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Self-Regulation Intervention for Unprotected Sex Decision-Making
N/A
Recruiting
Led By Tibor Palfai, PhD
Research Sponsored by Boston University Charles River Campus
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 90 days
Awards & highlights
Study Summary
This trial will study how heavy drinking influences sexual decision-making and test an intervention to reduce HIV risk among MSM who drink heavily.
Who is the study for?
This trial is for cisgender men who drink heavily (more than 14 drinks weekly or more than 4 on one occasion), are at least 18 years old, have had unprotected sex with another man recently, and own a smartphone. It's not for those with certain mental health conditions, current suicidal intent, HIV infection, those on PrEP or in a monogamous relationship, or undergoing substance abuse treatment.Check my eligibility
What is being tested?
The study aims to understand how heavy drinking affects sexual decision-making among men who have sex with men and to test an intervention designed to reduce risky sexual behavior related to alcohol use. Participants will receive either self-regulation strategies or brief advice and information.See study design
What are the potential side effects?
Since the interventions involve behavioral strategies rather than medications, there may be minimal physical side effects. However, participants might experience psychological discomfort when discussing personal behaviors or receiving feedback.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ past 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol Use: Experience Sampling
Average number of drinks per week from the Quick Drinking Screen
Condomless Anal Intercourse: Experience Sampling
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Regulation InterventionExperimental Treatment1 Intervention
Single session motivational intervention on reducing heavy drinking and sexual risk behavior, encouraging consideration of pre-exposure prophylaxis (PrEP), followed by 4 weeks of text messages on content relevant to drinking goals and support for healthy sexual choices
Group II: Brief Advice and InformationActive Control1 Intervention
Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Self-Regulation Intervention
2019
N/A
~90
Find a Location
Who is running the clinical trial?
Boston University Charles River CampusLead Sponsor
114 Previous Clinical Trials
11,936 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,091 Total Patients Enrolled
Syracuse UniversityOTHER
48 Previous Clinical Trials
117,220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a cisgender man who has had unprotected sex with another man recently.I have a history of severe mental health issues or currently feel suicidal.I am in a committed relationship with one partner only.I am HIV-positive.I am currently taking medication to prevent HIV.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Self-Regulation Intervention
- Group 2: Brief Advice and Information
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.
Is there an opportunity for participants to register for this experiment?
"Incorrect. At this time, the trial is not actively recruiting patients as per clinicaltrials.gov records which were last updated on February 6th 2023 when it was originally posted March 1st 2023. However, while this research study may be closed to new participants 335 other studies are currently enrolling volunteers."
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