Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention (Swerve)

Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use

A sample of 300 young (15-29) men who have sex with men (MSM) and transgender persons living in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based sampling and online ads to examine the efficacy of adding a substance use brief intervention (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful engagement in HIV care. The investigators will partner with Detroit-area AIDS Service Organizations (ASOs) to deliver the intervention.

Study Overview

• Status: Completed
• Conditions: HIV; Substance Use
• Intervention / Treatment: Behavioral: Standard of Care (SOC); Behavioral: Substance Use Brief Intervention

Detailed Description

The research activities involve a prospective 4-arm factorial RCT (SOC-only, SOC+SUBI, SUBI+SOC, SUBI+SUBI) of approximately 300 ATOD-using high-risk YMSM aged 15-29 in the DMA. The intervention comprises of two intervention visits, at which time participants may get either standard of care only (SOC-only) or standard of care plus SUBI. All participants will receive standard of care (SOC; i.e., Comprehensive HIV Testing and Counseling) at each visit. The substance use brief intervention (SUBI) will be added to SOC within the experimental arms. At intervention visit one, standard of care is the same for all participants: standard of care is Counseling Testing and Referral (CTR).CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients. Hence at visit one, 150 YMSM will receive CTR and 150 YMSM will receive CTR+SUBI. The investigators expect approximately 10-15% of participants to test HIV positive at intervention visit one. For intervention visit two, standard of care is sero-status specific. For HIV-negatives standard of care remains CTR. For HIV-positives standard of care is case management, as offered routinely by each ASO, which involves counseling on linkage to care and the importance of care retention. To examine how the sequencing and dosing of interventions impacts efficacy, the investigators propose to randomize at baseline into a factorial randomized controlled trial. The control arm will receive SOC-only at both intervention visit one and two (SOC-only). Experimental arm one (SOC+SUBI) will receive SOC at visit one and SUBI at visit two. Experimental arm two (SUBI+SOC) will receive SUBI at visit one and SOC at visit two. Experimental arm three (SUBI+SUBI) will receive the intervention condition at visits one and two.

The RCT thus answers two important questions: 1) What is the impact of the addition of SUBI to SOC on HIV engagement in care and sexual and substance-related risk-taking behaviors among high-risk YMSM? and 2) What combination of services (SOC-only, SOC+SUBI, SUBI+SOC, SUBI+SUBI) has the greatest impact on engagement in HIV prevention? (where engagement in care is defined as routine HIV testing for sero-negative YMSM and linkage/retention in care for sero-positive MSM).

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Center for Sexuality and Health Disparities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All participants must be ages 15-29
• All participants must currently reside in the DMA (verified by zip code)
• All participants must self-report as HIV sero-negative
• All participants must report at least one sexual experience with a man in the previous 6 months
• All participants must report either at least one binge-drinking episode and/or use of illicit substances in the previous 3 months
• All participants must identify as either a man who has sex with men (MSM) or as transgender
• All participants must speak English

Exclusion Criteria:

°Anyone not meeting all 6 inclusion criteria will be excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SOC + SOC; Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2.	Behavioral: Standard of Care (SOC); Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.
Experimental: SOC + SUBI; Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2.	Behavioral: Standard of Care (SOC); Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.; Behavioral: Substance Use Brief Intervention; SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.; Other Names: SUBI
Experimental: SUBI + SUBI; Participants will receive the SUBI at both visit 1 and visit 2.	Behavioral: Substance Use Brief Intervention; SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.; Other Names: SUBI
Experimental: SUBI + SOC; Participants will receive the SUBI at visit 1 and SOC at visit 2.	Behavioral: Standard of Care (SOC); Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.; Behavioral: Substance Use Brief Intervention; SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.; Other Names: SUBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increases in repeat HIV testing	Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreases in sexual risk behavior	Decreases in sexual risk behavior as measured by the "Sexual History" section of the questionnaires	18 months
Reduction in substance use and abuse as measured by the "Assist", "Audit", "Medical Marijuana", Synthetic Cannabis", "Energy Drinks", and "Substance Use (past 30 days)" sections of the questionnaires	Investigators will verify self-reported substance use by collecting and testing biological samples. Investigators will measure alcohol use with an Ethyl Glucuronide (ETG) urine test. Investigators will measure the use of other substances with an EZ Split Key Cup urine test.	18 months
Reduction in consequences of substance use as measured by the "Assist", "Audit" and "Overdose" sections of the questionnaires	Reduction in the number of participants who experience negative consequences of substance use as measured by the "Assist", "Audit" and "Overdose" sections of the questionnaires	18 months
Decreased STI incidence	Decreases in STI incidence as measured by the "STI History" section of the questionnaires	18 months
Increase in the number of participants who have been successfully engaged in care	The investigators define engagement in HIV care as linkage and retention in HIV care (per the Institute of Medicine guidelines of linkage, or first HIV-care related visit, within 90 days of diagnosis and at least two physician visits with a CD4 and viral load test in 12 months) and achievement of viral suppression.	18 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Rob Stephenson, PhD, Director, Professor

Publications and helpful links

General Publications

• Parker JN, Choi SK, Bauermeister JA, Bonar EE, Carrico AW, Stephenson R. HIV and Sexually Transmitted Infection Testing Among Substance-Using Sexual and Gender Minority Adolescents and Young Adults: Baseline Survey of a Randomized Controlled Trial. JMIR Public Health Surveill. 2022 Jul 1;8(7):e30944. doi: 10.2196/30944.
• Parker JN, Hunter AS, Bauermeister JA, Bonar EE, Carrico A, Stephenson R. Comparing Social Media and In-Person Recruitment: Lessons Learned From Recruiting Substance-Using, Sexual and Gender Minority Adolescents and Young Adults for a Randomized Control Trial. JMIR Public Health Surveill. 2021 Dec 1;7(12):e31657. doi: 10.2196/31657.
• Stephenson R, Bonar EE, Carrico A, Hunter A, Connochie D, Himmelstein R, Bauermeister J. Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 30;7(4):e114. doi: 10.2196/resprot.9414.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HUM00105125; R01DA041032-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No