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 — BEHAVIORALGiven 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: InterventionParticipants 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
- Jane R Montealegre, PHD713- 745-5008
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | Jane R Montealegre, PHD (PRINCIPAL_INVESTIGATOR) |
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