Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems

February 26, 2026 updated by: M.D. Anderson Cancer Center
To learn about the attitudes toward implementing self-collection among healthcare providers and staff, participants, and other stakeholders; and to inform the development of patient education and provider training materials to aid in the implementation of self-collection in clinical settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overarching goal of the implementation program is to increase cervical cancer screening, early detection, and linkage to treatment in underserved populations that receive care in safety net health systems. Specific goals are:

  1. To increase up-to-date cervical cancer screening coverage by 10%;
  2. To increase clinical encounters used for opportunistic cervical cancer screening using primary HR-HPV testing by 5% annually;
  3. To increase awareness and readiness for implementing primary HR-HPV testing with self-sampling in routine care among clinics in the ECHO Network;
  4. All patrticipants with abnormal screening results will be navigated to and receive diagnostic testing.

The overarching goal of program evaluation (i.e., research component of this protocol) is to evaluate the progress and achievement of program goals and to evaluate effectiveness and implementation outcomes:

Primary objective 1: Evaluate the effectiveness of primary HPV testing and self-collection to increase participation in cervical cancer screening among underscreened health system participants.

Primary objective 2: Evaluate implementation outcomes of the program across health systems and clinics and explore mechanisms underlying outcomes, guided by the Consolidated Framework for Implementation Research (CFIR)41,42 and RE-AIM (reach, effectiveness, adoption, implementation, maintenance)43.

Secondary Objectives Secondary objective 1: Compare the proportion of clinical encounters used for opportunistic cervical cancer screening across clinics.

Secondary objective 2: Evaluate proportion of participants receiving clinical follow-up after a positive HR-HPV test.

Secondary objective 3: Describe the prevalence of cervical cancer and pre-cancer among participants who self-collected and tested positive for HR-HPV.

Secondary objective 4: Compare the effectiveness of clinic-based primary HPV testing with self-collection with and without preceding telephone-based patient education by a participant navigator.

Study Type

Interventional

Enrollment (Estimated)

7100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jane R Montealegre, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria:

Populations involved in the research are: 1) stakeholder advisory board members; 2) Participants eligible for cervical cancer screening participating in the cluster randomized stepped-wedge trial; 3) Patients and community members participating in formative research activities; 4) Providers, clinic staff, and other health system stakeholders from partnering health systems; 5) Project ECHO Participants (providers, clinic staff, and other health system stakeholders from partner and non-partner institutions).

6) Other Clinical Networks (providers, clinic staff and other health system stakeholders from partner and non-partner institutions)

The eligibility criteria for each are:

Participants eligible for cervical cancer screening:

  • Currently a resident in the state of Texas
  • Attend for care at a partner clinic enrolled in the study
  • Women and persons with a cervix
  • Age 25-65
  • Due or past due for cervical cancer screening

Participants and community members participating in formative research activities:

• Purposively identified as a stakeholder for formative research by research staff

Providers, clinic staff, and other health system stakeholders from partnering health systems:

  • Employed at least part-time by a partnering health system
  • Age 18+

Project ECHO Participants:

  • Participate in at least one Project ECHO session
  • Age 18+

Other Clinical Networks:

  • Participate in at least one clinical network session
  • Age 18+

Exclusion Criteria:

Participants eligible for cervical cancer screening:

  • Report being currently pregnant
  • History of total hysterectomy
  • History of cervical cancer

Other study populations:

• Unable to communicate in English or Spanish

Vulnerable Populations Participants/samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults, or prisoners) will be prohibited from participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Participants participate in an interview or a focus group discussion and provide opinions about self-collection and/or education and training materials for participants and providers.

Partipants participation in this study may be limited to a single interview or focus group discussion. Some stakeholders will be asked to participate in additional interviews and/or focus groups.
Behavioral: HR-HPV Testing
Given by Interview and focus groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Adverse Events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Time Frame: Through study completion; an average of 1 year.
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0361
  • NCI-2025-01326 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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