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Recruiting NCT06444360

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

No phase Interventional HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMPACT, eSOC.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: 16 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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

Detailed 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 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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • University of California, Los Angeles — Los Angeles
  • Brown University — Providence

Identifiers

NCT: NCT06444360 · ATN170 · UM2HD111102 · UM2HD111076

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗