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

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

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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