Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT03175159
Collaborator
University of Miami (Other), The Fenway Institute (Other), Brown University (Other)
156
2
2
70
78
1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: IMPACT
  • Behavioral: Standard of Care
N/A

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 two-arm efficacy trial, comparing the Project IMPACT Intervention with a SOC arm. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Two-arm RTC, equally randomized between two arms: (1) the Project IMPACT intervention, "BA-RR" (behavioral activation and HIV risk reduction) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent sexual risk reduction counseling sessions.Two-arm RTC, equally randomized between two arms: (1) the Project IMPACT intervention, "BA-RR" (behavioral activation and HIV risk reduction) counseling, which lasts ten sessions; and (2) 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
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard of Care (SOC)

Sexual risk-reduction counseling sessions.

Behavioral: Standard of Care
Two counseling sessions

Experimental: Behavioral Activation & Risk Reduction Counseling

Behavioral activation with risk reduction counseling.

Behavioral: IMPACT
Ten counseling sessions

Outcome Measures

Primary Outcome Measures

  1. Reduction in Condomless Anal Sex Acts (CAS) over study follow-up [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

  1. Reduction in the number of stimulant use episodes over study follow-up [Baseline, 4 month, 8 month, 12 month]

    A self reported change in the number of stimulant use episodes over study follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

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 in the last four 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)-

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 331462926
2 Fenway Community Health Center Boston Massachusetts United States 022154302

Sponsors and Collaborators

  • University of California, Los Angeles
  • University of Miami
  • The Fenway Institute
  • Brown University

Investigators

  • Principal Investigator: Matthew J Mimiaga, ScD, MPH, University of California, Los Angeles, Fielding School of Public Health
  • Principal Investigator: Steve Safren, PhD, University of Miami

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Matthew Mimiaga, ScD, MPH, MA, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT03175159
Other Study ID Numbers:
  • 1R01DA042805-01A1
First Posted:
Jun 5, 2017
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Matthew Mimiaga, ScD, MPH, MA, Principal Investigator, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021