RCT of a Novel Oral Contraceptive Initiation Method

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Description (provided by applicant): Pregnancy rates are high among acceptors of oral contraceptives despite the effectiveness of the method. These pregnancies occur due to incorrect use and due to premature discontinuation of oral contraceptives. Failure to begin one contraceptives after receiving a prescription is a large subcategory. Up to 25% of adolescents who seek oral contraceptives from family planning clinics never take the first pill. Failure to begin oral contraceptives may occur due to ambivalence, confusion about starting instructions, or due to intervening pregnancy. Conventional starting instructions for oral contraceptives require waiting until the next menstrual period, which may leave the client at high risk of pregnancy. Novel approaches to initiation may improve continuation and decrease pregnancy rates among young women seeking oral contraceptives. In order to increase initiation rates we developed a quick start approach in which the client swallows the first pill during the clinic visit under direct observation and then continues daily pill use without waiting for her next menses. Pregnancy tests emergency contraception are used as clinically indicated. In a pilot study of 250 women, those who swallowed the first pill in the clinic were more likely to continue to their second pack of pills than women who received conventional starting instructions (adjusted CR 2.74, 2.74, 95% C.I. 1.1-6.8). We also carried out a randomized trial comparing 90-day bleeding patterns in 113 women who were randomized to quick start or conventional start of a monophasic 35ug EE OC. 104 women completed the study. Bleeding patterns were identical in the quick start and conventional start groups with excellent power to rule out clinically important differences. To further evaluate the usefulness of quick start we propose a multi-enter randomized clinical trial in which we will enroll 2l00 women aged less than 25 years. Subjects will be recruited from 3 publicly funded clinics that primarily serve Hispanic and African-American urban populations of low socio-economic status. They will complete a baseline, 3 month and 6 month questionnaire. The primary aim of the trial is to assess oral contraceptive continuation rates and pregnancy rates. We anticipate 75% low up at 6 months. The major secondary aim is to evaluate the predictive power of the Transtheoretical Model constructs relevant to adoption of and adherence to oral contraceptives. We will also assess dual method use for STD prevention in the study to adoption of and adherence to oral contraceptives. We will also assess dual method use for STD prevention in the study population.