N/A
N=602
Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02202109 ↗Enrolled (actual)
602
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants Completing a Self-sampling Test — 272; 257 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHW and Self-sampling for Cervical Cancer (Behavioral); Mailed Self Sampler (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- University of Miami
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing a Self-sampling Test |
272; 257 | — |
| SECONDARY Proportion of Change in Cervical Cancer Knowledge Among Participants |
0.033; 0.089 | — |
| SECONDARY Proportion of Participants With a Change in Access to Care |
0.160; 0.166 | — |
Summary
The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.
Eligibility Criteria
Inclusion Criteria
- Women
- Haitian, Hispanic, or African American
- Ages 30-65 years
- Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade
Exclusion Criteria
- Women who report having had a hysterectomy
- Women who have a history of cervical cancer
- Women who plan to move outside of Miami-Dade county during the next six months
- Women who are enrolled in any other cancer prevention/outreach related study
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Data sourced from ClinicalTrials.gov (NCT02202109). 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.