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Clinical Trials/NCT01459458
NCT01459458
Completed
Phase 3

Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

University of Pittsburgh1 site in 1 country3,687 target enrollmentOctober 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Violence
Sponsor
University of Pittsburgh
Enrollment
3687
Locations
1
Primary Endpoint
Change in partner violence victimization (summary score)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This is a community-based participatory study to test a brief intervention to reduce risk for intimate partner violence (IPV) and associated unintended pregnancy among young, medically underserved women attending family planning (FP) clinics. Women ages 16-29 years utilizing FP clinics report higher rates of IPV compared to their same-age peers, experiences associated with unintended pregnancy. A critical mechanism connecting IPV with poor reproductive health is abusive partners' control of women's reproduction through condom refusal, pressuring women to get pregnant, and birth control sabotage, a phenomenon described as reproductive coercion. In the investigative team's pilot intervention study 53% of young women using FP clinics reported ever experiencing IPV, and 25% reported reproductive coercion, the combination of which was strongly associated with unintended pregnancy. The proposed reproductive coercion/partner violence intervention was developed collaboratively by community-based practitioners, advocates, and researchers, with significant input from FP clients. Designed to be implemented within routine FP care, maximizing feasibility and sustainability of this program, the intervention provides 1) client education and assessment regarding IPV and reproductive coercion; 2) discussion of harm reduction behaviors to reduce risk for unintended pregnancy and IPV victimization, and 3) supported referrals to IPV victim services. This is a full-scale RCT to assess the effects of this innovative program on IPV, reproductive coercion and unintended pregnancy, major health threats for medically underserved women. Evaluation of this intervention will involve random assignment of 25 FP clinics (unit of randomization) in Western PA to either intervention or control (i.e., standard-of-care) conditions. Female FP clients ages 16-29 (N=3600) will be assessed at baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess intervention effects on knowledge and behaviors related to IPV, reproductive coercion and related harm reduction, as well as unintended pregnancy. Data will be collected via audio computer-assisted self-interview in English or Spanish. Chart extraction will track clinic utilization, pregnancy testing, and diagnosed pregnancies. Regression models appropriate for longitudinal data from cluster-randomized trials will be used to estimate intervention effects.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Miller

Chief of Adolescent Medicine

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • female clients not of the specified age range
  • neither English nor Spanish speaking
  • clients who are intoxicated or otherwise not able to provide their own consent

Outcomes

Primary Outcomes

Change in partner violence victimization (summary score)

Time Frame: baseline to 12 months

baseline-adjusted differences in post-intervention partner violence victimization up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

Change in reproductive coercion (summary score)

Time Frame: baseline to12 months

baseline-adjusted differences in post-intervention levels of reproductive coercion up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

Secondary Outcomes

  • Change in harm reduction self-efficacy (mean score)(baseline to 12 months)
  • Change in recognition of abusive behaviors (mean score)(baseline to 12 months)
  • Unintended pregnancy(12 months)
  • Harm reduction strategies uptake (summary score)(up to 12 months)
  • Knowledge regarding violence victimization resources(up to 12 months)

Study Sites (1)

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