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

NCT07011836RecruitingNAINTERVENTIONAL

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

Key Facts

Lead Sponsor

ISA Associates, Inc.

Enrollment

288

Start Date

2025-06-24

Completion Date

2026-05-31

Study Type

INTERVENTIONAL

Official Title

Enhancing the Effectiveness of Community Health Workers to Reduce Cervical Cancer Disparities in African American Women

Interventions

mNav Interactive Video + NavigatorEducational Video

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

21 Years – 65 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Completion of Cervical Cancer Screening

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.

Time frame: Within 6 months of enrollment

Secondary Outcomes

Cervical Cancer Screening Intention

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.

Time frame: Baseline and 6-month follow-up

Cervical Cancer Knowledge Scale

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.

Time frame: Baseline and 6-month follow-up

Locations

Family and Medical Counseling Service, Inc., Washington D.C., United States

ISA Associates, Arlington, United States

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.