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| ID | Type | Description | Link |
|---|---|---|---|
| NICHD | Other Grant/Funding Number | 1R01HD064407-01A1 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinics trained in brief intervention | Experimental | 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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| Control sites providing standard of care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Planning-based Partner Violence Intervention | Behavioral | The intervention includes three major components:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in partner violence victimization (summary score) | 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} | baseline to 12 months |
| Change in reproductive coercion (summary score) | 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} | baseline to12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Unintended pregnancy | incidence of unintended pregnancy | 12 months |
| Change in recognition of abusive behaviors (mean score) | 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} |
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Inclusion:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Miller, M.D., Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Pennsylvania Family Planning Clinics | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34057734 | Derived | Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2. | |
| 33464993 | Derived | Hill AL, Miller E, Borrero S, Zelazny S, Miller-Walfish S, Talis J, Switzer GE, Abebe KZ, Chang JC. Family Planning Providers' Assessment of Intimate Partner Violence and Substance Use. J Womens Health (Larchmt). 2021 Sep;30(9):1225-1232. doi: 10.1089/jwh.2020.8699. Epub 2021 Jan 18. |
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| baseline to 12 months |
| Change in harm reduction self-efficacy (mean score) | 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} | baseline to 12 months |
| Knowledge regarding violence victimization resources | 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} | up to 12 months |
| Harm reduction strategies uptake (summary score) | 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} | up to 12 months |
| 26892333 | Derived | Miller E, Tancredi DJ, Decker MR, McCauley HL, Jones KA, Anderson H, James L, Silverman JG. A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial. Contraception. 2016 Jul;94(1):58-67. doi: 10.1016/j.contraception.2016.02.009. Epub 2016 Feb 15. |
| 26245752 | Derived | Tancredi DJ, Silverman JG, Decker MR, McCauley HL, Anderson HA, Jones KA, Ciaravino S, Hicks A, Raible C, Zelazny S, James L, Miller E. Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES). BMC Womens Health. 2015 Aug 6;15:57. doi: 10.1186/s12905-015-0216-z. |
| 24331859 | Derived | Miller E, McCauley HL, Tancredi DJ, Decker MR, Anderson H, Silverman JG. Recent reproductive coercion and unintended pregnancy among female family planning clients. Contraception. 2014 Feb;89(2):122-8. doi: 10.1016/j.contraception.2013.10.011. Epub 2013 Dec 10. |