CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 754 enrolled
Drug / intervention
OraQuick Swab +5 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02970136
NCT02970136N/ACompleted

Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities

University of Miami·interventional·Posted Nov 21, 2016·Updated Dec 28, 2021

In Brief

A clinical study evaluating OraQuick Swab, Fecal Immunochemical Test, and 4 other interventions for Human Papillomavirus and 3 related conditions. Completed, enrolled 754 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 21, 2016
Enrollment StartApr 11, 2017
Primary CompletionOct 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.6 years ago

Interventions

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