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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorISA Associates, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • mNav Interactive Video + Navigator

    Behavioral

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

  • Educational Video

    Behavioral

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

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Education Control GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Within 6 months of enrollment

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ISA Associates, Inc.

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator