The Impact of Pack Supply on Birth Control Pill Continuation (SixPack)

December 11, 2012 updated by: Carolyn L. Westhoff, Columbia University

Impact of Pack Supply on Oral Contraception Continuation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center, Family Planning Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
enhanced initial supply of oral contraception
Other: enhanced initial supply of oral contraception
7 packs of pills, or 1 pack of pills and a prescription for 6 refills
Active Comparator: 2
conventional initial supply of oral contraception
Other: conventional initial supply of oral contraception
3 packs of pills, or 1 pack of pills and a prescription for 2 refills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oral contraception continuation
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Katharine O'Connell, MD, MPH, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 13, 2008

First Posted (Estimate)

May 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAC1723
  • 1 FPRPA0060250100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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