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Game Plan for PrEP for HIV Infection
Phase < 1
Waitlist Available
Led By Tyler Wray, PhD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up past 6 months
Awards & highlights
Study Summary
This trial will test whether an intervention inspired by motivational interviewing can help high-risk men who take PrEP moderate their alcohol use, and improve key outcomes of PrEP care, including adherence, persistence, and STI rates.
Eligible Conditions
- HIV Exposure
- Alcohol Abuse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ past 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Any sexually-transmitted infection (STI) diagnosis
Average number of drinks consumed per drinking day
Number of alcohol drinking days
+3 moreSecondary outcome measures
Phosphatidylethanol level
Tenofovir diphosphate level
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Game Plan for PrEPExperimental Treatment1 Intervention
Participants will be asked to use Game Plan for PrEP for however long they wish. Game Plan for PrEP is a web-based intervention that provides users with feedback about how much their risk for HIV is reduced on PrEP, their risk for bacterial STIs, and helps them make a plan to take their medication regularly and reduce their risk for STIs. Game Plan for PrEP also providers users with feedback about their alcohol use compared to others in their age group and encourages them to make a plan to reduce it.
Group II: Lifestyle Habits VideosPlacebo Group1 Intervention
Participants in this condition will view several videos that encourage them to adopt sleep hygiene and healthy diet behaviors. The videos were selected to last as long as the average time users engage with Game Plan for PrEP in its initial modules.
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Who is running the clinical trial?
Brown UniversityLead Sponsor
456 Previous Clinical Trials
562,981 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,411 Total Patients Enrolled
Tyler Wray, PhDPrincipal InvestigatorBrown University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe alcohol withdrawal symptoms or are at risk of experiencing them.You have used injected drugs within the last year.You are taking medication called PrEP to prevent HIV infection.You have missed taking your PrEP medication for more than three days in a row within the last three months.You have consumed a large amount of alcohol in the past month, which is more than 5 drinks in one sitting or more than 14 drinks in a week.
Research Study Groups:
This trial has the following groups:- Group 1: Game Plan for PrEP
- Group 2: Lifestyle Habits Videos
Awards:
This trial has 0 awards, including: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.
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