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

Cervical Cancer Clinical Trial

Official title:

Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202109
• Other study ID #: 20140249
• Secondary ID: 1R01CA183612-01
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: August 2017

Study information

• Verified date: December 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• CHW and Self-sampling for Cervical Cancer
Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
• Mailed Self Sampler
Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	Center for Haitian Studies, Health Choice Network, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Completing a Self-sampling Test	The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.	2 to 6 months
Secondary	Proportion of Change in Cervical Cancer Knowledge Among Participants	Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.	Baseline, 6 months
Secondary	Proportion of Participants With a Change in Access to Care	Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).	Baseline, 6 months