Impact of COVID-19 pandemic and vaccine perceptions on HPV vaccine hesitancy.

OBJECTIVE: This study evaluated the impact of the COVID-19 pandemic and vaccine perceptions on Human Papillomavirus (HPV) vaccine hesitancy. Secondary endpoints included comparing COVID-19 and HPV vaccination trends regarding time, community of residence, and unmet social needs. METHODS: This was a survey-based, cross-sectional study that included 101 participants who were recruited through the Wyandotte County Public Health Department. Participants were eligible for inclusion in this study if they were a parent/guardian of one or more children aged 13 to 17; English- or Spanish-speaking. This study took place in Wyandotte County, Kansas. Descriptive statistics and chi-square analyses were utilized. RESULTS: There was no difference in completion of COVID-19 and HPV vaccines (p = 0.0975). Significantly more individuals started and did not finish the HPV vaccine series compared to the COVID-19 vaccine series (p = 0.0004). Most participants indicated their opinion on the HPV vaccine had not changed due to the pandemic (71.3 %). Participants who felt familiar with HPV had higher rates of HPV vaccine completion. While 77 % of participants felt extremely or moderately familiar with HPV, 61.4 % were unaware of its association with oropharyngeal cancer. CONCLUSION: There was minimal change in parents' perception of the HPV vaccine due to the COVID-19 pandemic despite decreased rates of vaccination during this time. HPV vaccine series completion was significantly lower than COVID-19 vaccine series completion, highlighting a need to improve HPV vaccine completion counseling. Additionally, patient education should address the knowledge gap discovered regarding the link between HPV infection and oropharyngeal cancer.

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.

Importance: African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels. Objectives: To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers. Design, Setting, and Participants: The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018. Interventions: Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). Main Outcomes and Measures: The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Results: Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]). Conclusions and Relevance: Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers. Trial Registration: ClinicalTrials.gov Identifier: NCT02360631.

Fulfilling Ethical Responsibility: Moving Beyond the Minimal Standards of Protecting Human Subjects from Research Harm.

PROBLEM: Rules for protecting human subjects, in place federally since 1974, have focused primarily on guarding against placing research subjects at social, physical, or psychological risk or violating their privacy and confidentiality. Nevertheless, high-risk communities are routinely subjected to "sins of omission," which limit access to potentially significant research opportunities and result in the absence of studies that could confer high degree of community beneficence. PURPOSE OF ARTICLE: To describe "sins of omission" and provide examples from the Community Networks Program Centers (CNPC) to illustrate how community-based participatory research (CBPR) can prevent them. KEY POINTS: CBPR is an effective antidote to sins of omission. Activities undertaken by the CNPCs illustrate how adherence to CBPR principles can improve research access and outcomes. CONCLUSIONS: By working with community members as partners, we expand the concept of beneficence to include "community beneficence," thus reducing the probability of "sins of omission."

Targeting and Tailoring Health Communications in Breast Screening Interventions.

BACKGROUND: Members of underrepresented minority (URM) groups are at higher risk of disproportionately experiencing greater breast cancer-related morbidity and mortality and thus, require effective interventions that both appropriately target and tailor to their unique characteristics. OBJECTIVES: We sought to describe the targeting and tailoring practices used in the development and dissemination of three breast cancer screening interventions among URM groups. METHODS: Three national Community Network Programs (CNPs) funded by the National Cancer Institute have focused on breast cancer screening interventions as their major research intervention. Each targeted different populations and used participatory research methods to design their intervention tailored to the needs of their respective audience. The Alameda County Network Program (ACNP) to Reduce Cancer Disparities partnered with community members to design and conduct 2-hour "Tea Party" education sessions for Afghan women. The Kansas Community Cancer Disparities Network co-developed and deployed with community members a computerized Healthy Living Kansas (HLK) Breast Health program for rural Latina and American Indian women. The Johns Hopkins Center to Reduce Cancer Disparities employed a train-the-trainer COACH approach to educate urban African-American women about breast cancer. CONCLUSIONS: Each CNP program targeted diverse URM women and, using participatory approaches, tailored a range of interventions to promote breast cancer screening. Although all projects shared the same goal outcome, each program tailored their varying interventions to match the target community needs, demonstrating the importance and value of these strategies in reducing breast cancer disparities.

Chemoprevention in gastrointestinal physiology and disease. Natural products and microbiome.

The human intestinal tract harbors a complex ecosystem of commensal bacteria that play a fundamental role in the well-being of their host. There is a general consensus that diet rich in plant-based foods has many advantages in relation to the health and well-being of an individual. In adults, diets that have a high proportion of fruit and vegetables and a low consumption of meat are associated with a highly diverse microbiota and are defined by a greater abundance of Prevotella compared with Bacteroides, whereas the reverse is associated with a diet that contains a low proportion of plant-based foods. In a philosophical term, our consumption of processed foods, widespread use of antibiotics and disinfectants, and our modern lifestyle may have forever altered our ancient gut microbiome. We may never be able to identify or restore our microbiomes to their ancestral state, but dietary modulation to manipulate specific gut microbial species or groups of species may offer new therapeutic approaches to conditions that are prevalent in modern society, such as functional gastrointestinal disorders, obesity, and age-related nutritional deficiency. We believe that this will become an increasingly important area of health research.

Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial.

BACKGROUND: Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI.The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL) program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. METHODS: We will randomize 56 groups (8 smokers per group) to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01106456.

Engaging diverse underserved communities to bridge the mammography divide.

BACKGROUND: Breast cancer screening continues to be underutilized by the population in general, but is particularly underutilized by traditionally underserved minority populations. Two of the most at risk female minority groups are American Indians/Alaska Natives (AI/AN) and Latinas. American Indian women have the poorest recorded 5-year cancer survival rates of any ethnic group while breast cancer is the number one cause of cancer mortality among Latina women. Breast cancer screening rates for both minority groups are near or at the lowest among all racial/ethnic groups. As with other health screening behaviors, women may intend to get a mammogram but their intentions may not result in initiation or follow through of the examination process. An accumulating body of research, however, demonstrates the efficacy of developing 'implementation intentions' that define when, where, and how a specific behavior will be performed. The formulation of intended steps in addition to addressing potential barriers to test completion can increase a person's self-efficacy, operationalize and strengthen their intention to act, and close gaps between behavioral intention and completion. To date, an evaluation of the formulation of implementation intentions for breast cancer screening has not been conducted with minority populations. METHODS/DESIGN: In the proposed program, community health workers will meet with rural-dwelling Latina and American Indian women one-on-one to educate them about breast cancer and screening and guide them through a computerized and culturally tailored "implementation intentions" program, called Healthy Living Kansas-Breast Health, to promote breast cancer screening utilization. We will target Latina and AI/AN women from two distinct rural Kansas communities. Women attending community events will be invited by CHWs to participate and be randomized to either a mammography "implementation intentions" (MI2) intervention or a comparison general breast cancer prevention informational intervention (C). CHWs will be armed with notebook computers loaded with our Healthy Living Kansas-Breast Health program and guide their peers through the program. Women in the MI2 condition will receive assistance with operationalizing their screening intentions and identifying and addressing their stated screening barriers with the goal of guiding them toward accessing screening services near their community. Outcomes will be evaluated at 120-days post randomization via self-report and will include mammography utilization status, barriers, and movement along a behavioral stages of readiness to screen model. DISCUSSION: This highly innovative project will be guided and initiated by AI/AN and Latina community members and will test the practical application of emerging behavioral theory among minority persons living in rural communities.

Smoking cessation pharmacotherapy preferences in rural primary care.

Pharmacotherapy is a critical adjunct to smoking cessation therapy. Little is known about relative preferences for these agents among smokers in primary care settings. In the context of a population-based clinical trial, we identified 750 smokers in primary care practices and independent of their readiness to quit offered them a free treatment course of either bupropion or transdermal nicotine replacement (TNR). Smokers opting for pharmacotherapy completed standardized contraindication screens that were reviewed by the patient's primary care physician. Most participants (67%) requested pharmacotherapy. Use of pharmacotherapy was positively associated with higher nicotine dependence and readiness to quit. Of the smokers requesting pharmacotherapy, 51% requested bupropion and 49% requested TNR. Choice of bupropion was related to no history of heart disease and no previous use of bupropion. Although potential contraindications to treatments were identified for 21.7% of bupropion and 6.6% of TNR recipients, physicians rarely felt that these potential contraindications precluded the use of these agents. When cost is removed as a barrier, a large proportion of rural smokers are eager to use smoking cessation pharmacotherapy, especially agents that they have not tried before. Although some comorbid conditions and concurrent drug therapies were considered contraindications, particularly to bupropion, physicians rarely considered these clinically significant risks enough to deny pharmacotherapy.

Health fair screening: the clinical utility of the comprehensive metabolic profile.

BACKGROUND AND OBJECTIVES: Health fairs are a common method used by providers and health care organizations to provide screening tests, including comprehensive metabolic profiles (CMPs), to asymptomatic individuals. No national organizations currently recommend the complete CMP as a screening test for asymptomatic individuals in primary care settings. This study evaluated the value of CMPs in a health fair setting by measuring the ability of a health fair CMP to predict new medical diagnoses among residents of a sparsely populated rural county. METHODS: Volunteer participants submitted fasting blood samples at a health fair conducted by a county health center in a county with 2,531 total residents. CMP values were determined to be "normal" or "abnormal" based on laboratory reference ranges and clinical judgment of the health center physicians. Medical records were reviewed 4 months later to determine if participants with abnormal CMP values had been diagnosed with new medical conditions as a result of the screening tests. Analysis was conducted to evaluate CMP test characteristics and determine whether demographic factors or specific CMP values predicted new medical diagnoses in the participants. RESULTS: Out of 478 health fair participants, 73 individuals had at least one abnormal CMP value. The most frequently occurring abnormal value was an elevated glucose level, with Hispanic participants significantly more likely to have this abnormality than whites. After all evaluation was completed, only about 1% of tested subjects had a new diagnosis as a result of the screening CMP test; most abnormal CMP tests did not result in a new diagnosis. The positive predictive value for an abnormal test resulting in a new medical diagnosis was 0.356. CONCLUSIONS: Comprehensive metabolic profiles have limited value as a screening tool in asymptomatic populations at health fairs.

Impact of patient characteristics on physician's smoking cessation strategies.

BACKGROUND: The effectiveness of smoking cessation interventions may be influenced by a variety of patient characteristics, including level of nicotine addiction and readiness to change. We conducted this study to examine the relationship between these characteristics and the frequency of physician-initiated smoking cessation interventions. METHODS: We identified smokers seen during office visits to 1 of 38 primary care physicians in rural Kansas. Trained students observed the frequency and nature of doctor-patient discussions related to tobacco. Telephone surveys were conducted with these patients 1 to 3 days after the office visit. RESULTS: We completed observations and telephone surveys on 259 smokers. Tobacco-related discussions occurred during 66% of doctor-patient encounters. Although discussions overall were unrelated to a patient's readiness to quit, specific assistance with smoking cessation was offered less often to precontemplators (15%) than to contemplators (31%) or those preparing to quit (37%) (P < 0.05). While bupropion was discussed with 23% of smokers, nicotine replacement therapy was discussed with 12% and was unrelated to markers of nicotine addiction. CONCLUSIONS: Current efforts to promote smoking cessation are only marginally related to patient characteristics. Doctors are missing many opportunities to effectively intervene with patients who are contemplating smoking cessation or preparing to quit.