Hybrid STTR Intervention for Heterosexuals: Anonymous Testing and Confidential Care Linkage
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Detailed description: 
      The Brooklyn Community United (BCU) study is a supplement to the main research study to seek,
      test, treat and retain heterosexuals at high risk for HIV. The main research study is
      entitled "Peer Driven Intervention to Seek, Test, & Treat Heterosexuals at High Risk for
      HIV." The main study's field name is Brooklyn Community Action Project or BCAP (R01DA032083,
      R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV
      infection (Venue-based Sampling and Confidential Two-Session Testing with Navigation).

      We have studied HHR in New York City as part of the CDC's National HIV Behavioral
      Surveillance (NHBS) studies. Building on the NHBS work, we are currently in our third year of
      the main study (R01DA032083, R#: 11-01257), the primary aim of which is to compare the
      efficacy of a peer-driven intervention that uses a respondent-driven sampling strategy
      ("RDS-CTTN") and venue-based sampling (VBS) with respect to identifying previously
      undiagnosed HIV infection. The main study is located in central Brooklyn, a high-risk area
      (HRA) with elevated rates of poverty, high heterosexual HIV prevalence, and where a
      generalized HIV epidemic may be said to exist.

      To date, RDS-CTTN and VBS have enrolled approximately 45% of their samples (RDS-CTTN
      1338/3000; VBS 174/400). Participants in both samples evidence high rates of risk factors
      (substance use, incarceration, homelessness, unemployment). As hypothesized, PDI/RDS is
      reaching a population with higher rates of risk factors, and lower rates of HIV testing
      compared to VBS. Almost all in RDS-CTTN and VBS had been tested at least once previously (>
      86%), but fewer than half have been tested in the past year. Among those with lifetime
      testing, data suggest testing is infrequent with a median of 2.5 tests per ten years of
      adulthood. Interestingly, almost all of those who enroll in RDS-CTTN and VBS elected to test
      for HIV (> 90%), with no difference in HIV testing acceptance rates between those who tested
      previously and first-time testers. This suggests that those who enroll in the study, although
      they have known barriers to HIV testing and a range of risk factors for adverse outcomes, are
      open to confidential HIV testing. These findings support the promise of the RDS-CTTN
      approach, but preliminary studies also signal the need to reach those with the greatest fears
      of and barriers to HIV testing who will not engage in confidential testing.

      With approximately 45% of the sample enrolled, HIV prevalence in the RDS-CTTN sample is 3.45%
      (37/1071); 35.14% of these are newly diagnosed (13/37). Rates of newly diagnosed HIV
      infection may continue to increase as recruitment chains reach deeper into hidden and more
      vulnerable components of networks. In VBS, 1.89% is newly diagnosed with HIV (3/159). Yet
      these HIV prevalence rates are lower than those found in two previous heterosexual cycles of
      NHBS in the local area: 7% in HET1 and 12.3% in HET2 spurring our interest in additional
      innovative strategies to seek out those with undiagnosed HIV.

      Despite its high acceptability among enrolled participants and preliminary evidence of
      efficacy, the two-session RDS-CTTN approach may be less successful in enrolling those in the
      HRA who would decline confidential HIV testing in a formal setting or have poor access to
      such testing. The RDS-CTTN intervention may not be optimal for reaching those with the
      greatest psychosocial barriers to regular HIV testing, who may for a number of reasons have
      high rates of undiagnosed HIV, or individuals, particularly women, with multiple job and
      family responsibilities who may not have time for a two-session intervention. (Indeed women
      are under-represented in both RDS-CTTN [~ 40%] and VBS [~30%].) It is possible to test
      participants for HIV in a first encounter, aswe do in VBS and as other studies have done. In
      the supplement study, we build on lessons learned from themain study in progress and the
      literature to address this concern.

      Anonymous testing is available in state and local health departments, in cases of
      occupational exposure, through home test/self-test technologies, and research studies
      including our local NHBS studies with HHR. There is some evidence to suggest individuals who
      test anonymously do so earlier in the course of their HIV disease than those who engage in
      confidential testing. Additionally, anonymous testing may be useful for and/or preferred by
      individuals from marginalized populations. As Kegeles and colleagues have found, many who
      seek anonymous HIV-antibody testing would avoid it under other circumstances, and anonymous
      testing may be preferred among those who suspect they are infected, and by bisexual
      individuals, and those who fear stigma and discrimination. Thus, a brief, anonymous HIV
      testing effort may appeal to and engage HHR who face barriers to confidential HIV testing.

      While anonymous testing may be an effective and/or efficient strategy in the 'seek' phase of
      STTR, in the majority of studies and testing programs it does not address the vital step of
      linkage to care. Although anonymous testing tends to yield individuals earlier in their HIV
      disease, those who test anonymously are more likely to experience delays entering care,
      because anonymous testing sites and programs do not typically have the resources to engage
      individuals into linkage programs and are not co-located with medical care. For example, in a
      study of characteristics of the HIV testing encounter and linkage to care, Reed (2009) found
      that 36% of those testing anonymously did not enter care within three months of diagnosis,
      compared with 26% of those testing confidentially.

      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.
    

Intervention name(s): Seek and Test Phase; Treat and Retain Phase
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Intervention model: Single Group 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); Brooklyn