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Mobile Gaming App for PrEP Adherence
N/A
Waitlist Available
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Study Summary
This trial will test a mobile game (Viral Combat) to see if it helps people ages 15-34 taking PrEP care in the South and New England. Interviews will inform game adaptations and a Hybrid Type 1 RCT will test its efficacy. A summative evaluation will help with future implementation and dissemination.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves the use of a gaming app rather than medication, traditional side effects aren't applicable. However, participants may experience issues typical of mobile gaming like eye strain or repetitive stress injuries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tenofovir (TFV) blood concentration at 24 weeks
Secondary outcome measures
Medical appointment adherence at 24 weeks
Medical appointment adherence at 48 weeks
Self-reported Medication Adherence at 24 weeks
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Multilevel Gaming AdherenceExperimental Treatment1 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 Control1 Intervention
TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game.
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
71,534 Total Patients Enrolled
Larry K Brock, MDStudy DirectorRhode Island Hospital
Sharon Vuppula, MDStudy DirectorBoston Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Not applicable.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.
Research Study Groups:
This trial has the following groups:- Group 1: Multilevel Gaming Adherence
- Group 2: Treatment as Usual +
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being included in the study at this time?
"Unfortunately, clinicaltrials.gov records indicate that this trial is no longer accepting participants. The initial posting date was April 1st 2023 and the last update to the listing occurred on February 27th of 2023. Nevertheless, an abundance of other medical trials are presently searching for patients at this time - 569 in total."
Answered by AI
Does this research endeavor include participants aged 18 and above?
"This scientific research requires that all participants be aged between 15 and 34. Ancillary studies are in place to accommodate those under 18 years old (134 trials) and over 65 (425 trials)."
Answered by AI
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