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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-04860 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0182 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.
PRIMARY OBJECTIVES:
I. To examine the feasibility of conducting an education intervention trial regarding cervical cancer screening among women of Hispanic and African American origin living in public housing units in Houston, Texas.
SECONDARY OBJECTIVES:
I. Document cervical screening associated knowledge, attitudes and practices among Hispanic and African American women living in public housing units in Houston, Texas at pre- and post-health education.
II. Document Pap smear screening rate in last 3 years among participants. III. Document HPV positive rate among participants.
OUTLINE:
Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit.
After completion of study, participants are followed up at 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (questionnaire, health education, self-collection) | Experimental | Participants complete questionnaires, take part in a health education session, and receive HPV self-collection kit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Take part in health education session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant consent rate | Up to 1 month | |
| Human papillomavirus (HPV) self-collection uptake rate | Defined as the proportion of the participants who consent to the study and receive an HPV self-collection kit complete the self-collection and return the sample to the lab or research staff member or community health worker within timeline. | Up to 2 weeks after health education session |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical screening associated knowledge, attitudes and practices score | Paired t-tests or Wilcoxon signed-rank tests will be used to examine the change of the scores difference for cervical screening associated knowledge, attitudes and practices. For every participant, 'Knowledge' will be measured using a 12-question scale, which will have a 'Yes/No/Unsure' response. Each 'correct' response will be scored as 1, while 'incorrect' and 'unsure' as 0. A score 50% (≥6 correct responses) will be considered as optimal. 'Attitude' will be measured using a 6-question scale which will have 'Disagree/Neutral/Agree response. Attitude will be considered as favorable if we have three or more "Agree" responses. Being screened, before our education-intervention, for cervical cancer with Pap-smear, and after our intervention either with HPV self-sampling or Pap-smear, will be regarded as having good practice. Changes in Knowledge, Attitude and Practice, pre- and post-education intervention will be examined using Paired t-tests or Wilcoxon signed-rank tests. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Surendranath S Shastri | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38723214 | Derived | Shastri SS, McNeill LH, Shete S. Culturally Competent Education and Human Papillomavirus Self-Sampling Achieves Healthy People 2030 Cervical Screening Target Among Low-Income Non-Hispanic Black and Hispanic Women. JCO Glob Oncol. 2024 May;10:e2400005. doi: 10.1200/GO.24.00005. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2022 | Oct 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| HPV Self-Collection | Procedure | Receive HPV self-collection kit |
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| Questionnaire Administration | Other | Complete questionnaires |
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| Up to 1 month |
| Participants' self-reported Pap smear screening rate in last 3 years | Up to 1 month |
| HPV positive proportion | Up to 1 month |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |