N/A
Completed N=754
Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
Human Papillomavirus Infection · Human Immunodeficiency Virus Infection · Hepatitis C · Colorectal Cancer
Source: ClinicalTrials.gov NCT02970136 ↗
Enrolled (actual)
754
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Participants Who Are Screened for All Conditions — 25.18; 8.16; 32.63; 15.79 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Screened for All Conditions |
25.18; 8.16; 32.63; 15.79 | — |
| SECONDARY Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months |
71.88; 31.56; 46.15; 20.95; 24.47; 12.06 | — |
| SECONDARY Median Number of Screenings Completed |
1; 1; 4; 2; 1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02970136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.