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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06843720
Status
Recruiting

Conditions

  • HR-HPV Testing

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HR-HPV Testing — BEHAVIORAL
    Given by Interview and focus groups

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2031

Study Design

Enrollment
7,100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Jane R Montealegre, PHD
713-745-5008
Jane R Montealegre, PHD (PRINCIPAL_INVESTIGATOR)

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