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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA183612-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Health Choice Network | OTHER |
| Center for Haitian Studies | OTHER |
| National Cancer Institute (NCI) | NIH |
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The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHWs facilitated Self-Sampling | Active Comparator | CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test |
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| Mailed Self-Sampler | Active Comparator | Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHW and Self-sampling for Cervical Cancer | Behavioral | Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing a Self-sampling Test | The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days. | 2 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Change in Cervical Cancer Knowledge Among Participants | Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Kobetz, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28086983 | Derived | Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHWs Facilited Self-Sampling | CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes. |
| FG001 | Mailed Self-Sampler | Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CHWs Facilited Self-Sampling | CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Completing a Self-sampling Test | The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days. | Participants were given up to 6 months to complete HPV self-sampling. | Posted | Count of Participants | Participants | 2 to 6 months |
|
Data for adverse events was collected for a period of one 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 | CHWs Facilited Self-Sampling | CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Kobetz | University of Miami | 3052436185 | ekobetz@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2016 | May 7, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2017 | May 14, 2018 | SAP_001.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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|
| Mailed Self Sampler | Behavioral | Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; |
|
| Baseline, 6 months |
| Proportion of Participants With a Change in Access to Care | Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit). | Baseline, 6 months |
| BG001 | Mailed Self-Sampler | Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Mailed Self-Sampler | Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; |
|
|
| Secondary | Proportion of Change in Cervical Cancer Knowledge Among Participants | Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline, 6 months |
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|
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| Secondary | Proportion of Participants With a Change in Access to Care | Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit). | Only participants with complete information on access to care were included in the analysis. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline, 6 months |
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|
|
| 0 |
| 302 |
| 0 |
| 302 |
| 0 |
| 302 |
| EG001 | Mailed Self-Sampler | Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; | 0 | 300 | 0 | 300 | 0 | 300 |
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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 |