Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01607541 |
| Other study ID # |
R11-01257 |
| Secondary ID |
R01DA032083 |
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
April 2012 |
| Est. completion date |
April 2016 |
Study information
| Verified date |
June 2016 |
| Source |
New York University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
