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

Trial Summary

What is the purpose of this trial?

In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.

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 data supports the effectiveness of the treatment Multilevel Gaming Adherence Intervention, Treatment as Usual +?

Research shows that a gamified mobile health intervention improved adherence to PrEP among Black men who have sex with men, with users showing better medication adherence and fewer perceived barriers to taking their medication. This suggests that similar mobile gaming interventions can be effective in promoting adherence to treatments. ^{1 2 3 4 5}

Is the Mobile Gaming App for PrEP Adherence safe for humans?

The studies on the mobile gaming app for PrEP adherence, such as mSMART, indicate that it is generally safe for use. Participants did not report any significant issues with the app's functionality, and there was no study dropout, suggesting it is well-tolerated. ^{1 2 3 5 6}

How is the Mobile Gaming App for PrEP Adherence treatment different from other treatments?

This treatment is unique because it uses a gamified mobile app to improve adherence to PrEP (a medication to prevent HIV) by engaging users in a fun and interactive way, which is different from traditional methods that do not incorporate gaming elements. ^{1 2 3 5 7}

Research Team

Larry K Brock, MD

Principal Investigator

Rhode Island Hospital

Sharon Vuppula, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

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

English speaking

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

HIV negative as per clinician and clinical record

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Epic Allies: Development of a Gaming App to Improve Antiretroviral Therapy Adherence Among Young HIV-Positive Men Who Have Sex With Men. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial. [2021]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. [2019]

7. United States 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. [2023]