Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06843720

Conditions

HR-HPV Testing

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

HR-HPV Testing

Study Details

Brief summary:

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.

Conditions

HR-HPV Testing

Study ID

NCT06843720

Start date

Feb 17, 2025

Status verified date

Jun, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Populations involved in the research are:

1. stakeholder advisory board members;
2. patients 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:

Patients 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

Patients 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:

Patients 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 Design

Enrollment

7100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

HR-HPV Testing

Given by Interview and focus groups

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Jane R Montealegre, PHD

713- 745-5008jrmontealegre@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jane R Montealegre, PHD

713-745-5008jrmontealegre@mdanderson.org

Principal Investigator:

Jane R Montealegre, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-23.