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NCT Number: NCT06745895

Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening

This innovative Multilevel Action Toward Colorectal Cancer (CRC) and Hepatitis C Virus (HCV) Education and Screening (MATCHES) intervention aims to promote concurrent HCV and CRC screening among FQHC patients ages 45-75.

Recruiting

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Carol Boxtha

CONTACT

[email protected]

813-745-8963

Christy Shannon, PhD

PRINCIPAL_INVESTIGATOR

Clement K Gwede, PhD, MPH, RN

SUB_INVESTIGATOR

Susan T Vadaparampil, PhD

SUB_INVESTIGATOR

About this study

While this is a multi-level intervention study, only information related to the patient-level intervention is being reported for the purposes ClinicalTrials.gov.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be receiving care at one of the participating FQHC clinics.
  • Participants must be 45-75 years of age.
  • Participants must not be up to date with Colorectal Cancer (CRC) screening recommendations such as no colonoscopy in the past 10 years, occult blood test in the past 12 months.
  • Participants must never have had Hepatitis C Virus (HCV) antibody screening.
  • Participants must be able to read, write, and understand English or Spanish.
  • Participants must have no personal history of CRC or current presumptive CRC symptoms such as unresolved rectal bleeding or abdominal pain/bloating.
  • Participants must be at average risk for CRC (no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC).
  • Participants must be asymptomatic for HCV.
  • Participants receiving intervention materials must be able and willing to complete surveys and receive the patient level intervention.
  • Participants completing qualitative interviews must be willing to complete a remote interview via phone or teleconference software such as ZOOM.
  • Participants completing qualitative interviews must be willing to be audio recorded.
  • Participants recruited for qualitative interviews only (did not receive MATCHES intervention materials) must have a clinic visit within prior two months.
  • All Participants must be able to provide informed consent.

Exclusion criteria

  • Participants that do not meet all Inclusion Eligibility requirements will be excluded.

Treatment and study plan

MATCHES

Behavioral

Participants will be asked to complete a survey with specific topics including Hepatitis C (HCV) and Colorectal (CRC) knowledge and health beliefs, screening intentions and demographic characteristics.

Participants will be provided with education intervention materials (for example, a booklet) either in-person or via mail, access to free stool-based CRC screening, and access to free HCV screening.

Approximately 1-2 weeks after receiving the education materials, participants will be asked to complete a post-intervention survey about the same specific topics (for example, HCV and CRC knowledge, HCV and CRC health beliefs, HCV and CRC screening intentions, healthcare experiences, perceptions of the educational materials) over the phone with a trained study staff.

Participants with a positive HCV screening and/or CRC screening result will be navigated to follow-up care as needed.

Primary outcomes

  1. Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC)

    Time frame: Up to 12 Months

    Screening Uptake will be measured by the number of participants who complete both CRC and HCV screening documented via Electronic Health Record (EHR) at 12 months post-intervention.

Secondary outcomes

  1. Screening Completion for Hepatitis C Virus (HCV)

    Time frame: Up to 41 Months

    Screening Completion for HCV will be measured by the number of participants who complete HCV Screening at any time during the Study Period.

  2. Screening Completion for Colorectal Cancer (CRC)

    Time frame: Up to 41 Months

    Screening Completion for CRC will be measured by the number of participants who complete CRC Screening at any time during the Study Period.

  3. Screening Test Results for Hepatitis C (HCV)

    Time frame: Up to 41 Months

    Screening Test Results will be measured as abnormal vs normal

  4. Screening Test Results for Colorectal Cancer (CRC)

    Time frame: Up to 41 Months

    Screening Test Results will be measured as abnormal vs normal

  5. Completion of repeat CRC Screening

    Time frame: Up to 41 Months

    Completion of any repeat CRC Screening will be measured by the number of participants who repeat CRC Screening during the Study interval.

Study contacts

Contact information is provided by the study sponsor or research team.

Carol Boxtha

CONTACT

[email protected]

813-745-8963

Shannon Christy, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Biomedical Research Program - Bankhead Coley

Registry information

Official study title

Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)

Acronym: MATCHES

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

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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