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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607541
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marya Gwadz, New York University

Tracking Information
First Submitted Date  ICMJE May 23, 2012
First Posted Date  ICMJE May 30, 2012
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
  • proportion of newly diagnosed HIV infections [ Time Frame: 2 months post-baseline ]
  • time to HIV clinical appointment [ Time Frame: 12-months post intervention ]
  • time to initiation of HAART if medically indicated [ Time Frame: 12-months post intervention ]
  • viral load suppression [ Time Frame: 12-months post intervention ]
  • retention in care [ Time Frame: 12 months post-intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
Official Title  ICMJE Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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)
    Intervention: Behavioral: BCAP peer-driven intervention (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.
    Intervention: Behavioral: Control intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2012)
3400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607541
Other Study ID Numbers  ICMJE R11-01257
R01DA032083 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marya Gwadz, New York University
Study Sponsor  ICMJE New York University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Marya Gwadz, PhD New York University
PRS Account New York University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP