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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier:
NCT00677742
First received: May 12, 2008
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Oral Contraception
Other: enhanced initial supply of oral contraception
Other: conventional initial supply of oral contraception

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Pack Supply on Oral Contraception Continuation

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • oral contraception continuation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: June 2007
Study Completion Date: November 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677742

Locations
United States, New York
Columbia University Medical Center, Family Planning Clinic
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Katharine O'Connell, MD, MPH Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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
ClinicalTrials.gov Identifier: NCT00677742     History of Changes
Other Study ID Numbers: AAAC1723, 1 FPRPA0060250100
Study First Received: May 12, 2008
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
oral contraception
hormonal contraception
contraceptive behavior
patient compliance
Contraceptive behavior

ClinicalTrials.gov processed this record on July 29, 2014