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Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Miller, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01459458
First received: October 10, 2011
Last updated: November 30, 2015
Last verified: November 2015
History of Changes
  Purpose
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.

Condition Intervention Phase
Violence
Pregnancy
 Behavioral: Family Planning-based Partner Violence Intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change in partner violence victimization (summary score) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Unintended pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    incidence of unintended pregnancy

  • Change in recognition of abusive behaviors (mean score) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    baseline-adjusted differences in mean post-intervention levels of recognition of what constitutes abusive behavior up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

  • Change in harm reduction self-efficacy (mean score) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    baseline-adjusted differences in mean post-intervention levels of self-efficacy regarding uptake of harm reduction strategies up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

  • Knowledge regarding violence victimization resources [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    post-intervention levels of knowledge about violence victimization related resources up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

  • Harm reduction strategies uptake (summary score) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    post-intervention levels of uptake of harm reduction strategies up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}
Enrollment: 3687
Study Start Date: October 2011
Study Completion Date: September 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinics trained in brief intervention
Female clients ages 16-29 seeking care in 11 reproductive health clinics in Western Pennsylvania where clinic providers are trained to implement the brief partner violence/reproductive coercion intervention.
 Behavioral: Family Planning-based Partner Violence Intervention

The intervention includes three major components:

  1. Enhanced Screening and Education: scripted questions to assess for reproductive coercion and pregnancy risk combined with intimate partner violence (IPV) assessment and education regarding how IPV may affect women's reproductive health with the assistance of a safety/educational card created for this intervention.
  2. Harm Reduction Counseling: assisting clients in identifying and planning strategies to reduce their risk for future unintended pregnancies and IPV.
  3. Supported Referral: educating all clients regarding local resources for victims of IPV and problem-solving regarding barriers to acquisition of these resources as needed.
No Intervention: Control sites providing standard of care
Female clients ages 16-29 seeking care in 14 reproductive health clinics in Western Pennsylvania where clinic providers are providing standard domestic violence screening per usual standard of care.

  Eligibility
Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • female clients
  • ages 16-29
  • English or Spanish speaking
  • able to provide their own consent
  • plan to be in area for the next 12 months
  • willing to be contacted for follow up survey and able to provide additional contact information

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459458

Locations
United States, Pennsylvania
Western Pennsylvania Family Planning Clinics
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Elizabeth Miller, M.D., Ph.D. University of Pittsburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Elizabeth Miller, Chief of Adolescent Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01459458     History of Changes
Other Study ID Numbers: 11050458  NICHD 
Study First Received: October 10, 2011
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
intimate partner violence
gender-based violence
domestic violence
unintended pregnancy

ClinicalTrials.gov processed this record on September 27, 2016