HIV
Conditions
Keywords
Behavioral Activation, risk reduction, intervention, stimulant use, HIV sexual risk reduction
Brief summary
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
BEHAVIORALIMPACT
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.
BEHAVIORALeSOC
The eSOC group includes 2 sessions of HIV sexual RR counseling.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Westat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study is a two-arm, multi-site, randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses behavioral activation (BA)-an evidence-based, cognitive behavior therapy-as a treatment for stimulant use and sexual risk reduction (RR) counseling for adolescents and young adults. 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distinct acts of condomless sex without the protection of PrEP or viral suppression. | 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
| Measure | Time frame | Description |
|---|---|---|
| Days of stimulant use | 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 |
Countries
United States
Contacts
Primary ContactErin Ricketts
Outcome results
None listed