An interventional study of OraQuick Swab and Fecal Immunochemical Test in Human Papillomavirus, Human Immunodeficiency Virus and Hepatitis C, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-28.
Sponsored by University of Miami · Not applicable, Interventional, and Screening
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 754 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: OraQuick Swab · Device: Fecal Immunochemical Test · Device: OraQuick Fingerstick · Device: HPV Self-Sampling Test · Other: Home Based Screening Tests
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Other: Standard Screening Tests
OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical stool test specific for human hemoglobin
Patients will be tested for Hepatitis C infection using a fingerstick
Patients will be navigated to a local health center for standard screening tests
Patients will be using swab to check for HPV infection
Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
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
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
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
| Milestone | Home Based Screening | Clinic Based Screening |
|---|---|---|
| Started | 377 | 377 |
| Completed | 297 | 282 |
| Not completed | 80 | 95 |
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.
| Percentage of participants | Home Based Screening | Clinic Based Screening |
|---|---|---|
| Female Participants | 25.18 (20.22 to 30.24) | 8.16 (5.24 to 11.99) |
| Male Participants | 32.63 (23.36 to 43.02) | 15.79 (9.02 to 24.70) |
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.
| percentage of participants | Home Based Screening | Clinic Based Screening |
|---|---|---|
| HCV Screening Test | 71.88 (67.35 to 76.42) | 31.56 (26.87 to 36.26) |
| HIV Screening Test | 46.15 (41.12 to 51.19) | 20.95 (16.85 to 25.06) |
| HPV Screening Test | 24.47 (19.45 to 29.49) | 12.06 (8.26 to 15.86) |
| FIT Screening Test | 39.26 (34.33 to 44.19) | 18.57 (14.64 to 22.49) |
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.
| screenings completed | Home Based Screening | Clinic Based Screening |
|---|---|---|
| Female Participants at Baseline | 1 (1 to 2) | 1 (0 to 2) |
| Female Participants at 6 months | 4 (2 to 4) | 2 (1 to 3) |
| Male participants at Baseline | 1 (0 to 1) | 1 (0 to 1) |
| Male Participants at 6 months | 3 (2 to 3) | 2 (1 to 3) |
Collected over Up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Based Screening | 0/377 (0%) | 0/377 (0%) | 0/377 (0%) |
| Clinic Based Screening | 0/377 (0%) | 0/377 (0%) | 0/377 (0%) |
| Age, Continuous(years) | Home Based Screening | Clinic Based Screening | Total |
|---|---|---|---|
| Mean | 57.33 ± 4.54 | 57.40 ± 4.49 | 57.37 ± 4.51 |
| Sex: Female, Male(Participants) | Home Based Screening | Clinic Based Screening | Total |
|---|---|---|---|
| Female | 282 | 282 | 564 |
| Male | 95 | 95 | 190 |
| Ethnicity (NIH/OMB)(Participants) | Home Based Screening | Clinic Based Screening | Total |
|---|---|---|---|
| Hispanic or Latino | 239 | 241 | 480 |
| Not Hispanic or Latino | 138 | 136 | 274 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Home Based Screening | Clinic Based Screening | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 142 | 143 | 285 |
| White | 205 | 214 | 419 |
| More than one race | 28 | 19 | 47 |
| Unknown or Not Reported | 2 | 1 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Miami