Clinical trial · Interventional
Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness
Passport to Wellness-Full Intervention Phase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV | — | UNRESOLVED | — |
| Men | Multiple Endocrine Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control-Passport Only | Behavioral | — | UNRESOLVED |
| Intervention-Passport and Peer Mentor | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control-Passport Only
- description
- 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.
- interventionNames
- Behavioral: Control-Passport Only
- type
- EXPERIMENTAL
- label
- Intervention-Passport and Peer Mentor
- description
- 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.
- interventionNames
- Behavioral: Intervention-Passport and Peer Mentor
- Behavioral: Control-Passport Only
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available