Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Young Gay/Bisexual Minority Men (IMPACT)

HIV Clinical Trial

— IMPACT  

Official title:

Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Young Gay/Bisexual Sexual Minority Men (Project IMPACT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444360
• Other study ID #: ATN170
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 22, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: Westat
• Contact: Erin Ricketts
• Phone: 240-453-2786
• Email: erinricketts[@]westat.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk

Description:

IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT across various settings for translation into real-world practice using a hybrid effectiveness-implementation design.

The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV risk reduction (RR), 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention.

The enhanced Standard of Care (eSOC) group includes two HIV RR intervention sessions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• Age 16-24 years, inclusive, at enrollment

• Assigned male at birth

• Identifies as a cisgender boy or man

• Self-reports condomless anal sex (CAS) with another boy/man-receptive or insertive-while using stimulants (1 hour prior to, or during sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)

• Willing and able to provide written informed consent for study participation

In addition, virtual participants must meet all the below criteria:

• Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)

• Provide a mailing address where they can receive a package

• Access to stable internet that they can use for more than 2 hours at a time

• Have a private place (where no one else can see or hear) where they can complete visits online

• Reside within the continental U.S.

Exclusion Criteria:

• Unable to provide informed consent due to severe mental or physical illness

• Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable

• Non-English-speaking

• Is currently incarcerated or pending incarceration

• Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Site Consortium Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• IMPACT
The IMPACT intervention consists of 10 sessions: 2 sessions focused on HIV acquisition/transmission risk reduction (RR), 1 session focused on orienting and rationale to behavioral activation (BA), 6 sessions integrating BA and HIV RR counseling (including PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management.
• eSOC
The eSOC group consists of 2 sessions focused on HIV acquisition/transmission risk reduction (RR).

Locations

Country	Name	City	State
United States	Emory Atlanta Adolescent Consortium	Atlanta	Georgia
United States	The Fenway Institute	Boston	Massachusetts
United States	University Illinois Chicago	Chicago	Illinois
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	Tulane University	New Orleans	Louisiana
United States	Brown University	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Westat	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distinct acts of condomless anal sex (CAS) without the protection of PrEP or viral suppression.	The number of times participants report engaging in a CAS act without the protection of prevention-effective PrEP (for those not living with HIV) or viral suppression (for those living with HIV).	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
Secondary	Days of stimulant use	The number of days participants report having used stimulants	Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12 after enrollment