Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates

NCT ID: NCT01401816

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sexually Active

Keywords

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Adolescents Sexually Active Unprotected Sex Emergency Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Text Message

Intervention Type OTHER

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.

Control Group

Subjects in this group will receive a only a prescription for emergency contraception and no reminder text messages.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text Message

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Silverstein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Alpert 3442-3

Identifier Type: -

Identifier Source: org_study_id