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This pilot study will evaluate a computer-based intervention titled "Trauma-informed Personalized Scripts" (TIPS). The goal of this intervention is to improve patient-provider communication about sensitive topics such as intimate partner violence (IPV) and reproductive coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics using a randomized study design to compare the basic version of TIPS (a computer-based assessment with provider scripts only) to an enhanced TIPS containing a tailored brief intervention for patients along with provider scripts. The investigators plan to recruit 240 female patients ages 16-29 for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS-Basic | Active Comparator | Providers receive tailored scripts based on the patient's responses to the questions administered via tablet. |
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| TIPS-Plus | Experimental | Patients receive tailored messages in addition to the scripts given to providers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS-Plus | Behavioral | Patients receive brief psycho-educational messages on a tablet computer following completion of questionnaire about personal experiences of intimate partner violence (IPV), sexual assault (SA), and reproductive coercion (RC). These messages are tailored to each patient and are based on their responses to specific items. The messages serve as prompts to encourage the patient to continue the discussion about various topics (healthy relationships, birth control methods, harm reduction) with their provider during their clinic visit. Simultaneously, providers receive a print out with a series of scripts tailored to the patient's responses to introduce healthy relationships education, brief counseling, and harm reduction. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of intervention delivery by provider | Assessment of delivery of brief intervention previously tested and found to be helpful in family planning clinic settings (Addressing Reproductive Coercion in Health Settings (ARCHES), NCT01459458). Summary score based on patient responses on an after-visit exit survey inquiring about what elements of the intervention the provider discussed during clinic visit | Immediately following clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in pregnancy risk | 2.1 Change in condom use frequency: Assessment of pregnancy risk reduction through change in frequency of self-reported condom use from baseline to follow-up 2.2 Contraceptive use: Assessment of pregnancy risk reduction through differences in contraceptive use from baseline to follow-up | baseline to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Miller, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21310291 | Background | Miller E, Decker MR, McCauley HL, Tancredi DJ, Levenson RR, Waldman J, Schoenwald P, Silverman JG. A family planning clinic partner violence intervention to reduce risk associated with reproductive coercion. Contraception. 2011 Mar;83(3):274-80. doi: 10.1016/j.contraception.2010.07.013. | |
| 20227548 | Background |
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|
| TIPS-Basic | Behavioral | Patients complete tablet questionnaire about personal experiences of IPV/SA/RC and based on responses, providers receive a print out with a series of scripts tailored to the patient's responses to introduce healthy relationships education, brief counseling, and harm reduction. |
|
| Change in self-efficacy to enact harm reduction behaviors (mean score) |
Baseline-adjusted differences in mean post-intervention levels of self-efficacy regarding uptake of harm reduction strategies up to 4 months after baseline clinical encounter |
| Baseline to 4 months |
| Enacting harm reduction behaviors (summary score) | Summary score of use of any harm reduction strategies, measured by investigator developed items that include a range of harm reduction strategies that women may employ to increase their safety | 4 months |
| Change in knowledge of sexual and partner violence related services from baseline to follow up | Knowing about specified IPV/SV related services comparing baseline and follow up summary scores | Baseline to 4 months |
| Any use of sexual and partner violence related services | Any use of sexual violence related services (summary score) at 4 month follow up | 4 months |
| Change in violence victimization from baseline to follow up | Among those reporting exposure to violence (IPV/SV/RC) at baseline, summary score of any recent (past 3 months) violence victimization (including IPV/SV/RC), comparing before intervention to after the intervention | Baseline to 4 months |
| Miller E, Decker MR, McCauley HL, Tancredi DJ, Levenson RR, Waldman J, Schoenwald P, Silverman JG. Pregnancy coercion, intimate partner violence and unintended pregnancy. Contraception. 2010 Apr;81(4):316-22. doi: 10.1016/j.contraception.2009.12.004. Epub 2010 Jan 27. |
| 24331859 | Background | 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. |
| 26892333 | Background | 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. |
| 33211607 | Derived | Hill AL, Zachor H, Miller E, Talis J, Zelazny S, Jones KA. Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Follow-Up Findings from an Implementation Randomized Controlled Trial Study. J Womens Health (Larchmt). 2021 Apr;30(4):604-614. doi: 10.1089/jwh.2020.8527. Epub 2020 Nov 18. |
| 30969147 | Derived | Hill AL, Zachor H, Jones KA, Talis J, Zelazny S, Miller E. Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Preliminary Findings from an Implementation Randomized Controlled Trial. J Womens Health (Larchmt). 2019 Jun;28(6):863-873. doi: 10.1089/jwh.2018.7318. Epub 2019 Apr 10. |