An interventional study of Intervention-Passport and Peer Mentor and Control-Passport Only in HIV and Men, sponsored by Charles Drew University of Medicine and Science. Completed at 2 sites in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-02.
Sponsored by Charles Drew University of Medicine and Science · Not applicable, Interventional, and Prevention
The proposed research study will focus on Black men who have sex with men (BMSM) who
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).
55 studies on the registry are indexed under Multiple Endocrine Neoplasia Type 1; 20 are open to participants now.
This study's enrollment of 105 is above the median of 60 across 39 interventional studies indexed under Multiple Endocrine Neoplasia Type 1.
Browse Multiple Endocrine Neoplasia Type 1 studies →Charles Drew University of Medicine and Science is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion criteria:
is HIV-positive OR has tested between 1 and 13 months prior to enrollment.
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.
Behavioral: 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.
Behavioral: Intervention-Passport and Peer Mentor · Behavioral: Control-Passport Only
In addition to the passport and incentives described below for the control condition, participants assigned to the intervention will select a peer mentor trained in motivational interviewing. The mentor will help guide the participant to complete passport items and address priorities. Participants will also be incentivized for regular meetings with his peer mentor.
Also known as: Passport To Wellness
A trained staff member will use a needs assessment and the participant's own priorities to develop a 'Passport to Wellness,' a personalized set of services whose access may encourage HIV prevention or address barriers to HIV testing. Example passport items include: getting an HIV test, attending an informational session about PEP/PrEP, meeting with a PrEP provider, attending 12-step meetings, yoga classes, a massage or Reiki session, or reviewing specific HIV prevention information online. Participants will be incentivized for each passport item they complete.
Also known as: Control
Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
--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.
Time frame: 6 Months
Number with specific PrEP outcomes
--Number of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription.
Time frame: 6 Months
Number self-reporting specific Social and Behavioral Outcomes
--Number of participants who obtain social and behavioral services that support HIV prevention and care.
Time frame: 6 Months
Percentage self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
--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.
Time frame: 6 Months
Percentage with specific PrEP outcomes
--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.
Time frame: 6 Months
Percentage of self-reporting specific Social and Behavioral Outcomes
--Percentage of participants who obtain social and behavioral services that support HIV prevention and care.
Time frame: 6 Months
Number of referrals HIV tested
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
Time frame: 6 Months
Plan to share: No
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Multiple Endocrine Neoplasia Type 1 →
Charles Drew University of Medicine and Science