NCT02167386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

March 30, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

June 12, 2014

Last Update Submit

May 15, 2018

Conditions

HIV/AIDS

Keywords

Men who have sex with men (MSM)Black/African-American

Outcome Measures

Primary Outcomes (1)

  • adherence to daily Truvada use

    this is a measure of PrEP adherence, to be implemented through self-reported adherence and collection of dried blood spots

    twelve months after enrollment

Secondary Outcomes (4)

  • percentage of sexual acts where condom was used

    twelve months after enrollment

  • number of correct knowledge items

    twelve months after enrollment

  • number of participants remaining in care

    end of 12-month study period

  • positive HIV test

    during 12-month study period

Study Arms (2)

Enhanced PrEP Adherence

EXPERIMENTAL

Enhanced PrEP Adherence: peer navigators, PrEP support group, on-line support group, text message reminders

Behavioral: Enhanced PrEP Adherence

Standard PrEP Adherence

ACTIVE COMPARATOR

Standard PrEP Adherence: support groups, case management

Behavioral: Standard PrEP Adherence

Interventions

Enhanced PrEP AdherenceBEHAVIORAL
Enhanced PrEP Adherence
Standard PrEP AdherenceBEHAVIORAL
Standard PrEP Adherence

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harlem Prevention Center

New York, New York, 10027, United States

Location

Harlem United

New York, New York, 10027, United States

Location

Related Publications (1)

  • Colson PW, Franks J, Wu Y, Winterhalter FS, Knox J, Ortega H, El-Sadr WM, Hirsch-Moverman Y. Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. AIDS Behav. 2020 Dec;24(12):3436-3455. doi: 10.1007/s10461-020-02901-6.

    PMID: 32385678DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHomosexuality

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Paul W Colson, PhD

    ICAP, Mailman School of Public Health, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: combination drug and behavioral intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 19, 2014

Study Start

March 30, 2015

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

US(2)