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Completed

NCT Number: NCT04821297

Linguistically-Tailored Mobile Intervention for the Improvement of Follow Up for Abnormal Pap Test Results

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.

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Key information

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Promotion and Education

Other

Receive messages

Survey Administration

Other

Complete survey

interview

Other

Participate in an interview

Primary outcomes

  1. Patient Consent Rate

    Time frame: Up to 12 months

  2. Study Completion Rate

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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