Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

NCT03175159 | Completed

• 1 other identifier: 1R01DA042805-01A1
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

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.

Conditions

Stimulant Abuse; HIV Prevention; Substance Abuse

Keywords

Risk Reduction; Crystal Methamphetamine; Cocaine; Stimulant Abuse; HIV; Behavioral Activation

Outcome Measures

Primary Outcomes (1)

• Reduction in Condomless Anal Sex Acts (CAS) over study follow-up

  A self reported change in the number of CAS with men without protection of PrEP

  Baseline, 4 month, 8 month, 12 month

Secondary Outcomes (1)

• Reduction in the number of stimulant use episodes over study follow-up

  Baseline, 4 month, 8 month, 12 month

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

Sexual risk-reduction counseling sessions.

Behavioral: Standard of Care

Behavioral Activation & Risk Reduction Counseling

EXPERIMENTAL

Behavioral activation with risk reduction counseling.

Behavioral: IMPACT

Interventions

IMPACT BEHAVIORAL

Ten counseling sessions

Behavioral Activation & Risk Reduction Counseling

Standard of Care BEHAVIORAL

Two counseling sessions

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Intervention addresses stimulant use and HIV risk reduction in MSM
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

University of Miami

Miami, Florida, 331462926, United States

Location

Fenway Community Health Center

Boston, Massachusetts, 022154302, United States

Location

Related Publications (2)

• Klasko-Foster LB, Biello KB, Lodge W 2nd, Olson J, Mimiaga MJ. Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct HIV-Focused Interventions. Telemed J E Health. 2022 Jul;28(7):1070-1073. doi: 10.1089/tmj.2021.0190. Epub 2022 Jan 6.

  PMID: 34995162 DERIVED

• Mimiaga MJ, Pantalone DW, Biello KB, Glynn TR, Santostefano CM, Olson J, Pardee DJ, Hughto JMW, Garcia Valles J, Carrico AW, Mayer KH, Safren SA. A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol. BMC Public Health. 2018 Jul 25;18(1):914. doi: 10.1186/s12889-018-5856-0.

  PMID: 30045702 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Risk Reduction Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Matthew J Mimiaga, ScD, MPH

  University of California, Los Angeles, Fielding School of Public Health

  PRINCIPAL INVESTIGATOR

• Steve Safren, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will not be aware of the intervention assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The first time point at which outside investigators may request IPD will be after all of the baseline data has been collected and internal study staff have been offered the availability to write papers or give presentations on particular topics. A similar process will take place for outcome data following publication and release of the outcome paper(s). The MPIs (Mimiaga and Safren) will store the data indefinitely.
• Access Criteria: Raw data for additional analysis will be available to outside individuals through contacting the Multiple Principal Investigators (MPI). 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. 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.

Locations

US (2)