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The Impact of Pack Supply on Birth Control Pill Continuation

NCT ID: NCT00677742

Last Updated: 2012-12-12

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

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Oral Contraception

Keywords

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oral contraception hormonal contraception contraceptive behavior patient compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

enhanced initial supply of oral contraception

Group Type EXPERIMENTAL

enhanced initial supply of oral contraception

Intervention Type OTHER

7 packs of pills, or 1 pack of pills and a prescription for 6 refills

2

conventional initial supply of oral contraception

Group Type ACTIVE_COMPARATOR

conventional initial supply of oral contraception

Intervention Type OTHER

3 packs of pills, or 1 pack of pills and a prescription for 2 refills

Interventions

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enhanced initial supply of oral contraception

7 packs of pills, or 1 pack of pills and a prescription for 6 refills

Intervention Type OTHER

conventional initial supply of oral contraception

3 packs of pills, or 1 pack of pills and a prescription for 2 refills

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katharine O'Connell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center, Family Planning Clinic

New York, New York, United States

Site Status

Countries

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United States

References

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White KO, Westhoff C. The effect of pack supply on oral contraceptive pill continuation: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):615-622. doi: 10.1097/AOG.0b013e3182289eab.

Reference Type DERIVED
PMID: 21860291 (View on PubMed)

Other Identifiers

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1 FPRPA0060250100

Identifier Type: -

Identifier Source: secondary_id

AAAC1723

Identifier Type: -

Identifier Source: org_study_id