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Trial record 9 of 34 for:    substance abuse | Not yet recruiting Studies

Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

This study is not yet open for participant recruitment.
Verified August 2017 by Brown University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03175159
First Posted: June 5, 2017
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Miami
The Fenway Institute
Information provided by (Responsible Party):
Brown University
  Purpose
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.

Condition Intervention
Stimulant Abuse HIV Prevention Substance Abuse Behavioral: Time & Intensity Matched Control Behavioral: IMPACT Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Three-arm RTC, randomized 2:2:1 to three arms: (1) the Project IMPACT intervention, "BA-RR" (behavioral activation and HIV risk reduction) 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 comparison condition, including two equivalent sexual risk reduction counseling sessions.
Masking: Single (Outcomes Assessor)
Masking Description:
The outcome assessor will not be aware of the intervention assignment.
Primary Purpose: Prevention
Official Title: Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Reduction in Condomless Anal Sex Acts (CAS) over study follow-up [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    A self reported change in the number of CAS with men without protection of PrEP


Secondary Outcome Measures:
  • Reduction in the number of stimulant use episodes over study follow-up [ Time Frame: Baseline, 4 month, 8 month, 12 month ]
    A self reported change in the number of stimulant use episodes over study follow-up


Estimated Enrollment: 286
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: May 1, 2022
Estimated Primary Completion Date: May 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care (SOC)
Sexual risk-reduction counseling sessions.
Behavioral: Standard of Care
Two counseling sessions
Active Comparator: Time & Intensity Matched Control
Relaxation therapy with educational support.
Behavioral: Time & Intensity Matched Control
Ten counseling sessions
Experimental: Behavioral Activation & Risk Reduction Counseling
Behavioral activation with risk reduction counseling.
Behavioral: IMPACT
Ten counseling sessions

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Intervention addresses stimulant use and HIV risk reduction in MSM
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Self-identifies as MSM
  • HIV-uninfected
  • Self-reports in the past three months: CAS receptive or insertive with a non-monogamous male sexual partner, while using stimulants and without the protection of PrEP

Exclusion Criteria:

  • Has lived in the greater Boston or Miami areas for less than three months
  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175159


Contacts
Contact: Matthew J Mimiaga, ScD, MPH 401 863-6559 matthew_mimiaga@brown.du
Contact: Steve Safren, PhD 305 284-2814 ssafren@miami.edu

Sponsors and Collaborators
Brown University
University of Miami
The Fenway Institute
Investigators
Principal Investigator: Matthew J Mimiaga, ScD, MPH Brown University, School of Public Health, Center for Health Equity Research
Principal Investigator: Steve Safren, PhD University of Miami
  More Information

Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03175159     History of Changes
Other Study ID Numbers: 1R01DA042805-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2017
First Posted: June 5, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw data for additional analysis will be available to outside individuals through contacting the Multiple Principal Investigators (MPI) at two different times. The first will be after all of the baseline data is collected. We will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, we will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The MPIs (Mimiaga and Safren) will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the MPIs' program's web page. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brown University:
Risk Reduction
Crystal Methamphetamine
Cocaine
Stimulant Abuse
HIV
Behavioral Activation

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs