title: Antiretroviral medication treatment for all HIV-infected individuals: a protocol using innovative multilevel methodologies to evaluate New York City's universal ART policy among problem substance users.
abstract: The intersection of HIV-related health outcomes and problem substance use has been well documented. New York City continues to be a focal point of the U.S. HIV epidemic. In 2011, the NYC Department of Health and Mental Hygiene (NYC DOHMH) issued a recommendation that all HIV infected individuals should be offered antiretroviral therapy (ART) regardless of CD4 cell count or other indicators of disease progression. This policy is based in the concept of "treatment as prevention," in which providing ART to people living with HIV (PLWH) greatly reduces the likelihood of HIV transmission, while also improving individual health. The "ART for ALL" (AFA) study was designed to inform modifications to and identify gaps in the implementation of universal ART, and specifically to help guide allocation of resources to obtain local policy goals for increasing viral suppression among PLWH who have problem substance use.
  
  
  
  The AFA Study is informed by two complementary frameworks: Glasgow and colleagues' RE-AIM model, a multi-level framework developed to guide the evaluation of implementation of new policies, and Bronfrenbrenner's ecological systems model, which conceptualizes the bi-directional interplay between people and their environment. Using multi-level data and mixed methods, the primary aims of the AFA Study are to assess rates of viral load suppression, using the NYC HIV Surveillance Registry, within 12 months of HIV diagnosis with (a) yearly cohorts of high-risk-to-transmit, difficult-to-treat, substance using patients recruited from NYC Sexually Transmitted Disease clinics and a large detoxification unit and (b) yearly cohorts of all newly HIV diagnosed people in NYC. Further goals include (c) recruiting cross-sectional samples of HIV/AIDS service providers to assess ART initiation with problem substance users and d) examining geographic factors that influence rates of viral load suppression. An Implementation Collaborative Board meets regularly to guide study procedures and interpret results.
  
  
  
  The AFA Study has the unique strength of accessing and analyzing data at multiple levels using mixed methodology, taking advantage of NYC DOHMH biomedical surveillance data. If successful, others may benefit from lessons learned to inform local and state policies to improve the health of PLWH and further reduce HIV transmission.
authors.affiliation: Department of Psychiatry, Columbia University Medical Center, New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. anc2002@cumc.columbia.edu.
authors.forename: Aimee N C
authors.initials: AN
authors.lastname: Campbell
authors.affiliation: Icahn School of Medicine at Mount Sinai, 39 Broadway, 5th Floor, New York, NY, 10006, USA.
authors.forename: Don
authors.initials: D
authors.lastname: Des Jarlais
authors.affiliation: Department of Behavioral Science and Health Education, Emory University, Rollins School of Public Health, 1518 Clifton Road NE, Room 568, Atlanta, GA, 30322, USA.
authors.forename: Cooper
authors.initials: C
authors.lastname: Hannah
authors.affiliation: New York City Department of Health and Mental Hygiene, 42-09 28th Street, Long Island City, NY, 11101, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Braunstein
authors.affiliation: Department of Psychiatry, Columbia University Medical Center, New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA.|Department of Psychiatry and Behavioral Health, Mount Sinai St. Luke's Hospital, 1111 Amsterdam Avenue, 11th Floor, New York, NY, 10025, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Tross
authors.affiliation: New York City Department of Health and Mental Hygiene, 42-09 28th Street, Long Island City, NY, 11101, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Kersanske
authors.affiliation: New York City Department of Health and Mental Hygiene, 42-09 28th Street, Long Island City, NY, 11101, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Borges
authors.affiliation: Department of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th Street, 6th Floor, #637, New York, NY, 10032, USA.
authors.forename: Martina
authors.initials: M
authors.lastname: Pavlicova
authors.affiliation: Department of Behavioral Science and Health Education, Emory University, Rollins School of Public Health, 1518 Clifton Road NE, Room 568, Atlanta, GA, 30322, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Jefferson
authors.affiliation: Department of Psychiatry and Behavioral Health, Mount Sinai St. Luke's Hospital, 1111 Amsterdam Avenue, 11th Floor, New York, NY, 10025, USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Newville
authors.affiliation: Department of Psychiatry and Behavioral Health, Mount Sinai St. Luke's Hospital, 1111 Amsterdam Avenue, 11th Floor, New York, NY, 10025, USA.
authors.forename: Laurel
authors.initials: L
authors.lastname: Weaver
authors.affiliation: Department of Psychiatry and Behavioral Health, Mount Sinai St. Luke's Hospital, 1111 Amsterdam Avenue, 11th Floor, New York, NY, 10025, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Wolff
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003430:Cross-Sectional Studies; D018450:Disease Progression; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006291:Health Policy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009519:New York City / Q000453:epidemiology; D019966:Substance-Related Disorders; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents
keywords: Adherence; Affordable care act; Antiretroviral therapy; HIV/AIDS; Substance use