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Behavioural Intervention
Behavioral Activation + HIV Risk Reduction for Stimulant Abuse and HIV Prevention
N/A
Waitlist Available
Led By Matthew J Mimiaga, ScD, MPH
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reports in the past four months: CAS receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of Pre-Exposure Prophylaxis (PrEP)
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 month, 8 month, 12 month
Awards & highlights
Study Summary
This trial will test an intervention that combines behavioral activation with HIV risk reduction counseling, to see if it is more effective than just the standard of care (HIV risk reduction counseling) in reducing HIV risk behavior in men who have sex with men with stimulant use disorder.
Who is the study for?
This trial is for HIV-uninfected men who have sex with men (MSM), aged 18 or older, who use stimulants and are at risk of HIV through sexual behavior. They must not be on PrEP, live in the Boston or Miami areas, and be able to consent. Those with active suicidal thoughts or severe illness can't join.Check my eligibility
What is being tested?
The study compares Project IMPACT's integrated Behavioral Activation with HIV risk reduction counseling against standard care over ten sessions. Participants will be randomly assigned to either group and followed up for one year with assessments every four months.See study design
What are the potential side effects?
Since this trial focuses on counseling interventions rather than medications, typical drug side effects aren't expected. However, discussing sensitive topics may cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had unprotected sex with a cis male while using stimulants, without PrEP, in the last 4 months.
Select...
I am 18 years old or older.
Select...
I was assigned male at birth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 month, 8 month, 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 month, 8 month, 12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in Condomless Anal Sex Acts (CAS) over study follow-up
Secondary outcome measures
Reduction in the number of stimulant use episodes over study follow-up
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation & Risk Reduction CounselingExperimental Treatment1 Intervention
Behavioral activation with risk reduction counseling.
Group II: Standard of Care (SOC)Active Control1 Intervention
Sexual risk-reduction counseling sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMPACT
2013
Completed Phase 4
~2530
Find a Location
Who is running the clinical trial?
University of MiamiOTHER
901 Previous Clinical Trials
409,830 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,046 Total Patients Enrolled
1 Trials studying Stimulant Abuse
170 Patients Enrolled for Stimulant Abuse
The Fenway InstituteOTHER
14 Previous Clinical Trials
2,671 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had unprotected sex with a cis male while using stimulants, without PrEP, in the last 4 months.I am 18 years old or older.I was assigned male at birth.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Behavioral Activation & Risk Reduction Counseling
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 there any opportunities remaining to participate in this clinical trial?
"The information provided on clinicaltrials.gov reveals that this research project is still enrolling patients. The study was launched on March 1st 2018 and the most recent update occurred just a few days ago, November 3rd 2022."
Answered by AI
Is there a limitation to the number of participants who can take part in this clinical trial?
"Yes, clinicaltrials.gov reveals that this medical experiment is currently looking for individuals to join in. Initially posted on the 1st of March 2018 and most recently edited on the 3rd of November 2022, roughly 156 participants are needed across two sites."
Answered by AI
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