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

Columbia University

Status: Completed

Conditions: Oral Contraception

Treatments: Other: enhanced initial supply of oral contraception; Other: conventional initial supply of oral contraception

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00677742

1 FPRPA0060250100

AAAC1723

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 patients

Sex: Female

Ages: Under 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

700 participants in 2 patient groups

1

Experimental group

Description:

enhanced initial supply of oral contraception

Treatment:

Other: enhanced initial supply of oral contraception

2

Active Comparator group

Description:

conventional initial supply of oral contraception

Treatment:

Other: conventional initial supply of oral contraception