NCT03830567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

February 2, 2019

Last Update Submit

April 2, 2024

Conditions

Contraception

Keywords

Hormonal ContraceptionBirth ControlPharmacists

Outcome Measures

Primary Outcomes (1)

  • Contraceptive continuation rates

    Percentage of contraceptive continuation assessed through survey at 12 months among women who present for contraception in pharmacies.

    12 months

Study Arms (2)

Pharmacist prescription

Other: Pharmacist prescription

Clinician prescription

Other: Clinician prescription

Interventions

Pharmacist prescriptionOTHER

Pharmacist prescribed hormonal contraception (initiation or continuation).

Pharmacist prescription
Clinician prescriptionOTHER

Clinician prescribed hormonal contraception (initiation or continuation).

Clinician prescription

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women presenting to initiate hormonal contraception at a study pharmacy.

You may qualify if:

  • Women presenting to initiate hormonal contraception at a study pharmacy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Study Officials

  • Maria I Rodriguez, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

January 27, 2019

Primary Completion

February 2, 2021

Study Completion

February 28, 2022

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

US(1)