Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06843720
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-01326 | OTHER | NCI-CTRP Clinical Registry | View |