Using CHWs and HPV Home Tests to Increase Cervical Cancer Screening in Minority Populations
This trial is active, not recruiting.
|Treatments||chw outreach and hpv self-sampling, chw outreach|
|Sponsor||University of Miami|
|Collaborator||Health Choice Network|
|Start date||June 2011|
|End date||August 2016|
|Trial size||600 participants|
|Trial identifier||NCT02121548, 20100834|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Having had a pap smear in last 6 months
time frame: 6 months
Cervical Cancer Knowledge and Access to Care
time frame: 6 months
Female participants from 30 years up to 65 years old.
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
|Official title||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:|
|Principal investigator||Olveen Carrasquillo, MD, MPH|
|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.|
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