HIV Clinical Trial
Official title:
Passport to Wellness-Full Intervention Phase
The proposed research study will focus on Black men who have sex with men (BMSM) who
- are HIV- or unknown status AND
- have not received HIV testing in over a year or
- who test irregularly (on 9/21/2016, the protocol was changed to modify the last to
criteria and focus on those who have not used PrEP in the prior six months).
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 (including PrEP), testing, care, and treatment services. 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 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).
;
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