NCT01607541

Brief Summary

Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience serious barriers to entering care compared to other groups. The investigators research team has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to target HHR in central Brooklyn. The primary goal of the proposed study is to evaluate the efficacy of a peer-driven intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a peer-based approach) versus venue-based sampling (a location-based approach). The two main study hypotheses are: (H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV compared to those recruited via venue-based sampling (VBS). H2): Participants in the "Test and Treat: phase of the peer-driven intervention (all of whom will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter time to starting HIV medication (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 3, 2022

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

May 23, 2012

Last Update Submit

October 31, 2022

Conditions

HIV/AIDS

Keywords

HIV/AIDSvulnerable populationsheterosexuals at high riskpeer-driven interventiontailored interventionAfrican-AmericanLatino/HispanicSeek, test, treat, and retain (STTR)

Outcome Measures

Primary Outcomes (5)

  • proportion of newly diagnosed HIV infections

    2 months post-baseline

  • time to HIV clinical appointment

    12-months post intervention

  • time to initiation of HAART if medically indicated

    12-months post intervention

  • viral load suppression

    12-months post intervention

  • retention in care

    12 months post-intervention

Study Arms (2)

Peer-driven intervention

EXPERIMENTAL

The PDI entails structured intervention sessions including a computerized "CARE for Prevention" tool and HIV pre-test and post-test counseling, the opportunity to educate three peers on core education messages, and navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and six months of navigation)

Behavioral: BCAP peer-driven intervention (PDI)

Control

ACTIVE COMPARATOR

The control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care.

Behavioral: Control intervention

Interventions

Control interventionBEHAVIORAL

The control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care.

Control
BCAP peer-driven intervention (PDI)BEHAVIORAL

The Brooklyn Community Action Project (BCAP) PDI entails structured sessions including the computerized "CARE for Prevention" tool, 3 peer education experiences, and 6 months of navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and navigation).

Also known as: Brooklyn Community Action Project (BCAP) PDI
Peer-driven intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-60 years
  • sexually active (vaginal, anal) with at least 1 opposite sex partner within the previous year
  • reside in the central Brooklyn HRA defined in the Development Phase
  • African-American or Latino/Hispanic race/ethnicity
  • comprehend English or Spanish
  • willing to provide locator information
  • willing to try to recruit peers
  • not actively psychotic based on valid screening instrument
  • not a participant in the two past NHBS studies with HHR (called HET1/HET2); not enrolled already in VBS or PDI/RDS in this study
  • willing to be randomly assigned to intervention arm (initial seeds only, for PDI component)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University College of Nursing

New York, New York, 10003, United States

Location

Related Publications (1)

  • Gwadz M, Cleland CM, Hagan H, Jenness S, Kutnick A, Leonard NR, Applegate E, Ritchie AS, Banfield A, Belkin M, Cross B, Del Olmo M, Ha K, Martinez BY, McCright-Gill T, Swain QL, Perlman DC, Kurth AE; BCAP Collaborative Research Team. Strategies to uncover undiagnosed HIV infection among heterosexuals at high risk and link them to HIV care with high retention: a "seek, test, treat, and retain" study. BMC Public Health. 2015 May 10;15:481. doi: 10.1186/s12889-015-1816-0.

    PMID: 25958200DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Diseases

Study Officials

  • Marya Gwadz, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 30, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2015

Study Completion

April 1, 2016

Last Updated

November 3, 2022

Record last verified: 2016-06

Locations

US(1)