Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02945436 |
| Other study ID # |
HUM00105125 |
| Secondary ID |
R01DA041032-02 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2017 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 (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.
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).
