Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness

NCT02932384 | Completed

• 1 other identifier: TL13-LACA-576
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Men

Keywords

HIV; Black/African American; Men; Gay/bisexual; Los Angeles

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  6 Months

Secondary Outcomes (1)

• Number of referrals HIV tested

  6 Months

Study Arms (2)

Control-Passport Only

ACTIVE COMPARATOR

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

Intervention-Passport and Peer Mentor

EXPERIMENTAL

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

Interventions

Intervention-Passport and Peer Mentor BEHAVIORAL

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

Intervention-Passport and Peer Mentor

Control-Passport Only BEHAVIORAL

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

Control-Passport Only; Intervention-Passport and Peer Mentor

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self identify as male
• self-identify as Black or African American
• sex with a male or male-to-female transgender in the last 6 months
• intercourse without a condom in the last 6 months
• Los Angeles County resident,
• 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
• \) Modified 9/21/2016 to has not taken PrEP in the prior 6 months

You may not qualify if:

• self-identify as female or transgender male or female
• does not self-identify as Black or African American
• no sex with a man or a male-to-female transgender in the last 6 months
• no sexual intercourse in the last 6 months
• resides outside of Los Angeles County
• is HIV-positive OR has tested between 1 and 13 months prior to enrollment.
• \) Modified 9/21/2016 to has not taken PrEP in the prior 6 months

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• University of California, Los Angeles: collaborator
• University of Southern California: collaborator
• Los Angeles Centers for Alcohol and Drug Addiction (L.A. CADA): collaborator

Study Sites (2)

Los Angeles Centers for Alcohol and Drug Abuse (LA CADA)

Los Angeles, California, 90013, United States

Location

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Nina T. Harawa, PhD; MPH

  UCLA; Charles R. Drew University of Science

  PRINCIPAL INVESTIGATOR

• Ricky Bluthenthal, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Charles McWells

  Los Angeles Centers for Alcohol and Drug Addiction (LA CADA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: October 13, 2016
• Study Start: August 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)