NCT03483610

Brief Summary

The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention. The study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. If the patient is not up-to-date, then they will be randomly assigned to one of two interventions. One intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. The other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

March 23, 2018

Results QC Date

September 24, 2024

Last Update Submit

January 22, 2025

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Scheduled or Completed Cervical Cancer Screening

    150 days

Study Arms (2)

screening and referral

ACTIVE COMPARATOR
Behavioral: Provider Referral

behavioral intervention

ACTIVE COMPARATOR
Behavioral: Text Messaging

Interventions

Provider ReferralBEHAVIORAL

Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.

screening and referral
Text MessagingBEHAVIORAL

Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.

behavioral intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly women get cervical cancer screening
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered patient in the Emergency Department of the University of Rochester Medical Center
  • Women
  • Age 21 - 65

You may not qualify if:

  • Past hysterectomy with cervical removal
  • Known infection with HIV (screening recommendations for women with HIV differ from the general population)
  • Non-English speaking
  • Inability to consent
  • Lack of text-capable mobile phone and/or inability to use text function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester, Department of Emergency Medicine

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Research Administrator
Organization
University of Rochester
peter_macdowell@urmc.rochester.edu
585-274-1509

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 30, 2018

Study Start

June 25, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

January 24, 2025

Results First Posted

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Withing one year of publication

Locations

US(1)