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

Study Overview
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Brief Summary
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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.

Official Title
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Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: CHW and Self-sampling for Cervical Cancer
* Behavioral: Mailed Self Sampler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHWs facilitated Self-Sampling<br>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test | Behavioral: CHW and Self-sampling for Cervical Cancer<br>* 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.<br>|
| Active Comparator: Mailed Self-Sampler<br>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone | Behavioral: Mailed Self Sampler<br>* 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;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screen, self-sampler, cervical, cancer, women, community health workers, Hispanic/ Latinas, Haitian, Focus of study is cervical cancer