Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

Study Overview
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Brief Summary
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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.

Official Title
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Trauma-informed Personalized Scripts (TIPS) to Address Relationship Abuse and Reproductive Coercion in Family Planning Clinics

Conditions
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Violence, Abuse

Intervention / Treatment
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* Behavioral: TIPS-Plus
* Behavioral: TIPS-Basic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age 16-29 English speaking Plans to stay in the area for next 6 months Exclusion Criteria: Female clients not of the specified age range. Clients who are intoxicated or otherwise not able to provide their own consent will not be eligible to participate. Clients who are not able to read English will also be excluded from this pilot study as the survey questions presented via the tablet computer have not been validated yet in any other language.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIPS-Basic<br>Providers receive tailored scripts based on the patient's responses to the questions administered via tablet. | Behavioral: TIPS-Basic<br>* 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.<br>|
| Experimental: TIPS-Plus<br>Patients receive tailored messages in addition to the scripts given to providers. | Behavioral: TIPS-Plus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intimate partner violence, reproductive coercion, women's health, relationship abuse