Burden of Human Papillomavirus among Haitian Immigrants in Miami, Florida: Community-Based Participatory Research in Action

Background. Haitian immigrant women residing in Little Haiti, a large ethnic enclave in Miami-Dade County, experience the highest cervical cancer incidence rates in South Florida. While this disparity primarily reflects lack of access to screening with cervical cytology, the burden of human papillomavirus (HPV) which causes virtually all cases of cervical cancer worldwide, varies by population and may contribute to excess rate of disease. Our study examined the prevalence of oncogenic and nononcogenic HPV types and risk factors for HPV infection in Little Haiti. Methods. As part of an ongoing community-based participatory research initiative, community health workers recruited study participants between 2007 and 2008, instructed women on self-collecting cervicovaginal specimens, and collected sociodemographic and healthcare access data. Results. Of the 242 women who contributed adequate specimens, the overall prevalence of HPV was 20.7%, with oncogenic HPV infections (13.2% of women) outnumbering nononcogenic infections (7.4%). Age-specific prevalence of oncogenic HPV was highest in women 18–30 years (38.9%) although the prevalence of oncogenic HPV does not appear to be elevated relative to the general U.S. population. The high prevalence of oncogenic types in women over 60 years may indicate a substantial number of persistent infections at high risk of progression to precancer

The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial

Background: Patients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes. Methods: Forty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care PlanTM integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The study engages patients, caregivers, and other stakeholders (including policymakers, advocacy groups, payers, and local community coalitions) to advise and support the design, implementation, and sustainability of the COMPASS care model. Discussion: Given the high societal and economic burden of stroke, identifying a care model to improve recovery, independence, and quality of life is critical for stroke survivors and their caregivers. The pragmatic trial design provides a real-world assessment of the COMPASS care model effectiveness and will facilitate rapid implementation into clinical practice if successful

An original phylogenetic approach identified mitochondrial haplogroup T1a1 as inversely associated with breast cancer risk in BRCA2 mutation carriers

Introduction: Individuals carrying pathogenic mutations in the BRCA1 and BRCA2 genes have a high lifetime risk of breast cancer. BRCA1 and BRCA2 are involved in DNA double-strand break repair, DNA alterations that can be caused by exposure to reactive oxygen species, a main source of which are mitochondria. Mitochondrial genome variations affect electron transport chain efficiency and reactive oxygen species production. Individuals with different mitochondrial haplogroups differ in their metabolism and sensitivity to oxidative stress. Variability in mitochondrial genetic background can alter reactive oxygen species production, leading to cancer risk. In the present study, we tested the hypothesis that mitochondrial haplogroups modify breast cancer risk in BRCA1/2 mutation carriers. Methods: We genotyped 22,214 (11,421 affected, 10,793 unaffected) mutation carriers belonging to the Consortium of Investigators of Modifiers of BRCA1/2 for 129 mitochondrial polymorphisms using the iCOGS array. Haplogroup inference and association detection were performed using a phylogenetic approach. ALTree was applied to explore the reference mitochondrial evolutionary tree and detect subclades enriched in affected or unaffected individuals. Results: We discovered that subclade T1a1 was depleted in affected BRCA2 mutation carriers compared with the rest of clade T (hazard ratio (HR) = 0.55; 95% confidence interval (CI), 0.34 to 0.88; P = 0.01). Compared with the most frequent haplogroup in the general population (that is, H and T clades), the T1a1 haplogroup has a HR of 0.62 (95% CI, 0.40 to 0.95; P = 0.03). We also identified three potential susceptibility loci, including G13708A/rs28359178, which has demonstrated an inverse association with familial breast cancer risk. Conclusions: This study illustrates how original approaches such as the phylogeny-based method we used can empower classical molecular epidemiological studies aimed at identifying association or risk modification effects.Peer reviewe

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Barriers to Cervical Cancer Screening Among Haitian Immigrant Women in Little Haiti, Miami

Previous research has not examined barriers to Pap test screening among Haitian immigrant women through their own discourse. Community Health Workers conducted in-depth interviews with Haitian women in Little Haiti, Miami. We used a grounded theory approach to analyze data from the in-depth interviews. Emergent themes coalesced into three core categories of screening barriers: structural, psychosocial, and sociocultural. We developed a model of screening barriers to depict the themes within each core category. Screening barriers must be examined and understood from the social contexts in which they are produced in order to create meaningful interventions

The sociocultural context of gynecological health among Haitian immigrant women in Florida: applying ethnographic methods to public health inquiry

Objective. Twalet deba, a culturally mediated feminine hygiene practice, is widespread in Little Haiti, the predominately Haitian neighborhood in Miami, Florida. This practice may have important implications for susceptibility to sexually transmitted infections, including human papillomavirus, the principal cause of cervical cancer. Previous research has not examined the full context of twalet deba in consideration of cultural beliefs and norms about women's hygiene and sexual health. Design. Ethnographic methods guided two phases of exploratory research. The first phase included observation, participant observation, and semi-structured in-depth interviews, which were conducted with key consultants (n=6) and a subsequent purposive sample of 35 women regarding gynecological health beliefs, hygiene practices, and associated home remedy agents. These data informed the second research phase, which involved observation and informal interviews with owners of botánicas in Little Haiti, Miami, FL, USA, to assess the availability of various ethnomedical remedies, their preparation, and preferred uses. All data were analyzed qualitatively to discern patterns in interview responses and using grounded theory to identify key themes. Results. Cultural constructions of gynecological health and illness were generally incongruent with the biomedical model and emphasized the control of self-defined non-specific vaginal infections through routine hygienic practices using ethnobotanical and commercial agents to avert illness, including cancer. Such practices also encourage vaginal tightness and dryness, characteristics desired by male sexual partners, on whom women were frequently economically dependent. Data from the second phase of research reinforced these findings and revealed a wide variety of feminine hygiene agents available for purchase in local botánicas. Conclusion. The results suggest that cultural beliefs about gynecological health and dependence on male partners influence women's routine feminine hygiene practices. Botánicas are culturally salient sites for health information. Ethnographic methods were critical for collecting personal sensitive data that are necessary to inform future intervention

Abstract B10: Variability in HPV knowledge among Hispanic women of diverse ancestry and country of origin

In the United States, women who are categorized as Hispanic for public health research purposes, experience an increased risk of developing and dying from cervical cancer. This disparity primarily reflects underutilization of Pap smear screening, the best method available for prevention and early detection of disease. Previous research has not examined, in great detail, the factors that predict screening underutilization among Hispanic women or evaluated how known determinants of screening, such as cancer literacy, function across this population sub-group. Historically, all Hispanic persons, regardless of ancestry or country of origin, have been categorized as one group for cancer research and control efforts. This practice likely masks variability in exposure to determinants of disease, as well as, risk of cancer incidence and mortality. Our research examines potential differences in HPV knowledge between Hispanic women of diverse ancestral backgrounds. HPV is the primary risk factor for cervical carcinogenesis. Insufficient knowledge about this sexually transmitted infection (STI) and its association with cervical cancer may impact willingness to be vaccinated against HPV, screening utilization, and accordingly, women9s risk of disease onset and progression. Identifying variation in HPV knowledge between women of seemingly the same ethnicity, but different ancestral backgrounds, is essential for understanding, and ultimately attenuating, cervical cancer disparities. Study data were collected as part of a cross-sectional study conducted at the National Cancer Institute (NCI), Cancer Information Service (CIS), Spanish Call Center. Between July 2007 and March 2008, all callers to this service were asked whether they were willing to answer a short survey related to their knowledge of cervical cancer and associated risk factors. Where possible, survey items were derived from previously validated instruments and questionnaires. The HPV knowledge questions, in particular, were taken from the Health Information National Trends Survey (HINTS), conducted by the National Cancer Institute (NCI) on a biennial basis, with the intent of better understanding cancer information needs and experiences in the United States. Study data suggest that knowledge of HPV was high among our respondents (n=873; 69%), relative to a representative sample of US women of diverse/racial ethnic backgrounds. However, this knowledge varied by country of origin, even after controlling for acculturation, language preference, and number of years in the United States. Women from Mexico were far more likely than their South American and Caribbean counterparts to have heard of the virus. Such findings suggest that continuing to classify persons of similar ethnicity, but different cultural backgrounds and lifetime exposures as one group for research purposes, may preclude opportunity to understand, as well as attenuate, health disparity

Abstract A37: A biocultural framework for understanding the excess cervical cancer incidence and mortality in Little Haiti, Miami, Florida

In Miami, Florida, Haitian women shoulder a disproportionate burden of cervical cancer incidence, morbidity and mortality. Between 2000–2004, the estimated incidence of disease in Little Haiti, the predominately Haitian neighborhood in Miami, was 38/100,000, relative to 9/100,000 for other low income, minority enclaves in the larger metropolitan area. This disparity reflects the interplay of multiple factors, including lack of access to, and underutilization of, routine Pap smear screening, untimely follow up for cervical abnormalities, and increased susceptibility to Human Papillomavirus (HPV) infection, the primary risk factor for cervical cancer. When compared to other racial/ethnic minorities and immigrant groups in Miami, Haitian women are less likely to report a history of Pap smear screening, and more likely to be infected with HPV, including high-risk, oncogenic viral types. As part of our ongoing Community-based Participatory Research (CBPR) in Little Haiti, we have found that the increased rate of HPV infection among Haitian women is likely associated with their practice of twalet deba, which involves intravaginal washing with herbal and chemical agents to cleanse, dry and tighten the vagina, primarily for enhanced sexual pleasure of male partners. Using data from a series of ethnographic interviews, we have begun developing a biocultural model to explain the socio-cultural significance of twalet deba, and how this behavioral practice can affect HPV transmission and, potentially, cellular transformation. Our model posits that intravaginal washing among Haitian women reflects cultural constructions of health, which uphold bodily fluids, including vaginal secretions, as indicative of infection and immorality. To sufficiently dry the vagina, Haitian women wash intravaginally with various agents, including potassium permanganate, aluminum sulfate, and boric acid, that may exfoliate the superficial layers of the cervix, exposing the basement membrane to HPV, and/or impair innate immunity, reducing the body9s potential for clearing infection. Persistent infection with HPV, particularly high-risk viral types, is associated with cervical abnormalities. In communities such as Little Haiti, where women underutilize routine Pap smear screening, such abnormalities go largely undetected, thereby increasing the risk of disease onset and progression. We are currently conducting additional research to test the validity of our model and inform future intervention strategies. Preliminary findings suggest that understanding the complex interplay between culture, behavior, and biology is necessary to attenuate health disparity in Little Haiti, as well as, other ethnic enclaves that similarly contribute to excess cancer morbidity and mortality