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

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University of Miami

Status

Completed

Conditions

Cervical Cancer

Treatments

Behavioral: Mailed Self Sampler
Behavioral: CHW and Self-sampling for Cervical Cancer

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02202109
1R01CA183612-01 (U.S. NIH Grant/Contract)
20140249

Details and patient eligibility

About

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.

Enrollment

602 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

602 participants in 2 patient groups

CHWs facilitated Self-Sampling
Active Comparator group
Description:
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
Treatment:
Behavioral: CHW and Self-sampling for Cervical Cancer
Mailed Self-Sampler
Active Comparator group
Description:
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Treatment:
Behavioral: Mailed Self Sampler

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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