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

NCT02421159 | Completed DMC

• 1 other identifier: 14-00963
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV/AIDS; vulnerable populations; heterosexuals at high risk; peer-driven intervention; tailored intervention; African-American; Latino/Hispanic; Seek, test, treat, and retain (STTR); Brooklyn

Outcome Measures

Primary Outcomes (1)

• proportion of newly diagnosed HIV infections

  1 week post-baseline

Secondary Outcomes (2)

• proportion linked to care

  3 months post-baseline

• time to the HIV care appointment

  3 months post-baseline

Interventions

Seek and Test Phase BEHAVIORAL

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.

Treat and Retain Phase BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sexually active (vaginal, anal) with at least one partner of the opposite sex within the previous year;
• reside in the 7 zip code central Brooklyn HRA (initial seeds only; peers may reside in the larger 19 zip code HRA);
• comprehend English or Spanish;
• HIV negative or unknown HIV status (initial seeds only; peers may be 'known positives');
• willing to try to recruit peers;

You may not qualify if:

• actively psychotic based on valid screening instrument;
• participant in the past NHBS studies with HHR (called HET1, 2, 3);
• enrolled already in the supplement study (RDS-ASTN), VBS or RDS-CTTN in the main study

Sponsors & Collaborators

• New York University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York University College of Nursing

New York, New York, 10003, United States

Location

Related Publications (1)

• Gwadz M, Cleland CM, Leonard NR, Kutnick A, Ritchie AS, Banfield A, Hagan H, Perlman DC, McCright-Gill T, Sherpa D, Martinez BY; BCAP Collaborative Research Team. Hybrid STTR intervention for heterosexuals using anonymous HIV testing and confidential linkage to care: a single arm exploratory trial using respondent-driven sampling. BMC Public Health. 2015 Nov 16;15:1133. doi: 10.1186/s12889-015-2451-5.

  PMID: 26572865 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Marya Gwadz, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 3, 2022

Record last verified: 2017-03

Locations

US (1)