Implementing packaged HIV-prevention interventions for HIV-positive individuals: considerations for clinic-based and community-based interventions.

Providing efficacious human immunodeficiency virus (HIV) prevention services to HIV-positive individuals is an appropriate strategy to reduce new infections. The Centers for Disease Control and Prevention (CDC) has identified interventions with evidence of efficacy for prevention with positives (PwP). Through its process of disseminating evidence-based interventions (EBIs), CDC has attempted to diffuse four of these interventions into practice. One of these interventions has been diffused to community-based organizations, whereas another has been diffused to medical clinics serving HIV-positive people. A third intervention was originally developed with HIV-positive individuals using methadone, but uptake by methadone clinics has not occurred. A fourth intervention for HIV-positive adolescents and young adults has had disappointing adoption levels. Unique implementation challenges have been encountered in various intervention settings. Lessons learned in the dissemination of the first four PwP interventions will facilitate implementation of three new PwP EBIs currently being packaged for dissemination.

A barber-based intervention for hypertension in African American men: design of a group randomized trial.

BACKGROUND: Barbershops constitute potential sites for community health promotion programs targeting hypertension (HTN) in African American men but such programs previously have not been formally evaluated. METHODS: A randomized trial (ClinicalTrials.gov no. NCT00325533) will test whether a continuous HTN detection and medical referral program conducted by influential peers (barbers) in a receptive community setting (barbershops) can promote treatment-seeking behavior and thus lower blood pressure (BP) among the regular customers with HTN. Barbers will offer a BP check with each haircut and encourage appropriate medical referral using real stories of other customers modeling the desired behaviors. A cohort of 16 barbershops will go through a pretest/posttest group-randomization protocol. Serial cross-sectional data collection periods (10 weeks each) will be conducted by interviewers to obtain accurate snapshots of HTN control in each barbershop before and after 10 months of either barber-based intervention or no active intervention. The primary outcome is BP control: BP <135/85 mm Hg (nondiabetic subjects) and <130/80 mm Hg (diabetic subjects) measured in the barbershop during the 2 data collection periods. The multilevel analysis plan uses hierarchical models to assess the effect of covariates on HTN control and secondary outcomes while accounting for clustering of observations within barbershops. CONCLUSIONS: By linking community health promotion to the health care system, this program could serve as a new model for HTN control and cardiovascular risk reduction in African American men on a nationwide scale.

Comparing the mutagenicity of toxaphene after aging in anoxic soils and accumulating in fish.

A test program was conducted to evaluate the mutagenicity of toxaphene residuals extracted from aged soils and from fish collected in creeks near a toxaphene-contaminated site. The ultimate objective was to determine if the residual toxaphene congeners were more or less mutagenic than those in technical-grade toxaphene. The study showed that the mutagenicity of the bioaccumulated toxaphene congeners in fish, expressed as colony revertants per microg of residual toxaphene, was no greater than that of technical-grade toxaphene. The mutagenic impact of the toxaphene residuals in aged soil statistically was less than that for technical-grade toxaphene. Two specific congeners, a hexachlorobornane (labeled Hx-Sd) and a heptachlorobornane (labeled Hp-Sd), were found to accumulate over time in both soil and fish extracts, but did not show increased mutagenic impacts relative to that produced by technical-grade toxaphene.

Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania.

BACKGROUND: The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research. METHODS: We reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016. Each protocol was searched for the terms sex, gender, male, female, man, and woman and justifications related to the population under study. A PubMed search was conducted to determine the current state of knowledge regarding potential sex and/or gender differences with respect to protocol topic. Data were summarized using descriptive statistics. RESULTS: Of the 165 (68.8%) protocols that included one of the search terms, only 24 (14.5%) provided justification for the choice of the sex/gender of the population studied. Sixty-three percent (n = 151) of the protocols focused on topics for which the extant literature supports at least a moderate degree of sex/gender differences in some aspect of the disorder/condition being studied. Of these, only three (2.0%) indicated that the investigator would consider sex or gender impact on their primary outcomes. CONCLUSIONS: Review of a subset of IRB protocols submitted at a major research institution suggests that very few investigators are considering sex or gender as important variables in their clinical research at the stage of protocol development. IRBs are in an excellent position to encourage investigators to consider SABV and gender in order to enhance the rigor of research design, maximize the importance of the resulting knowledge, and ensure that subject selection is equitable. These findings serve as the basis for developing an intervention at the level of IRB protocol development and submission that will promote consideration of SABV and/or gender, factors with critical import to patient safety and efficacy of interventions.

An open-label, multicenter, randomized phase Ib/II study of eribulin mesylate administered in combination with pemetrexed versus pemetrexed alone as second-line therapy in patients with advanced nonsquamous non-small-cell lung cancer.

INTRODUCTION: New treatment options are needed for second-line therapy in patients with NSCLC. PATIENTS AND METHODS: This was a phase Ib/II study in patients with nonsquamous NSCLC in whom 1 previous platinum-based chemotherapy regimen had failed. Fifteen patients were enrolled in a dose escalation of eribulin mesylate in combination with pemetrexed (E+P). In phase II (n = 80), E+P at the maximum tolerated dose was compared with P. RESULTS: In phase Ib, the maximum tolerated dose of E+P was defined as eribulin 0.9 mg/m(2) with pemetrexed (500 mg/m(2)) each on day 1 of a 21-day cycle. In phase II, adverse events were comparable between groups. PFS and OS were similar between treatment groups. Median PFS was 21.4 weeks for E+P (n = 26; 95% confidence interval [CI], 12.7-39.6) and 23.4 weeks for P (n = 29; 95% CI, 17.1-29.9), with a hazard ratio of 1.0 (95% CI, 0.6-1.7). CONCLUSION: During phase Ib, E+P was tolerated only at a markedly lower dosing intensity relative to the eribulin monotherapy regimen approved for breast cancer and used in phase II studies of NSCLC. At the selected phase II dosing regimen, E+P was generally safe and well tolerated but provided no therapeutic advantage for the second-line treatment of locally advanced or metastatic nonsquamous NSCLC.

Lay beliefs about high blood pressure in a low- to middle-income urban African-American community: an opportunity for improving hypertension control.

PURPOSE: Lay beliefs about illness are a potential barrier to improving the control of hypertension. We investigated the extent to which lay beliefs about hypertension diverge from current medical understanding. METHODS: We conducted street intercept interviews and focus group discussions in six predominantly African-American census tracts in the southern sector of Dallas County, Texas. Sixty subjects, aged 18 to 67 years, were stopped along popular thoroughfares and administered a brief survey. Additionally, 107 participants were interviewed in 12 homogeneous focus groups, balanced by sex and age (18 to 74 years). Participants were asked about the meaning, causes, consequences, and treatment of high blood pressure. RESULTS: The street intercept data indicated that 35% (n = 21) of respondents related high blood pressure to eating pork or other foods that makes the blood travel too fast to the head, and only 15% (n = 9) related hypertension to an elevated pressure in blood vessels. The focus group data indicated that hypertension was causally linked to eating pork in 8 of the 12 groups; was perceived as a symptomatic illness in all 12 groups; and was considered treatable with vitamins, garlic, and other herbs in 11 groups, with prescription medications in 10 groups and with lifestyle modifications such as weight loss in 8 groups. Hypertension was mentioned as a leading cause of death among African Americans in none of the 4 focus groups of 18-year-old to 29-year-old participants, in 2 of the 4 focus groups of 30-year-old to 49-year-old participants, and in 3 of the 4 focus groups of 50-year-old to 74-year-old participants. CONCLUSIONS: In a low- to middle-income urban African-American community, the predominant beliefs about hypertension diverged sharply from current medical understanding. Lack of appreciation of these lay beliefs by providers may contribute to noncompliance and poor rates of hypertension control.

Bioavailability of a novel midazolam gel after intranasal administration in dogs.

OBJECTIVE: To compare the pharmacokinetics of a novel bioadhesive gel formulation of midazolam after intranasal (IN) administration with that of midazolam solution after IN, IV, and rectal administration to dogs. ANIMALS: 10 (5 males and 5 females) healthy adult Beagles. PROCEDURES: Dogs were assigned to 4 treatment groups for a crossover study design. Initially, midazolam solution (5 mg/mL) was administered (0.2 mg/kg) IV to group 1, rectally to group 2, and IN to group 3; a 0.4% hydroxypropyl methylcellulose midazolam gel formulation (50 mg/mL) was administered (0.2 mg/kg, IN) to group 4. Each dog received all 4 treatments; there was a 7-day washout period between subsequent treatments. Blood samples were collected before and after midazolam administration. Plasma concentration of midazolam was determined by use of high-performance liquid chromatography. RESULTS: The peak plasma concentration after IN administration of the gel formulation was significantly higher than that after IN and rectal administration of the solution. Mean ± SD time to peak concentration was 11.70 ± 2.63 minutes (gel IN), 17.50 ± 2.64 minutes (solution IN), and 39 ± 14.49 minutes (solution rectally). Mean bioavailability of midazolam was 70.4% (gel IN), 52.0% (solution IN), and 49.0% (solution rectally). Bioavailability after IN administration of the gel formulation was significantly higher than that after IN and rectal administration of the solution. CONCLUSIONS AND CLINICAL RELEVANCE: IN administration of midazolam gel was superior to both IN and rectal administration of midazolam solution with respect to peak plasma concentration and bioavailability.

Cervical dermoid sinus in a cat: case presentation and review of the literature.

A 6-month-old female spayed domestic shorthair cat was presented for evaluation of a focal subcutaneous swelling on the dorsal neck at the level of atlas. The magnetic resonance imaging and surgical treatment of a dermoid sinus associated with the cervical vertebrae is described. To the authors' knowledge, a dermoid sinus in this location has not been described previously in the cat. The prognosis following surgical resection appears favorable.

Effectiveness of a barber-based intervention for improving hypertension control in black men: the BARBER-1 study: a cluster randomized trial.

BACKGROUND: Barbershop-based hypertension (HTN) outreach programs for black men are becoming increasingly common, but whether they are an effective approach for improving HTN control remains uncertain. METHODS: To evaluate whether a continuous high blood pressure (BP) monitoring and referral program conducted by barbers motivates male patrons with elevated BP to pursue physician follow-up, leading to improved HTN control, a cluster randomized trial (BARBER-1) of HTN control was conducted among black male patrons of 17 black-owned barbershops in Dallas County, Texas (March 2006-December 2008). Participants underwent 10-week baseline BP screening, and then study sites were randomized to a comparison group that received standard BP pamphlets (8 shops, 77 hypertensive patrons per shop) or an intervention group in which barbers continually offered BP checks with haircuts and promoted physician follow-up with sex-specific peer-based health messaging (9 shops, 75 hypertensive patrons per shop). After 10 months, follow-up data were obtained. The primary outcome measure was change in HTN control rate for each barbershop. RESULTS: The HTN control rate increased more in intervention barbershops than in comparison barbershops (absolute group difference, 8.8% [95% confidence interval (CI), 0.8%-16.9%]) (P = .04); the intervention effect persisted after adjustment for covariates (P = .03). A marginal intervention effect was found for systolic BP change (absolute group difference, -2.5 mm Hg [95% CI, -5.3 to 0.3 mm Hg]) (P = .08). CONCLUSIONS: The effect of BP screening on HTN control among black male barbershop patrons was improved when barbers were enabled to become health educators, monitor BP, and promote physician follow-up. Further research is warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00325533.

Factors associated with hypertension awareness, treatment, and control in Dallas County, Texas.

BACKGROUND: Hypertension (HTN) control rates in the United States remain lower in black than white persons, particularly before 65 years of age. Potential sociocultural factors have not been sufficiently addressed. METHODS: We analyzed data from structured interviews and blood pressure measurements in a population-based sample of 1514 hypertensive (1194 non-Hispanic black and 320 non-Hispanic white) subjects aged 18 to 64 years in Dallas County, Texas, from 2000 to 2002 to identify sociocultural factors associated with low rates of HTN control. We calculated adjusted odds ratios (aORs) and 95% confidence intervals (CIs) using multivariate logistic regression. RESULTS: Awareness, treatment, and control of HTN were negatively associated with a common perception of good health, with aORs (95% CIs) of 0.37 (0.27-0.50) for awareness, 0.47 (0.36-0.62) for treatment, and 0.66 (0.51-0.86) for control. They were positively associated with having a regular physician, with aORs (95% CIs) of 3.81 (2.86-5.07) for awareness, 8.36 (5.95-11.74) for treatment, and 5.23 (3.30-8.29) for control. Among untreated hypertensive subjects, lack of perceived need for a regular physician was associated with perceived good health (aOR [95% CI], 2.2 [1.2-4.0]), male gender (aOR [95% CI], 2.4 [1.4-4.1]), and black race/ethnicity (aOR [95% CI], 2.1 [1.0-4.4]). The HTN outcomes were unrelated to perceived racism or lay beliefs about the causes, consequences, and treatment of HTN. CONCLUSIONS: Among young to middle-aged hypertensive subjects, a perception of good health and the lack of perceived need for a regular physician remain major factors associated with untreated and uncontrolled HTN at the community level-particularly among black men. These factors merit greater emphasis in professional education and public health programs on HTN.

Barbershops as hypertension detection, referral, and follow-up centers for black men.

Barbershops constitute potential sites for community health promotion programs targeting hypertension (HTN) in black men, but such programs have not been evaluated previously. Here we conducted 2 nonrandomized feasibility studies to determine whether an enhanced intervention program of continuous blood pressure (BP) monitoring and peer-based health messaging in a barbershop lowers BP more than standard screening and health education (study 1) and can be implemented by barbers rather than research personnel (study 2). In study 1, we measured changes in HTN treatment and BP in regular barbershop customers with poorly controlled HTN assigned for 8 months to either an enhanced intervention group (n=36) or a contemporaneous comparison group (n=27). Groups were similar at baseline. BP fell by 16+/-3/9+/-2 mm Hg in the enhanced intervention group but was unchanged in the comparison group (P<0.0001, adjusted for age and body mass index). HTN treatment and control increased from 47% to 92% (P<0.001) and 19% to 58% (P<0.001), respectively, in the enhanced intervention group, whereas both remained unchanged in the comparison group. In study 2, barbers were trained to administer the enhanced intervention continuously for 14 months to the entire adult black male clientele (n=321) in 1 shop. Six barbers recorded 8953 BP checks during 11 066 haircuts, thus demonstrating a high degree of intervention fidelity. Furthermore, among 107 regular customers with HTN, treatment and control increased progressively with increasing intervention exposure (P<0.01). Taken together, these data suggest that black-owned barbershops can be transformed into effective HTN detection, referral, and follow-up centers. Further research is warranted.

Formative assessment of use of behavioral data in HIV prevention: Texas.

A formative assessment was conducted with Texas HIV prevention community planning group (CPG) members, prevention provider staff, and supervisors of those staff to better understand how to enhance their use of epidemiologic and behavioral data in the selection and prioritization of prevention interventions. Semi-structured interviews, mail surveys, and content analysis of funding proposals were used to determine the current use of these data, their perceived value, and the most trusted sources for data. CPG members, prevention provider staff, and supervisors valued information from their peers and networking most, and made more use of socially available information than they did research or systematically collected assessment data. CPG members wanted more local data and data on specific sub-populations of interest. Prevention providers viewed the utility of behavioral data as limited, and were primarily concerned with the pragmatic aspects of fielding interventions; however, this group also expressed an interest in rapid community assessment methods and learning more about new and effective prevention interventions. These results led to the development of training and technical assistance materials.

After the innovation: outcomes from the Texas behavioral data project.

The Texas Department of Health and University of Texas Southwestern staff, using formative assessment data, developed a set of innovative methods and tools to increase the use of behavioral and epidemiologic data in decision-making about HIV prevention interventions by HIV prevention community planning groups (CPGs) and HIV prevention providers. Semistructured interviews, mail surveys, meeting observations, and content analysis of funding proposals were used to measure the results of the multifaceted intervention. Compared to baseline measures, CPG members reported that data played a more central and desired role in their decision-making. HIV prevention providers exposed to the project's materials were more likely to choose evidence-based interventions to conduct. The tools and structural intervention methods of this project were diffused and had an impact on the use of behavioral data by community planning groups and HIV prevention providers. The structural interventions were not sufficient without the additional effect of the trained peers acting as advocates and intervention innovators.

Bridging data and decision making: development of techniques for improving the HIV prevention community planning process.

Assessments of community planning in Massachusetts and Texas were used to develop tools for increasing the use of data by HIV prevention community planning groups (CPGs) and prevention providers while also increasing participation of CPG members. Barriers to data use included organizational problems in CPGs (e.g., lack of clear procedures, distrust of peers and leadership) and technical assistance needs for CPG members and researchers who provide data. The absence of data relevant to local epidemics was another barrier. Specific linkages are provided between the assessments of these needs and the development of a technical assistance tools (e.g., websites, templates for data presentation, experiential involvement in data use) and strategies for organizational change in CPGs, as well as efforts to better use available data and create or identify new sources of local data.

Improving the use of data for HIV prevention decision making: lessons learned.

HIV prevention community planning was developed to promote identification of local prevention priorities through a process that was evidence-based and provided community input. There are a variety of barriers to effective use of data in community planning which include characteristics of data (availability, timeliness, relevance to planning tasks), characteristics of planning group members and providers of data (e.g., skills in understanding and applying data), and social-organizational aspects of community-planning groups (CPGs). Lessons learned from this project illustrate how to create locally relevant sources of data, build data use skills of CPG members and data providers, and address social-organizational aspects of planning, while also better integrating community planning with implementation of prevention plans. Adaptation of tools and methods is discussed along with future considerations for research and planning practice.

Environmental influences on safer sex in young gay men: a situational presentation approach to measuring influences on sexual health.

Environmental influences on sexual behavior are difficult to examine given their temporal distance from the sexual act and the cost of long-term longitudinal studies. We examined environmental influences on risky sexual behavior in young gay men using the Situational Presentation (Sitpres) methodology, where situations in which relevant environmental variables are presented as computer vignettes with the variables randomly allocated, and participants rate the likelihood of their engaging in unsafe sexual behavior. A total of 100 gay men aged between 18 and 26 years of age completed 20 situational presentations with the outcome being the likelihood of engaging in unprotected anal intercourse. On regression analysis, 3 environmental variables significantly predicted safer sex: perceived gay/bisexual men's norms toward condom use; availability of HIV prevention messages; and what one's religion says about gay sex. Not significant were family, media, legal, and work/school attitudes to homosexuality. Demographic variables that were predictors included education, age, sexual orientation, and degree of being "out" about sexual orientation. These data suggest that environmental factors can be approximated using the Sitpres methodology, and that more proximal environmental variables have a stronger impact than distal ones.