title: Hybrid STTR intervention for heterosexuals using anonymous HIV testing and confidential linkage to care: a single arm exploratory trial using respondent-driven sampling.
abstract: BACKGROUND
  An estimated 14 % of the 1.2 million individuals living with HIV in the U.S. are unaware of their status. Yet this modest proportion of individuals with undiagnosed HIV is linked to 44-66 % of all new infections. Thus innovative intervention approaches are needed to seek out and test those with undiagnosed HIV, and link them to HIV treatment with high retention, an approach referred to as "Seek, Test, Treat, and Retain" (STTR). The present protocol describes a creative "hybrid" STTR approach that uses anonymous HIV testing followed by confidential care linkage, focused on heterosexuals at high risk (HHR) for HIV, who do not test as frequently as, and are diagnosed later, than other risk groups.
  
  
  METHODS
  This is a single-arm exploratory intervention efficacy trial. The study has two phases: one to seek out and test HHR, and another to link those found infected to HIV treatment in a timely fashion, with high retention. We will recruit African American/Black and Latino adult HHR who reside in urban locations with high poverty and HIV prevalence. Participants will be recruited with respondent-driven sampling, a peer recruitment method. The "Seek and Test" phase is comprised of a brief, convenient, single-session, anonymous HIV counseling and testing session. The "Treat and Retain" component will engage those newly diagnosed with HIV into a confidential research phase and use a set of procedures called care navigation to link them to HIV primary care. Participants will be followed for 6 months with objective assessment of outcomes (using medical records and biomarkers).
  
  
  CONCLUSIONS
  Undiagnosed HIV infection is a major public health problem. While anonymous HIV testing is an important part of the HIV testing portfolio, it does not typically include linkage to care. The present study has potential to produce an innovative, brief, cost-effective, and replicable STTR intervention, and thereby reduce racial/ethnic disparities in HIV/AIDS.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT02421159 , Registered April 15, 2015.
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. mg2890@nyu.edu.
authors.forename: Marya
authors.initials: M
authors.lastname: Gwadz
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. cmc13@nyu.edu.
authors.forename: Charles M
authors.initials: CM
authors.lastname: Cleland
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. nrl4@nyu.edu.
authors.forename: Noelle R
authors.initials: NR
authors.lastname: Leonard
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. alexandra.kutnick@nyu.edu.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Kutnick
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. asr5@nyu.edu.
authors.forename: Amanda S
authors.initials: AS
authors.lastname: Ritchie
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. adb12@nyu.edu.
authors.forename: Angela
authors.initials: A
authors.lastname: Banfield
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. hh50@nyu.edu.|Mount Sinai Beth Israel Medical Center, 120 East 16th Street, New York, NY, USA. hh50@nyu.edu.
authors.forename: Holly
authors.initials: H
authors.lastname: Hagan
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. dperlman@chpnet.org.|Mount Sinai Beth Israel Medical Center, 120 East 16th Street, New York, NY, USA. dperlman@chpnet.org.
authors.forename: David C
authors.initials: DC
authors.lastname: Perlman
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. talayamccrightgill@yahoo.com.
authors.forename: Talaya
authors.initials: T
authors.lastname: McCright-Gill
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. ds4578@nyu.edu.
authors.forename: Dawa
authors.initials: D
authors.lastname: Sherpa
authors.affiliation: Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, 433 First Avenue, 6th floor, New York, 10010, NY, USA. bym1@nyu.edu.
authors.forename: Belkis Y
authors.initials: BY
authors.lastname: Martinez
mesh_terms: D000328:Adult; D001741:Black or African American; D003219:Confidentiality; D003376:Counseling; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D006293:Health Promotion / Q000458:organization & administration; D020010:Heterosexuality; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care; D011204:Poverty Areas; D012107:Research Design; D012307:Risk Factors; D014481:United States