Implementing Two Randomized Pragmatic Trials of HPV Self-sampling among Underserved Women: Challenges and Lessons Learned.

BACKGROUND: Haitian and Hispanic immigrant women experience substantial disparities in cervical cancer screening. Recently, our team completed two randomized trials of human papillomavirus (HPV) self-sampling as a cervical cancer screening strategy among Haitian and Hispanic women, using a community-based participatory research (CBPR) approach. OBJECTIVE: To reflect on lessons learned in the process of completing two large randomized cancer screening trials within underserved communities. METHODS: Haitian and Hispanic women were randomized to HPV self-sampling versus navigation to Pap smear versus standard cervical cancer screening education in the first trial, and HPV self-sampling delivered in-person versus via mail in the second trial. LESSONS LEARNED: During the two trials, our team encountered several challenges. The lessons learned from these challenges allowed for the strengthening of our community partnerships, study procedures, and our ability to conduct CBPR within an academic setting. CONCLUSIONS: Lessons learned from our trials may be useful to other researchers engaging in CBPR within underserved communities.

HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial.

BACKGROUND: Ethnic minority women are at increased risk of cervical cancer. Self-sampling for high-risk human papillomavirus (HPV) is a promising approach to increase cervical screening among hard-to-reach populations. OBJECTIVE: To compare a community health worker (CHW)-led HPV self-sampling intervention with standard cervical cancer screening approaches. DESIGN: A 26-week single-blind randomized pragmatic clinical trial. PARTICIPANTS: From October 6, 2011 to July 7, 2014, a total of 601 Black, Haitian, and Hispanic women aged 30-65 years in need of cervical cancer screening were recruited, 479 of whom completed study follow-up. INTERVENTIONS: Participants were randomized into three groups: (1) outreach by CHWs and provision of culturally tailored cervical cancer screening information (outreach), (2) individualized CHW-led education and navigation to local health care facilities for Pap smear (navigation), or (3) individualized CHW-led education with a choice of HPV self-sampling or CHW-facilitated navigation to Pap smear (self-swab option). MAIN MEASURES: The proportion of women in each group whom self-reported completion of cervical cancer screening. Women lost to follow-up were considered as not having been screened. KEY RESULTS: Of the 601 women enrolled, 355 (59%) were Hispanic, 210 (35%) were Haitian, and 36 (6%) were non-Haitian Black. In intent-to-treat analyses, 160 of 207 (77%) of women in the self-swab option group completed cervical cancer screening versus 57 of 182 (31%) in the outreach group (aOR 95% CI, p < 0.01) and 90 of 212 (43%) in the navigation group (aOR CI, p = 0.02). CONCLUSIONS: As compared to more traditional approaches, CHW-facilitated HPV self-sampling led to increased cervical cancer screening among ethnic minority women in South Florida. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02121548.

Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial.

BACKGROUND: Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening. SUCCESS trial participants, as well as our community partners, provided feedback that women may prefer the HPV self-sampler to be delivered through the mail, such that they would not need to schedule an appointment with the CHW. Thus, our current trial aims to elucidate the efficacy of the HPV self-sampling method when delivered via mail. DESIGN: We are conducting a randomized controlled trial among 600 Haitian, Hispanic, and African-American women from the South Florida communities of Little Haiti, Hialeah, and South Dade. Women between the ages of 30 and 65 years who have not had a Pap smear within the past 3 years are eligible for the study. Women are recruited by CHWs and complete a structured interview to assess multilevel determinants of cervical cancer risk. Women are then randomized to receive HPV self-sampling delivered by either the CHW (group 1) or via mail (group 2). The primary outcome is completion of HPV self-sampling within 6 months post enrollment. DISCUSSION: Our trial is among the first to examine the efficacy of the mailed HPV self-sampling approach. If found to be efficacious, this approach may represent a cost-effective strategy for cervical cancer screening within underserved and underscreened minority groups. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02202109 . Registered on 9 July 2014.

Cancer Screening Utilization Among Immigrant Women in Miami, Florida.

BACKGROUND: Routine cancer screening for cervical, breast, and colorectal cancers reduces disease-associated morbidity and mortality through early detection and treatment. Lack of access to health care is a major barrier to screening in immigrant populations. OBJECTIVES: We aimed to characterize compliance with national cancer screening guidelines and to assess predictors of screening compliance among women residing in each of two distinct immigrant communities in Miami-Dade County--Little Haiti (Haitian) and Hialeah (Cuban). METHODS: Through a collaborative community-based participatory research (CBPR) initiative, researchers, key community stakeholders, and community members developed the study design. Data were collected from a total of 234 women via a rapid assessment survey administered by community health workers (CHWs). RESULTS: Compliance with national screening guidelines for breast, cervical, and colorectal screening was low in both community samples relative to national averages, and for cervical cancer screening was significantly lower in Little Haiti than Hialeah (p<.01). In addition, knowledge of cervical cancer etiology was significantly greater in Hialeah than in Little Haiti (p<.01). Health insurance and having a usual source of health care were significant correlates of cancer screening. CONCLUSION: Given the disparities in cancer screening between our samples and the larger sociodemographic groups in which they are often included, targeted approaches that address structural barriers (lack of health insurance or usual source of care) may improve access to cancer screening among recent immigrants. Community partnerships may be essential in facilitating the interventions needed to overcome cancer-related disparities in these groups.

Patient Experience in Health Center Medical Homes.

The Human Resource and Services Administration, Bureau of Primary Health Care Health Center program was developed to provide comprehensive, community-based quality primary care services, with an emphasis on meeting the needs of medically underserved populations. Health Centers have been leaders in adopting innovative approaches to improve quality care delivery, including the patient centered medical home (PCMH) model. Engaging patients through patient experience assessment is an important component of PCMH evaluation and a vital activity that can help drive patient-centered quality improvement initiatives. A total of 488 patients from five Health Center PCMHs in south Florida were surveyed in order to improve understanding of patient experience in Health Center PCMHs and to identify quality improvement opportunities. Overall patients reported very positive experience with patient-centeredness including being treated with courtesy and respect (85 % responded "always") and communication with their provider in a way that was easy to understand (87.7 % responded "always"). Opportunities for improvement included patient goal setting, referrals for patients with health conditions to workshops or educational programs, contact with the Health Center via phone and appointment availability. After adjusting for patient characteristics, results suggest that some patient experience components may be modified by educational attainment, years of care and race/ethnicity of patients. Findings are useful for informing quality improvement initiatives that, in conjunction with other patient engagement strategies, support Health Centers' ongoing transformation as PCMHs.