Clinical trial NCT03913104: Mail Order Mifepristone Study
Official title: Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion Early
Pregnancy Related
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 536
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.

Detailed description: This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.

Eligibility criteria: Inclusion Criteria:

* Women seeking medication abortion through 63 days gestation
* Eligible for MifeprexⓇ at a study site
* English or Spanish speaking
* Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit

Exclusion Criteria:

* Not pregnant
* Not seeking medication abortion
* under the age of 15
* Over 63 days gestation
* Contraindicated for medication abortion

Primary outcomes:
measure: Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
timeFrame: Day 14 following initial medication abortion visit
measure: Acceptability: Would Use Mail-Order Dispensing Again
timeFrame: Day 14 following initial medication abortion visit
Secondary outcomes:
measure: Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3
timeFrame: Day 3 following initial medication abortion visit
measure: Feasibility: Confidentiality Maintained When Receiving Medications by Mail
timeFrame: Day 3 following initial medication abortion visit
measure: Clinical Effectiveness of Mail-Order Medication Abortion
timeFrame: Up to 6 weeks after initial medication abortion visit.
measure: Clinical Safety of Mail-Order Medication Abortion
timeFrame: Up to 6 weeks after initial medication abortion visit.
measure: Provider Acceptability of Mail-Order Dispensing of Medication Abortion
timeFrame: Up to 3 months after data collection completed.
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Highland Hospital
state: California
city: Oakland
country: United States
facility: Children's Hospital Oakland
state: California
city: Denver
country: United States
facility: Planned Parenthood Rocky Mountains
state: Colorado
city: Wilmington
country: United States
facility: Christiana Care Health System
state: Delaware
city: Atlanta
country: United States
facility: Atlanta Comprehensive Wellness Clinic
state: Georgia
city: New York
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Vestal
country: United States
facility: Southern Tier Women's Health Services
state: New York
city: Chester
country: United States
facility: Delaware County Women's Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Reproductive Health Center
state: Pennsylvania
city: Pawtucket
country: United States
facility: Brown Family Medicine
state: Rhode Island
city: Providence
country: United States
facility: Lifespan
state: Rhode Island
Study officials:
affiliation: University of California, San Francisco
name: Daniel Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grossman D, Raifman S, Morris N, Arena A, Bachrach L, Beaman J, Biggs MA, Hannum C, Ho S, Schwarz EB, Gold M. Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment. Contraception. 2022 Mar;107:36-41. doi: 10.1016/j.contraception.2021.09.008. Epub 2021 Sep 20.