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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Carcinoma

Intervention / Treatment
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* Other: Health Promotion and Education
* Other: Survey Administration
* Other: Interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (message)<br>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. | Other: Health Promotion and Education<br>* Receive messages<br>Other: Survey Administration<br>* Complete survey<br>Other: Interview<br>* Participate in an interview<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Consent Rate |  | Up to 12 months | 
| Study Completion Rate |  | Up to 12 months |