Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): BCAP peer-driven intervention (PDI); Control intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; 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.
Other intervention name(s): Brooklyn Community Action Project (BCAP) PDI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV/AIDS; vulnerable populations; heterosexuals at high risk; peer-driven intervention; tailored intervention; African-American; Latino/Hispanic; Seek, test, treat, and retain (STTR)