Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness

The proposed research study focuses on BMSM who have not received HIV testing in over a year,
or who test irregularly, and implement an innovative, culturally-informed, peer-based, and
client-centered approach that is designed to increase their awareness of their HIV status and
their timely entry into prevention, care, and treatment services. On 9/21/2016, the protocol
was changed to focus on those who have not used PrEP in the prior six months.

The research design compares the effect of an incentives-only approach to one that uses
incentives, along with the involvement of peer mentors to support timely entry into
prevention, testing, care and treatment. This phase of the study is designed to assess
peer-supported intervention group versus a passport/incentive-only control group over an
18-month period using a randomized trial approach.

The Specific Aims of the full intervention phase are:

2 (Modified). To assess the effectiveness of a peer-supported, incentivized, and
client-centered approach (PtW) compared to a non-peer supported, incentivized, and
client-centered approach (Control) for linking at-risk BMSM to biomedical (PEP, STD testing),
structural or behavioral services that support HIV prevention and care.

2a. Hypothesis: the peer-supported model (PtW) will lead to more frequent and earlier
linkages to services than the non-peer supported model (Control).

2b. Hypothesis: the peer-supported model (PtW) will lead to greater reductions in HIV risk
behaviors than the non-peer-supported model (Control).

3 (NEW). To assess the effectiveness of a peer-supported, incentivized, and client-centered
approach (PtW) compared to a non-peer supported, incentivized, and client-centered approach
(Control) for linking at-risk BMSM to PrEP services.

3a. Hypothesis: the peer-supported model (PtW) will lead to more frequent receipt of PrEP
education and consultations than the non-peer-supported model (Control) 3b. Hypothesis: the
peer-supported model (PtW) will lead to more frequent uptake of PrEP (defined as taking PrEP
at six month follow-up) than the non-peer-supported model (Control).

Inclusion criteria:

1. self identify as male

2. self-identify as Black or African American

3. sex with a male or male-to-female transgender in the last 6 months

4. intercourse without a condom in the last 6 months

5. Los Angeles County resident,

6. either is unaware of HIV status and has not tested for HIV in the last 12 months or
has recently tested (within 30 days), but had not received testing in the prior 12
months

- 6) Modified 9/21/2016 to has not taken PrEP in the prior 6 months

Exclusion criteria:

1. self-identify as female or transgender male or female

2. does not self-identify as Black or African American

3. no sex with a man or a male-to-female transgender in the last 6 months

4. no sexual intercourse in the last 6 months

5. resides outside of Los Angeles County

6. is HIV-positive OR has tested between 1 and 13 months prior to enrollment.

- 6) Modified 9/21/2016 to has not taken PrEP in the prior 6 months