Impact of Pack Supply on Oral Contraception Continuation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- oral contraception continuation
Study Overview
Brief Summary
The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.
Detailed Description
Discontinuation of oral contraceptive use in the initial months is common; successful early continuation is predictive of long term continuation and prevention of unintended pregnancy. The conventional approach to initiation of hormonal contraceptives in publicly funded clinics across the United States is to give the patient a limited supply of OCs, or a prescription with a limited number of refills, and then have her return to the clinic for a refill. This approach requires the patient to make frequent visits to the clinic, a barrier to method continuation.
This randomized trial will evaluate a simple but potentially powerful change in family planning clinic practice, i.e., the effect of dispensing more versus fewer cycles of oral contraception (OC). The study will be carried out in an urban, publicly funded family planning clinic that serves a population that is poor, young and primarily Hispanic or AfricanAmerican. This population was targeted as its members are at increased risk of discontinuing contraception in the first year of use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 35 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English or Spanish speaker
- •age less than or equal to 35 years requesting OC as their primary method of contraception
- •currently sexually active or anticipating sexual activity within the next 30 days
Exclusion Criteria
- •contraindications to oral contraceptives per clinic protocol (e.g., hypertension and pregnancy)
- •currently using OCs (that is, current users requesting a routine refill)
- •desiring pregnancy within the next 6 months
- •leaving the clinic catchment area within 6 months
- •previous participation in this study
Outcomes
Primary Outcomes
oral contraception continuation
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Carolyn L. Westhoff
Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center
Columbia University
