The Impact of Pack Supply on Birth Control Pill Continuation

Not Applicable

Completed

• Conditions: Oral Contraception
• Interventions: Other: enhanced initial supply of oral contraception; Other: conventional initial supply of oral contraception

• Registration Number: NCT00677742
• Lead Sponsor: Columbia University

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-14
• Primary Completion: 2009-04
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	enhanced initial supply of oral contraception	enhanced initial supply of oral contraception
2	conventional initial supply of oral contraception	conventional initial supply of oral contraception

Primary Outcome Measures

Name	Time	Method
oral contraception continuation	6 months

Trial Locations

Locations (1)

Columbia University Medical Center, Family Planning Clinic; 🇺🇸 New York, New York, United States