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

NCT07011836 | Recruiting

• 2 other identifiers: MD0152215R44MD015221-04
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

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

Conditions

Uterine Cervical Neoplasms

Keywords

Early Detection of Cancer; Health Behavior; Patient Navigation; African Americans

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 months of enrollment

Secondary Outcomes (2)

• Cervical Cancer Screening Intention

  Baseline and 6-month follow-up

• Cervical Cancer Knowledge Scale

  Baseline and 6-month follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants use an interactive, personalized video-based navigation tool (mNav) and receive navigator support.

Behavioral: mNav Interactive Video + Navigator

Education Control Group

ACTIVE COMPARATOR

Participants view a general cervical cancer education video made for Black women, without personalized content or navigator support.

Behavioral: Educational Video

Interventions

mNav Interactive Video + Navigator BEHAVIORAL

A personalized, video-based tool paired with navigator support to address individual screening barriers.

Intervention Group

Educational Video BEHAVIORAL

A culturally tailored cervical cancer education video without additional support or tailoring.

Education Control Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Women with a cervix.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \*None

Sponsors & Collaborators

• ISA Associates, Inc.: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Family and Medical Counseling Service, Inc.

Washington D.C., District of Columbia, 20020, United States

RECRUITING

ISA Associates

Arlington, Virginia, 22203, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Health Behavior

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Central Study Contacts

Douglas Billings, PhD

CONTACT

7037390882; dbillings@isagroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Datasets will be available at a minimum once the data have been accepted for peer-reviewed publication, and earlier if the data are deemed by the PI to be clean and the sharing of data is not expected to inhibit future opportunities for publication.
• Access Criteria: A data sharing agreement must be completed and signed by the requesting investigator and the Principal Investigator before this transfer of data can be made.

Locations

US (2)