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Pharmacists Expand Access to Reproductive heaLthcare

NCT ID: NCT03830567

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-27

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pharmacist prescription

Pharmacist prescription

Intervention Type OTHER

Pharmacist prescribed hormonal contraception (initiation or continuation).

Clinician prescription

Clinician prescription

Intervention Type OTHER

Clinician prescribed hormonal contraception (initiation or continuation).

Interventions

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Clinician prescription

Clinician prescribed hormonal contraception (initiation or continuation).

Intervention Type OTHER

Pharmacist prescription

Pharmacist prescribed hormonal contraception (initiation or continuation).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laura and John Arnold Foundation

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Maria Rodriguez, MD, MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria I Rodriguez, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU IRB 16158

Identifier Type: -

Identifier Source: org_study_id

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