Passport to Wellness-Full Intervention Phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Charles Drew University of Medicine and Science
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
Time Frame: 6 Months
--Number of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline.
Number with specific PrEP outcomes
Time Frame: 6 Months
--Number of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription.
Number self-reporting specific Social and Behavioral Outcomes
Time Frame: 6 Months
--Number of participants who obtain social and behavioral services that support HIV prevention and care.
Percentage with specific PrEP outcomes
Time Frame: 6 Months
--Percentage of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription. Summary items may include the percentage who report doing any of these three PrEP activities.
Percentage self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
Time Frame: 6 Months
--Percentage of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline. Summary data may include the percentage who report HIV or STD testing.
Percentage of self-reporting specific Social and Behavioral Outcomes
Time Frame: 6 Months
--Percentage of participants who obtain social and behavioral services that support HIV prevention and care.
Secondary Outcomes
- Number of referrals HIV tested(6 Months)