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NCT01459458 · ClinicalTrials.gov registry record · Phase 3
Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy
A Phase 3 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,687
- Enrollment target
NCT01459458 is a Phase 3 study that has completed, run by University of Pittsburgh. The registered enrollment target is 3,687 participants.
The verdict
NCT01459458, a Phase 3 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,687 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Family Planning-based Partner Violence Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,687 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01459458
The ClinicalTrials.gov registry entry for NCT01459458 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,687 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Family Planning-based Partner Violence Intervention is the first listed.
NCT01459458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01459458 about?
NCT01459458 is a clinical study titled "Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy". 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...
What is the current status of trial NCT01459458?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,687 participants. The study started on 2011-10. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01459458?
The interventions under investigation include: Family Planning-based Partner Violence Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01459458?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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