Reducing Teen Pregnancy in the Emergency Department

Contraception Clinical Trial

— ERICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866811
• Other study ID #: 1K23HD096060-01
• Secondary ID: 1K23HD096060-01
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2019
• Est. completion date: July 2, 2020

Study information

• Verified date: October 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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"

Related Conditions & MeSH terms

• Adolescent Behavior
• Contraception
• Emergencies
• Reproductive Behavior
• Sexual Behavior

Intervention

Behavioral:
• Dr. Erica
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.

Locations

Country	Name	City	State
United States	Morgan Stanley Children's Hospital Emergency Department	Manhattan	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Efficacy Outcome: Change in Preventive Reproductive Care Follow up measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]	Difference in percentages of those who follow up to preventive reproductive care in the intervention versus the control group based on telephone or online survey results	3 months
Other	Exploratory Efficacy Outcome: Change in Contraception Self-Efficacy measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]	Difference in contraception self-efficacy between those in the intervention and control groups based on data collected on the telephone or online follow up survey	3 months
Primary	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
Primary	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	Feasibility: Percentage of refusal [Baseline at enrollment]	Percentage of eligible participants who refused enrollment	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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