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PrEPared and Strong: Clinic-Based PrEP for Black MSM (P&S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02167386
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : May 17, 2018
National Institute of Mental Health (NIMH)
Gilead Sciences
Information provided by (Responsible Party):
Paul Colson, Columbia University

Brief Summary:
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 or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Enhanced PrEP Adherence Behavioral: Standard PrEP Adherence Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: combination drug and behavioral intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PrEP for Black MSM: Community-Based Ethnography and Clinic-Based Treatment
Actual Study Start Date : March 30, 2015
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. adherence to daily Truvada use [ Time Frame: twelve months after enrollment ]
    this is a measure of PrEP adherence, to be implemented through self-reported adherence and collection of dried blood spots

Secondary Outcome Measures :
  1. percentage of sexual acts where condom was used [ Time Frame: twelve months after enrollment ]
    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

  2. number of correct knowledge items [ Time Frame: twelve months after enrollment ]
    this is one outcome measure from a knowledge, attitudes, and practices (KAP) questionnaire related to HIV prevention in general and PrEP in particular

  3. number of participants remaining in care [ Time Frame: end of 12-month study period ]
    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.

  4. positive HIV test [ Time Frame: during 12-month study period ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male at birth
  • self-identify as Black, African American, Caribbean Black, African, or multiethnic Black
  • are 18 years of age or older
  • any male or transgender woman (TGW) partners in past 6 months;
  • not in a monogamous partnership with a recently tested, HIV-negative man;
  • have at least one of the following:
  • reporting condomless anal and/or receptive neovaginal intercourse with at least one man or TGW in the past six months;
  • any STI diagnosed or reported in past 6 months;
  • is in on-going sexual relationship with an HIV-positive male or TGW partner;
  • able to provide written informed consent in English;
  • able to provide a street address or residence or phone number for themselves or two personal contacts who would know their whereabouts during participation in the study

Exclusion Criteria:

  • current participation in any other PrEP study;
  • having taken PrEP in programmatic context more than 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02167386

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United States, New York
Harlem Prevention Center
New York, New York, United States, 10027
Harlem United
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
National Institute of Mental Health (NIMH)
Gilead Sciences
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Principal Investigator: Paul W Colson, PhD ICAP, Mailman School of Public Health, Columbia University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paul Colson, Associate Research Scientist, Columbia University Identifier: NCT02167386    
Other Study ID Numbers: AAAO0852
5R01MH098723 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Paul Colson, Columbia University:
Men who have sex with men (MSM)
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases