title: A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial.
abstract: BACKGROUND
  Few data exist on the use of text messaging as a tool to promote retention in HIV care and virologic suppression at the clinic level in the United States. We describe the protocol for a study designed to investigate whether a text messaging intervention that supports healthy behaviors, encourages consistent engagement with care, and promotes antiretroviral persistence can improve retention in care and virologic suppression among patients in an urban safety-net HIV clinic in San Francisco.
  
  
  METHODS
  Connect4Care (C4C) is a single-site, randomized year-long study of text message appointment reminders vs. text message appointment reminders plus thrice-weekly supportive, informational, and motivational text messages. Eligible consenting patients are allocated 1:1 to the two arms within strata defined by HIV diagnosis within the past 12 months (i.e. "newly diagnosed") vs. earlier. Study participants must receive primary care at the San Francisco General Hospital HIV clinic, speak English, possess a cell phone and be willing to send/receive up to 25 text messages per month, a have viral load >200 copies/μL, and be either new to the clinic or have a history of poor retention. The primary efficacy outcome is virologic suppression at 12 months and the key secondary outcome, which will also be examined as a mediator of the primary outcome, is retention in HIV care, as operationalized by kept and missed primary care visits. Process outcomes include text message response rate and percent of time in study without cell phone service. Generalized estimating equation log-binomial models will be used for intent to treat, per protocol, and mediation analyses. An assessment of the cost and cost-effectiveness of the intervention is planned along with a qualitative evaluation of the intervention.
  
  
  CONCLUSIONS
  Findings from this study will provide valuable information about the use of behavioral-theory based text messaging to promote retention in HIV care and virologic suppression, further elucidate the challenges of using texting technology with marginalized urban populations, and help guide the development of new mobile health strategies to improve HIV care cascade outcomes.
  
  
  BACKGROUND
  NCT01917994.
authors.affiliation: HIV/AIDS Division, San Francisco General Hospital, University of California San Francisco, 995 Potrero Avenue, 4th Floor, San Francisco, CA, 94110, USA. christopoulosk@php.ucsf.edu.
authors.forename: Katerina A
authors.initials: KA
authors.lastname: Christopoulos
authors.affiliation: HIV/AIDS Division, San Francisco General Hospital, University of California San Francisco, 995 Potrero Avenue, 4th Floor, San Francisco, CA, 94110, USA. Elise.Riley@ucsf.edu.
authors.forename: Elise D
authors.initials: ED
authors.lastname: Riley
authors.affiliation: HIV/AIDS Division, San Francisco General Hospital, University of California San Francisco, 995 Potrero Avenue, 4th Floor, San Francisco, CA, 94110, USA. Jacqueline.Tulsky@ucsf.edu.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Tulsky
authors.affiliation: School of Nursing, University of California San Francisco, San Francisco, CA, USA. Adam.Carrico@ucsf.edu.
authors.forename: Adam W
authors.initials: AW
authors.lastname: Carrico
authors.affiliation: Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. JudithMoskowitz@northwestern.edu.
authors.forename: Judith T
authors.initials: JT
authors.lastname: Moskowitz
authors.affiliation: School of Pharmacy, University of California San Francisco, San Francisco, CA, USA. Leslie.Wilson@ucsf.edu.
authors.forename: Leslie
authors.initials: L
authors.lastname: Wilson
authors.affiliation: HIV/AIDS Division, San Francisco General Hospital, University of California San Francisco, 995 Potrero Avenue, 4th Floor, San Francisco, CA, 94110, USA. Lara.Coffin@ucsf.edu.
authors.forename: Lara S
authors.initials: LS
authors.lastname: Coffin
authors.affiliation: Global Health Sciences, University of California San Francisco, San Francisco, CA, USA. Veesta.Falahati@ucsf.edu.
authors.forename: Veesta
authors.initials: V
authors.lastname: Falahati
authors.affiliation: HIV Services, The Shanti Project, San Francisco, CA, USA. jakerley@gmail.com.
authors.forename: Jordan
authors.initials: J
authors.lastname: Akerley
authors.affiliation: Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Joan.Hilton@ucsf.edu.
authors.forename: Joan F
authors.initials: JF
authors.lastname: Hilton
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000627:therapeutic use; D001071:Appointments and Schedules; D040421:Cell Phone; D003362:Cost-Benefit Analysis; D015536:Down-Regulation / Q000187:drug effects; D005260:Female; D015658:HIV Infections / Q000191:economics / Q000453:epidemiology / Q000628:therapy* / Q000821:virology; D015438:Health Behavior; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010358:Patient Participation; D017010:Reminder Systems / Q000191:economics; D064876:Safety-net Providers / Q000191:economics / Q000706:statistics & numerical data; D012495:San Francisco / Q000453:epidemiology; D060145:Text Messaging / Q000191:economics; D014481:United States / Q000453:epidemiology; D014505:Urban Population / Q000706:statistics & numerical data; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents