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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01326 | Other Identifier | NCI-CTRP Clinical Registry |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR-HPV Testing | Behavioral | Given by Interview and focus groups |
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| Measure | Description | 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 | Through study completion; an average of 1 year. |
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Inclusion Criteria:
Populations involved in the research are:
The eligibility criteria for each are:
Patients eligible 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:
Project ECHO Participants:
Other Clinical Networks:
Exclusion Criteria:
Patients eligible for cervical cancer screening:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane R Montealegre, PHD | Contact | 713- 745-5008 | jrmontealegre@mdanderson.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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