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

Primary Purpose

HIV, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Substance Use Brief Intervention
Standard of Care (SOC)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

15 Years - 29 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Sexuality and Health Disparities

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

SOC + SOC

SOC + SUBI

SUBI + SUBI

SUBI + SOC

Arm Description

Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2.

Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2.

Participants will receive the SUBI at both visit 1 and visit 2.

Participants will receive the SUBI at visit 1 and SOC at visit 2.

Outcomes

Primary Outcome Measures

Increases in repeat HIV testing
Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires

Secondary Outcome Measures

Full Information

First Posted
October 17, 2016
Last Updated
July 5, 2022
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02945436
Brief Title
Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention
Acronym
Swerve
Official Title
Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOC + SOC
Arm Type
Active Comparator
Arm Description
Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2.
Arm Title
SOC + SUBI
Arm Type
Experimental
Arm Description
Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2.
Arm Title
SUBI + SUBI
Arm Type
Experimental
Arm Description
Participants will receive the SUBI at both visit 1 and visit 2.
Arm Title
SUBI + SOC
Arm Type
Experimental
Arm Description
Participants will receive the SUBI at visit 1 and SOC at visit 2.
Intervention Type
Behavioral
Intervention Name(s)
Substance Use Brief Intervention
Other Intervention Name(s)
SUBI
Intervention Description
SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increases in repeat HIV testing
Description
Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Decreases in sexual risk behavior
Description
Decreases in sexual risk behavior as measured by the "Sexual History" section of the questionnaires
Time Frame
18 months
Title
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
Description
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.
Time Frame
18 months
Title
Reduction in consequences of substance use as measured by the "Assist", "Audit" and "Overdose" sections of the questionnaires
Description
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
Time Frame
18 months
Title
Decreased STI incidence
Description
Decreases in STI incidence as measured by the "STI History" section of the questionnaires
Time Frame
18 months
Title
Increase in the number of participants who have been successfully engaged in care
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Stephenson, PhD
Organizational Affiliation
Director, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Sexuality and Health Disparities
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35776441
Citation
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.
Results Reference
derived
PubMed Identifier
34855613
Citation
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.
Results Reference
derived
PubMed Identifier
29712625
Citation
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.
Results Reference
derived

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

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