Clinical trial NCT02932384: Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness
Official title: Passport to Wellness-Full Intervention Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Men
Keywords: HIV
Black/African American
Men
Gay/bisexual
Los Angeles
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Southern California
name: Los Angeles Centers for Alcohol and Drug Addiction (L.A. CADA)
First posted: 2016-10-13
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
timeFrame: 6 Months
measure: Number with specific PrEP outcomes
timeFrame: 6 Months
measure: Number self-reporting specific Social and Behavioral Outcomes
timeFrame: 6 Months
measure: Percentage self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
timeFrame: 6 Months
measure: Percentage with specific PrEP outcomes
timeFrame: 6 Months
measure: Percentage of self-reporting specific Social and Behavioral Outcomes
timeFrame: 6 Months
Secondary outcomes:
measure: Number of referrals HIV tested
timeFrame: 6 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Centers for Alcohol and Drug Abuse (LA CADA)
state: California
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: UCLA; Charles R. Drew University of Science
name: Nina T. Harawa, PhD; MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Ricky Bluthenthal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Angeles Centers for Alcohol and Drug Addiction (LA CADA)
name: Charles McWells
role: PRINCIPAL_INVESTIGATOR
References: