Reducing Teen Pregnancy in the Emergency Department (ERICA)
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|ClinicalTrials.gov Identifier: NCT03866811|
Recruitment Status : Completed
First Posted : March 7, 2019
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Reproductive Behavior Sexual Behavior Adolescent Behavior Contraception||Behavioral: Dr. Erica||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized controlled trial with two arms|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome assessor will be blinded to study enrollment arm.|
|Official Title:||Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy|
|Actual Study Start Date :||March 3, 2019|
|Actual Primary Completion Date :||July 2, 2020|
|Actual Study Completion Date :||July 2, 2020|
Experimental: Intervention arm
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
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.
No Intervention: Control arm
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
- 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
- Potential Efficacy: Contraceptive at Last Intercourse Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]Rates of contraceptive use at last intercourse will be reported by participants via telephone or online survey. Condom use will be included.
- Feasibility: Percentage of refusal [Baseline at enrollment] [ Time Frame: Baseline ]Percentage of eligible participants who refused enrollment
- Feasibility: Opt outs measured via mobile platform [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]Percentage of enrolled participants in the intervention group who texted to stop receiving messages
- Feasibility: Loss to follow up measured via online or telephone survey [Close of intervention at 12 weeks] [ Time Frame: 3 months ]Percentage of enrolled participants who do not complete follow up via either telephone or online survey
- Feasibility/Acceptability: Interaction with text messages measured via mobile platform provider [[Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]Percentage of participants in the intervention group who replied to each interactive text message
- Acceptability: Satisfaction with the intervention measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]Percentage of participants in the intervention group who answer that they like the program and would recommend it to friends
- 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)] [ Time Frame: 3 months ]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
- 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)] [ Time Frame: 3 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866811
|United States, New York|
|Morgan Stanley Children's Hospital Emergency Department|
|Manhattan, New York, United States, 10032|
|Principal Investigator:||Lauren Chernick, MD MSc||Columbia University|