HIVSwerveNCT02945436
Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention
A study testing Substance Use Brief Intervention in people with HIV and Substance Use, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Use
- What is being tested?
- Substance Use Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- °Anyone not meeting all 6 inclusion criteria will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Sexuality and Health Disparities
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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).
- Conditions
- HIV, Substance Use
- Being tested
- Substance Use Brief Intervention, Standard of Care (SOC)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance Use Brief InterventionBehavioural
Also called SUBI
SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.
Standard of Care (SOC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SOC + SOC | Active comparator | Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2. Receives: Behavioral: Standard of Care (SOC) |
| SOC + SUBI | Experimental | Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2. Receives: Behavioral: Substance Use Brief Intervention; Behavioral: Standard of Care (SOC) |
| SUBI + SUBI | Experimental | Participants will receive the SUBI at both visit 1 and visit 2. Receives: Behavioral: Substance Use Brief Intervention |
| SUBI + SOC | Experimental | Participants will receive the SUBI at visit 1 and SOC at visit 2. Receives: Behavioral: Substance Use Brief Intervention; Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increases in repeat HIV testing
Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start7 Apr 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Stephenson, University of Michigan
- Investigators
- Rob Stephenson, PhD, Principal investigator, Director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945436
- Sponsor's protocol ID
- HUM00105125
- Other IDs
- R01DA041032-02
- Acronym
- Swerve
- Status last verified
- Jul 2022
- First submitted
- 17 Oct 2016
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35776441Parker 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.
PubMed 34855613Stephenson 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.
PubMed 29712625
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use
- ClinicalTrials.gov ID
- NCT02945436
- Acronym / sponsor ID
- Swerve / HUM00105125
- Conditions
- HIV, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SOC + SOC | Active comparator | Behavioral: Standard of Care (SOC)Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2. |
| SOC + SUBI | Experimental | Behavioral: Substance Use Brief Intervention, Behavioral: Standard of Care (SOC)Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2. |
| SUBI + SUBI | Experimental | Behavioral: Substance Use Brief InterventionParticipants will receive the SUBI at both visit 1 and visit 2. |
| SUBI + SOC | Experimental | Behavioral: Substance Use Brief Intervention, Behavioral: Standard of Care (SOC)Participants will receive the SUBI at visit 1 and SOC at visit 2. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- °Anyone not meeting all 6 inclusion criteria will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance Use Brief InterventionAlso: SUBISUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants. | Behavioural | SOC + SUBI, SUBI + SOC, SUBI + SUBI |
| 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. | Behavioural | SOC + SOC, SOC + SUBI, SUBI + SOC |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 35776441Parker 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.
- Derived from this study: PubMed 34855613Parker 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.
- Derived from this study: PubMed 29712625Stephenson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Stephenson, PhD principal investigator
Director, Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substance Use Brief Intervention in people with HIV and Substance Use, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increases in repeat HIV testing (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945436, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022; AzTrials last refreshed its copy on 1 Nov 2026.