An interventional study of IMPACT and eSOC in HIV, sponsored by Westat. Recruiting at 2 sites in United States. Open to participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Westat · Not applicable, Interventional, and Prevention
Among 584 studies in Behavior with a site in United States — 87 open to participants now, 119 under way, 2 of them phase 3. Behavior · United States.
Among the 584 studies in Behavior with a site in United States, this one is the 130th largest by planned enrollment of the 494 interventional ones, is one of 34 that started in 2025, is one of 430 with no phase, reaches primary completion later than 107 of the 117 other live ones, and was the 506th registered.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 360 is above the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →87 of the 584 studies in Behavior with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 178 Behavior studies recruiting now, 76 (43%) set no upper age limit and 74 (42%) stop at 75 or younger; 58 take children under 18; 100 take healthy volunteers.
This study: 16 Years to 24 Years · all sexes · healthy volunteers too.
The full table on the hub →584 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 34 started in 2025.
Median enrollment 121 across the 494 interventional studies, 122 across the 89 observational. Of the 430 that completed or were terminated, 108 (25%) have results posted.
29 of 584 have an industry lead sponsor. The 10 most frequent:
Westat is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Westat has 1 study filed under Behavior — fewer than ten, so there is no comparison to draw.
49 of the studies in Behavior with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07217145Phase 3University of UtahPREVENT HPV -Related Cancers Trial | 2026-11 |
| NCT06099197Indiana UniversityI-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals | 2026-11 |
| NCT06725134University of MichiganImpact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures | 2026-11-10 |
| NCT04481061Children's Hospital Medical Center, CincinnatiEngaging Adolescents in Decisions About Return of Genomic Research Results | 2026-11-30 |
| NCT05677360H. Lee Moffitt Cancer Center and Research InstituteHPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS) | 2026-12 |
Among the 584 studies in Behavior with a site in United States, from their registry updates:
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
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.
The criteria were revised on the registry on Nov 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: IMPACT
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.
Behavioral: eSOC
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jun 2029, 43 months after the start.
Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 43 months is above that.
Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Westat