSMART could effectively enhance medication adherence and reduce barriers to taking PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. Mitchell, JT., Burns, CM., Atkinson, B., et al.[2023]

A pilot study involving 16 HIV-negative men who have sex with men (MSM) demonstrated that a digital pill system (DPS) is a feasible and acceptable method for measuring adherence to daily PrEP, with 92.2% of expected ingestions recorded accurately.

The DPS showed strong correlations between recorded adherence and actual drug levels in the blood, indicating its effectiveness in tracking PrEP use, which is crucial for preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. Chai, PR., Mohamed, Y., Bustamante, MJ., et al.[2023]

Text message reminders (TMR) significantly improved medication adherence among 1678 patients with coronary heart disease, showing a 2.85 times greater adherence rate compared to the control group.

TMR also led to notable reductions in systolic blood pressure and cholesterol levels, contributing to better clinical outcomes, although it did not affect mortality or diastolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. Zhao, YY., Dang, FP., Zhai, TT., et al.[2022]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

In a study involving 1172 participants in the iPrEx open-label extension, self-reported recent PrEP dosing was generally reliable, with 84% of participants reporting at least one dose in the past 3 days, and 83% of these having quantifiable drug levels.

However, 82% of those who reported no doses in the past 3 days actually had no detectable drug, indicating a significant discrepancy, particularly among younger individuals and those with lower educational attainment, highlighting the need for better monitoring strategies for PrEP adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. Amico, KR., Mehrotra, M., Avelino-Silva, VI., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7522735/

A Mobile Gaming Intervention for Persons on Pre-Exposure ... This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/62/NCT02611362/Prot_SAP_000.pdf

A Multilevel Gaming Intervention for Persons on PrEP successfully achieves improvements in adherence to PrEP as well as improvements in HIV prevention ... data on PrEP related adherence and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8085097/

The Impact of a Mobile Gaming Intervention to Increase ... Discussion. Our data indicate that Viral Combat was effective in improving PrEP adherence for diverse young MSM. · Conclusions · Acknowledgements:.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05762705

A Mobile Gaming App to Improve Adherence to PrEP | ... In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving ...

5. games.jmir.org games.jmir.org/2019/1/e11861/

Creating a Theoretically Grounded Gaming App to Increase ... Data show that PrEP's safety and effectiveness could be greatly compromised by suboptimal adherence to treatment, and there is concern about the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02611362

A Multilevel Gaming Intervention for Persons on PrEP This study will develop and test a novel, smartphone based gaming intervention to improve adherence to medication to prevent HIV (known as Pre-exposure ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30916652/

Lessons From the Development of the Viral Combat Mobile ... Data show that PrEP's safety and effectiveness could be greatly compromised by suboptimal adherence to treatment, and there is concern about the ...