title: Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES).
abstract: BACKGROUND
  Women ages 16-29 utilizing family planning clinics for medical services experience higher rates of intimate partner violence (IPV) and reproductive coercion (RC) than their same-age peers, increasing risk for unintended pregnancy and related poor reproductive health outcomes. Brief interventions integrated into routine family planning care have shown promise in reducing risk for RC, but longer-term intervention effects on partner violence victimization, RC, and unintended pregnancy have not been examined.
  
  
  METHODS
  The 'Addressing Reproductive Coercion in Health Settings (ARCHES)' Intervention Study is a cluster randomized controlled trial evaluating the effectiveness of a brief, clinician-delivered universal education and counseling intervention to reduce IPV, RC and unintended pregnancy compared to standard-of-care in family planning clinic settings. The ARCHES intervention was refined based on formative research. Twenty five family planning clinics were randomized (in 17 clusters) to either a three hour training for all family planning clinic staff on how to deliver the ARCHES intervention or to a standard-of-care control condition. All women ages 16-29 seeking care in these family planning clinics were eligible to participate. Consenting clients use laptop computers to answer survey questions immediately prior to their clinic visit, a brief exit survey immediately after the clinic visit, a first follow up survey 12-20 weeks after the baseline visit (T2), and a final survey 12 months after the baseline (T3). Medical record chart review provides additional data about IPV and RC assessment and disclosure, sexual and reproductive health diagnoses, and health care utilization. Of 4009 women approached and determined to be eligible based on age (16-29 years old), 3687 (92 % participation) completed the baseline survey and were included in the sample.
  
  
  CONCLUSIONS
  The ARCHES Intervention Study is a community-partnered study designed to provide arigorous assessment of the short (3-4 months) and long-term (12 months) effects of a brief, clinician-delivered universal education and counseling intervention to reduce IPC, RC and unintended pregnancy in family planning clinic settings. The trial features a cluster randomized controlled trial design, a comprehensive data collection schedule and a large sample size with excellent retention.
  
  
  BACKGROUND
  ClinicialTrials.gov NCT01459458. Registered 10 October 2011.
authors.affiliation: UC Davis Department of Pediatrics and Center for Healthcare Policy and Research, 2103 Stockton Blvd Suite 2224, Sacramento, CA, 95817, USA. djtancredi@ucdavis.edu.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Tancredi
authors.affiliation: Division of Global Public Health in the Department of Medicine & Center on Gender Equity and Health, University of California, San Diego, 9500 Gilman Drive #0507, La Jolla, CA, 92093-0507, USA. jgsilverman@ucsd.edu.
authors.forename: Jay G
authors.initials: JG
authors.lastname: Silverman
authors.affiliation: Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, E4142, Baltimore, MD, 21205, USA. mdecker@jhsph.edu.
authors.forename: Michele R
authors.initials: MR
authors.lastname: Decker
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA. heather.mccauley@chp.edu.
authors.forename: Heather L
authors.initials: HL
authors.lastname: McCauley
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA. heather.anderson@chp.edu.
authors.forename: Heather A
authors.initials: HA
authors.lastname: Anderson
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA. jonesk5@upmc.edu.
authors.forename: Kelley A
authors.initials: KA
authors.lastname: Jones
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA.
authors.forename: Samantha
authors.initials: S
authors.lastname: Ciaravino
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Hicks
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA.
authors.forename: Claire
authors.initials: C
authors.lastname: Raible
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Zelazny
authors.affiliation: Futures Without Violence, 100 Montgomery Street, The Presidio, San Francisco, CA, 94129, USA. ljames@futureswithoutviolence.org.
authors.forename: Lisa
authors.initials: L
authors.lastname: James
authors.affiliation: Department of Pediatrics, Division of Adolescent Medicine, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, 3420 Fifth Ave, Pittsburgh, PA, 15213, USA. elizabeth.miller@chp.edu.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Miller
mesh_terms: D000293:Adolescent; D000328:Adult; D003068:Coercion; D003376:Counseling / Q000379:methods; D005193:Family Planning Services / Q000379:methods*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011275:Pregnancy, Unwanted / Q000523:psychology; D011320:Primary Health Care / Q000379:methods*; D015397:Program Evaluation; D012747:Sexual Partners / Q000523:psychology*; D013179:Spouse Abuse / Q000517:prevention & control*; D055815:Young Adult