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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01228 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P01CA229143 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.
PRIMARY OBJECTIVES:
Determine the effectiveness of the intervention in increasing cervical cancer screening.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.
GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (intervention) | Experimental | Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. |
|
| Group II (usual care continued) | Active Comparator | Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Human Papillomavirus (HPV) Intervention | The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system. | Up to 1 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Reiter, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States | ||
| Ohio State University Comprehensive Cancer Center |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Intervention) | Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive patient navigation. HPV Self-Collection: Receive HPV self-testing intervention Informational Intervention: Receive information about cervical cancer Patient Navigation Program: Receive patient navigation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2023 |
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| HPV Self-Collection | Procedure | Receive HPV self-testing intervention |
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| Informational Intervention | Other | Receive information about cervical cancer |
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| Patient Navigation Program | Behavioral | Receive telephone-based patient navigation |
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| Columbus |
| Ohio |
| 43210 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| FG001 | Group II (Usual Care Continued) | Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. Best Practice: Receive usual care Informational Intervention: Receive information about cervical cancer |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Intervention) | Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive patient navigation. HPV Self-Collection: Receive HPV self-testing intervention Informational Intervention: Receive information about cervical cancer Patient Navigation Program: Receive patient navigation |
| BG001 | Group II (Usual Care Continued) | Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. Best Practice: Receive usual care Informational Intervention: Receive information about cervical cancer |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Human Papillomavirus (HPV) Intervention | The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system. | Posted | Count of Participants | Participants | Up to 1 years |
|
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Intervention) | Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive patient navigation. HPV Self-Collection: Receive HPV self-testing intervention Informational Intervention: Receive information about cervical cancer Patient Navigation Program: Receive patient navigation | 0 | 464 | 0 | 464 | 0 | 464 |
| EG001 | Group II (Usual Care Continued) | Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. Best Practice: Receive usual care Informational Intervention: Receive information about cervical cancer | 0 | 338 | 0 | 338 | 0 | 338 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Reiter | Ohio State University | 614-292-4803 | reiter.36@osu.edu |
| Nov 5, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Between 18 and 65 years |
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| >=65 years |
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