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Pharmacists Expand Access to Reproductive heaLthcare (PEARL)

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ClinicalTrials.gov Identifier: NCT03830567
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Laura and John Arnold Foundation
Information provided by (Responsible Party):
Maria Rodriguez, Oregon Health and Science University

Brief Summary:
Prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates, as well as measures of safety and acceptability.

Condition or disease Intervention/treatment
Contraception Other: Pharmacist prescription Other: Clinician prescription

Detailed Description:

Direct prescription of hormonal contraception (HC) by pharmacists, without a doctor's visit or medical prescription, is a strategy to improve access to contraception and reduce unintended pregnancy. Oregon is the first state in the nation to implement legislation, as of January 1, 2016, expanding the scope of pharmacists to prescribe short-acting HCs. House Bill (HB) 2879 allows pharmacists to directly prescribe HC including the patch and pill, without a medical prescription. Women over 18 years of age can either initiate or continue HCs with a pharmacist, and women under 18 can continue a prescription.

This prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist, aims to determine contraceptive continuation and incident pregnancy rates between women receiving hormonal contraception from a pharmacist versus other prescriber. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates.


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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacists Expand Access to Reproductive Healthcare: Reducing Unintended Pregnancy Through Pharmacist Prescription of Contraception
Actual Study Start Date : January 27, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
Pharmacist prescription Other: Pharmacist prescription
Pharmacist prescribed hormonal contraception (initiation or continuation).

Clinician prescription Other: Clinician prescription
Clinician prescribed hormonal contraception (initiation or continuation).




Primary Outcome Measures :
  1. Contraceptive continuation rates [ Time Frame: 12 months ]
    Percentage of contraceptive continuation assessed through survey at 12 months among women who present for contraception in pharmacies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women presenting to initiate hormonal contraception at a study pharmacy.
Criteria

Inclusion Criteria:

  • Women presenting to initiate hormonal contraception at a study pharmacy

Exclusion Criteria:

  • Pregnancy
  • Contraindications to hormonal contraception
  • Under 18 years of age
  • Unable or unwilling to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830567


Contacts
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Contact: Women's Health Research Unit Confidential Recruitment Line 503-494-3666 whru@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit Confidential Recruitment Line    503-494-3666    whru@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Laura and John Arnold Foundation
Investigators
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Principal Investigator: Maria I Rodriguez, MD, MPH Oregon Health and Science University

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Responsible Party: Maria Rodriguez, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03830567     History of Changes
Other Study ID Numbers: OHSU IRB 16158
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Rodriguez, Oregon Health and Science University:
Hormonal Contraception
Birth Control
Pharmacists