HIVIMPACTNCT06444360
Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults
A study testing IMPACT and eSOC in people with HIV, run by Westat at 2 sites in United States.
Trial summary
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- IMPACT and eSOC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-24 years, inclusive, at enrollment
- Self-reports condomless 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.
Who cannot join
- 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 of study prior to March 2025 study pause
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
IMPACT 170 Staff, 310-825-3094, impactstudy@ph.ucla.edu
Matthew Mimiaga, ScD, MPH
- Recruiting
Brown University
Providence, Rhode Island, 02912
IMPACT 170 Staff, 401-863-3292, impact170@brown.edu
Katie Biello, PhD, MPH
About this study
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)
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
Read the detailed description
IMPACT is a status-neutral intervention that uses behavioral activation (BA) integrated with sexual health (SH) counseling to support stimulant use reduction and safer sex practices for adolescents and young adults. 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 sexual education and counseling, 1 session focused on psychoeducation and reflection around stimulants, 1 session orienting BA and harm reduction strategies, 5 sessions integrating BA, SH, and coping skills, and 1 final session on reviewing progress and planning for the future.
The enhanced Standard of Care (eSOC) group receives two SH counseling sessions only.
- Conditions
- HIV
- Being tested
- IMPACT, eSOC
- Keywords
- Behavioral activation, Intervention, Stimulant use, HIV sexual health counseling, Behavior, Sexual education and counseling
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACTBehavioural
The IMPACT intervention includes 10 sessions: 2 sessions of sexual education and counseling, 1 session focused on psychoeducation and reflection around stimulants, 1 session orienting BA and harm reduction strategies, 5 sessions integrating BA, SH, and coping skills, and 1 final session on reviewing progress and planning for the future.
eSOCBehavioural
The enhanced Standard of Care (eSOC) group receives two SH counseling sessions only.
| Study group | Role | What they receive |
|---|---|---|
| IMPACT Group | Experimental | Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. Receives: Behavioral: IMPACT |
| Enhanced Standard of Care (eSOC) Group | Active comparator | Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention. Receives: Behavioral: eSOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Nov 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a two-arm, multi-site, randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses BA integrated with SH counseling to support stimulant use reduction and safer sex practices for adolescents and young adults. The IMPACT intervention includes 10 sessions: 2 sessions of sexual education and counseling, 1 session focused on psychoeducation and reflection around stimulants, 1 session orienting BA and harm reduction strategies, 5 sessions integrating BA, SH, and coping skills, and 1 final session on reviewing progress and planning for the future. The enhanced Standard of Care (eSOC) group receives two SH counseling sessions only.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Katie B. Biello, PhD, MPH, Study chair, Brown UniversityMatthew Mimiaga, ScD, MPH, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444360
- Sponsor's protocol ID
- ATN170
- Other IDs
- UM2HD111102, UM2HD111076
- Acronym
- IMPACT
- Status last verified
- Oct 2026
- First submitted
- 30 May 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06444360
- Acronym / sponsor ID
- IMPACT / ATN170
- Conditions
- HIV
- Keywords
- Behavioral activation, Intervention, Stimulant use, HIV sexual health counseling, Behavior, Sexual education and counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
Detailed description
IMPACT is a status-neutral intervention that uses behavioral activation (BA) integrated with sexual health (SH) counseling to support stimulant use reduction and safer sex practices for adolescents and young adults. 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 sexual education and counseling, 1 session focused on psychoeducation and reflection around stimulants, 1 session orienting BA and harm reduction strategies, 5 sessions integrating BA, SH, and coping skills, and 1 final session on reviewing progress and planning for the future.
The enhanced Standard of Care (eSOC) group receives two SH counseling sessions only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a two-arm, multi-site, randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses BA integrated with SH counseling to support stimulant use reduction and safer sex practices for adolescents and young adults. The IMPACT intervention includes 10 sessions: 2 sessions of sexual education and counseling, 1 session focused on psychoeducation and reflection around stimulants, 1 session orienting BA and harm reduction strategies, 5 sessions integrating BA, SH, and coping skills, and 1 final session on reviewing progress and planning for the future. The enhanced Standard of Care (eSOC) group receives two SH counseling sessions only.
| Arm | Type | Receives |
|---|---|---|
| IMPACT Group | Experimental | Behavioral: IMPACTParticipants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. |
| Enhanced Standard of Care (eSOC) Group | Active comparator | Behavioral: eSOCParticipants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 16-24 years, inclusive, at enrollment
- Self-reports condomless 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
Key exclusion criteria (7 listed)
- 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 of study prior to March 2025 study pause
- Non-English-speaking
- Is currently incarcerated or pending incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPACTThe IMPACT intervention includes 10 sessions: 2 sessions of sexual education and counseling, 1 session focused on psychoeducation and reflection around stimulants, 1 session orienting BA and harm reduction strategies, 5 sessions integrating BA, SH, and coping skills, and 1 final session on reviewing progress and planning for the future. | Behavioural | IMPACT Group |
| eSOCThe enhanced Standard of Care (eSOC) group receives two SH counseling sessions only. | Behavioural | Enhanced Standard of Care (eSOC) Group |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katie B. Biello, PhD, MPH study chair
Brown University
Matthew Mimiaga, ScD, MPH study chair
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT and eSOC in people with HIV, run by Westat at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Ricketts (240-453-2786, erinricketts@westat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.