Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01MD010614-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
The purpose of this research study is to determine the best way to increase screening for cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic, Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The investigator will compare home testing led by a community health worker (CHW) versus clinic testing guided by a CHW. Community Health Workers are people who have undergone several weeks of community outreach and health education training. During the study period the participant will continue to receive all of their regular medical care from their regular health care providers. If the participant does not have a health care provider, the Community Health Workers would be able to help in referring the participant for care at a local health care clinic located in their community.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Based Screening | Experimental | The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker |
|
| Clinic Based Screening | Active Comparator | The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OraQuick Swab | Device | OraQuick for oral fluid HIV antibody testing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Screened for All Conditions | As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT. | Baseline, Up to 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olveen Carrasquillo, MD | 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 |
|---|---|---|---|
| 32349789 | Derived | Carrasquillo O, Seay J, Jhaveri V, Long T, Kenya S, Thomas E, Sussman D, Trevil D, Koru-Sengul T, Kobetz E. Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial. Trials. 2020 Apr 29;21(1):368. doi: 10.1186/s13063-020-4213-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Home Based Screening | The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker OraQuick Swab: OraQuick for oral fluid HIV antibody testing Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick HPV Self-Sampling Test: Patients will be using swab to check for HPV infection Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Feb 11, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fecal Immunochemical Test |
| Device |
Fecal Immunochemical stool test specific for human hemoglobin |
|
| OraQuick Fingerstick | Device | Patients will be tested for Hepatitis C infection using a fingerstick |
|
| Standard Screening Tests | Other | Patients will be navigated to a local health center for standard screening tests |
|
| HPV Self-Sampling Test | Device | Patients will be using swab to check for HPV infection |
|
| Home Based Screening Tests | Other | Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests |
|
| Median Number of Screenings Completed |
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT. |
| At baseline and at 6 months |
| FG001 | Clinic Based Screening | The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Home Based Screening | The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker OraQuick Swab: OraQuick for oral fluid HIV antibody testing Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick HPV Self-Sampling Test: Patients will be using swab to check for HPV infection Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests |
| BG001 | Clinic Based Screening | The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Participants Who Are Screened for All Conditions | As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT. | There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT. | There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Up to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Median Number of Screenings Completed | As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT. | There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT. | Posted | Median | Inter-Quartile Range | screenings completed | At baseline and at 6 months |
|
Up to 6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Based Screening | The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker OraQuick Swab: OraQuick for oral fluid HIV antibody testing Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick HPV Self-Sampling Test: Patients will be using swab to check for HPV infection Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests | 0 | 377 | 0 | 377 | 0 | 377 |
| EG001 | Clinic Based Screening | The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests | 0 | 377 | 0 | 377 | 0 | 377 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olveen Carrasquillo | University of Miami | 305-243-5505 | ocarrasquillo@miami.edu |
| Oct 29, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006526 | Hepatitis C |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Male Participants |
|
|
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests |
|
|
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests
|
|