Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness
- Conditions
- MenHIV
- Interventions
- Behavioral: Intervention-Passport and Peer MentorBehavioral: Control-Passport Only
- Registration Number
- NCT02932384
- Lead Sponsor
- Charles Drew University of Medicine and Science
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention-Passport and Peer Mentor Intervention-Passport and Peer Mentor In addition to the "Passport to Wellness" developed with project staff, study participants will select a peer mentor trained in motivational interviewing. The peer mentor will help guide the participant to complete passport items. Part of passport development will include compensation for meeting with peer mentors to form strategies for meeting goals and addressing barriers/challenges that arise. Intervention-Passport and Peer Mentor Control-Passport Only In addition to the "Passport to Wellness" developed with project staff, study participants will select a peer mentor trained in motivational interviewing. The peer mentor will help guide the participant to complete passport items. Part of passport development will include compensation for meeting with peer mentors to form strategies for meeting goals and addressing barriers/challenges that arise. Control-Passport Only Control-Passport Only Complete a needs assessment and develop a written "Passport to Wellness," an itemized set of health promoting behaviors and services aligned with lifestyle and goals. Participants are compensated based on the items they complete, services they attend.
- Primary Outcome Measures
Name Time Method Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes 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 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 6 Months --Number of participants who obtain social and behavioral services that support HIV prevention and care.
Percentage with specific PrEP outcomes 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 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 6 Months --Percentage of participants who obtain social and behavioral services that support HIV prevention and care.
- Secondary Outcome Measures
Name Time Method Number of referrals HIV tested 6 Months The investigators will compare between the two arms, the number of HIV tested referrals from study participants in each arm who were 1) BMSM, 2) BMSM newly diagnosed with HIV, and 3) people from other race/gender/sexual orientation groups
Trial Locations
- Locations (2)
Charles Drew University of Medicine and Science
🇺🇸Los Angeles, California, United States
Los Angeles Centers for Alcohol and Drug Abuse (LA CADA)
🇺🇸Los Angeles, California, United States