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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945436
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : July 6, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Robert Stephenson, University of Michigan

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.

Condition or disease Intervention/treatment Phase
HIV Substance Use Behavioral: Substance Use Brief Intervention Behavioral: Standard of Care (SOC) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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: 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 Name: SUBI

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: 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 Name: SUBI

Experimental: SUBI + SOC
Participants will receive the SUBI at visit 1 and SOC at 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 Name: SUBI

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.




Primary Outcome Measures :
  1. Increases in repeat HIV testing [ Time Frame: 18 months ]
    Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires


Other Outcome Measures:
  1. Decreases in sexual risk behavior [ Time Frame: 18 months ]
    Decreases in sexual risk behavior as measured by the "Sexual History" section of the questionnaires

  2. 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 [ Time Frame: 18 months ]
    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.

  3. Reduction in consequences of substance use as measured by the "Assist", "Audit" and "Overdose" sections of the questionnaires [ Time Frame: 18 months ]
    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

  4. Decreased STI incidence [ Time Frame: 18 months ]
    Decreases in STI incidence as measured by the "STI History" section of the questionnaires

  5. Increase in the number of participants who have been successfully engaged in care [ Time Frame: 18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945436


Locations
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United States, Michigan
Center for Sexuality and Health Disparities
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Rob Stephenson, PhD Director, Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Stephenson, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02945436    
Other Study ID Numbers: HUM00105125
R01DA041032-02 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders