Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women

Not Applicable

Not yet recruiting

• Conditions: Uterine Cervical Neoplasms

• Registration Number: NCT07011836
• Lead Sponsor: ISA Associates, Inc.

Brief Summary

The goal of this clinical trial is to test whether an interactive, video-based patient navigation program can improve cervical cancer screening among African American women who are currently overdue for screening.

The main questions it aims to answer are:

Can an interactive video navigation tool (mNav), when paired with in-person navigation, improve screening adherence compared to a standard educational video alone?

Does the intervention improve knowledge, reduce barriers, and increase intentions to get screened?

Researchers will compare participants who receive both the interactive video (guided by an on-screen navigator) and in-person navigation to those who receive only a standard educational video to see if the tailored support increases screening rates.

Participants will:

Complete two phone surveys (one at the beginning and one six months later)

Be randomly assigned to one of two groups:

One group will receive an interactive video experience tailored to their concerns plus support from an in-person navigator

The other group will receive a standard educational video designed for African American women

Have their clinic records reviewed six months later to check for cervical cancer screening completion

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-12
• Study Start: 2025-06-15
• Primary Completion: 2026-05-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 288

Inclusion Criteria

• Black or African American woman
• Nonadherent to USPSTF cervical cancer screening guidelines (no Pap test in the past 3 years or no HPV test in the past 5 years)
• Age 21 to 65 years old
• Not currently pregnant
• No history of hysterectomy
• Access to a mobile phone capable of receiving text messages and watching video content

Exclusion Criteria

*None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion of Cervical Cancer Screening	Within 6 months of enrollment	Whether participants completed cervical cancer screening, as verified through medical record review. Screening includes a Pap test, HPV test, or co-test, consistent with current guidelines.

Secondary Outcome Measures

Name	Time	Method
Cervical Cancer Screening Intention	Baseline and 6-month follow-up	Measures participants' self-reported likelihood of obtaining cervical cancer screening in the next 6 months. This is a single-item Likert scale ranging from 0 to 4, with higher scores indicating a greater likelihood of screening. Scale anchors are: 0 = Not at all likely, 1 = A little likely, 2 = Somewhat likely, 3 = Likely, 4 = Very likely.
Cervical Cancer Knowledge Scale	Baseline and 6-month follow-up	Assessed using a structured survey at baseline and follow-up, this 20-item True/False scale evaluates participant knowledge of cervical cancer risks, screening methods, and guidelines. Scale scores range from 0 to 20, with higher scores indicating greater knowledge. Each correct response is scored as 1; incorrect or missing responses are scored as 0. The total score represents the number of correct responses.

Trial Locations

Locations (1)

ISA Associates; 🇺🇸 Arlington, Virginia, United States