Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy
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ClinicalTrials.gov Identifier: NCT01459458 |
Recruitment Status
:
Completed
First Posted
: October 25, 2011
Last Update Posted
: December 2, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Violence Pregnancy | Behavioral: Family Planning-based Partner Violence Intervention | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3687 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
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.
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Behavioral: Family Planning-based Partner Violence Intervention
The intervention includes three major components:
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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.
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- 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}
- Unintended pregnancy [ Time Frame: 12 months ]incidence of unintended pregnancy
- Change in recognition of abusive behaviors (mean score) [ Time Frame: baseline to 12 months ]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 ]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 ]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 ]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}

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Ages Eligible for Study: | 16 Years to 29 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459458
United States, Pennsylvania | |
Western Pennsylvania Family Planning Clinics | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Elizabeth Miller, M.D., Ph.D. | University of Pittsburgh |
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 ( Other Grant/Funding Number: 1R01HD064407-01A1 ) |
First Posted: | October 25, 2011 Key Record Dates |
Last Update Posted: | December 2, 2015 |
Last Verified: | November 2015 |
Keywords provided by Elizabeth Miller, University of Pittsburgh:
intimate partner violence gender-based violence domestic violence unintended pregnancy |