Overview

This trial is active, not recruiting.

Condition cervical cancer
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose screening
Arm
(Placebo Comparator)
Gets outreach materials and info on where to get screened by CHW.
chw outreach
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.
(Active Comparator)
Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation
chw outreach and hpv self-sampling
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.
(Active Comparator)
Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling
chw outreach
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.

Primary Outcomes

Measure
Having had a pap smear in last 6 months
time frame: 6 months

Secondary Outcomes

Measure
Cervical Cancer Knowledge and Access to Care
time frame: 6 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Miami.