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

University of Miami

Status: Completed

Conditions: Cervical Cancer

Treatments: Behavioral: CHW Outreach and HPV Self-sampling; Behavioral: CHW Outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT02121548

20100834

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 601 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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601 participants in 3 patient groups, including a placebo group

Outreach

Placebo Comparator group

Description:

Gets outreach materials and info on where to get screened by CHW.

Treatment:

Behavioral: CHW Outreach

CHW Outreach

Active Comparator group

Description:

Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation

Treatment:

Behavioral: CHW Outreach and HPV Self-sampling

CHW Outreach and HPV Self-Sampling

Active Comparator group

Description:

Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling

Treatment:

Behavioral: CHW Outreach