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Completed

NCT Number: NCT03866811

Reducing Teen Pregnancy in the Emergency Department

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.

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Key information

Conditions

Reproductive Behavior Adolescent Behavior Behavior Contraception Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Morgan Stanley Children's Hospital Emergency Department

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Dr. Erica

Behavioral

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.

Primary outcomes

  1. Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]

    Time frame: 3 months

    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

Secondary outcomes

  1. Feasibility: Percentage of Refusal

    Time frame: Baseline

    Percentage of eligible participants who refused

  2. Feasibility: Opt Outs Measured Via Mobile Platform

    Time frame: 3 months

    Percentage of enrolled participants in the intervention group who texted to stop receiving messages.

  3. Number of Enrolled Participants Who do Not Complete Follow up

    Time frame: 3 months

    Measurement of the feasibility of Dr. Erica among adolescent female users

  4. Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey

    Time frame: 3 months

    Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends

  5. Any Sex Over the Past 3 Months

    Time frame: 1 year

    Self-report of any over the past 3 months.

Other outcomes

  1. Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care

    Time frame: 3 months

    Participants who reported they did not go to the Columbia Family Planning Clinic over the past 3 months and answered "yes" to the question: "Over the past 3 months, have you seen a doctor for medical care?" In this Outcome, "preventative reproductive care" is defined as any visit to a doctor for the purposes of reproductive health.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: ERICA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2019
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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