Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa.

Due to sporadic and not easily accessible cervical cancer screening, human papillomavirus (HPV)-related cervical cancer is a leading cause of cancer death in Sub-Saharan African women. This study was designed to assess the safety and immunogenicity of a quadrivalent human papillomavirus (qHPV) vaccine in sub-Saharan African women. This seven month, double-blind study enrolled 250 healthy, human immunodeficiency virus (HIV)-uninfected females ages 9-26 residing in Ghana, Kenya, and Senegal. Thirty females ages 13-15 and 120 females ages 16-26 received qHPV vaccine. In addition, 100 females ages 9-12 y were randomized in a 4:1 ratio to receive either qHPV vaccine (n = 80) or placebo (n = 20 ). The primary immunogenicity hypothesis was that an acceptable percentage of subjects who received the qHPV vaccine seroconvert to HPV6/11/16/18 at 4 weeks post-dose 3, defined as the lower bound of the corresponding 95% confidence interval (CI) exceeding 90%. The primary safety objective was to demonstrate that qHPV vaccine was generally well tolerated when administered in a 3-dose regimen. The pre-specified statistical criterion for the primary immunogenicity hypothesis was met: the lower bound of the 95% exact binomial CI on the seroconversion rate was at least 98% for each vaccine HPV type and all subjects seroconverted by 4 weeks post-dose 3. Across vaccination groups, the most common adverse events (AE) were at the injection site, including pain, swelling, and erythema. No subject discontinued study medication due to an AE and no serious AEs were reported. There were no deaths. This study demonstrated that qHPV vaccination of sub-Saharan African women was highly immunogenic and generally well tolerated.

Improving access and provision of preventive oral health care for very young, poor, and low-income children through a new interdisciplinary partnership.

OBJECTIVES: We provided oral health care services at 2 sites using a nurse practitioner-dietitian team to increase dental workforce capacity and improve access to care for low-income preschool children. METHODS: Our team provided oral health assessments and education, fluoride varnish application, and dentist referrals. The primary endpoint was participants' access to oral health care. Secondary endpoints included increasing the practice scope of registered dietitians through training programs for oral health assessment and the application of fluoride varnishes for children. The oral health and hygiene and dietary habits of the participants were also determined. RESULTS: From 2010 to 2013, 4360 children received fluoride varnishes in 7195 total visits. Although the proportion of children with dental caries at the first visit was greater at the urban site, both sites were similar by visits 2 and 3. The number of caries declined with increased program visits, which coincided with an increase in the proportion of participants visiting a dentist. CONCLUSIONS: Progress toward eliminating dental health disparities requires addressing barriers to dental care access. We showed that expanding access to oral health services through nurse practitioner-dietitian cooperation improved access to preventive fluoride varnishing use in low-income children.

Use of CHAID decision trees to formulate pathways for the early detection of metabolic syndrome in young adults.

Metabolic syndrome (MetS) in young adults (age 20-39) is often undiagnosed. A simple screening tool using a surrogate measure might be invaluable in the early detection of MetS. Methods. A chi-squared automatic interaction detection (CHAID) decision tree analysis with waist circumference user-specified as the first level was used to detect MetS in young adults using data from the National Health and Nutrition Examination Survey (NHANES) 2009-2010 Cohort as a representative sample of the United States population (n = 745). Results. Twenty percent of the sample met the National Cholesterol Education Program Adult Treatment Panel III (NCEP) classification criteria for MetS. The user-specified CHAID model was compared to both CHAID model with no user-specified first level and logistic regression based model. This analysis identified waist circumference as a strong predictor in the MetS diagnosis. The accuracy of the final model with waist circumference user-specified as the first level was 92.3% with its ability to detect MetS at 71.8% which outperformed comparison models. Conclusions. Preliminary findings suggest that young adults at risk for MetS could be identified for further followup based on their waist circumference. Decision tree methods show promise for the development of a preliminary detection algorithm for MetS.

Expanding oral health preventative services for young children: a successful interprofessional model.

Progressive solutions are needed to solve the oral health chronic disease problem in the U.S. The importance of oral health coupled with urgent community oral health needs, shortage of primary providers, and emphasis on interprofessional collaboration make the timing ripe for allied health training and practice in oral health preventative services. A successful model is described that addressed the unmet oral health care needs of low-income and at-risk children. The model is a guide for integrating an oral health screen, fluoride varnish, anticipatory guidance, and dental referrals into allied health practice. An alternative oral health provider approach was used to address the low rate of early caries detection, preventative oral care, and access for underserved children. A comprehensive system for the administrative and clinical components of the project, including implementation plan, clinical protocols, prescriptive authority, a dental home referral system, clinical training and competency testing, was developed. The interprofessional project increased oral health services capacity and practice acceptance of oral health screening and fluoride varnishing among dietitians. Oral health care services provide allied health practitioners with unique opportunities to impact the poor access and unmet needs of at risk children and adults and to improve overall health.

Dietary challenges of managing type 2 diabetes in African-American women.

The purpose of this qualitative study was to explore the challenge of self-management of diet in African-American women living with type 2 diabetes. Specifically, the women were asked to talk about dietary challenges of managing diabetes in the context of their personal lifestyle factors, such as daily routines, family responsibilities, and individual needs. Using a phenomenological approach, a descriptive, exploratory design was implemented using four facilitated focus groups. A convenience sample of 24 African-American women was recruited from a family practice center in the midwest. Data from each of the four focus groups were audiotaped and transcribed verbatim. Themes were compared and contrasted within and across each of the four focus groups until consensus was reached. Four themes were identified: frequent difficulties in changing dietary habits, need for individual guidance, support, and misinformation gaps. Overall, the participants expressed the need for more attention to the personal lifestyle factors they viewed as obstacles to managing diabetes.

Navigating practice and academic change in collaborative partnership with a community advisory board.

University-based allied health programs must prepare entry-level professionals for a continually-evolving practice landscape. Health care education must demonstrate relevance to community needs in an environment of diminishing resources and increased scrutiny from governmental and accreditation bodies. Diverse perspectives, insights, and strategic counsel are needed to meet these challenges. Strategies associated with the development and functions of corporate and non-profit boards were used to tailor a community advisory board for a dietetics program at a public university. Over a 4-year period, this new board established an annual scholarship conference, funded an endowed scholarship, organized a student mentorship program, and secured new program equipment. The board played a pivotal role in development of and securing administrative approval for the establishment of a Nutrition Center for research, innovative practice, and service learning. In a recent accreditation site visit report, the role of the advisory board was cited as helping to meet education standards. An active advisory board can support strategic program innovation, resource development and help prepare health professionals for 21st century practice. The change-oriented, creative approach described can serve as a model for professional education programs seeking to engage the community in the success of their students.

Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials.

OBJECTIVE: To present a combined analysis of the pregnancy outcomes for women aged up to 45 years enrolled in five phase III clinical studies of the prophylactic quadrivalent human papillomavirus 6/11/16/18 vaccine. METHODS: Twenty thousand five hundred fifty-one women aged 15-45 years received quadrivalent HPV vaccine or placebo at day 1 and months 2 and 6. Urine pregnancy tests were performed immediately before each injection; participants testing positive were not vaccinated. Women who became pregnant after enrollment were discontinued from further vaccination until resolution of pregnancy. All pregnancies were followed for outcomes. RESULTS: During the studies, 1,796 vaccine and 1,824 placebo recipients became pregnant, resulting in 2,008 and 2,029 pregnancies with known outcomes. No significant differences were noted overall for the proportions of pregnancies resulting in live birth, fetal loss, or spontaneous abortion. A total of 40 neonates born to vaccinated women and 30 neonates born to women given placebo had one or more congenital anomalies (P=.20). The anomalies were diverse and consistent with those most commonly observed in the general population. The vaccine was well tolerated among women who became pregnant. CONCLUSION: Administration of quadrivalent human papillomavirus vaccine to women who became pregnant during the phase III clinical trials did not appear to negatively affect pregnancy outcomes. The vaccine is a U.S. Food and Drug Administration pregnancy category B medication (animal studies revealed no evidence of fetal harm, but there are no adequate and well-controlled studies in pregnant women); however, vaccination is not recommended during pregnancy. Postlicensure surveillance is ongoing. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00092521, NCT00092534, NCT00092495, NCT00092547 and NCT00090220. LEVEL OF EVIDENCE: II.

Efficacy, safety, and tolerability of long-term combination antiretroviral therapy in asymptomatic treatment-naïve adults with early HIV infection.

BACKGROUND: Initiating antiretroviral therapy in the early stages of HIV infection may afford benefits over delaying treatment. We evaluated the long-term efficacy and tolerrability of indinavir, zidovudine, and lamivudine begun in asymptomatic treatment-naïve adults with baseline CD4 counts 500 cells/mm3 and HIV (v)RNA levels >1000 copies/mL in an open-label, noncomparative study. METHOD: Proportions of participants with suppressed viremia were assessed using observed data, a model derived from generalized estimating equations counting only treatment-related discontinuations as failures (TRD=F), and a strict intention-to-treat analysis counting all noncompleters as failures (NC=F). RESULTS: 199 participants (median age 34; 79% men; 61% White) with a median CD4 count of 574 (range 130-1204) cells/mm3 and vRNA level of 3.89 (range 2.30-6.50) log10 copies/mL were followed up to 319 weeks. Overall, 142 participants (71%) discontinued the study after a median time of 112 weeks, including 4 (2%) due to unsuppressed viremia and 40 (20%) due to adverse events. After 156 weeks, 98%, 76%, and 53% of participants achieved <400 vRNA copies/mL based on observed data, TRD=F, and NC=F analyses, respectively; corresponding percentages <50 copies/mL were 93%, 72%, and 51%. Mean CD4 count increased by >250 cells/mm3 from baseline. Nausea (69%), fatigue (49%), diarrhea (37%), headache (28%), abdominal pain (28%), hematuria (27%), flank pain (26%), and hyperbilirubinemia (25%) were the most common drug-related adverse events. CONCLUSION: A minority of participants in this study completed follow-up. Despite durable HIV suppression in most participants remaining on treatment, treatment fatigue may interfere with long-term therapy in asymptomatic HIV-infected patients.

Water and food safety in the developing world: global implications for health and nutrition of infants and young children.

Contaminated water and food are major causes of malnutrition and mortality in the developing world, particularly among children. Infants are most vulnerable to diarrheal illnesses when introduced to fluids and foods as they are weaned from breastfeeding to a mixed diet. There is scant literature about the role of nutrition professionals in addressing this problem. Considerable progress has been made in identifying strategies to prevent diarrhea in children. Strategies include implementing low-technology methods of sanitizing water, emphasizing the benefits of breastfeeding, protecting prepared foods from unclean environments, and educating and motivating food preparers. Resolution of water and food safety problems requires a collaborative interdisciplinary approach among health professionals and involvement of community leaders. Dietetic professionals have the training to empower individuals and communities with skills to create a safe water and food environment.