- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401816
Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%). It has been estimated that if Emergency Contraception (Plan B) was used after every contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions annually.
Previous studies have showed the effectiveness of emergency contraception decreases with time after intercourse; the sooner it is taken-even if it means a matter of hours-the more effective it is in preventing pregnancy. Based on previous studies, it is clear that relying on obtaining emergency contraception on the same day or even the day after unprotected intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the adolescent mystery caller did not have the medication available the day of the call and almost all of the pharmacies not stocking the medication would take greater than 24 hours to obtain it through their ordering system.
Thus, the concept of advanced provision of emergency contraception has been proposed to assure that the medication can be taken as soon as possible. Although this practice is known to be safe and has not shown any association with increased sexual risk or behaviors, it is unclear how often/if adolescents will fill a prescription for a medication that is not needed at the time of a medical encounter.
The investigators propose a randomized pilot study (n=60) of a text-messaging intervention that aims to increase the rate at which prescriptions for emergency contraception are filled. Based on practice norms in the BMC Adolescent Center, sexually active female adolescents (ages 13-21) in both the control and intervention groups will be provided a prescription for emergency contraception. The intervention group, however, will receive follow-up text message on their phone reminding them to fill the prescription.
Boston Medical Center Health Plan will provide prescription fill data regarding the prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all study participants will be contacted for a follow-up survey.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sexually Active
- Boston Medical Center Health Plan Insurance
- Personal Cell Phone
Exclusion Criteria:
- Pregnant
- Currently using a long-acting form of contraception (IUD, Depo, Implanon)
- No personal cell phone
- Insurance other than Boston Medical Center Health Plan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Subjects in this group will receive a prescription for emergency contraception and then text-messages (on Day 1, 3 and 5 after enrollment) to their personal cell phone with a reminder to fill their prescription.
|
Subjects will receive a text message on their personal cell phone on Days 1, 3 and 5 after enrollment reminding them to fill their prescription.
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|
No Intervention: Control Group
Subjects in this group will receive a only a prescription for emergency contraception and no reminder text messages.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prescription Fill Rates
Time Frame: 1 month
|
The primary outcome is whether the advanced provision prescription for emergency contraception is filled or not.
This will be measured through insurance claims data obtained from BMC Health Plan a month after enrollment.
Furthermore, the time to fill the prescription from the time of enrollment can be examined.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Activity
Time Frame: 6 weeks
|
Each study participant will receive a follow-up telephone call to his or her personal cell phone six weeks after enrollment to complete a follow-up survey that will consist of questions related to sexual activity since enrollment.
|
6 weeks
|
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Contraception Use
Time Frame: 6 weeks
|
Each participant will receive a follow-up telephone survey and answer questions regarding their use of contraception (if any) and how often they utilized such methods since enrollment.
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6 weeks
|
|
Risk of Pregnancy
Time Frame: 6 weeks
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Each study participant will receive a telephone survey and be asked if they have used emergency contraception (EC) since enrolling in the study or if they have taken a pregnancy test since enrolling.
|
6 weeks
|
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Knowledge of Emergency Contraception
Time Frame: 6 weeks
|
Each study participant will receive a follow-up telephone survey and answer questions on the time-frame and accessibility of emergency contraception.
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6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alpert 3442-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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