Pharmacists Expand Access to Reproductive heaLthcare (PEARL)

April 2, 2024 updated by: Maria Rodriguez, MD, MPH, Oregon Health and Science University

Pharmacists Expand Access to Reproductive Healthcare: Reducing Unintended Pregnancy Through Pharmacist Prescription of Contraception

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women presenting to initiate hormonal contraception at a study pharmacy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Laura and John Arnold Foundation

Investigators

  • Principal Investigator: Maria I Rodriguez, MD, MPH, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2019

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

February 2, 2019

First Submitted That Met QC Criteria

February 2, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OHSU IRB 16158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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