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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-10

Study Completion Date

2015-02-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02202109

Cervical Cancer

COMPLETED NA

Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention

NCT03613493

Cervical Cancer

TERMINATED NA

HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women

NCT03012932

Cervical Cancer Screening

COMPLETED NA

Effectiveness of an EHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women

NCT06741241

Cervical Cancer Screening

NOT_YET_RECRUITING NA

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

NCT02427399

Uterine Cervical Neoplasms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Outreach

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

Group Type PLACEBO_COMPARATOR

CHW Outreach

Intervention Type BEHAVIORAL

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.

CHW Outreach

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

Group Type ACTIVE_COMPARATOR

CHW Outreach and HPV Self-sampling

Intervention Type BEHAVIORAL

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.

CHW Outreach and HPV Self-Sampling

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

Group Type ACTIVE_COMPARATOR

CHW Outreach

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes