Assessing perceptions of establishing a vaccine pooled procurement mechanism for the Western Pacific Region.

This study explored the demand and interest among countries in the World Health Organization Western Pacific Region (WPR) to establish and participate in a regional vaccine pooled procurement mechanism. National counterparts affiliated with Ministries of Health that are involved in the national procurement of vaccines within the WPR were identified and invited to complete surveys. Out of 80 counterparts invited, 17 (21%) responded, representing 13 of the 27 WPR countries. Five countries expressed interest in participating in a regional pooled procurement mechanism, 3 expressed lack of interest and 5 did not respond to the question. Preferred characteristics of the procurement mechanism, included flexible participation (i.e. non-compulsory), payment in local currency before receipt of goods and a fixed price for vaccines (i.e. not tiered pricing). Vaccine pricing disparities were noted among upper middle-income and high-income countries for five of the 13 routine vaccines surveyed. Eight countries listed budget planning, quality of vaccines, timely delivery, cost-saving and payment after receipt as potential benefits of pooled procurement.

The economic burden of rotavirus hospitalization among children < 5 years of age in selected hospitals in Bangladesh.

BACKGROUND: Rotavirus is a common cause of severe acute gastroenteritis among young children. Estimation of the economic burden would provide informed decision about investment on prevention strategies (e.g., vaccine and/or behavior change), which has been a potential policy discussion in Bangladesh for several years. METHODS: We estimated the societal costs of children <5 years for hospitalization from rotavirus gastroenteritis (RVGE) and incidences of catastrophic health expenditure. A total of 360 children with stool specimens positive for rotavirus were included in this study from 6 tertiary hospitals (3 public and 3 private). We interviewed the caregiver of the patient and hospital staff to collect cost from patient and health facility perspectives. We estimated the economic cost considering 2015 as the reference year. RESULTS: The total societal per-patient costs to treat RVGE in the public hospital were 126 USD (95% CI: 116-136) and total household costs were 161 USD (95% CI: 145-177) in private facilities. Direct costs constituted 38.1% of total household costs. The out-of-pocket payments for RVGE hospitalization was 23% of monthly income and 76% of households faced catastrophic healthcare expenditures due to this expense. The estimated total annual household treatment cost for the country was 10 million USD. CONCLUSIONS: A substantial economic burden of RVGE in Bangladesh was observed in this study. Any prevention of RVGE through cost-effective vaccination or/and behavioural change would contribute to substantial economic benefits to Bangladesh.

Molecular characterization of rotavirus diarrhea among children aged under five years in the Philippines, 2013-2015.

With the availability of new and existing rotavirus vaccines, credible and reliable data on burden of rotavirus-associated disease are needed to enable evidence-based decision making regarding the introduction of rotavirus vaccines. The national rotavirus surveillance program in the Philippines, a sentinel-based surveillance, was established in 2012 to determine the proportion of laboratory-confirmed rotavirus cases among children under five years with acute gastroenteritis and to describe the geographic distribution and molecular epidemiology of rotavirus in the country. During 2013 to 2015, rotavirus infection was the cause of acute gastroenteritis among children under five years admitted to hospitals or evaluated in emergency rooms, constituting more than one-third of gastroenteritis hospitalizations at the sentinel site hospitals. The predominant genotype observed was G1P[8]. Although a rotavirus surveillance network has been established, findings suggest the need to strengthen the network in the country and to continue monitoring prevalent rotavirus strains to help identify the possible emergence of new strains.

Preparing for safety monitoring after rotavirus vaccine introduction - Assessment of baseline epidemiology of intussusception among children <2 years of age in four Asian countries.

Intussusception is the invagination of one segment of the bowel into a distal segment, characterized by symptoms of bloody stool, vomiting, and abdominal pain. Previous studies have found regional differences in incidence but the etiology of most intussusception cases is unknown. Rotavirus vaccines were associated with a slightly of increased risk of intussusception in post-licensure evaluations in high- and middle-income countries, but not in low income African countries. To describe the baseline epidemiology of intussusception in young children prior to rotavirus vaccine implementation, active sentinel hospital surveillance for intussusception in children < 2 years of age was conducted in 4 low income Asian countries (Bangladesh, Nepal, Pakistan and Vietnam). Over a 24-month period, 15 sites enrolled 1,415 intussusception cases, of which 70% were enrolled in Vietnam. Overall, 61% of cases were male and 1% (n = 16) died, ranging from 8% in Pakistan to 0% in Vietnam. The median age of cases enrolled ranged from 6 months in Bangladesh and Pakistan to 12 months in Vietnam. The proportion of cases receiving surgical management was 100% in Bangladesh, 88% in Pakistan, 61% in Nepal, and 1% in Vietnam. The high proportion of males and median age of cases around 6 months of age found in this regional surveillance network are consistent with previous descriptions of the epidemiology of intussusception in these countries and elsewhere. Differences in management and the fatality rate of cases between the countries likely reflect differences in access to healthcare and availability of diagnostic modalities. These baseline data will be useful for post-rotavirus vaccine introduction safety monitoring.

Pediatric hospitalizations attributable to rotavirus gastroenteritis among Cambodian children: Seven years of active surveillance, 2010-2016.

BACKGROUND: Each year, approximately 1,066 Cambodian children under five years old die of diarrhea, and 51% of these deaths are due to rotavirus gastroenteritis. Quantifying childhood hospitalizations caused by severe rotavirus infections is also important in demonstrating disease burden caused by this virus. The objective of this study is to update and confirm the current burden of pediatric hospitalizations attributable to rotavirus gastroenteritis among Cambodian children using seven years of continuous active, prospective surveillance from 2010 to 2016. We also characterize the circulating rotavirus genotypic strains during this period. METHODS: Active surveillance for rotavirus gastroenteritis was conducted from January 2010 through December 2016 at a national hospital in Phnom Penh, Cambodia. Children <60 months of age who were hospitalized for acute gastroenteritis (AGE) were consented and enrolled. Information on gender, age, clinical characteristics, and month of onset were collected. Stool specimens were collected and tested by enzyme immunoassay for the presence of rotavirus antigen, and genotyping was performed on rotavirus test-positive specimens to characterize predominant rotavirus strains during the surveillance period. RESULTS: Of 7007 children enrolled with AGE and having specimens collected, 3473 (50%) were attributed to rotavirus gastroenteritis. The majority of rotavirus hospitalizations occurred in children younger than two years old (92%). Year-round rotavirus transmission was observed, with seasonal peaks during the cooler, dry months between November and May. Genotypic trends in rotavirus were observed over the surveillance period; the predominant rotavirus strains changed from G1P[8] (2010-2012), to G2P[4] (2013-2014), the emergence of genotype G8P[8] in 2015, and G3P[8] in 2016. CONCLUSIONS: Rotavirus is the leading cause of severe acute gastroenteritis hospitalizations in Cambodian children under five years old, with 50% of such hospitalizations attributable to rotavirus. Over 90% of rotavirus hospitalizations occurred in children under 2 years of age. Changes in the predominant rotavirus strains occurred over time among these unvaccinated children. This information is important to understand and prioritize the current potential impacts upon child health that could be achieved through the introduction of rotavirus vaccines in Cambodia.

Epidemiology of childhood intussusception in Bangladesh: Findings from an active national hospital based surveillance system, 2012-2016.

INTRODUCTION: Rotavirus vaccines have significantly decreased the burden of diarrheal diseases in countries that have introduced them into their immunization programs. In some studies, there has been a small association between rotavirus vaccines and intussusception in post-marketing surveillance, highlighting the importance of tracking incidence before and after vaccine introduction. The objective of this study was to describe the epidemiology of intussusception among Bangladeshi children pre-vaccine introduction. METHODS: We conducted active, hospital-based surveillance for intussusception at 7 tertiary care hospitals with pediatric surgical facilities during July 2012 to September 2016. Hospitalized children under 2years of age were identified according to Brighton Collaboration level 1 criteria for intussusception. The frequency and proportion of intussusception among overall surgical admissions, as well as the demographic and clinical information of the cases is described. RESULTS: Overall 153 cases of intussusception among children <2years-old were identified at participating sites over the enrolment period, confirmed by Level 1 Brighton criteria. These cases represented 2% of all surgical admissions under 2years of age. One hundred twelve cases (73%) were male; the median age was 7months; and the median duration of hospitalization was 7days. One hundred forty-six (95%) children with intussusception required surgery, and 11 (7%) died. CONCLUSIONS: Confirmed cases of intussusception represented nearly 2% of pediatric surgical admissions at tertiary referral centers in Bangladesh during the study period and 7% of children with intussusception died. Given the high burden of rotavirus disease in Bangladesh, vaccine introduction is warranted, however, further studies after introduction of rotavirus vaccine are necessary to determine any association between vaccine and intussusception in this setting.

Migration Patterns and Characteristics of Sexual Partners Associated with Unprotected Sexual Intercourse Among Hispanic Immigrant and Migrant Women in the United States.

In 2011, Hispanic immigrant women comprised 44% of HIV diagnoses among Hispanic women in the United States but little is known about factors that may place these women at risk for infection with HIV or sexually transmitted diseases. From March 2005 to February 2007, women were recruited at community-based organizations offering services to immigrant and migrant communities in five U.S. states. We report factors independently associated with unprotected anal and vaginal sex in the past 12 months among Hispanic immigrant and migrant women. Greater work-related mobility was associated with unprotected anal sex, while recency of immigration and prior refusal of HIV testing were associated with women's reports of unprotected vaginal sex. Prior sex with an injection drug user was associated with reports of both unprotected anal and vaginal sex. Findings highlight the need for HIV/STD risk reduction interventions designed specifically for Hispanic immigrant and migrant women.

Behavioral and clinical characteristics of persons receiving medical care for HIV infection - Medical Monitoring Project, United States, 2009.

PROBLEM: As of December 31, 2009, an estimated 864,748 persons were living with human immunodeficiency virus (HIV) infection in the 50 U.S. states, the District of Columbia, and six U.S.-dependent areas. Whereas HIV surveillance programs in the United States collect information about persons with a diagnosis of HIV infection, supplemental surveillance systems collect in-depth information about the behavioral and clinical characteristics of persons receiving outpatient medical care for HIV infection. These data are needed to reduce HIV-related morbidity and mortality and HIV transmission. REPORTING PERIOD COVERED: Data were collected during June 2009-May 2010 for patients receiving medical care at least once during January-April 2009. DESCRIPTION OF THE SYSTEM: The Medical Monitoring Project (MMP) is an ongoing surveillance system that assesses behaviors and clinical characteristics of HIV-infected persons who have received outpatient medical care. For the 2009 data collection cycle, participants must have been aged ≥18 years and have received medical care during January-April 2009 at sampled facilities that provide HIV medical care within participating MMP project areas. Behavioral and selected clinical data were collected using an in-person interview, and most clinical data were collected using medical record abstraction. A total of 23 project areas in 16 states and Puerto Rico were funded to collect data during the 2009 data collection cycle. The data were weighted for probability of selection and nonresponse to be representative of adults receiving outpatient medical care for HIV infection in the United States and Puerto Rico. Prevalence estimates are presented as weighted percentages. The period of reference is the 12 months before the patient interview unless otherwise noted. RESULTS: The patients in MMP represent 421,186 adults who received outpatient medical care for HIV infection in the United States and Puerto Rico during January-April 2009. Of adults who received medical care for HIV infection, an estimated 71.2% were male, 27.2% were female, and 1.6% were transgender. An estimated 41.4% were black or African American, 34.6% were white, and 19.1% were Hispanic or Latino. The largest proportion (23.1%) were aged 45-49 years. Most patients (81.1%) had medical coverage; 40.3% had Medicaid, 30.6% had private health insurance, and 25.7% had Medicare. An estimated 69.6% of patients had three or more documented CD4+ T-lymphocyte cell (CD4+) or HIV viral load tests. Most patients (88.7%) were prescribed antiretroviral therapy (ART), and 71.6% had a documented viral load that was undetectable or ≤200 copies/mL at their most recent test. Among sexually active patients, 55.0% had documentation in the medical record of being tested for syphilis, 23.2% for gonorrhea, and 23.9% for chlamydia. Noninjection drugs were used for nonmedical purposes by an estimated 27.1% of patients, whereas injection drugs were used for nonmedical purposes by 2.1% of patients. Overall, 12.9% of patients engaged in unprotected sex with a partner of negative or unknown HIV status. Unmet supportive service needs were prevalent, with an estimated 22.8% in need of dental care and 12.0% in need of public benefits, including Social Security Income or Social Security Disability Insurance. Fewer than half of patients (44.8%) reported receiving HIV and sexually transmitted disease prevention counseling from a health-care provider. INTERPRETATION: The findings in this report indicate that most adults living with HIV who received medical care in 2009 were taking ART, had CD4+ and HIV viral load testing at regular intervals, and had health insurance or other coverage. However, some patients did not receive clinical services and treatment in accordance with guidelines. Some patients engaged in behaviors, such as unprotected sex, that increase the risk for transmitting HIV to sex partners, and some used noninjection or injection drugs or both. PUBLIC HEALTH ACTIONS: Local and state health departments and federal agencies can use MMP data for program planning to determine allocation of services and resources, guide prevention planning, assess unmet medical and supportive service needs, inform health-care providers, and help focus intervention programs and health policies at the local, state, and national levels.

HIV screening practices and hospital characteristics in the US, 2009-2010.

OBJECTIVES: The Centers for Disease Control and Prevention recommends HIV screening in U.S. health-care settings unless providers document a yield of undiagnosed HIV infections of <1 per 1,000 population. However, implementation of this guidance has not been widespread and little is known of the characteristics of hospitals with screening practices in place. We assessed how screening practices vary with hospital characteristics. METHODS: We used a national hospital survey of HIV testing practices, linked to HIV prevalence for the county, parish, borough, or city where the hospital was located, to assess HIV screening of some or all patients by hospitals. We used multivariate logistic regression analysis to assess the association between screening practices and hospital characteristics that were significantly associated with screening in bivariate analyses. RESULTS: Of 376 hospitals in areas of prevalence ≥0.1%, only 25 (6.6%) reported screening all patients for HIV and 131 (34.8%) reported screening some or all patients. Among 638 hospitals included, screening some or all patients was significantly (p<0.05) more common at teaching hospitals, hospitals with higher numbers of annual admissions, and hospitals with a high proportion of Medicaid admissions. In multivariable analysis, screening some or all patients was independently associated with admitting more than 15% of Medicaid patients and receiving resources or reimbursement for screening tests. CONCLUSION: We found that few hospitals surveyed reported screening some or all patients, and failure to screen is common across all types of hospitals in all regions of the country. Expanded reimbursement for screening may increase compliance with the recommendations.

Clinical and behavioral characteristics of adults receiving medical care for HIV infection --- Medical Monitoring Project, United States, 2007.

PROBLEM: As of December 31, 2008, an estimated 663,084 persons were living with a diagnosis of human immunodeficiency virus (HIV) infection in the 40 U.S. states that have had confidential name-based HIV infection reporting since at least January 2006. Although HIV surveillance programs in the United States collect information about persons who have received a diagnosis of HIV infection and acquired immunodeficiency syndrome (AIDS), supplemental surveillance projects are needed to collect information about care-seeking behaviors, health-care use, and other behaviors among persons living with HIV. Data on the clinical and behavioral characteristics of persons receiving medical care for HIV infection are critical to reduce HIV-related morbidity and mortality and for program planning to allocate services and resources, guide prevention planning, assess unmet medical and ancillary service needs, and help develop intervention programs and health policies at the local, state, and national levels. REPORTING PERIOD COVERED: Data were collected during June 2007-September 2008 for patients who received medical care in 2007 (sampled from January 1-April 30). DESCRIPTION OF THE SYSTEM: The Medical Monitoring Project (MMP) is an ongoing, multisite supplemental surveillance project that assesses behaviors, clinical characteristics, and quality of care of HIV-infected persons who are receiving medical care. Participants must be aged ≥ 18 years and have received medical care at sampled facilities that provide HIV medical care within participating MMP project areas. Self-reported behavioral and selected clinical data are collected using an in-person interview. A total of 26 project areas in 19 states and Puerto Rico were funded to collect data during the 2007 MMP data collection cycle. RESULTS: The results from the 2007 MMP cycle indicated that among 3,643 participants, a total of 3,040 (84%) had some form of health insurance or coverage during the 12 months before the interview; of these, 45% reported having Medicaid, 37% reported having private health insurance or coverage through a health maintenance organization, and 30% reported having Medicare. A total of 3,091 (85%) of the participants were currently taking antiretroviral medications. Among 3,609 participants who reported ever having a CD4 T-lymphocyte test, 2,996 (83%) reported having three or more CD4 T-lymphocyte tests in the 12 months before the interview. Among 3,567 participants who reported ever having an HIV viral load test, 2,946 (83%) reported having three or more HIV viral load tests in the 12 months before the interview. Among 3,643 participants, 45% needed HIV case management, 33% needed mental health counseling, and 32% needed assistance finding dental services during the 12 months before the interview; 8%, 13%, and 25% of these participants who needed the services, respectively, had not received these services by the time of the interview. Noninjection drugs were used for nonmedical purposes by 1,117 (31%) participants during the 12 months before the interview, and 122 (3%) participants had used injection drugs for nonmedical purposes. Unprotected anal intercourse was reported by 527 (54%) of 970 men who reported having anal sex with a man during the 12 months before the interview. Unprotected anal or vaginal intercourse was reported by 176 (32%) of the 553 men who reported having anal or vaginal intercourse with a woman during the 12 months before the interview. Unprotected anal or vaginal intercourse was reported by 216 (42%) of the 516 women who reported having anal or vaginal intercourse with a man during the 12 months before the interview. INTERPRETATION: The findings in this report indicate that in 2007, most persons with HIV infection who were receiving medical care were taking antiretroviral therapy and had some form of health insurance or coverage; however, some persons were not receiving needed critical ancillary services, such as HIV case management or help finding dental services. In addition, some persons living with HIV infection engaged in behaviors, such as unprotected sex, that increase the risk for transmitting HIV to sexual partners, and some used noninjection or injection drugs for nonmedical purposes, which might decrease adherence to antiretroviral therapy and increase health-risk behaviors. PUBLIC HEALTH ACTIONS: MMP data can be used to monitor the national HIV/AIDS strategy goal of increasing access to care and optimizing health outcomes among persons living with HIV. Persons infected with HIV who are not receiving needed ancillary services highlight missed opportunities for access to care and other supportive services, information that can be used to advocate for additional resources. Drug use among persons with HIV infection underscores the continued need for substance abuse treatment services for this population. In addition, prevention services and programs are needed to decrease the number of HIV-infected persons engaging in unprotected sex. The data in this report can be included in local, state, and national HIV/AIDS epidemiologic profiles and shared with community stakeholders. Although data from the 2007 MMP cycle might not be representative of all persons receiving medical care for HIV infection in the United States or in the individual project areas, future MMP cycles are expected to yield weighted national estimates representing all HIV-infected persons receiving medical care in the United States.

Missed opportunities for HIV testing in health care settings among young African American men who have sex with men: implications for the HIV epidemic.

Limited health care access and missed opportunities for HIV and other sexually transmitted infection (STI) education and testing in health care settings may contribute to risk of HIV infection. In 2008, we conducted a case-control study of African American men who have sex with men (MSM) in a southeastern city (Jackson, Mississippi) with an increase in numbers of newly reported HIV cases. Our aims were to evaluate associations between health care and HIV infection and to identify missed opportunities for HIV/STI testing. We queried 40 potential HIV-infected cases and 936 potential HIV-uninfected controls for participation in this study. Study enrollees included HIV-infected cases (n=30) and HIV-uninfected controls (n=95) who consented to participate and responded to a self-administered computerized survey about sexual risk behaviors and health care utilization. We used bivariate analysis and logistic regression to test for associations between potential risk factors and HIV infection. Cases were more likely than controls to lack health insurance (odds ratio [OR]=2.5; 95% confidence interval [CI]=1.1-5.7), lack a primary care provider (OR=6.3; CI=2.3-16.8), and to not have received advice about HIV or STI testing or prevention (OR=5.4; CI=1.3-21.5) or disclose their sexual identity (OR=7.0; CI=1.6-29.2) to a health care provider. In multivariate analysis, lacking a primary health care provider (adjusted odds ratio [AOR]=4.5; CI=1.4-14.7) and not disclosing sexual identity to a health care provider (AOR=8.6; CI=1.8-40.0) were independent risk factors for HIV infection among African American MSM. HIV prevention interventions for African American MSM should address access to primary health care providers for HIV/STI prevention and testing services and the need for increased discussions about sexual health, sexual identity, and sexual behaviors between providers and patients in an effort to reduce HIV incidence and HIV-related health disparities.

Cost-effectiveness of HIV screening in STD clinics, emergency departments, and inpatient units: a model-based analysis.

BACKGROUND: Identifying and treating persons with human immunodeficiency virus (HIV) infection early in their disease stage is considered an effective means of reducing the impact of the disease. We compared the cost-effectiveness of HIV screening in three settings, sexually transmitted disease (STD) clinics serving men who have sex with men, hospital emergency departments (EDs), settings where patients are likely to be diagnosed early, and inpatient diagnosis based on clinical manifestations. METHODS AND FINDINGS: We developed the Progression and Transmission of HIV/AIDS model, a health state transition model that tracks index patients and their infected partners from HIV infection to death. We used program characteristics for each setting to compare the incremental cost per quality-adjusted life year gained from early versus late diagnosis and treatment. We ran the model for 10,000 index patients for each setting, examining alternative scenarios, excluding and including transmission to partners, and assuming HAART was initiated at a CD4 count of either 350 or 500 cells/µL. Screening in STD clinics and EDs was cost-effective compared with diagnosing inpatients, even when including only the benefits to the index patients. Screening patients in STD clinics, who have less-advanced disease, was cost-effective compared with ED screening when treatment with HAART was initiated at a CD4 count of 500 cells/µL. When the benefits of reduced transmission to partners from early diagnosis were included, screening in settings with less-advanced disease stages was cost-saving compared with screening later in the course of infection. The study was limited by a small number of observations on CD4 count at diagnosis and by including transmission only to first generation partners of the index patients. CONCLUSIONS: HIV prevention efforts can be advanced by screening in settings where patients present with less-advanced stages of HIV infection and by initiating treatment with HAART earlier in the course of infection.

HIV screening programs in US emergency departments: a cross-site comparison of structure, process, and outcomes.

OBJECTIVE: We present findings from a multisite evaluation that systematically compares HIV screening programs in 6 emergency departments (EDs). METHODS: From 2007 to 2008, we collected previous-year data on structural factors, process attributes, testing outcomes, and cost-effectiveness from 6 ED HIV testing programs operating for 6 months or longer. We administered questionnaires to program directors, conducted site visits, and interviewed key informants. RESULTS: HIV care providers (n=3 sites), emergency physicians (n=2), or health departments (n=1) initiated the testing programs. ED leadership and providers helped design and implement the programs (n=5), and emergency physicians or administrators provided daily oversight (n=5). Testing strategies included targeted (patients selected from at-risk populations; n=2), nontargeted (patients selected without regard to risk or intention of testing all; n=3), and universal (all patients selected; n=1) screening. Testing was conducted by supplemental staff (n=4) and existing hospital staff (n=2). ED testing programs were funded by grants (n=3), city HIV prevention/care budgets (n=2), or the hospital (n=1). The median percentage of census tested was 4.7% (range 2.1% to 8.4%). The median rate of preliminary positive test results was 1.2% (range 1.0% to 7.3%). The median confirmed new HIV diagnosis rate was 0.9% (range 0.8% to 6.4%). The median linkage to care rate was 92.0% (range 50% to 100%). The median cost per patient receiving a new diagnosis and linked to care was $10,200 (range $3,400 to $12,300). CONCLUSION: Although structure and process of screening programs varied across EDs, outcomes were similar, which suggests that with current ED environments, testing methods, and resources available, the capacity and structure to increase testing in EDs has limits. These ED HIV screening programs were cost-effective according to standard thresholds.

Costs and effectiveness of finding new HIV diagnoses by using rapid testing in transgender communities.

We assessed the costs and effectiveness of rapid HIV testing services provided to transgender communities in New York City and San Francisco from April 2005 to December 2006. Program costs were estimated based on service provider's perspective and included the costs attributable to staff time, incentives, transportation, test kits, office space, equipment, supplies, and utilities. The average annual numbers of persons tested were 195 and 106 persons and numbers notified of new HIV diagnoses were 35 (18.2%) in New York City and 8 (7.3%) in San Francisco, respectively. The estimated annual program costs were $125,879 and $64,323 and average costs per person notified of new diagnosis were $3,563 and $8,284 in New York City and San Francisco, respectively. The primary reason for differences in program costs by site was differences in the proportion of undiagnosed HIV infection among persons tested. Our findings can inform decisions about program planning and allocation of limited HIV testing resources.

Cost-effectiveness of pooled nucleic acid amplification testing for acute HIV infection after third-generation HIV antibody screening and rapid testing in the United States: a comparison of three public health settings.

BACKGROUND: Detection of acute HIV infection (AHI) with pooled nucleic acid amplification testing (NAAT) following HIV testing is feasible. However, cost-effectiveness analyses to guide policy around AHI screening are lacking; particularly after more sensitive third-generation antibody screening and rapid testing. METHODS AND FINDINGS: We conducted a cost-effectiveness analysis of pooled NAAT screening that assessed the prevention benefits of identification and notification of persons with AHI and cases averted compared with repeat antibody testing at different intervals. Effectiveness data were derived from a Centers for Disease Control and Prevention AHI study conducted in three settings: municipal sexually transmitted disease (STD) clinics, a community clinic serving a population of men who have sex with men, and HIV counseling and testing sites. Our analysis included a micro-costing study of NAAT and a mathematical model of HIV transmission. Cost-effectiveness ratios are reported as costs per quality-adjusted life year (QALY) gained in US dollars from the societal perspective. Sensitivity analyses were conducted on key variables, including AHI positivity rates, antibody testing frequency, symptomatic detection of AHI, and costs. Pooled NAAT for AHI screening following annual antibody testing had cost-effectiveness ratios exceeding US$200,000 per QALY gained for the municipal STD clinics and HIV counseling and testing sites and was cost saving for the community clinic. Cost-effectiveness ratios increased substantially if the antibody testing interval decreased to every 6 months and decreased to cost-saving if the testing interval increased to every 5 years. NAAT was cost saving in the community clinic in all situations. Results were particularly sensitive to AHI screening yield. CONCLUSIONS: Pooled NAAT screening for AHI following negative third-generation antibody or rapid tests is not cost-effective at recommended antibody testing intervals for high-risk persons except in very high-incidence settings.

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Emergency medicine public health research funded by federal agencies: progress and priorities.

The emergency department (ED) visit provides an opportunity to impact the health of the public throughout the entire spectrum of care, from prevention to treatment. As the federal government has a vested interest in funding research and providing programmatic opportunities that promote the health of the public, emergency medicine (EM) is prime to develop a research agenda to advance the field. EM researchers need to be aware of federal funding opportunities, which entails an understanding of the organizational structure of the federal agencies that fund medical research, and the rules and regulations governing applications for grants. Additionally, there are numerous funding streams outside of the National Institutes of Health (NIH; the primary federal health research agency). EM researchers should seek funding from agencies according to each agency's mission and aims. Finally, while funds from the Department of Health and Human Services (HHS) are an important source of support for EM research, we need to look beyond traditional sources and appeal to other agencies with a vested interest in promoting public health in EDs. EM requires a broad skill set from a multitude of medical disciplines, and conducting research in the field will require looking for funding opportunities in a variety of traditional and not so traditional places within and without the federal government. The following is the discussion of a moderated session at the 2009 Academic Emergency Medicine consensus conference that included panel discussants from the National Institutes of Mental Health, Drug Abuse, and Alcoholism and Alcohol Abuse and the Centers for Disease Control and Prevention (CDC). Further information is also provided to discuss those agencies and centers not represented.

Cost-effectiveness of finding new HIV diagnoses using rapid HIV testing in community-based organizations.

OBJECTIVE: We assessed the cost-effectiveness of determining new human immunodeficiency virus (HIV) diagnoses using rapid HIV testing performed by community-based organizations (CBOs) in Kansas City, Missouri, and Detroit, Michigan. METHODS: The CBOs performed rapid HIV testing during April 2004 through March 2006. In Kansas City, testing was performed in a clinic and in outreach settings. In Detroit, testing was performed in outreach settings only. Both CBOs used mobile testing vans. Measures of effectiveness were the number of HIV tests performed and the number of people notified of new HIV diagnoses, based on rapid tests. We retrospectively collected program costs, including those for personnel, test kits, mobile vans, and facility space. RESULTS: The CBO in Kansas City tested a mean of 855 people a year in its clinic and 703 people a year in outreach settings. The number of people notified of new HIV diagnoses was 19 (2.2%) in the clinic and five (0.7%) in outreach settings. The CBO in Detroit tested 976 people a year in outreach settings, and the number notified of new HIV diagnoses was 15 (1.5%). In Kansas City, the cost per person notified of a new HIV diagnosis was $3,637 in the clinic and $16,985 in outreach settings. In the Detroit outreach settings, the cost per notification was $13,448. CONCLUSIONS: The cost of providing a new HIV diagnosis was considerably higher in the outreach settings than in the clinic. The variation can be largely explained by differences in the number of undiagnosed infections among the people tested and by the costs of purchasing and operating a mobile van.