Clinical trial NCT01607541: Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
Official title: Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV/AIDS
Keywords: HIV/AIDS
vulnerable populations
heterosexuals at high risk
peer-driven intervention
tailored intervention
African-American
Latino/Hispanic
Seek, test, treat, and retain (STTR)
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-05-30
Enrollment: 3400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: proportion of newly diagnosed HIV infections
timeFrame: 2 months post-baseline
measure: time to HIV clinical appointment
timeFrame: 12-months post intervention
measure: time to initiation of HAART if medically indicated
timeFrame: 12-months post intervention
measure: viral load suppression
timeFrame: 12-months post intervention
measure: retention in care
timeFrame: 12 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University College of Nursing
state: New York
Study officials:
affiliation: New York University
name: Marya Gwadz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.