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Clinical Trials/NCT04821297
NCT04821297
Completed
Not Applicable

An Innovative and Linguistically-Tailored Mobile Intervention to Improve Follow-Up for Abnormal Pap Test Results: CervixChat

Thomas Jefferson University1 site in 1 country30 target enrollmentFebruary 18, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Carcinoma
Sponsor
Thomas Jefferson University
Enrollment
30
Locations
1
Primary Endpoint
Patient Consent Rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

This clinical trial evaluates the feasibility of a linguistically-tailored mobile intervention, called CervixChat in improving the follow-up of patients with abnormal Papanicolaou (pap) test results. A text messaging program, such as CervixChat may support patients who need a colposcopy.

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of CervixChat intervention in a mix method design, through participants consent rate and the study completion rate. SECONDARY OBJECTIVE: I. To evaluate the acceptability of CervixChat intervention using a validated Likert-scale participant satisfaction questionnaire, as well as participant's interview data. EXPLORATORY OBJECTIVE: I. To evaluate the preliminary impact of CervixChat intervention, by comparing the colposcopy appointment adherence rate in the study cohort against a 1:1 matched control sample selected based on matching age, race and ethnicity, from participants at Jefferson Obstetrics and Gynecology (Ob-Gyn) department scheduled for a colposcopy in 2019. OUTLINE: Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy. After completion of study, patients are followed up periodically.

Registry
clinicaltrials.gov
Start Date
February 18, 2021
End Date
September 10, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female, aged 21 to 65 years of age
  • Had received an abnormal Pap smear result
  • Scheduled colposcopy
  • Able to communicate with ease in English or Spanish
  • Have a cell phone with text (TXT) ability
  • Competent to give consent

Exclusion Criteria

  • Are pregnant at the time of recruitment
  • Display current evidence of positive invasive carcinoma of the cervix

Outcomes

Primary Outcomes

Patient Consent Rate

Time Frame: Up to 12 months

Study Completion Rate

Time Frame: Up to 12 months

Study Sites (1)

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