Evaluation of a Hospital-Based Post-Prescription Review and Feedback Pilot in Kathmandu, Nepal.

Capacity building is needed in low- and middle-income countries (LMICs) to combat antimicrobial resistance (AMR). Stewardship programs such as post-prescription review and feedback (PPRF) are important components in addressing AMR. Little data are available regarding effectiveness of PPRF programs in LMIC settings. An adapted PPRF program was implemented in the medicine, surgery, and obstetrics/gynecology wards in a 125-bed hospital in Kathmandu. Seven "physician champions" were trained. Baseline and post-intervention patient chart data were analyzed for changes in days of therapy (DOT) and mean number of course days for intravenous and oral antibiotics, and for specific study antibiotics. Charts were independently reviewed to determine justification for prescribed antibiotics. Physician champions documented recommendations. Days of therapy per 1,000 patient-days for courses of aminoglycoside (P < 0.001) and cephalosporin (P < 0.001) decreased. In the medicine ward, data indicate increased justified use of antibiotics (P = 0.02), de-escalation (P < 0.001), rational use of antibiotics (P < 0.01), and conforming to guidelines in the first 72 hours (P = 0.02), and for definitive therapy (P < 0.001). Physician champions documented 437 patient chart reviews and made 138 recommendations; 78.3% of recommendations were followed by the attending physician. Post-prescription review and feedback can be successfully implemented in LMIC hospitals, which often lack infectious disease specialists. Future program adaptation and training will focus on identifying additional stewardship programming and support mechanisms to optimize antibiotic use in LMICs.

Social and Economic Burden Associated With Typhoid Fever in Kathmandu and Surrounding Areas: A Qualitative Study.

Typhoid fever is a significant contributor to infectious disease mortality and morbidity in low- and middle-income countries, particularly in South Asia. With increasing antimicrobial resistance, commonly used treatments are less effective and risks increase for complications and hospitalizations. During an episode of typhoid fever, households experience multiple social and economic costs that are often undocumented. In the current study, qualitative interview data from Kathmandu and surrounding areas provide important insights into the challenges that affect those who contract typhoid fever and their caregivers, families, and communities, as well as insight into prevention and treatment options for health providers and outreach workers. When considering typhoid fever cases confirmed by blood culture, our data reveal delays in healthcare access, financial and time costs burden on households, and the need to increase health literacy. These data also illustrate the impact of limited laboratory diagnostic equipment and tools on healthcare providers' abilities to distinguish typhoid fever from other febrile conditions and treatment challenges associated with antimicrobial resistance. In light of these findings, there is an urgent need to identify and implement effective preventive measures including vaccination policies and programs focused on at-risk populations and endemic regions such as Nepal.

Health Disparities and Triple-Negative Breast Cancer in African American Women: A Review.

Importance: Variation in cancer incidence and outcome has well-documented correlations with racial/ethnic identity. In the United States, the possible genetic and ancestral hereditary explanations for these associations are confounded by socioeconomic, cultural, and lifestyle patterns. Differences in the breast cancer burden of African American compared with European/white American women represent one of the most notable examples of disparities in oncology related to racial/ethnic identity. Elucidating the source of these associations is imperative in achieving the promise of the national Precision Medicine Initiative. Observations: Population-based breast cancer mortality rates have been higher for African American compared with white American women since the early 1980s, largely reflecting declines in mortality that have been disproportionately experienced among white American patients and at least partly explained by the advent of endocrine therapy that is less effective in African American women because of the higher prevalence of estrogen receptor-negative disease. The increased risk of triple-negative breast cancer in African American women as well as western, sub-Saharan African women compared with white American, European, and east African women furthermore suggests that selected genetic components of geographically defined African ancestry are associated with hereditary susceptibility for specific patterns of mammary carcinogenesis. Disentangling health care access barriers, as well as reproductive, lifestyle, and dietary factors from genetic contributions to breast cancer disparities remains challenging. Epigenetics and experiences of societal inequality (allostatic load) increase the complexity of studying breast cancer risk related to racial/ethnic identity. Conclusions and Relevance: Oncologic anthropology represents a transdisciplinary field of research that can combine the expertise of population geneticists, multispecialty oncologists, molecular epidemiologists, and behavioral scientists to eliminate breast cancer disparities related to racial/ethnic identity and advance knowledge related to the pathogenesis of triple-negative breast cancer.

"You need to be an advocate for yourself": Factors associated with decision-making regarding influenza and pneumococcal vaccine use among US older adults from within a large metropolitan health system.

In the United States, influenza and pneumonia account significantly to emergency room use and hospitalization of adults >65 y. The Centers for Disease Control and Prevention recommends use of the annual influenza vaccine and 2 pneumococcal vaccines for older adults to decrease risks of morbidity and mortality. However, actual vaccine up-take is estimated at 61.3% for pneumococcal vaccines and 65% for influenza vaccine in the 2013-2014 season. Vaccine up-take is affected by multiple socio-cultural and economic factors including general healthcare access and utilization, social networks and norms, communication with health providers and health information sources, as well as perceptions related to vaccines and targeted diseases. In this study, 8 focus group discussions (total N = 48) were conducted with adults 65+ years living in urban and suburban communities in the Detroit Metropolitan Area. The research objective was to increase understanding of barriers and facilitators to vaccine up-take in this age cohort within the context of general healthcare availability and accessibility, social networks, information sources, and personal perceptions of diseases and vaccines. The data suggest the need to integrate broader health care service experiences, concepts of knowledge of one's own well-being and vulnerabilities, and self-advocacy as factors associated with older adults' vaccine-use decisions. These data also support recognition of multiple levels of vaccine acceptance which can be disease specific. Implications include potential for increasing vaccine up-take through general improvement in health care delivery and services, as well as specific vaccine-focused patient and provider education programs.

Uptake during an oral cholera vaccine pilot demonstration program, Odisha, India.

Approximately 30% of reported global cholera cases occur in India. In 2011, a household survey was conducted 4 months after an oral cholera vaccine pilot demonstration project in Odisha India to assess factors associated with vaccine up-take and exposure to a communication and social mobilization campaign. Nine villages were purposefully selected based on socio-demographics and demonstration participation rates. Households were stratified by level of participation and randomly selected. Bivariate and ordered logistic regression analyses were conducted. 517/600 (86%) selected households were surveyed. At the household level, participant compared to non-participant households were more likely to use the local primary health centers for general healthcare (P < 0.001). Similarly, at the village level, higher participation was associated with use of the primary health centers (P < 0.001) and private clinics (p = 0.032). Also at the village level, lower participation was associated with greater perceived availability of effective treatment for cholera (p = 0.013) and higher participation was associated with respondents reporting spouse as the sole decision-maker for household participation in the study. In terms of pre-vaccination communication, at the household level verbal communication was reported to be more useful than written communication. However written communication was perceived to be more useful by respondents in low-participating villages compared to average-participating villages (p = 0.007) These data on participation in an oral cholera vaccine demonstration program are important in light of the World Health Organization's (WHO) recommendations for pre-emptive use of cholera vaccine among vulnerable populations in endemic settings. Continued research is needed to further delineate barriers to vaccine up-take within and across targeted communities in low- and middle-income countries.

Desirability for a typhoid fever vaccine among rural residents, Pemba Island, Tanzania.

BACKGROUND: Surveillance data indicate that Salmonella enterica serotype Typhi (S. Typhi) is a significant cause of morbidity and mortality in Africa. With limited anticipated short-term improvements in sanitation and water infrastructure, targeted vaccination campaigns may be an important prevention tool for typhoid fever. METHODS: A cross-sectional survey was conducted with 435 randomly selected households in four rural villages on Pemba Island, Tanzania. A dichotomous 'readiness to pay' variable was created to assess vaccine desirability. Data analyses included univariate and bivariate descriptive statistics and binary logistic regression. Bivariate outcomes (ANOVA, t-tests, and chi-square) and odds ratios with 95% confidence intervals are reported. RESULTS: A total of 66% respondents stated that they would pay for a typhoid fever vaccine in the future. Readiness to pay was not significantly associated with household expenditures. Readiness to pay was associated with use of local Primary Health Care Units (PHCUs) compared to use of cottage or district hospitals (OR 1.8 [95% CI, 1.2-2.7]: p=.007) and with knowledge of someone being sick from typhoid fever (OR 2.2 [95% CI, 1.0-4.5]: p=.039). Respondents perceiving prevention measures as more effective (OR 1.0 [95% CI, 1.0-1.2]: p=.009) were also more likely ready to pay. Preferred methods of communication of information about a typhoid fever vaccine included broadcasting via microphone ('miking'), radio, and door-to-door visits. CONCLUSIONS: With rapid increase in numbers of licensed and promising vaccines, policy makers and health administrators are faced with decisions regarding allocation of scarce health resources for competing interventions. Community residents need to be informed about diseases which may not be readily recognized, diagnosed, and treated. Perceived vulnerability to the disease may increase likelihood of vaccine desirability. A better local understanding of typhoid fever is needed for general prevention measures, increasing treatment access, and future vaccination campaigns.

Utilization and accessibility of healthcare on Pemba Island, Tanzania: implications for health outcomes and disease surveillance for typhoid fever.

Salmonella enterica serotype Typhi (S. Typhi) was estimated to cause over 200,000 deaths and more than 21 million illnesses worldwide, including over 400,000 illnesses in Africa. The current study was conducted in four villages on Pemba Island, Zanzibar, in 2010. We present data on policy makers', health administrators', and village residents' and leaders' perceptions of typhoid fever, and hypothetical and actual health care use among village residents for typhoid fever. Qualitative data provided descriptions of home-based treatment practices and use of western pharmaceuticals, and actual healthcare use for culture-confirmed typhoid fever. Survey data indicate health facility use was associated with gender, education, residency, and perceptions of severity for symptoms associated with typhoid fever. Data have implications for education of policy makers and health administrators, design and implementation of surveillance studies, and community-based interventions to prevent disease outbreaks, decrease risks of complications, and provide information about disease recognition, diagnosis, and treatment.

Evaluation of three adolescent sexual health programs in ha noi and khanh hoa province, Vietnam.

With an increase in sexual activity among young adults in Vietnam and associated risks, there is a need for evidence-based sexual health interventions. This evaluation of three sexual health programs based on the Protection Motivation Theory (PMT) was conducted in 12 communes in Ha Noi, Nha Trang City, and Ninh Hoa District. Inclusion criteria included unmarried youth 15-20 years residing in selected communes. Communes were randomly allocated to an intervention, and participants were randomly selected within each commune. The intervention programs included Vietnamese Focus on Kids (VFOK), the gender-based program Exploring the World of Adolescents (EWA), and EWA plus parental and health provider education (EWA+). Programs were delivered over a ten-week period in the communities by locally trained facilitators. The gender-based EWA program with parental involvement (EWA+) compared to VFOK showed significantly greater increase in knowledge. EWA+ in comparison to VFOK also showed significant decrease at immediate postintervention for intention to have sex. Sustained changes are observed in all three interventions for self-efficacy condom use, self-efficacy abstinence, response efficacy for condoms, extrinsic rewards, and perceived vulnerability for HIV. These findings suggest that theory-based community programs contribute to sustained changes in knowledge and attitudes regarding sexual risk among Vietnamese adolescents.

Social Stigma, Social Capital Reconstruction and Rural Migrants in Urban China: A Population Health Perspective.

In this study, we examine migrant stigma and its effect on social capital reconstruction among rural migrants who possess legal rural residence but live and work in urban China. After a review of the concepts of stigma and social capital, we report data collected through in-depth interviews with 40 rural migrant workers and 38 urban residents recruited from Beijing, China. Findings from this study indicate that social stigma against rural migrants is common in urban China and is reinforced through media, social institutions and their representatives, and day-to-day interactions. As an important part of discrimination, stigma against migrant workers creates inequality, undermines trust, and reduces opportunities for interpersonal interactions between migrants and urban residents. Through these social processes, social stigma interferes with the reconstruction of social capital (including bonding, bridging and linking social capital) for individual rural migrants as well as for their communities. The interaction between stigma and social capital reconstruction may present as a mechanism by which migration leads to negative health consequences. Results from this study underscore the need for taking measures against migrant stigma and alternatively work toward social capital reconstruction for health promotion and disease prevention among this population.

Gender, Alcohol Consumption Patterns, and Engagement in Sexually Intimate Behaviors Among Adolescents and Young Adults in Nha Trang, Viet Nam.

A randomly selected cross-sectional survey was conducted with 880 youth (16 to 24 years) in Nha Trang City to assess relationships between alcohol consumption and sexual behaviors. A timeline followback method was employed. Chi-square, generalized logit modeling and logistic regression analyses were performed. Of the sample, 78.2% male and 56.1% female respondents ever consumed alcohol. Males reporting sexual behaviors (vaginal, anal, oral sex) had a significantly higher calculated peak BAC of 0.151 compared to 0.082 for males reporting no sexual intimacy (p < .0001). Females reporting sexual behaviors had a peak BAC of 0.072 compared to 0.027 for those reporting no sexual intimacy (p = .016). Fifty percent of (33/66) males and 30.4% (7/23) females report event specific drinking and engagement in sexual behaviors. Males reporting 11+ drinks in 30 days had more sexual partners than those reporting 1 to 10 drinks (p = .037). Data suggest different physical and psychosocial mediators between alcohol consumption and sexual behaviors by gender.

Parent-youth communication and concordance between parents and adolescents on reported engagement in social relationships and sexually intimate behaviors in Hanoi and Khanh Hoa Province, Vietnam.

PURPOSE: Parent-child communication is associated with positive outcomes for youths' engagement in sexual behaviors. Limited data are available regarding parent-child communication in transitional countries. We present data from Vietnamese parent-youth dyads on parent reproductive health (RH) knowledge, comfort of communication, frequency of talk, and discordancy between youths' reported and parents' perceptions for engagement in relationships and sexually intimate behaviors. METHODS: The cohort included 185 randomly selected parent-youth dyads in four communes in Hanoi and Khanh Hoa Province. Descriptive and comparative analysis included chi-squared tests, independent samples t-tests, and ANOVA. Linear regression analysis was used to assess relationships between parental knowledge, level of comfort, frequency of talk, and discordancy. RESULTS: Seventy-six percent of parents and 44% of youth were female. The mean age of youth was 17.2 years. The mean score for parental "RH knowledge" was 24.74 (SD, 3.84; range, 15-34). Lower parental RH knowledge was positively associated with lower levels of education (F = 2.983; df, 184; p = .014). Data indicate a linear model in which knowledge is related to "comfort" (ß = .17; p = .048), and "comfort" to frequency of "talk" (ß = .6; p < .0001). Frequency of "talk" is not related to parents' discordant perceptions regarding their child's reported involvement in relationships (ß = .002; p = .79) or sexual touching (ß = .57; p = .60). CONCLUSIONS: Parent and youth in Vietnam are engaged in limited communication about RH. There is a need for more data to assess the effect of these communication patterns on youths' engagement in sexual behaviors and for development of family-centered interventions to increase parental knowledge and skills for positive communication.

Social capital and risk and protective behaviors: a global health perspective.

Social capital and health research has emerged as a focus of contemporary behavioral epidemiology, while intervention research is seeking more effective measures to increase health protective behaviors and decrease health-risk behaviors. In this review we explored current literature on social capital and health outcomes at the micro-, mesa-, and macro-levels with a particular emphasis on research that incorporates a social capital framework, and adolescent and young adult engagement in risk behaviors. These data indicate that across a broad range of socio-cultural and economic contexts, social capital can affect individuals' risk for negative health outcomes and their engagement in risk behaviors. Further research is needed which should focus on differentiating and measuring positive and negative social capital within both mainstream and alternative social networks, assessing how social constructions of gender, ethnicity, and race - within specific cultural contexts - mediate the relationship between social capital and risk and/or protective behaviors. This new research should integrate the existing research within historical socioeconomic and political conditions. In addition, social capital scales need to be developed to be both culturally and developmentally appropriate for use with adolescents living in a diversity of settings. Despite the proliferation of social capital research, the concept remains underutilized in both assessment and intervention development for adolescents' and young adults' engagement in risk behaviors and their associated short- and long-term poor health outcomes.

Rural and urban Vietnamese mothers utilization of healthcare resources for children under 6 years with pneumonia and associated symptoms.

Worldwide, pneumonia causes 14% of deaths among children and infants (ages 4 weeks to 5 years). UNICEF and WHO have established treatment guidelines to reduce risk of death from pneumonia including caregiver symptom recognition, appropriate care, and use of antibiotics. In June 2008, cross-sectional survey data were collected in Khanh Hoa Province Viet Nam with 329 mothers of children under 6 years. In relation to pneumonia and associated symptoms (fever >38 °C, strong cough, "fast or difficult" breathing), data were collected on perceptions of symptom severity and child vulnerability, reported healthcare utilization including use of antibiotics, sources of health information, and barriers to care. Pearson's chi square, independent t tests, and multinomial analysis were conducted to assess different patterns of reported healthcare utilization in relation to residency (rural/urban), mother's education, and household income. Outcomes include rural and urban residency-based patterns related to perceptions of child's vulnerability and symptom severity, health facility utilization and barriers to care, and reported use of antibiotics during previous episodes of pneumonia. Implications include the need to target different healthcare facilities in urban and rural Viet Nam in relation to education about symptoms of childhood pneumonia and associated treatments.

Applying the information-motivation-behavioral skills model in medication adherence among Thai youth living with HIV: a qualitative study.

With disproportionately higher rates of HIV/AIDS among youth and increasing access to antiretroviral therapy (ART) in Thailand, there is a growing urgency in understanding the challenges to medication adherence confronting this population and in developing theory-based interventions to address these challenges. One potentially relevant model, the information-motivation-behavioral skills (IMB) model of adherence, was developed in Western settings characterized by a more individualistic culture in contrast to the more collectivistic culture of Thailand. We explored the application and adaptability of IMB on ART adherence among HIV-positive Thai youth through the analysis of qualitative data from a pilot motivational interviewing study. Twenty-two interview sessions from 10 HIV-positive Thai youth (17-24 years) were analyzed; 6 youth were on ART. Data support the utility of IMB as a potential framework for understanding ART adherence in this population. However, data indicate a consideration to expand the motivation construct of IMB to incorporate youths' perceived familial and social responsibilities and the need to adhere to medications for short- and long-term well-being of self, family, and society in a context of Buddhist values. These modifications to IMB could be relevant in other cultural settings with more collectivistic worldviews.

Vaccine desirability during an effectiveness trial of the typhoid fever polysaccharide Vi vaccine in Kolkata India.

BACKGROUND: High rates of typhoid fever and the emergence of multi-drug resistant strains create a need for prevention efforts including vaccines. Socio-behavioral research can provide important data for participation in future trials and public health vaccination campaigns. DESIGN: A 3b phase clinical trial in Kolkata India including pre- and post-vaccination socio-behavioral surveys. RESULTS: 47.9% of respondents were male. Ward 29 respondents included 32.4% Hindu and Ward 30 respondents were 99.0% Hindu. Lower rates of participation were found among Muslim respondents and those with post high school education. Lack of information and negative information affected participation. Joint decision-making within households increased participation rates. METHODS: seven hundred households were randomly selected 503 respondents (71.85%) completed both the pre- and post-closed-ended surveys. Data analysis included descriptive statistics, Pearson's chi-square tests, independent t-tests, and stepwise logistic regression analysis. Four open-ended questions were included in the survey. These qualitative data were coded and reviewed for common themes and patterns. CONCLUSIONS: Individuals' decisions to participate or not participate in a vaccine trial entail a balance between individual beliefs, household dynamics and socio-political influences. Efforts prior to vaccination trials need to develop strategies which address potential underlying mediators for belief systems as well as structural factors which may reinforce individuals' beliefs and perceptions about vaccination trials.

AIDS orphanages in China: reality and challenges.

With the increasing number of AIDS orphans in China, the government has been building AIDS orphanages since 2004 to accommodate some of those children who have lost both parents to AIDS. However, no data are available regarding the quality of this model of institutional care of AIDS orphans in China. This study, based on qualitative data from children and workers in AIDS orphanages, examines the daily lives, needs, and feelings of orphans and explores the advantages and disadvantages of institutionalized care of AIDS orphans in China. The current study was conducted in 2006-2007 in two rural counties of central China. Data in the current study included individual in-depth interviews with 23 children who lost both of their parents to HIV/AIDS (ages 8 to 17 years) living in AIDS orphanages and 5 AIDS orphanage workers. Findings in this study reveal that children living in orphanages mostly felt that the living conditions were better than the families they lived with after the death of their parents. However, according to the children and orphanage workers, the institutional care has some disadvantages, such as administrative restraints, limited psychological guidance, stigma, lack of education on AIDS, and financial burdens of the operation. Implications for intervention programs include continuing support from the government and nongovernmental organizations, improvements in administrative styles, and the need of incorporating psychological support within the institutions.

Strategies for developing gender-specific HIV prevention for adolescents in Vietnam.

In Vietnam, between 2000 and 2006, HIV rates among 15- to 49-year-olds in the general population have increased from 27% to 53%. The HIV epidemic is occuring in a context of rapid socioeconomic changes, which have brought about conflicting ideals and norms between "traditional" and "modern" gender roles. We discuss the processes for developing the Exploring the World of Adolescents gender-specific HIV prevention curricula for 15- to 21-year-old adolescents living in both rural and urban Vietnam. The curricula are modeled after an existing HIV prevention program previously adapted and evaluated in Vietnam (Vietnamese Focus on Kids) and based in social learning theory (prevention motivation theory) contextualized within socioeconomic changes. The overall capacity building and participatory strategies for program development included (a) review of the HIV/AIDS and socioeconomic conditions in Vietnam, (b) review of the Vietnamese Focus on Kids curriculum themes and the theoretical constructs from the protection motivation theory, () analysis of qualitative and quantitative needs assessment data to incorporate culturally significant issues of gender and sexuality, and (d) a review of themes and activities from existing evidence-based adolescent reproductive health curricula.

Sexual stigma, sexual behaviors, and abstinence among Vietnamese adolescents: implications for risk and protective behaviors for HIV, sexually transmitted infections, and unwanted pregnancy.

As rates of HIV increase in Vietnam, there is a need for data on social relations and sexual risk and protective behaviors among Vietnamese adolescents in a context of rapid social and economic changes. The authors report results from qualitative interviews with 159 Vietnamese adolescents living in Hanoi, Nha Trang City, and Ninh Hoa District and a survey of 886 adolescents in these same three sites. In the qualitative interviews, youths report a strong adherence to ideals and values regarding abstinence outside of marriage. Youths reported low rates of engagement in vaginal, anal, and/or oral sex with a significant difference in reported behaviors between males (29/469, 6.2%) and females (7/416, 1.7%; p = .000). A total of 15 of 32 (46.9%) sexually active youths reported rarely or never using condoms. Females had significantly higher scores for perceived sexual stigma than males (t = -10.22 [95% confidence interval (CI); -3.72 to -2.52; p = .000) whereas males scored significantly lower than females on a scale of perceived self-efficacy for abstinence (t = 5.31 [95% CI; .27 to .59]; p = .000). The stigmatization of sexual relations outside of marriage particularly for young women reinforces abstinence; however, these same values decrease adolescents' ability to obtain accurate information about sexuality and HIV and sexually transmitted infections and engage in safer sex.

Trial participation and vaccine desirability for Vi polysaccharide typhoid fever vaccine in Hue City, Viet Nam.

OBJECTIVES: To identify demand for Vi typhoid fever vaccine for school-age children; obstacles and enabling factors for vaccine delivery; and socio-behavioural factors associated with trial participation and possible predictors of future vaccine acceptance, in Hue City, Viet Nam. METHODS: Pre- and post-trial surveys of randomly selected households with children aged 6-17 years. Simple multinomial logistic analyses for ratios of relative risks (RRR) and significance on trial participation by demographics and variables related to typhoid fever, vaccination, and pre-trial experiences with information and consents. Multiple logistic regressions to assess differences in participation based on child's characteristics. RESULTS: As many as 62.6% of households let all school age children participate, 10.2% let some participate, and 26.8% let none of their children participate in the trial. Factors associated with all children participating included past use of healthcare facilities (RRR, 0.45; 95% CI, 0.24-0.83), knowledge of vaccines (RRR, 0.17; 95% CI, 0.03-0.86), and perceived causes of typhoid fever (RRR, 0.90; 95% CI, 0.81-0.99). Factors associated with some children participating included utilization of healthcare facilities (RRR, 0.08; 95% CI, 0.01-0.66) and perceived severity of typhoid fever (RRR, 0.64; 95% CI 0.46-0.88). Participation was associated with satisfaction regarding pre-vaccination information and consent procedures. Children and adolescents were active decision-makers. Only 14 of 461 (2.2%) respondents would not use the Vi vaccine in the future for their child(ren). CONCLUSIONS: Inter-related factors contribute to participation in a clinical vaccine trial, which may differ from desire to participate in a public health campaign. Educational campaigns need to be targeted to children and adolescents, and consideration for assent procedures for minors. Obtaining informed consent may affect trial participation within a social and political system unaccustomed to these procedures.