Human PapillomavirusNCT02970136
Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
A study testing OraQuick Swab, Fecal Immunochemical Test and OraQuick Fingerstick in people with Human Papillomavirus and Human Immunodeficiency Virus, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus, Human Immunodeficiency Virus, Hepatitis C
- What is being tested?
- OraQuick Swab, Fecal Immunochemical Test and OraQuick Fingerstick
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- live in one of the three target communities
- self-identify as Haitian, Hispanic and/or Black.
- be 50-64 years old
- 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.
Who cannot join
- plan to move out of the community during the next six months;
- current or prior enrollment (5 five years) in any research study that involved screening for these conditions.
- Are adults unable to consent
- Are individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities
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.
- Being tested
- OraQuick Swab, Fecal Immunochemical Test, OraQuick Fingerstick, Standard Screening Tests, HPV Self-Sampling Test
- Keywords
- Increased Screening Uptake, Community Health Worker, Medically Underserved
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuick SwabDevice
OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical TestDevice
Fecal Immunochemical stool test specific for human hemoglobin
OraQuick FingerstickDevice
Patients will be tested for Hepatitis C infection using a fingerstick
Standard Screening TestsOther
Patients will be navigated to a local health center for standard screening tests
HPV Self-Sampling TestDevice
Patients will be using swab to check for HPV infection
Home Based Screening TestsOther
Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: OraQuick Swab; Device: Fecal Immunochemical Test; Device: OraQuick Fingerstick; Device: HPV Self-Sampling Test; Other: Home Based Screening Tests |
| 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 Receives: Other: Standard Screening Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start11 Apr 2017
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Olveen Carrasquillo, University of Miami
- Investigators
- Olveen Carrasquillo, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970136
- Sponsor's protocol ID
- 20160023
- Other IDs
- 1U01MD010614-01
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2016
- Last updated
- 28 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32349789
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities
- ClinicalTrials.gov ID
- NCT02970136
- Acronym / sponsor ID
- 20160023
- Keywords
- Increased Screening Uptake, Community Health Worker, Medically Underserved
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 28 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Based Screening | Experimental | Device: OraQuick Swab, Device: Fecal Immunochemical Test, Device: OraQuick Fingerstick, Device: HPV Self-Sampling Test, Other: Home Based Screening TestsThe 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 | Other: Standard Screening TestsThe participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- live in one of the three target communities
- self-identify as Haitian, Hispanic and/or Black.
- be 50-64 years old
- 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.
Key exclusion criteria (6 listed)
- plan to move out of the community during the next six months;
- current or prior enrollment (5 five years) in any research study that involved screening for these conditions.
- Are adults unable to consent
- Are individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraQuick SwabOraQuick for oral fluid HIV antibody testing | Device | Home Based Screening |
| Fecal Immunochemical TestFecal Immunochemical stool test specific for human hemoglobin | Device | Home Based Screening |
| OraQuick FingerstickPatients will be tested for Hepatitis C infection using a fingerstick | Device | Home Based Screening |
| Standard Screening TestsPatients will be navigated to a local health center for standard screening tests | Other | Clinic Based Screening |
| HPV Self-Sampling TestPatients will be using swab to check for HPV infection | Device | Home Based Screening |
| Home Based Screening TestsPatients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests | Other | Home Based Screening |
Primary outcome
Percentage of Participants Who Are Screened for All Conditions
Time frame: 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.
2 secondary outcomes
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
Time frame: Baseline, Up to 6 months
Median Number of Screenings Completed
Time frame: At baseline and at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32349789Carrasquillo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olveen Carrasquillo, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OraQuick Swab, Fecal Immunochemical Test and OraQuick Fingerstick in people with Human Papillomavirus and Human Immunodeficiency Virus, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Are Screened for All Conditions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.