Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence Among Black Men Who Have Sex With Men (BMSM) in Three U.S. Cities

HIV Prevention Trials Network3 sites in 1 country226 target enrollmentAugust 15, 2013

ConditionsHIV

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: HIV
Sponsor: HIV Prevention Trials Network
Enrollment: 226
Locations: 3
Primary Endpoint: Initiation of PrEP
Status: Completed
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.

Detailed Description

An open label demonstration study with PrEP and Client Centered Care Coordination (C4) to assess the initiation, acceptability, safety, and feasibility of PrEP for Black MSM (BMSM) in three US Cities. A subset of participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP. The study will recruit HIV-uninfected BMSM at risk for HIV infection in three US Cities. Enrollment will include those aged 18 and over with an effort to recruit an equal number of BMSM under age 25 and over age 25 with a total of 225 participants (75 per site).

Registry

clinicaltrials.gov

Start Date

August 15, 2013

End Date

September 30, 2015

Last Updated

12 months ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

HIV Prevention Trials Network

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•BMSM who meet all of the following criteria are eligible for inclusion in this study:
•18 years of age or older
•No prior HIV diagnosis (self-report)
•Male at birth
•High risk for acquiring HIV infection including any one of the following in the previous 6 months:
•Unprotected sex during receptive or insertive anal intercourse with a male partner
•Any protected or unprotected:
•i. Receptive or insertive anal intercourse with more than three male sex partners ii. Exchange of money, gifts, shelter or drugs for receptive or insertive anal sex with a male partner iii. Receptive or insertive anal sex while under the influence of drugs or alcohol (i.e., high or drunk within two hours of the sex act) according to self-report"
•STI diagnosis (i.e., syphilis, gonorrhea and chlamydia) by self-report
•Willing to provide locator information in accordance with the Study Specific Procedures (SSP) Manual

Exclusion Criteria

•BMSM who meet any of the following criteria will be excluded from this study:
•Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
•Transgender
•Active or chronic hepatitis B infection (as evidenced by HBsAg, HbsAb, and HbcAb testing)
•Planning to move out of the area or to travel for more than 3 months during the study follow-up period
•Unwilling to adhere to study procedures
•Current participation in any research study via self-report (however, strictly non-HIV centered observational studies are not exclusionary)
•Previous participation in an HIV vaccine study is exclusionary unless documented evidence of enrollment into a placebo arm
•Use of ARV drugs (PrEP or PEP) in the last 60 days
•Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption (provided by self-report, or obtained from medical history or records)