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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Women's Health 1/2015

Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES)

Zeitschrift:
BMC Women's Health > Ausgabe 1/2015
Autoren:
Daniel J. Tancredi, Jay G. Silverman, Michele R. Decker, Heather L. McCauley, Heather A. Anderson, Kelley A. Jones, Samantha Ciaravino, Angela Hicks, Claire Raible, Sarah Zelazny, Lisa James, Elizabeth Miller
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

EM and JGS secured funding. DJT, EM, MRD, JGS and HLM made substantial contributions to the conception and design of the study. HA, SC, APH, CR, SMZ and EM made substantial contributions to the acquisition of study data. EM, DJT, KAJ, MRD, HLM, JGS and LJ made substantial contributions to the analysis and interpretation of study data. DJT and KAJ developed the initial drafts of the manuscript. Substantial revisions were made by EM, HLM, JGS and MRD. All authors read and approved the final manuscript.

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/Design

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.

Discussion

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.

Trial Registration

ClinicialTrials.gov NCT01459458. Registered 10 October 2011.
Literatur
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