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Home > "T" Clinical Trials Conditions > The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies  The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies
The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies
For Condition: Contraception
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Hormonal birth control methods include birth control pills, patches, and vaginal rings; they are normally available only with a doctor’s prescription. This study will evaluate a program designed to increase the availability of birth control by allowing pharmacists to give women hormonal birth control without a doctor’s prescription. Under this program, pharmacists will evaluate women who want to use birth control according to specific guidelines created by doctors. If a woman meets the criteria in the guidelines, a pharmacist could then give her the appropriate form of hormonal birth control.
Details: The Institute of Medicine’s Committee on Unintended Pregnancy urges increasing access to contraception through broadening the range of health professionals that provide birth control. Evidence-based family planning practice no longer requires a physical examination before prescribing hormonal contraceptives to women. Community pharmacists efficiently provide emergency contraceptive pills (ECP) and women report satisfaction with the direct access. These women, as well as many women purchasing less effective over-the-counter (OTC) contraceptive methods, could benefit from more pharmacist-dispensed birth control choices, such as hormonal methods. The Direct Access Study will assess the feasibility of pharmacists, under Collaborative Drug Therapy Agreements with independent prescribers, providing hormonal contraceptives in community pharmacies. Specifically, the study will evaluate the impact upon hormonal contraception initiation and continuation rates when women's care is managed by pharmacists. Using Collaborative Drug Therapy Agreements jointly developed with licensed prescribers (physicians and nurse practitioners), pharmacists in four Fred Meyer pharmacies will identify women who are at risk of unintended pregnancy and will offer to evaluate them for their suitability to safely use oral contraceptives, contraceptive patches, or the contraceptive vaginal ring. Through self-administered medical and contraceptive history questionnaires, interested women will select the most suitable contraceptive methods. Pharmacists will then complete the screening process and prescribe hormonal contraceptives according to the protocol guidelines. Pharmacists will encourage women to follow up with a primary care practitioner or family planning clinic for cervical exams and reproductive tract infection screening as indicated. Pharmacists will have authority to provide an initial 3-month prescription and an additional 9-month prescription if blood pressure is normal at a three-month revisit. Effectiveness of pharmacists' interventions will be measured by initiation and continuation of hormonal methods by women to whom pharmacists have offered them. Feasibility will be determined by measurement of both acceptability and sustainability. Acceptability will be measured by surveys of women, pharmacists, and prescribers. Sustainability will be measured by economic and work-flow outcomes for the pharmacies, including evidence that women, private third-party payers, and public payers are willing to pay for the services. If safety is documented after preliminary analysis, injectable contraceptive methods will be added to the study.
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - At risk for unintended pregnancy - Access to participating Fred Meyer Pharmacy - English-speaking - Health insurance or ability to pay for contraceptive care
Total Enrollment: 275
Location and Contact Information:
Overall Study Official:
JacquelineGardner, Principal Investigator, University of Washington
Fred Meyer Pharmacy
Kent, Washington,
United States
Fred Meyer Pharmacy
South Hill, Washington,
United States
Fred Meyer Pharmacy
Seattle, Washington,
United States
Fred Meyer Pharmacy
Kirkland, Washington,
United States
Additional Information:
Study ID Numbers: HD42427;
Study Start Date: June 2003
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065871
Other Contraception Studies:
1. Emergency Contraception (ECP): Reducing Unintended Pregnancies
2. The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies
3. Effects of St. John's Wort on the Effectiveness of Oral Contraceptives
4. Quick Start Approach to Birth Control Pills
Related Studies:
Other Contraception Clinical Trials
Other Florida Clinical Trials
Other Clinical Trials
The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies
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