Clinical trial NCT03175159: Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
Official title: Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stimulant Abuse
HIV Prevention
Substance Abuse
Keywords: Risk Reduction
Crystal Methamphetamine
Cocaine
Stimulant Abuse
HIV
Behavioral Activation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Miami
name: The Fenway Institute
name: Brown University
First posted: 2017-06-05
Enrollment: 205
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in Condomless Anal Sex Acts (CAS) over study follow-up
timeFrame: Baseline, 4 month, 8 month, 12 month
Secondary outcomes:
measure: Reduction in the number of stimulant use episodes over study follow-up
timeFrame: Baseline, 4 month, 8 month, 12 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Fenway Community Health Center
state: Massachusetts
Study officials:
affiliation: University of California, Los Angeles, Fielding School of Public Health
name: Matthew J Mimiaga, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Steve Safren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.