Contraception Clinical Trial
— ERICAOfficial title:
Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy
Verified date | October 2020 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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" |
Country | Name | City | State |
---|---|---|---|
United States | Morgan Stanley Children's Hospital Emergency Department | Manhattan | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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 |
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