Health TrialsbyHealthPanel

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

ConditionHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-24
SponsorWestat

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: IMPACT GroupExperimental treatment 1 intervention
Group B: Enhanced Standard of Care (eSOC) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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).

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 outcomes

1

Days of stimulant use

The number of days participants report having used stimulants

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Westat

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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