Clinical Trials Directory

Trials / Completed

CompletedNCT01459458

Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
3,687 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
Female
Age
16 Years – 29 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFamily Planning-based Partner Violence InterventionThe 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.

Timeline

Start date
2011-10-01
Primary completion
2014-02-01
Completion
2015-09-01
First posted
2011-10-25
Last updated
2015-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01459458. Inclusion in this directory is not an endorsement.