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

NCT ID: NCT07011836

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-24

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Cervical Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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

Group Type EXPERIMENTAL

mNav Interactive Video + Navigator

Intervention Type BEHAVIORAL

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

Education Control Group

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

Group Type ACTIVE_COMPARATOR

Educational Video

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mNav Interactive Video + Navigator

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

Intervention Type BEHAVIORAL

Educational Video

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

ISA Associates, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Family and Medical Counseling Service, Inc.

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

Site Status RECRUITING

ISA Associates

Arlington, Virginia, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Douglas Billings, PhD

Role: CONTACT

7037390882

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vilma Kathy Argueta

Role: primary

202-800-4722

Mary Morcos, MPH

Role: primary

703-264-7223

Douglas Billings, PhD

Role: backup

7037390882

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R44MD015221-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MD015221

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.