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

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, 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

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.

Figures

Fig. 1
Fig. 1
Study design, including timing of assessments and targeted enrollment. Patients in this cluster randomized trial are scheduled for assessments at three timepoints. The targeted enrollment was based on power calculations with cautious assumptions regarding patient retention at follow-up timepoints
Fig. 2
Fig. 2
Definition of intervals for use in electronic medical record abstraction. To match the reporting periods spanned by the T1, T2 and T3 surveys, events identified in electronic medical record (EMR) data are assigned to patient-specific intervals using the displayed definitions
Fig. 3
Fig. 3
Conceptual model for ARCHES
Fig. 4
Fig. 4
Interview schedule. For patients not completing T2, a Non-respondent interview is collected to enhance retention at T3
Fig. 5
Fig. 5
CONSORT flow diagram

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