PrEP for Black Men Who Have Sex With Men (MSM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Columbia University
Sponsor:
Collaborators:
Gilead Sciences
Information provided by (Responsible Party):
Paul Colson, Columbia University
ClinicalTrials.gov Identifier:
NCT02167386
First received: June 12, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

Black men who have sex with men (MSM) have among the highest rates of new HIV infections of any group in the United States. Developing effective HIV prevention interventions that work with this group is a critical element of the National HIV/AIDS Strategy. In the first phase of our study ("the ethnographic phase"), the investigators will carry out community-based research that will explore structural, social and cultural factors relevant to how Black MSM might engage with Pre-Exposure Prophylaxis (PrEP). This phase of community-based research will inform the design of an enhanced PrEP adherence intervention, which will be subsequently tested at a community-based health clinic in Harlem in the second phase of the project.


Condition Intervention Phase
HIV/AIDS
Behavioral: Enhanced PrEP Adherence
Behavioral: Standard PrEP Adherence
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PrEP for Black MSM: Community-Based Ethnography and Clinic-Based Treatment

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • number of participants with correct pill count [ Time Frame: twelve months after enrollment ] [ Designated as safety issue: No ]
    this is a measure of PrEP adherence, to be implemented through unannounced pill counts conducted through telephone interviews


Secondary Outcome Measures:
  • percentage of sexual acts where condom was used [ Time Frame: twelve months after enrollment ] [ Designated as safety issue: No ]
    this is one measure of sexual risk behaviors. Other such measures include number and type of sexual partner, specific sexual acts, drug/alcohol use during sex, transactional sex

  • number of correct knowledge items [ Time Frame: twelve months after enrollment ] [ Designated as safety issue: No ]
    this is one outcome measure from a knowledge, attitudes, and practices (KAP) questionnaire related to HIV prevention in general and PrEP in particular

  • number of participants remaining in care [ Time Frame: end of 12-month study period ] [ Designated as safety issue: No ]
    this is a measure of retention in care. As each participants finishes his 12-month study period, retention will be determined by number of care visits completed.

  • positive HIV test [ Time Frame: during 12-month study period ] [ Designated as safety issue: No ]
    this is a measure of seroconversion. Participants who test HIV-positive at any quarterly care visit will exit the study and will be referred for HIV care.


Estimated Enrollment: 200
Study Start Date: August 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced PrEP Adherence
Enhanced PrEP Adherence: peer navigators, PrEP support group, on-line support group, text message reminders
Behavioral: Enhanced PrEP Adherence
Active Comparator: Standard PrEP Adherence
Standard PrEP Adherence: support groups, case management
Behavioral: Standard PrEP Adherence

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male at birth
  • self-identify as Black, African American, Caribbean Black, African, or multiethnic Black
  • are 18 years of age or older
  • have had unprotected receptive anal sex with another man during the preceding 6 months
  • have health insurance, are eligible for health insurance or are homeless
  • are HIV-uninfected
  • have normal renal function

Exclusion Criteria:

  • current participation in any other PrEP study
  • currently taking or have recently taken PrEP
  • are undocumented but not homeless
  • have signs and symptoms of acute HIV infection
  • active psychiatric condition or other illness that determine would hinder the participant's ability to provide informed consent, would cause non-adherence to the provisions of the study, and/or would threaten the safety of both the participant and/or research personnel
  • inability to speak and understand spoken English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167386

Contacts
Contact: Paul W Colson, PhD 646-448-0956 pwc2@columbia.edu
Contact: Jennifer Hirsch, PhD 212-305-1185 jsh2124@columbia.edu

Locations
United States, New York
Harlem Prevention Center Not yet recruiting
New York, New York, United States, 10027
Contact: Sharon Mannheimer, MD    212-939-2940    sbm20@columbia.edu   
Principal Investigator: Paul W Colson, PhD         
Harlem United Not yet recruiting
New York, New York, United States, 10027
Contact: Jeannine Bookhardt-Murray, MD    212-803-2850    jbookhardt@harlemunited.org   
Sub-Investigator: Jeannine Bookhardt-Murray, MD         
Sponsors and Collaborators
Columbia University
Gilead Sciences
Investigators
Principal Investigator: Paul W Colson, PhD ICAP, Mailman School of Public Health, Columbia University
  More Information

No publications provided

Responsible Party: Paul Colson, Associate Research Scientist, Columbia University
ClinicalTrials.gov Identifier: NCT02167386     History of Changes
Other Study ID Numbers: 5R01MH098723, 5R01MH098723
Study First Received: June 12, 2014
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Men who have sex with men (MSM)
Black/African-American

ClinicalTrials.gov processed this record on September 16, 2014