By Ludmilla Paul, MPH – Research Program Coordinator at Health Choice Network

Cervical cancer is a disease of major public health importance. Although screening and immunization against human papilloma virus (HPV), which causes cervical cancer, provide highly effective prevention, many women do not have access to or routinely receive preventive services. Cervical cancer remains the second most common cancer among women worldwide. Disparities in access and care delivery disproportionately impact medically underserved women. This includes lack of access to a formal healthcare system; language and literacy barriers that affect health communication; limited knowledge about cancer and the importance of early detection of disease; and cultural concerns about the acceptability of Pap smear screening.

Over the past ten years, in an effort to address such challenges, Health Choice Network (HCN) has partnered with Erin Kobetz, PhD, MPH, Professor of Medicine and Public Health Sciences at the University of Miami Miller School of Medicine and Associate Director, Sylvester Comprehensive Cancer Center. Dr. Kobetz’ s work focuses on advancing the science of self-sampling for Human Papillomavirus (HPV), the principal cause of cervical cancer. This type of screening enables women to self-collect a cervical cell sample at home or in other non-clinical settings, thereby avoiding many known barriers to screening uptake. Below we describe four projects HCN has partnered on to test this new approach to cervical cancer prevention and screening. These research programs were conducted at HCN’s member community health centers. HCN provides coordination and guidance to the participating health centers.

Clinical guidelines recommend HPV testing in addition to looking for abnormal cervical cells with a traditional Pap smear. In 2014, the Food and Drug Administration approved one type of HPV test for screening without a Pap smear. Perhaps the greatest advantage of HPV testing alone is its flexibility; it does not necessarily require a healthcare provider and can be done outside a clinical setting. This study used Community Health Workers (CHWs) in two HCN member community health centers for both participant recruitment and delivery of an HPV self-sampling intervention. CHWs identified 600 “hard to reach” women in the Miami metropolitan area who had limited to no access to the formal healthcare system and randomized them to three study groups. The first group served as the control and only received community education; the second group received comprehensive CHW outreach including home visits and patient navigation to access standard cervical cancer screening (Pap smear) at their closest participating community health center. The third group also received the CHW intervention and were offered a self-sampling kit during the CHW visit. Cervical cancer screening rates 6 months after the intervention were: 31% in the control group, 43% in the FQHC group, and 77% in the group offered HPV self-sampling. These findings demonstrated the effectiveness of self-sampling for cervical cancer screening in an underserved population and raised questions about whether CHWs were necessary in facilitating this process.

This study aimed to test the significance of the CHW role in SUCCESS by comparing delivery of self-sampling kits by a CHW or through US mail. To our knowledge, this trial is the first in the US to evaluate the effectiveness of mailed self-sampling for increasing cervical cancer screening among medically underserved women. HIYA had three aims. First, to determine which method of self-sampling resulted in higher screening rates; second, to compare self-sampling rates by demographics such as age, race, ethnicity, and county of birth; and, third, to evaluate secondary outcomes such as women’s knowledge, attitudes, and beliefs about cervical cancer screening, early detection, and access to care – especially for abnormal results – and compared costs of CHW versus mail delivery. We recruited 600 women ages 30-65 who had not had a Pap smear in the past three years and randomized them into two groups: one receiving a HPV self-sampling kit from a CHW and one receiving the kit by mail. Nearly two-thirds (65%) of women taking part were Hispanic and one-third (35%) were Haitian or non-Hispanic Black. Two-thirds (67%) were uninsured and 43% had an income of less than $20,000/year. Results showed significantly more screening completion among women in the CHW delivery group (81%) compared to the mail delivery group (72%). Although screening in the mail group was lower, both self-sampling groups far exceeded clinic-based screening rates and suggest mailing HPV kits is an effective strategy to increase cervical cancer screening among underserved immigrant and ethnic minority women without the resource requirements of a CHW-based approach. HCN provided oversight for all aspects of the study at HCNFL including study implementation, study conduct, data collection and ethical and human subject issues.

In partnership with HCN leadership, Dr. Kobetz recently conducted a small, quality improvement pilot to examine the feasibility of implementing self-sampling in a clinical rather than community setting. In this pilot, we sought to identify women 30-65 years of age, who were past due for cervical cancer screening. Currently, only 50% of age-eligible women at Miami Beach Community Health Center (MBCHC) are up to date with recommended screening. We queried the electronic health record (EHR) to gather names and contact information for eligible patients, identifying nearly 9000 women. We trained Center Care Coordinators on the implementation procedure, including mailing the self-sampling kits and managing the returned samples. Care Coordinators worked through the EHR-based list to verify women’s eligibility and enroll them as they agreed to take part. 50 eligible participants were recruited and mailed a self-sampler with brief education about cervical cancer and the importance of early detection of disease. Twenty five (50%) of participants returned their completed kits. Care Coordinator feedback indicated women were generally receptive to the mailed self-sampler, and that mailed kits fit nicely within their job responsibility and existing flow of patient contact. The Care Coordinators requested additional training to improve their communication and educational techniques, and suggested changes to the information pulled from the EHR for patient identification and outreach. Care Coordinator feedback will greatly benefit strategies to further develop, disseminate, and sustain self-sampling approaches.

HCN and the ADVANCE Clinical Research Network

As one of ADVANCE’s three data sharing partners, HCN is an active collaborator and contributor to one of the nation’s largest research data warehouses focused on CHC populations and care settings. Beyond the intervention trials HCN has participated in, HCN is also part of the OCHIN led EVERYWOMAN project – a mixed-methods study using EHR and community vital signs data from ADVANCE to assess women’s preventive, contraceptive, prenatal, and postpartum care before and after Affordable Care Act implementation. HCN’s commitment to cervical cancer prevention research continues in partnership with ADVANCE and through the development of strategies aimed at increasing HPV vaccination among populations served by HCN member organizations.