Trial record 2 of 32 for:    " May 09, 2012":" June 08, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV (BCAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by New York University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marya Gwadz, New York University
ClinicalTrials.gov Identifier:
NCT01607541
First received: May 23, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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

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.


Condition Intervention Phase
HIV/AIDS
Vulnerable Populations
Heterosexuals at High Risk
Behavioral: BCAP peer-driven intervention (PDI)
Behavioral: Control intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • proportion of newly diagnosed HIV infections [ Time Frame: 2 months post-baseline ] [ Designated as safety issue: No ]
  • time to HIV clinical appointment [ Time Frame: 12-months post intervention ] [ Designated as safety issue: No ]
  • time to initiation of HAART if medically indicated [ Time Frame: 12-months post intervention ] [ Designated as safety issue: No ]
  • viral load suppression [ Time Frame: 12-months post intervention ] [ Designated as safety issue: No ]
  • retention in care [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 3400
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peer-driven intervention
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)
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).
Other Name: Brooklyn Community Action Project (BCAP) PDI
Active Comparator: Control
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
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.

Detailed Description:

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. Our 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. Reduced rates of HIV testing and treatment among HHR are due to structural (e.g., poor access), social (e.g., peer norms), and individual-level (e.g., low perceived risk) barriers. Thus active recruitment approaches modeled after NHBS are needed to overcome structural barriers, and peer-delivered interventions effectively reduce individual and social barriers to testing and treatment. The primary goal of the proposed study is to evaluate the efficacy of a multi-level enhanced peer-driven intervention (PDI) to seek, test, treat and retain HHR. The enhanced PDI is tailored specifically for HHR and includes computerized, navigation, and peer-delivered components to enhance future sustainability. The design of the intervention is guided by the Theories of Triadic Influence and Normative Regulation. Similar to NHBS, the enhanced PDI will use respondent-driven sampling (RDS). NHBS protocols use both venue-based sampling (VBS) and RDS for reaching populations at high risk. However, VBS and RDS have not yet been directly compared in terms of their yield of undiagnosed HIV infections. Thus the specific aims of this five-year proposed study are to: (1) compare the yield and efficiency of RDS and VBS to identify undiagnosed HIV infection among HHR; (2) measure the efficacy of an enhanced PDI compared to a control in terms of time to HIV care and HAART initiation, viral load suppression, and retention among those newly-diagnosed; (3) examine whether the effects of the PDI on HIV health/treatment outcomes are mediated by changes in individual (e.g., perceived risk), social (e.g., peer norms), and structural influences (e.g., enhanced access), and/or whether other factors (e.g., substance use) moderate its effects; and (4) to project the costs and cost-effectiveness of RDS vs. VBS and PDI.

The investigators will conduct the enhanced PDI (N=3000) in central Brooklyn, a location hyperendemic for HIV and where HHR experience poor access to testing and treatment. Simultaneously, VBS (N=400) will be undertaken in central Brooklyn. The proposed study complements local and national HIV prevention initiatives and is designed to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. The vast majority of HHR are African-American or Latino; therefore the proposed study may also impact racial/ethnic disparities in HIV/AIDS.

The study's main hypotheses are as follows:

(H1): Compared with venue-based sampling (VBS), and controlling for potential differences on key sociodemographic characteristics across the samples, participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV for the first time.

H2): Participants in the Test and Treat Phase of the BCAP PDI's intervention arm (all of whom will be HIV-infected) will evidence a shorter time to an HIV clinical appointment, a shorter time to initiating HAART (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18-50 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
  • HIV negative or unknown HIV status
  • not tested for HIV within the past 12 months
  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607541

Contacts
Contact: Marya Gwadz, Ph.D. 212-992-7147 mg2890@nyu.edu
Contact: Amanda Ritchie, MAA 212-992-7186 amanda.ritchie@nyu.edu

Locations
United States, New York
New York University College of Nursing Recruiting
New York, New York, United States, 10003
Sponsors and Collaborators
New York University
Investigators
Principal Investigator: Marya Gwadz, PhD New York University
  More Information

No publications provided

Responsible Party: Marya Gwadz, Senior Research Scientist, New York University
ClinicalTrials.gov Identifier: NCT01607541     History of Changes
Other Study ID Numbers: R11-01257, R01DA032083
Study First Received: May 23, 2012
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by New York University:
HIV/AIDS
vulnerable populations
heterosexuals at high risk
peer-driven intervention
tailored intervention
African-American
Latino/Hispanic
Seek, test, treat, and retain (STTR)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014