Clinical trial NCT01401816: Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
Official title: Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Active
Keywords: Adolescents
Sexually Active
Unprotected Sex
Emergency Contraception
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prescription Fill Rates
timeFrame: 1 month
Secondary outcomes:
measure: Sexual Activity
timeFrame: 6 weeks
measure: Contraception Use
timeFrame: 6 weeks
measure: Risk of Pregnancy
timeFrame: 6 weeks
measure: Knowledge of Emergency Contraception
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Michael Silverstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: