Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | March 1, 2018 |
| End Date: | May 1, 2022 |
| Contact: | Matthew J Mimiaga, ScD, MPH |
| Email: | matthew_mimiaga@brown.edu |
| Phone: | 401 863-6559 |
Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse
This study seeks primarily to test, in a three-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 randomized 2:2:1 to three arms: (1) the Project
IMPACT intervention, BA-RR counseling, which lasts ten sessions; (2) the time- and
intensity-matched control condition, including ten sessions of relaxation therapy with
educational support; and (3) 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.
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 randomized 2:2:1 to three arms: (1) the Project
IMPACT intervention, BA-RR counseling, which lasts ten sessions; (2) the time- and
intensity-matched control condition, including ten sessions of relaxation therapy with
educational support; and (3) 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.
Project IMPACT targets both stimulant use and sexual risk reduction in effort to help
individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates
BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity,
incorporated with RR counseling aimed to reduce risky sexual practices, and potential HIV
acquisition. This RCT is a three-arm efficacy trial, comparing the Project IMPACT
Intervention with a time and intensity matched control arm and a SOC arm. Comparing Project
IMPACT intervention against a credible time- and intensity-matched control will determine if
the intervention is efficacious above general counseling with the same intensity and duration
(e.g., attention spent with the therapist vs. the content). Relaxation therapy and
educational support will be utilized for the time- and intensity- matched intervention. All
participants will receive HIV testing, pre-/post-test risk reduction counseling, oral swab
toxicology test at baseline and 12 months, assessment of interest/indication for Pre-Exposure
Prophylaxis (PrEP) per Center for Disease Control guidelines, and active referral to local
PrEP services as standard-of-care. Finally, the RCT will integrate resource utilization and
cost-effectiveness analyses to examine cost efficiency of the Project IMPACT Intervention as
a component of data analysis.
individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates
BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity,
incorporated with RR counseling aimed to reduce risky sexual practices, and potential HIV
acquisition. This RCT is a three-arm efficacy trial, comparing the Project IMPACT
Intervention with a time and intensity matched control arm and a SOC arm. Comparing Project
IMPACT intervention against a credible time- and intensity-matched control will determine if
the intervention is efficacious above general counseling with the same intensity and duration
(e.g., attention spent with the therapist vs. the content). Relaxation therapy and
educational support will be utilized for the time- and intensity- matched intervention. All
participants will receive HIV testing, pre-/post-test risk reduction counseling, oral swab
toxicology test at baseline and 12 months, assessment of interest/indication for Pre-Exposure
Prophylaxis (PrEP) per Center for Disease Control guidelines, and active referral to local
PrEP services as standard-of-care. Finally, the RCT will integrate resource utilization and
cost-effectiveness analyses to examine cost efficiency of the Project IMPACT Intervention as
a component of data analysis.
Inclusion Criteria:
- Age 18 or older
- Assigned male at birth
- Self-identifies as MSM with cisgender men
- HIV-uninfected
- 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 PrEP*
- Able to read, speak, and understand English
- Willing and able to provide informed consent
Exclusion Criteria:
- 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
- Unable to provide informed consent due to severe mental or physical illness, or
substance intoxication at the time of interview
- Discovery of active suicidal ideation at the time of interview (participants will be
referred immediately for treatment, but may join the study once resolved)-
- Involvement in any other HIV Prevention study that may interfere with the ability to
test major study outcomes
We found this trial at
2
sites
Click here to add this to my saved trials
University of Miami A private research university with more than 15,000 students from around the...
Click here to add this to my saved trials