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Budgetary and Timing Constraints
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The proposed study aims to increase HPV screening behaviors in Jamaican women by examining the acceptability of HPV Deoxyribonucleic Acid (DNA) self-sampling tools, and to determine the most culturally appropriate and effective message design for promoting such a tool in this context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV self-sampling kit + Interview | Other | Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. |
|
| Culturally-targeted Fear appeal message HPV self-sampling kit | Experimental | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message |
|
| Fear appeal message HPV self-sampling kit | Experimental | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message |
|
| HPV self-sampling kit | Active Comparator | Participants will receive an HPV self-sampling kit to screen for HPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV self-sampling kit | Diagnostic Test | The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Used and Returned Their Self-sampler Kit. | Number of participants that used and returned their self-sampler kit was evaluated. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Morgan, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HPV Self-sampling Kit + Interview | Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative). |
| FG001 | Culturally-targeted Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit. |
| FG002 | Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit. |
| FG003 | HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to budgetary constraints, participants were not enrolled into the Fear Appeal HPV self-sampler kit arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | HPV Self-sampling Kit + Interview | Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants That Used and Returned Their Self-sampler Kit. | Number of participants that used and returned their self-sampler kit was evaluated. | Data was not collected for the fear appeal message HPV self-sampling condition due to lack of funding. | Posted | Count of Participants | Participants | 2 weeks |
|
4 months
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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 | HPV Self-sampling Kit + Interview | Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Morgan | University of Miami | 7654094919 | semorgan@miami.edu |
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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 | Apr 27, 2018 | Jul 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Culturally-targeted Fear Appeal Message | Behavioral | Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit. |
|
| Fear Appeal Message | Behavioral | Participants will receive fear appeal messages (only) in a graphically designed kit. |
|
| Interview | Behavioral | Participants will be interviewed about experiences using the self-sampling tool (qualitative). |
|
| BG001 | Culturally-targeted Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit. |
| BG002 | Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit. |
| BG003 | HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Prior pap test experience | Number | participants |
|
| OG001 | Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit. |
| OG002 | HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. |
| OG003 | HPV Self-sampling Kit + Interview | Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative). |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Culturally-targeted Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG002 | HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. | 0 | 89 | 0 | 89 | 0 | 89 |
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| 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |