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Behavioral Intervention

Behavioral Therapy for Reducing HIV Risk (IMPACT Trial)

N/A
Waitlist Available
Research Sponsored by Westat
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 16-24 years, inclusive, at enrollment
Assigned male at birth
Must not have
Unable to provide informed consent due to severe mental or physical illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will recall and report acts of cas and medication adherence for the 30 days prior to each of 4 visits: baseline, month 4, month 8 and month 12 after enrollment
Awards & highlights

Summary

This trial aims to use a type of therapy to help people reduce their use of stimulant drugs and lower their risk of transmitting HIV through sexual activity.

Who is the study for?
This trial is for young gay/bisexual minority men who are sexually active. It's designed to help those who use stimulants and may be at risk of HIV transmission. Specific eligibility details aren't provided, but typically participants must meet certain health and demographic criteria.
What is being tested?
The trial is testing a behavioral intervention called IMPACT, compared with an electronic Social Networking (eSOC) strategy, to see if they can reduce stimulant use and lower the risk of HIV among participants.
What are the potential side effects?
Since this study focuses on behavioral interventions rather than medications, traditional side effects are not expected. However, there might be emotional or psychological responses due to changes in behavior or social dynamics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 16 and 24 years old.
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I was assigned male at birth.
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I identify as a cisgender male.
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I have had unprotected sex with men while using stimulants like meth, cocaine, or MDMA in the last 4 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form due to a severe illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will recall and report acts of cas and medication adherence for the 30 days prior to each of 4 visits: baseline, month 4, month 8 and month 12 after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will recall and report acts of cas and medication adherence for the 30 days prior to each of 4 visits: baseline, month 4, month 8 and month 12 after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Distinct acts of condomless anal sex (CAS) without the protection of PrEP or viral suppression.
Secondary outcome measures
Days of stimulant use

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IMPACT GroupExperimental Treatment1 Intervention
A multifaceted training and implementation strategy across sites and formats will be used. Participants who report stimulant use in the context of condomless anal sex (CAS), will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. The participants in this arm participate in 10 sessions (approximately 50 minutes each) delivered over the course of approximately 10 weeks.
Group II: Enhanced Standard of Care (eSOC) Control GroupActive Control1 Intervention
The comparison arm will receive the same 2 HIV sexual risk reduction (RR) intervention sessions and referrals to substance use and mental health treatment, per SOC.
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?

National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,459 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,223 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,163 Total Patients Enrolled
~240 spots leftby Dec 2028
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