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Published in: BMC Women's Health 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: 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

Published in: BMC Women's Health | Issue 1/2015

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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.
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Metadata
Title
Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES)
Authors
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
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Women's Health / Issue 1/2015
Electronic ISSN: 1472-6874
DOI
https://doi.org/10.1186/s12905-015-0216-z

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