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

Charles Drew University of Medicine and Science

Status: Completed

Conditions: Men; HIV

Treatments: Behavioral: Control-Passport Only; Behavioral: Intervention-Passport and Peer Mentor

Study type: Interventional

Funder types: Other

Identifiers

NCT02932384

TL13-LACA-576

Details and patient eligibility

About

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.

Full 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).

Enrollment: 105 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Control-Passport Only

Active Comparator group

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.

Treatment:

Behavioral: Control-Passport Only

Intervention-Passport and Peer Mentor

Experimental group

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.

Treatment:

Behavioral: Intervention-Passport and Peer Mentor

Behavioral: Control-Passport Only