Recruiting
mNav

Interactive Video Navigation for Cervical Cancer Screening in African American Women

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

mNav Interactive Video + Navigator

+ Educational Video
Behavioral
Who is being recruted

Uterine Cervical Neoplasms

From 21 to 65 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Screening Study

Interventional
Study Start: June 2025

See protocol details

Summary

Principal SponsorISA Associates, Inc.
Study ContactDouglas Billings, PhD
Last updated: June 29, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 24, 2025Actual date on which the first participant was enrolled.

This clinical trial focuses on improving cervical cancer screening rates among African American women who are overdue for screening. The study aims to determine if a new, interactive video-based navigation program, called mNav, can be more effective than a standard educational video alone. The program is designed to address specific concerns and barriers that may prevent women from getting screened. By testing this approach, researchers hope to find a better way to encourage timely cervical cancer screenings, ultimately reducing health disparities and catching potential issues earlier for better health outcomes. Participants in the study are randomly placed into one of two groups. One group receives a personalized interactive video experience with guidance from an in-person navigator, while the other group watches a standard educational video tailored for African American women. Participants will complete two phone surveys, one at the start and another six months later, to assess changes in knowledge, attitudes, and intentions regarding screening. Six months after the start of the study, researchers will review clinic records to see if participants have completed cervical cancer screening. This approach helps to evaluate if the interactive video and personal support increase the likelihood of screening.

Official TitleEnhancing the Effectiveness of Community Health Workers to Reduce Cervical Cancer Disparities in African American Women 
Principal SponsorISA Associates, Inc.
Study ContactDouglas Billings, PhD
Last updated: June 29, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
288 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Screening Study
Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 21 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Uterine Cervical Neoplasms
Criteria
6 inclusion criteria required to participate
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

Show More Criteria

1 exclusion criteria prevent from participating
\*None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants use an interactive, personalized video-based navigation tool (mNav) and receive navigator support.
Group II
Active Comparator
Participants view a general cervical cancer education video made for Black women, without personalized content or navigator support.
Study Objectives
Primary Objectives

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 Objectives

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Recruiting
Family and Medical Counseling Service, Inc.Washington, United StatesSee the location
Recruiting soon
ISA AssociatesArlington, United States
Recruiting
2 Study Centers