The Impact of Pack Supply on Birth Control Pill Continuation

Study Overview
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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.

Official Title
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Impact of Pack Supply on Oral Contraception Continuation

Conditions
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Oral Contraception

Intervention / Treatment
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* Other: enhanced initial supply of oral contraception
* Other: conventional initial supply of oral contraception


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral contraception continuation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral contraception, hormonal contraception, contraceptive behavior, patient compliance