Uterine Cervical NeoplasmsmNavNCT07011836
Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women
A study testing mNav Interactive Video + Navigator and Educational Video in people with Uterine Cervical Neoplasms, run by ISA Associates, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- mNav Interactive Video + Navigator and Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
ISA Associates
Arlington, Virginia, 22203
Mary Morcos, MPH, 7032647223, mmorcos@isagroup.com
Douglas Billings, PhD, 7037390882, dbillings@isagroup.com
- Recruiting
Family and Medical Counseling Service, Inc.
Washington D.C., District of Columbia, 20020
Vilma Kathy Argueta, (202) 800-4722, vargueta@fmcsinc.org
About this study
Official title: Enhancing the Effectiveness of Community Health Workers to Reduce Cervical Cancer Disparities in African American Women
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:
Read more
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
- Being tested
- mNav Interactive Video + Navigator, Educational Video
- Keywords
- Early Detection of Cancer, Health Behavior, Patient Navigation, African Americans
- Medical subject headings
- Uterine Cervical Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNav Interactive Video + NavigatorBehavioural
A personalized, video-based tool paired with navigator support to address individual screening barriers.
Educational VideoBehavioural
A culturally tailored cervical cancer education video without additional support or tailoring.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants use an interactive, personalized video-based navigation tool (mNav) and receive navigator support. Receives: 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. Receives: Behavioral: Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months of enrollment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISA Associates, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011836
- Sponsor's protocol ID
- MD015221
- Other IDs
- 5R44MD015221-04
- Acronym
- mNav
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The mode of dissemination of public datasets will be via archive files accessible in the public domain. Public datasets will be de-identified so that data cannot be linked to individual research participants
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Effectiveness of Community Health Workers to Reduce Cervical Cancer Disparities in African American Women
- ClinicalTrials.gov ID
- NCT07011836
- Acronym / sponsor ID
- mNav / MD015221
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Early Detection of Cancer, Health Behavior, Patient Navigation, African Americans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- ISA Associates, Inc.University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: mNav Interactive Video + NavigatorParticipants use an interactive, personalized video-based navigation tool (mNav) and receive navigator support. |
| Education Control Group | Active comparator | Behavioral: Educational VideoParticipants view a general cervical cancer education video made for Black women, without personalized content or navigator support. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNav Interactive Video + NavigatorA personalized, video-based tool paired with navigator support to address individual screening barriers. | Behavioural | Intervention Group |
| Educational VideoA culturally tailored cervical cancer education video without additional support or tailoring. | Behavioural | Education Control Group |
Primary outcome
Completion of Cervical Cancer Screening
Time frame: Within 6 months of enrollment
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.
2 secondary outcomes
Cervical Cancer Screening Intention
Time frame: Baseline and 6-month follow-up
Cervical Cancer Knowledge Scale
Time frame: Baseline and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. The mode of dissemination of public datasets will be via archive files accessible in the public domain. Public datasets will be de-identified so that data cannot be linked to individual research participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mNav Interactive Video + Navigator and Educational Video in people with Uterine Cervical Neoplasms, run by ISA Associates, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douglas Billings, PhD (7037390882, dbillings@isagroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Cervical Cancer Screening (time frame: Within 6 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.