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

NCT02202109 | Completed Results

• 2 other identifiers: 201402491R01CA183612-01
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Keywords

Screen; self-sampler; cervical, cancer; women; community health workers; Hispanic/ Latinas; Haitian; Focus of study is cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of Change in Cervical Cancer Knowledge Among Participants

  Baseline, 6 months

• Proportion of Participants With a Change in Access to Care

  Baseline, 6 months

Study Arms (2)

CHWs facilitated Self-Sampling

ACTIVE COMPARATOR

CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test

Behavioral: CHW and Self-sampling for Cervical Cancer

Mailed Self-Sampler

ACTIVE COMPARATOR

Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone

Behavioral: Mailed Self Sampler

Interventions

CHW and Self-sampling for Cervical Cancer BEHAVIORAL

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.

CHWs facilitated Self-Sampling

Mailed Self Sampler BEHAVIORAL

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;

Mailed Self-Sampler

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Health Choice Network: collaborator
• Center for Haitian Studies: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.

  PMID: 28086983 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. Erin Kobetz
• Organization: University of Miami

ekobetz@med.miami.edu

3052436185

Study Officials

• Erin Kobetz, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 28, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-12

Locations

US (1)