ContraceptionPEARLNCT03830567
Pharmacists Expand Access to Reproductive heaLthcare
An observational study of Contraception, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Pharmacist prescription and Clinician prescription
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women presenting to initiate hormonal contraception at a study pharmacy.
Who may be able to join
- Women presenting to initiate hormonal contraception at a study pharmacy
Who cannot join
- Pregnancy
- Contraindications to hormonal contraception
- Under 18 years of age
- Unable or unwilling to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Pharmacist prescription, Clinician prescription
- Keywords
- Hormonal Contraception, Birth Control, Pharmacists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist prescriptionOther
Pharmacist prescribed hormonal contraception (initiation or continuation).
Clinician prescriptionOther
Clinician prescribed hormonal contraception (initiation or continuation).
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist prescription | Not described Receives: Other: Pharmacist prescription | |
| Clinician prescription | Not described Receives: Other: Clinician prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive continuation rates
Percentage of contraceptive continuation assessed through survey at 12 months among women who present for contraception in pharmacies.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start27 Jan 2019
- Primary completion2 Feb 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Laura and John Arnold Foundation
- Responsible party
- Principal investigator, Maria Rodriguez, MD, MPH, Oregon Health and Science University
- Investigators
- Maria I Rodriguez, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830567
- Sponsor's protocol ID
- OHSU IRB 16158
- Acronym
- PEARL
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2019
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists Expand Access to Reproductive Healthcare: Reducing Unintended Pregnancy Through Pharmacist Prescription of Contraception
- ClinicalTrials.gov ID
- NCT03830567
- Acronym / sponsor ID
- PEARL / OHSU IRB 16158
- Conditions
- Contraception
- Keywords
- Hormonal Contraception, Birth Control, Pharmacists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Laura and John Arnold Foundation
- Study start
- 27 Jan 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist prescription | – | Other: Pharmacist prescription |
| Clinician prescription | – | Other: Clinician prescription |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women presenting to initiate hormonal contraception at a study pharmacy.
Key inclusion criteria (1 listed)
- Women presenting to initiate hormonal contraception at a study pharmacy
Key exclusion criteria (4 listed)
- Pregnancy
- Contraindications to hormonal contraception
- Under 18 years of age
- Unable or unwilling to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist prescriptionPharmacist prescribed hormonal contraception (initiation or continuation). | Other | Pharmacist prescription |
| Clinician prescriptionClinician prescribed hormonal contraception (initiation or continuation). | Other | Clinician prescription |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria I Rodriguez, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive continuation rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.