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

Cervical Cancer Clinical Trial

— SUCCESS  

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:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121548
• Other study ID #: 20100834
• Status: Completed
• Phase: N/A
• Start date: October 10, 2011
• Est. completion date: February 17, 2015

Study information

• Verified date: October 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: February 17, 2015
• Est. primary completion date: July 7, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Center for Haitian Studies, Health Choice Network

Country where clinical trial is conducted

United States, 

References & Publications (5)

Carrasquillo O, McCann S, Amofah A, Pierre L, Rodriguez B, Alonzo Y, Ilangovan K, Gonzalez M, Trevil D, Byrne MM, Koru-Sengul T, Kobetz E. Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial. Trials. 2014 Jul 23;15:299. doi: 10.1186/1745-6215-15-299. — View Citation

Carrasquillo O, Seay J, Amofah A, Pierre L, Alonzo Y, McCann S, Gonzalez M, Trevil D, Koru-Sengul T, Kobetz E. HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial. J Gen Intern Med. 2018 Jul;33( — View Citation

Ilangovan K, Kobetz E, Koru-Sengul T, Marcus EN, Rodriguez B, Alonzo Y, Carrasquillo O. Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening. J Womens Health (Larchmt). 2016 Sep;25(9):944-51. doi: 10.1089/jwh.2015.5469. Epub 2016 Feb 18. — View Citation

Kenya S, Carrasquillo O, Fatil M, Jones J, Jean C, Huff I, Kobetz E. Human Papilloma Virus and Cervical Cancer Education Needs among HIV-Positive Haitian Women in Miami. Womens Health Issues. 2015 May-Jun;25(3):262-6. doi: 10.1016/j.whi.2014.12.007. Epub 2015 Apr 9. — View Citation

Kenya S, Okoro IS, Wallace K, Ricciardi M, Carrasquillo O, Prado G. Can Home-Based HIV Rapid Testing Reduce HIV Disparities Among African Americans in Miami? Health Promot Pract. 2016 Sep;17(5):722-30. doi: 10.1177/1524839916629970. Epub 2016 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup Analysis	Potential additional analysis will if the either of the two planned intervention was more efficacious among women in one location versus another. In addition using data obtained from our study questionnaire, we will also examine if there was a differential impact of the intervention among women who were uninsured, lower education, lower acculturation level or had lower levels of baseline cervical cancer knowledge.	6 months
Primary	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	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