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NCT Number: NCT02970136

Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention

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.

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Key information

Conditions

Human Papillomavirus Acquired Immunodeficiency Syndrome Blood-Borne Infections Colonic Diseases Colorectal Cancer Colorectal Neoplasms Communicable Diseases Digestive System Diseases Digestive System Neoplasms Flaviviridae Infections Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Intestinal Neoplasms Lentivirus Infections Liver Diseases Neoplasms Neoplasms by Site RNA Virus Infections Rectal Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

OraQuick Swab

Device

OraQuick for oral fluid HIV antibody testing

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months

    Time frame: 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.

  2. Median Number of Screenings Completed

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2016
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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