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Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01459458
Enrollment
3687
Registered
2011-10-25
Start date
2011-10-31
Completion date
2015-09-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Violence

Keywords

intimate partner violence, gender-based violence, domestic violence, unintended pregnancy

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.

Interventions

BEHAVIORALFamily 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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 29 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in partner violence victimization (summary score)baseline to 12 monthsbaseline-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)baseline to12 monthsbaseline-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

MeasureTime frameDescription
Change in harm reduction self-efficacy (mean score)baseline to 12 monthsbaseline-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}
Unintended pregnancy12 monthsincidence of unintended pregnancy
Harm reduction strategies uptake (summary score)up to 12 monthspost-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}
Knowledge regarding violence victimization resourcesup to 12 monthspost-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}
Change in recognition of abusive behaviors (mean score)baseline to 12 monthsbaseline-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}

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026