Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Substance Abuse Clinical Trial

Official title:

Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03175159
• Other study ID #: 1R01DA042805-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Prevention
• Stimulant Abuse
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• IMPACT
Ten counseling sessions
• Standard of Care
Two counseling sessions

Locations

Country	Name	City	State
United States	Fenway Community Health Center	Boston	Massachusetts
United States	University of Miami	Miami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Los Angeles	Brown University, The Fenway Institute, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in the number of stimulant use episodes over study follow-up	A self reported change in the number of stimulant use episodes over study follow-up	Baseline, 4 month, 8 month, 12 month