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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

No Placebo-Only Group

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Distinct acts of condomless anal sex (CAS) without the protection of PrEP or viral suppression.

Secondary study objectives

Days of stimulant use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2730

0 / 5Eligibility criteria met