Reducing Teen Pregnancy in the Emergency Department

Study Overview
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Brief Summary
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This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.

Detailed Description
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Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the ED are at particularly high risk of unintended pregnancy. To date, no intervention has successfully increased contraception use among this high risk, hard-to-reach ED population. In this study, the investigators will conduct a pilot randomized controlled trial of a user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy. The investigators hypothesize that high risk adolescent female ED patients who receive Dr. Erica will more often initiate contraceptives than those females who receive standard discharge instructions alone. At baseline and follow-up assessment at 3 months, participants will provide information regarding effective contraception initiation, any contraception at last intercourse, follow up with reproductive preventive health services, and contraception self-efficacy.

Official Title
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Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy

Conditions
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Reproductive Behavior, Sexual Behavior, Adolescent Behavior, Contraception

Intervention / Treatment
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* Behavioral: Dr. Erica


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female emergency department patient age 14-19 years sexually active with males in the past 3 months Exclusion Criteria: currently using any effective form of contraception do not own a mobile phone with texting are pregnant are too ill for participation per the attending physician are cognitively impaired do not live locally do not speak English want to become pregnant in the next year

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 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
Interventional Model Description: A randomized controlled trial with two arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week). | Behavioral: Dr. Erica<br>* The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.<br>|
| No Intervention: Control arm<br>Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] | Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An effective form of contraception (as defined by the World Health Organization) includes the following: intrauterine device birth control implant birth control patch birth control pills or oral contraceptives injectable birth control a vaginal ring | 3 months | 
| Potential Efficacy: Contraceptive at Last Intercourse Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] | Rates of contraceptive use at last intercourse will be reported by participants via telephone or online survey. Condom use will be included. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Percentage of refusal [Baseline at enrollment] | Percentage of eligible participants who refused enrollment | Baseline | 
| Feasibility: Opt outs measured via mobile platform [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] | Percentage of enrolled participants in the intervention group who texted to stop receiving messages | 3 months | 
| Feasibility: Loss to follow up measured via online or telephone survey [Close of intervention at 12 weeks] | Percentage of enrolled participants who do not complete follow up via either telephone or online survey | 3 months | 
| Feasibility/Acceptability: Interaction with text messages measured via mobile platform provider [[Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] | Percentage of participants in the intervention group who replied to each interactive text message | 3 months | 
| Acceptability: Satisfaction with the intervention measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] | Percentage of participants in the intervention group who answer that they like the program and would recommend it to friends | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency medicine, reproductive health, sexual health, adolescent health, emergency department, text messaging, mobile health, digital health