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Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Primary Purpose

Stimulant Abuse, HIV Prevention, Substance Abuse

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IMPACT

Standard of Care

About this trial

This is an interventional prevention trial for Stimulant Abuse focused on measuring Risk Reduction, Crystal Methamphetamine, Cocaine, Stimulant Abuse, HIV, Behavioral Activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

University of Miami
Fenway Community Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care (SOC)

Behavioral Activation & Risk Reduction Counseling

Arm Description

Sexual risk-reduction counseling sessions.

Behavioral activation with risk reduction counseling.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03175159

First Posted

June 1, 2017

Last Updated

September 26, 2023

Sponsor

University of California, Los Angeles

Collaborators

University of Miami, The Fenway Institute, Brown University

1. Study Identification

Unique Protocol Identification Number

NCT03175159

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

University of Miami, The Fenway Institute, Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stimulant Abuse, HIV Prevention, Substance Abuse

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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.

Masking

Outcomes Assessor

Masking Description

The outcome assessor will not be aware of the intervention assignment.

Allocation

Randomized

Enrollment

156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care (SOC)

Arm Type

Active Comparator

Arm Description

Sexual risk-reduction counseling sessions.

Arm Title

Behavioral Activation & Risk Reduction Counseling

Arm Type

Experimental

Arm Description

Behavioral activation with risk reduction counseling.

Intervention Type

Behavioral

Intervention Name(s)

IMPACT

Intervention Description

Ten counseling sessions

Intervention Type

Behavioral

Intervention Name(s)

Standard of Care

Intervention Description

Two counseling sessions

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, 4 month, 8 month, 12 month

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, 4 month, 8 month, 12 month

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Intervention addresses stimulant use and HIV risk reduction in MSM

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew J Mimiaga, ScD, MPH

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steve Safren, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

331462926

Country

United States

Facility Name

Fenway Community Health Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

022154302

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing 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.

Citations:

PubMed Identifier

34995162

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.

Results Reference

derived

PubMed Identifier

30045702

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.

Results Reference

derived

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Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

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