Hybrid STTR Intervention for Heterosexuals: Anonymous Testing and Confidential Care Linkage

Summary

The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)).

HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in the VBS sample.

The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central Brooklyn.

The supplement study hypotheses are:

(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.

(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.

(H3): Most participants (\> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.

(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (\> 70%), all of whom will be HIV infected, will be linked to care within 3 months.

Conditions

• HIV/AIDS

Interventions

BEHAVIORAL

Seek and Test Phase

The primary endpoint for this phase is the proportion of newly identified HIV infections of the RDS-ASTN intervention. Components for eligible and willing participants are a computerized baseline interview, counseling session, blood draw for HIV testing, HIV pre-test counseling, use of blood samples for clinical lab tests if found to be HIV infected, semi-structured interviews (if selected), the opportunity to recruit peers for the study, and the post-test counseling session.

BEHAVIORAL

Treat and Retain Phase

The primary endpoints for this phase are: proportion linked to care within three months and time to the HIV care appointment. Participants with HIV infection who are interested in participating will be enrolled in this phase and navigated to HIV primary care over three months. Components are the locator form, patient navigation and support contacts, medical report form, follow-up contacts to update locator information, semi-structured interviews, follow-up interview, and blood draw for clinical lab testing.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• New York University

  lead OTHER

Principal Investigators

• Marya Gwadz, PhD · New York University

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2016-01-31

Completion

2016-12-31

Countries

• United States

Study Locations