Sexually Active Clinical Trial
Official title:
Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
| Verified date | June 2011 |
| Source | Boston Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | May 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 13 Years to 21 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | Boston Medical Center | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prescription Fill Rates | 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 | No |
| Secondary | Sexual Activity | 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 | No |
| Secondary | Contraception Use | 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. | 6 weeks | No |
| Secondary | Risk of Pregnancy | 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 | No |
| Secondary | Knowledge of Emergency Contraception | Each study participant will receive a follow-up telephone survey and answer questions on the time-frame and accessibility of emergency contraception. | 6 weeks | No |