NCT03175159Completed
Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse
Source: ClinicalTrials.gov · Last updated 25 Jul 2024
Brief summary (registry, in English)
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) the standard of care (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 1 Jun 2017
- Start date
- 1 Mar 2018
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- University of California, Los Angeles
- Diseases
- HIV
- NCT number
- NCT03175159
What you commit to
- Study type: Interventional
- Participants enrolled: 205
- From 1 Mar 2018 to the primary completion date, 1 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Involvement in any other HIV Prevention study that may interfere with the ability to test major study outcomes (e.g. another sexual risk reduction intervention or PrEP adherence intervention)
Other
- Does not live in the greater Boston or Miami areas, or will move away from Boston or Miami within the next 12 months
- Self-reports being 100% adherent to PrEP in the last four months
- Discovery of active suicidal ideation at the time of interview (participants will be referred immediately for treatment, but may join the study once resolved)-
Who the study is looking for
- Age 18 or older
- Assigned male at birth
- HIV-uninfected verified via rapid HIV test
- Self-reports in the past four months: CAS receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of Pre-Exposure Prophylaxis (PrEP)\*
- Able to read, speak, and understand English
- Willing and able to provide informed consent
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Community Health Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.