Human Papillomavirus, Human Immunodeficiency Virus, Hepatitis C, ColoRectal Cancer
Conditions
Keywords
Increased Screening Uptake, Community Health Worker, Medically Underserved
Brief summary
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.
Interventions
DEVICEOraQuick Swab
OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical stool test specific for human hemoglobin
DEVICEOraQuick Fingerstick
Patients will be tested for Hepatitis C infection using a fingerstick
OTHERStandard Screening Tests
Patients will be navigated to a local health center for standard screening tests
DEVICEHPV Self-Sampling Test
Patients will be using swab to check for HPV infection
OTHERHome Based Screening Tests
Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. live in one of the three target communities 2. self-identify as Haitian, Hispanic and/or Black. 3. be 50-64 years old 4. need at least one of the four recommended screening services as per US Preventive Service Task Force 121 guidelines as follows: never having had a HIV test b) never having had a Hepatitis C Virus (HCV) test c) not having a Pap smear in the last three years d) not having had a colonoscopy in last 10 years and/or stool-based test in the last year.
Exclusion criteria
1. plan to move out of the community during the next six months; 2. current or prior enrollment (5 five years) in any research study that involved screening for these conditions. 3. Are adults unable to consent 4. Are individuals who are not yet adults (infants, children, teenagers) 5. Pregnant women 6. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Are Screened for All Conditions | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | Baseline, Up 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. |
| Median Number of Screenings Completed | At baseline and at 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 377 |
| 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 | 377 |
| Total | 754 |
Baseline characteristics
| Characteristic | Clinic Based Screening | Total | Home Based Screening |
|---|---|---|---|
| Age, Continuous | 57.40 years STANDARD_DEVIATION 4.49 | 57.37 years STANDARD_DEVIATION 4.51 | 57.33 years STANDARD_DEVIATION 4.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 241 Participants | 480 Participants | 239 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 136 Participants | 274 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 143 Participants | 285 Participants | 142 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 47 Participants | 28 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 214 Participants | 419 Participants | 205 Participants |
| Sex: Female, Male Female | 282 Participants | 564 Participants | 282 Participants |
| Sex: Female, Male Male | 95 Participants | 190 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 377 | 0 / 377 |
| other Total, other adverse events | 0 / 377 | 0 / 377 |
| serious Total, serious adverse events | 0 / 377 | 0 / 377 |
Outcome results
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Home Based Screening | Percentage of Participants Who Are Screened for All Conditions | Female Participants | 25.18 Percentage of participants |
| Home Based Screening | Percentage of Participants Who Are Screened for All Conditions | Male Participants | 32.63 Percentage of participants |
| Clinic Based Screening | Percentage of Participants Who Are Screened for All Conditions | Female Participants | 8.16 Percentage of participants |
| Clinic Based Screening | Percentage of Participants Who Are Screened for All Conditions | Male Participants | 15.79 Percentage of participants |
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.
Time frame: Baseline, Up to 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Home Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | HCV Screening Test | 71.88 percentage of participants |
| Home Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | HIV Screening Test | 46.15 percentage of participants |
| Home Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | HPV Screening Test | 24.47 percentage of participants |
| Home Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | FIT Screening Test | 39.26 percentage of participants |
| Clinic Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | FIT Screening Test | 18.57 percentage of participants |
| Clinic Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | HCV Screening Test | 31.56 percentage of participants |
| Clinic Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | HPV Screening Test | 12.06 percentage of participants |
| Clinic Based Screening | Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months | HIV Screening Test | 20.95 percentage of participants |
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.
Time frame: At baseline and at 6 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Home Based Screening | Median Number of Screenings Completed | Female Participants at Baseline | 1 screenings completed |
| Home Based Screening | Median Number of Screenings Completed | Female Participants at 6 months | 4 screenings completed |
| Home Based Screening | Median Number of Screenings Completed | Male participants at Baseline | 1 screenings completed |
| Home Based Screening | Median Number of Screenings Completed | Male Participants at 6 months | 3 screenings completed |
| Clinic Based Screening | Median Number of Screenings Completed | Male Participants at 6 months | 2 screenings completed |
| Clinic Based Screening | Median Number of Screenings Completed | Female Participants at Baseline | 1 screenings completed |
| Clinic Based Screening | Median Number of Screenings Completed | Male participants at Baseline | 1 screenings completed |
| Clinic Based Screening | Median Number of Screenings Completed | Female Participants at 6 months | 2 screenings completed |