Using CHWs and HPV Home Tests to Increase Cervical Cancer Screening in Minority Populations

Study Overview
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Brief Summary
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Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened for cervical cancer than the general population. One promising approach is outreach strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW programs, many women remain unscreened. In our NCI Community Networks sponsored project, we are testing an approach that combines CHWs with self sampling for the human papilloma virus (HPV) as a screening strategy among such hard to reach populations.

Detailed Description
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Building on our existing community partnerships, we propose a randomized CBPR study among 600 women in three underserved communities in Miami-Dade County to determine optimal approaches to increase cervical cancer screening among Caribbean and other underserved women. The study is a three arm study with 200 women randomized at each site over 3 years. Women in the control group would be exposed to NCI approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. Our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the CHW group, women randomized to a CHW intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the CHW group without HPV sampling. Secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.

Official Title
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Research Project of the South Florida Center for Reducing Cancer Disparities (SUCCESS): Testing CHWs and HPV Self-Sampling to Increase Cervical Cancer Screening Among Minority Immigrants in Miami-Dade County:

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: CHW Outreach and HPV Self-sampling
* Behavioral: CHW Outreach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Haitian, Hispanic or African American women ages 30-65 years not having had a pap smear in the last three years live in Miami-Dade County Exclusion Criteria: having had a hysterectomy history of cervical cancer plan to move out of the neighborhood during the next six months are enrolled in any other cancer prevention/outreach related study

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Outreach<br>Gets outreach materials and info on where to get screened by CHW. | Behavioral: CHW Outreach<br>* The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes.<br>|
| Active Comparator: CHW Outreach<br>Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation | Behavioral: CHW Outreach and HPV Self-sampling<br>* The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes. Women who are randomized to this arm will also include information on the alternative screening method. They will be told that cervical self-sampling is an alternative screening technique for the Pap smear and they will be offered the choice of having the HPV screen done during that home visit or have a Pap Smear at the participating FQHC.<br>|
| Active Comparator: CHW Outreach and HPV Self-Sampling<br>Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling | Behavioral: CHW Outreach<br>* The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Having had a pap smear in last 6 months | Primary Outcome: The primary outcome is patient self-reporting on whether they had a Pap smear of HPV testing done since the initial evaluation. As an additional analysis, patients whom were contacted by phone but do no wish to return for follow-up evaluation will be asked by phone if they had the Pap Smear of HPV testing done. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Cancer Knowledge and Access to Care | Cervical Cancer Knowledge: Baseline and follow-up knowledge information will also be examined as a secondary outcome. Access to Care: We will also examine access to care (having health insurance, usual of care of care and visits to a provider) as additional secondary outcome. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screen, cervical, cancer, HPV, women, community health workers, Hispanic/ Latinas, Haitian