Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06444360

Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HIV Behavior Risk Reduction Behavior

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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 for translation into real-world practice using a hybrid effectiveness-implementation design.

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

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 16-24 years, inclusive, at enrollment
  • Male or female
  • Self-reports condomless anal or vaginal sex while using stimulants (5 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
  • 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)
  • Randomized to IMPACT arm prior to March 2025 study stop
  • Non-English-speaking
  • Is currently incarcerated or pending incarceration
  • Is currently pregnant or planning to become pregnant
  • Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results

Treatment and study plan

IMPaCT

Behavioral

The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling (including PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management.

eSOC

Behavioral

The eSOC group includes 2 sessions of HIV sexual RR counseling.

Primary outcomes

  1. Distinct acts of condomless sex without the protection of PrEP or viral suppression.

    Time frame: Participants will recall and report acts of condomless sex and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12.

    The number of times participants report engaging in condomless sex without the protection of PrEP (for those not living with HIV) or viral suppression (for those living with HIV).

Secondary outcomes

  1. Days of stimulant use

    Time frame: Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits and will also have urine drug testing done. The visits are at: Baseline, Month 4, Month 8 and Month 12.

    The number of days participants report having used stimulants

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Ricketts

CONTACT

[email protected]

240-453-2786

Sponsors and collaborators

Lead sponsor

Westat

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Adolescents and Young Adults (Project IMPACT)

Acronym: IMPACT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 5, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.