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

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CHW and Self-sampling for Cervical Cancer

Mailed Self Sampler

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Screen, self-sampler, cervical, cancer, women, community health workers, Hispanic/ Latinas, Haitian, Focus of study is cervical cancer

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CHWs facilitated Self-Sampling

Mailed Self-Sampler

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT02202109

First Posted

July 9, 2014

Last Updated

December 13, 2018

Sponsor

University of Miami

Collaborators

Health Choice Network, Center for Haitian Studies, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02202109

Brief Title

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

Official Title

Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

Health Choice Network, Center for Haitian Studies, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

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

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

602 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHWs facilitated Self-Sampling

Arm Type

Active Comparator

Arm Description

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

Arm Title

Mailed Self-Sampler

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

CHW and Self-sampling for Cervical Cancer

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Mailed Self Sampler

Intervention Description

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;

Primary Outcome Measure Information:

Title

Number of Participants Completing a Self-sampling Test

Description

Time Frame

2 to 6 months

Secondary Outcome Measure Information:

Title

Proportion of Change in Cervical Cancer Knowledge Among Participants

Description

Time Frame

Baseline, 6 months

Title

Proportion of Participants With a Change in Access to Care

Description

Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).

Time Frame

Baseline, 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Kobetz, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28086983

Citation

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.

Results Reference

derived

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

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