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N/A N=602 Randomized Single-blind Screening

Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida

Cervical Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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