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

The research activities involve a prospective 4-arm factorial RCT (SOC-only, SOC+SUBI,
SUBI+SOC, SUBI+SUBI) of approximately 600 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, 300 YMSM will
receive CTR and 300 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).

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