Loneliness among older adults living with HIV: the "older old" may be less lonely than the "younger old".

Loneliness is common among older (age 50+) people living with HIV (PLWH). However, little is known about the prevalence of loneliness across subgroups of older PLWH, and the factors that impact loneliness. An online questionnaire was used to collect data from 998 older PLWH. Of those, 61% were 50-59 years old and 39% were 60 or older. The majority were male (89%), gay (77%), and white (69%). Fifty-one percent of participants were classified as lonely. The prevalence of loneliness was lower in the older age group, 46.2% vs. 53.8% (Χ2 = 5.53, p = 0.02). Covariates associated with loneliness included being younger, being single, having at least a four-year college degree, living alone, screening positive for depression, using recreational drugs, smoking tobacco, having a lower quality of life, and not feeling close to friends. Logistic regression analysis showed that the "younger old" were at 26% greater risk of loneliness, after controlling for the effects of these covariates (RR 1.26, 95% CI: 1.06-1.45). Reasons why the "older old" were less lonely may include lower rates of depression and lower likelihood of feeling distant from friends. Understanding factors that protect the "older old" against loneliness may provide guidance for future interventions.

Identifying an early treatment window for predicting breast cancer response to neoadjuvant chemotherapy using immunohistopathology and hemoglobin parameters.

BACKGROUND: Breast cancer pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) varies with tumor subtype. The purpose of this study was to identify an early treatment window for predicting pCR based on tumor subtype, pretreatment total hemoglobin (tHb) level, and early changes in tHb following NAC. METHODS: Twenty-two patients (mean age 56 years, range 34-74 years) were assessed using a near-infrared imager coupled with an Ultrasound system prior to treatment, 7 days after the first treatment, at the end of each of the first three cycles, and before their definitive surgery. Pathologic responses were dichotomized by the Miller-Payne system. Tumor vascularity was assessed from tHb; vascularity changes during NAC were assessed from a percentage tHb normalized to the pretreatment level (%tHb). After training the logistic prediction models using the previous study data, we assessed the early treatment window for predicting pathological response according to their tumor subtype (human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), triple-negative (TN)) based on tHb, and %tHb measured at different cycles and evaluated by the area under the receiver operating characteristic (ROC) curve (AUC). RESULTS: In the new study cohort, maximum pretreatment tHb and %tHb changes after cycles 1, 2, and 3 were significantly higher in responder Miller-Payne 4-5 tumors (n = 13) than non-or partial responder Miller-Payne 1-3 tumors (n = 9). However, no significance was found at day 7. The AUC of the predictive power of pretreatment tHb in the cohort was 0.75, which was similar to the performance of the HER2 subtype as a single predictor (AUC of 0.78). A greater predictive power of pretreatment tHb was found within each subtype, with AUCs of 0.88, 0.69, and 0.72, in the HER2, ER, and TN subtypes, respectively. Using pretreatment tHb and cycle 1 %tHb, AUC reached 0.96, 0.91, and 0.90 in HER2, ER, and TN subtypes, respectively, and 0.95 regardless of subtype. Additional cycle 2 %tHb measurements moderately improved prediction for the HER2 subtype but did not improve prediction for the ER and TN subtypes. CONCLUSIONS: By combining tumor subtypes with tHb, we predicted the pCR of breast cancer to NAC before treatment. Prediction accuracy can be significantly improved by incorporating cycle 1 and 2 %tHb for the HER2 subtype and cycle 1 %tHb for the ER and TN subtypes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02092636 . Registered in March 2014.

Prevalence of Medical Conditions Potentially Amenable to Cellular Therapy among Families Privately Storing Umbilical Cord Blood.

Introduction Little is known about the prevalence of conditions potentially amenable to cellular therapy among families storing umbilical cord blood in private cord blood banks. Methods A cross-sectional study of families with at least one child who stored umbilical cord blood in the largest private cord blood bank in the United States was performed. Respondent families completed a questionnaire to determine whether children with stored cord blood or a first-degree relative had one or more of 16 conditions amenable primarily to allogeneic stem cell transplant ("transplant indications") or 16 conditions under investigation for autologous stem cell infusion ("regenerative indications"), regardless of whether they received a transplant or infusion. Results 94,803 families responded, representing 33.3 % of those surveyed. Of respondent families, 16.01 % indicated at least one specified condition. 1.64 % reported at least one first-degree member with a transplant indication potentially treatable with an allogeneic stem cell transplant. The most common transplant indications reported among first-degree family members were Non-Hodgkin's Lymphoma (0.33 %), Hodgkin's Lymphoma (0.30 %), and Acute Lymphoblastic Leukemia (0.28 %). 4.23 % reported at least one child with a regenerative indication potentially treatable with an autologous stem cell infusion. The most common regenerative indications among children with stored umbilical cord blood were Autism/Autism Spectrum Disorder/Apraxia (1.93 %), Other Developmental Delay (1.36 %), and Congenital Heart Defect (0.87 %). Discussion Among families storing umbilical cord blood in private cord blood banks, conditions for which stem cell transplant or infusion may be indicated, or are under investigation, appear to be prevalent, especially for regenerative medicine indications.

Assessment of Functional Differences in Malignant and Benign Breast Lesions and Improvement of Diagnostic Accuracy by Using US-guided Diffuse Optical Tomography in Conjunction with Conventional US.

Purpose To investigate ultrasonography (US)-guided diffuse optical tomography to distinguish the functional differences of hemoglobin concentrations in a wide range of malignant and benign breast lesions and to improve breast cancer diagnosis in conjunction with conventional US. Materials and Methods The study protocol was approved by the institutional review boards and was HIPAA compliant. Written informed consent was obtained from all patients. Patients (288 women; mean age, 50 years; range, 17-94 years) who underwent US-guided biopsy were imaged with a handheld US and optical probe. The US-imaged lesion was used to guide reconstruction of light absorption maps at four wavelengths, and total hemoglobin (tHb), oxygenated hemoglobin (oxyHb), and deoxygenated hemoglobin (deoxyHb) were computed from the absorption maps. A threshold (80 µmol/L) was chosen on the basis of this study population. Two radiologists retrospectively evaluated US images on the basis of the US Breast Imaging Reporting and Data System lexicon, and a lesion was considered malignant when a score of 4C or 5 was given or a lesion had tHb greater than 80 µmol/L. A two-sample t test was used to calculate significance between groups, and Spearman ρ was computed between hemoglobin parameters and tumor pathologic grades. Results Three tumors were Tis, 37 were T1, 19 were T2-T4 carcinomas, and 233 were benign lesions. The mean maximum tHb, oxyHb, and deoxyHb of Tis-T1 and T2-T4 groups were 89.3 µmol/L ± 20.2 (standard deviation), 65.0 µmol/L ± 20.8, and 33.5 µmol/L ± 11.3, respectively, and 84.7 µmol/L ± 32.8, 57.1 µmol/L ± 19.8, and 34.7 µmol/L ± 18.9, respectively. The corresponding values of benign lesions were 54.1 µmol/L ± 23.5, 38.0 µmol/L ± 17.4, and 25.2 µmol/L ± 13.8, respectively. The mean maximum tHb, oxyHb, and deoxyHb were significantly higher in the malignant groups than the benign group (P <.001, <.001, and .041, respectively). For malignant lesions, the mean maximum tHb moderately correlated with tumor histologic grade and nuclear grade (ρ = 0.283 and 0.315, respectively). The mean maximum oxyHb moderately correlated with tumor nuclear grade (ρ = 0.267). When radiologists' US diagnosis and the tHb were used together, the sensitivity, specificity, positive predictive value, and negative predictive value were 96.6%-100%, 77.3%-83.3%, 52.7%-59.4%, and 99.0%-100%, respectively, for the combined malignant group. Conclusion The tHb and oxyHb correlate with breast cancer pathologic grade and can be used as an adjunct to US to improve sensitivity and negative predictive value in breast cancer diagnosis. (©) RSNA, 2016 Online supplemental material is available for this article.

Demographic determinants of syphilis seroprevalence among U.S. blood donors, 2011-2012.

BACKGROUND: No cases of transfusion-transmitted syphilis have been described for over four decades. While there is mandatory transfusion screening for syphilis, the absence of transmission is in part ascribed to a low prevalence of syphilis in the blood donor population, the concomitant use of antibiotics in a high proportion of transfusion recipients, allied with poor survival of T. pallidum during refrigerated storage of blood products. METHODS: A cross-sectional retrospective data analysis was conducted to ascertain the prevalence of Treponema pallidum antibodies in U.S. blood donors by demography and geography. Routine blood donation testing data and demographics were extracted from the data warehouse of a large network of U.S. blood centers. Crude and adjusted prevalence of T. pallidum antibodies and active syphilis infection were calculated, and GIS mapping was used to illustrate geographic distribution. RESULTS: The prevalence of T. pallidum seropositivity and active syphilis in first time donors was 162.6 (95% CI 145.5-181.2) per 100,000 donors and 15.8 (95% CI 10.8-22.3) per 100,000 donors, respectively. The odds of T. pallidum seropositivity were significantly elevated in African American (OR = 18.9, 95% CI 14.2-25.2), and Hispanic (OR = 2.8, 95% CI 2.0-3.8) as compared to Caucasian donors. Similarly, the odds of active T. pallidum infections were significantly higher in African American (OR 15.0, 95% CI 7.0-32.3) and Hispanic (OR = 5.8, 95% CI 2.9-11.6) as compared to Caucasian donors. Syphilis seropositivity was associated with first time blood donation, increasing age, lower education, birth outside the US, and positive tests for HIV and HCV. Geographically, T. pallidum seropositivity was increased in southern and western regions of the US. CONCLUSIONS: Given the low seroprevalence of syphilis in blood donors, continued screening remains debatable; however it may provide a public health benefit through surveillance of at-risk populations.

Breast cancer: assessing response to neoadjuvant chemotherapy by using US-guided near-infrared tomography.

PURPOSE: To assess initial breast tumor hemoglobin (Hb) content before the initiation of neoadjuvant chemotherapy, monitor the Hb changes at the end of each treatment cycle, and correlate these findings with tumor pathologic response. MATERIALS AND METHODS: The HIPAA-compliant study protocol was approved by the institutional review boards of both institutions. Written informed consent was obtained from all patients. Patients who were eligible for neoadjuvant chemotherapy were recruited between December 2007 and May 2011, and their tumor Hb content was assessed by using a near-infrared imager coupled with an ultrasonography (US) system. Thirty-two women (mean age, 48 years; range, 32-82 years) were imaged before treatment, at the end of every treatment cycle, and before definitive surgery. The patients were graded in terms of their final pathologic response on the basis of the Miller-Payne system as nonresponders and partial responders (grades 1-3) and near-complete and complete responders (grades 4 and 5). Tumor vascularity was assessed from total Hb (tHb), oxygenated Hb (oxyHb), and deoxygenated Hb (deoxyHb) concentrations. Tumor vascularity changes during treatment were assessed from percentage tHb normalized to the pretreatment level. A two-sample two-sided t test was used to calculate the P value and to evaluate statistical significance between groups. Bonferroni-Holm correction was applied to obtain the corrected P value for multiple comparisons. RESULTS: There were 20 Miller-Payne grade 1-3 tumors and 14 grade 4 or 5 tumors. Mean maximum pretreatment tHb, oxyHb, and deoxyHb levels were significantly higher in grade 4 and 5 tumors than in grade 1-3 tumors (P = .005, P = .008, and P = .017, respectively). The mean percentage tHb changes were significantly higher in grade 4 or 5 tumors than in grade 1-3 tumors at the end of treatment cycles 1-3 (P = .009 and corrected P = .009, P = .002 and corrected P = .004, and P < .001 and corrected P < .001, respectively). DISCUSSION: These findings indicate that initial tumor Hb content is a strong predictor of final pathologic response. Additionally, the tHb changes during early treatment cycles can further predict final pathologic response.

Early-stage invasive breast cancers: potential role of optical tomography with US localization in assisting diagnosis.

PURPOSE: To investigate the potential role of optical tomography in the near-infrared (NIR) spectrum with ultrasonographic (US) localization as a means of differentiating early-stage cancers from benign lesions of the breast. MATERIALS AND METHODS: The protocol was approved by the institutional review boards and was HIPAA compliant; all participants signed an informed consent. One hundred seventy-eight consecutive women (mean age, 52 years; range, 21-89 years) who underwent US-guided biopsy were imaged with a hand-held probe consisting of a coregistered US transducer and an NIR imager. The lesion location provided by coregistered US was used to guide optical imaging. Light absorption was measured at two optical wavelengths. From this measurement, tumor angiogenesis was assessed on the basis of calculated total hemoglobin concentration (tHb) and was correlated with core biopsy results. For patients diagnosed with carcinomas and followed up with subsequent excision, the tHb was correlated with pathologic parameters. RESULTS: There were two in situ carcinomas (Tis), 35 T1 carcinomas, 24 T2-T4 carcinomas, and 114 benign lesions. The mean maximum and mean average tHb of the Tis-T1 group were 102.0 micromol/L +/- 28.5 (standard deviation) and 71.9 micromol/L +/- 18.8, and those of the T2-T4 group were 100.3 micromol/L +/- 26.4 and 67.0 micromol/L +/- 18.3, respectively. The mean maximum and mean average tHb of the benign group were 55.1 micromol/L +/- 22.7 and 39.1 micromol/L +/- 14.9, respectively. Both mean maximum and mean average tHb levels were significantly higher in the malignant groups than they were in the benign group (P < .001). The sensitivity, specificity, positive predictive value, and negative predictive value for Tis-T1 cancers were 92%, 93%, 81%, and 97%. The corresponding values for T2-T4 tumors were 75%, 93%, 69%, and 95%. CONCLUSION: The angiogenesis (tHb) contrast imaged by using the NIR technique with US holds promise as an adjunct to mammography and US for distinguishing early-stage invasive breast cancers from benign lesions.

Global implementation of human papillomavirus (HPV) vaccine: lessons from hepatitis B vaccine.

Development of safe and effective vaccines against human papillomavirus (HPV)-the second vaccine against a major human cancer-is one of the most important medical and public health achievements of this century. As with all new vaccines, HPV is currently expensive and this cost precludes its use in the developing world, which has the greatest burden of disease from HPV-related cancers. Hepatitis B (HB) virus vaccine, which prevents chronic HB infection and related cirrhosis and liver cancer, has been successfully introduced as a routine vaccine for children in 89% of countries, including the poorest. The success of this vaccine provides a model for the introduction of HPV vaccine and control of cervical and other HPV-related cancers and genital warts. Lessons learned from HB vaccine introduction are relevant to our efforts to introduce HPV vaccine globally. As with HB vaccine, introduction of HPV vaccine into national immunization programs and routine use of this vaccine, funded by governments, will be needed to control HPV-related disease on a global basis. Global funding support will be needed to make control a reality for the poorest countries, and the program to accomplish this, the Global Alliance for Vaccines and Immunization (GAVI), has already expressed great interest in including HPV vaccine. For this to occur, the manufacturers will need to dramatically reduce the vaccine price for the poorest developing countries, and tier prices for wealthier developing countries not eligible for GAVI support. Countries will need to decide on the priority of HPV control in the context of other important new vaccines against pneumococcal pneumonia and rotavirus diarrhea.

Comparison of children diagnosed with cerebral palsy in a private cord blood bank to an epidemiological sample.

BACKGROUND: Although cord blood (CB) stem cell research is being conducted for treatment of cerebral palsy (CP), little is known about children with CP and stored CB. AIMS: To compare demographic and clinical characteristics of children with CP and stored CB to children with CP identified in a population-based study. METHODS AND PROCEDURES: The Longitudinal Umbilical Stem cell monitoring and Treatment REsearch (LUSTRE®) Registry recruited children from the largest US private CB bank. Demographics, co-morbidities, and gross motor function (GMFCS level and walking ability) were collected and, where possible, compared with the CDC's Autism and Developmental Disabilities Monitoring (ADDM) Network. OUTCOMES AND RESULTS: 114 LUSTRE participants were compared to 451 ADDM participants. LUSTRE participants were more likely to be white, but sex distribution was similar. Co-morbidities (autism and epilepsy) and functional mobility were also similar. CONCLUSIONS AND IMPLICATIONS: The results of this analysis suggest that while children diagnosed with CP and with access to stored CB differ from a broader population sample in terms of demographics, they have similar clinical severity and comorbidity profiles. As such, LUSTRE may serve as a valuable source of data for the characterization of individuals with CP, including individuals who have or will receive CB infusions.

Optimal probing of optical contrast of breast lesions of different size located at different depths by US localization.

We report a frequency domain optical tomography system utilizing three RF modulation frequencies, which are optimized for probing breast lesions of different size located at different depths. A real-time co-registered ultrasound scanner is used to provide on-site estimation of lesion size and location. Based on the lesion information, an optimal light modulation frequency can be selected, which may yield more accurate estimates of lesion angiogenesis and hypoxia. Phantom experiments have demonstrated that a high modulation frequency, such as 350Mhz, is preferable for probing small lesions closer to the surface while a low modulation frequency, such as 50Mhz, is desirable for imaging deeper and larger lesions. A clinical example of a large invasive carcinoma is presented to demonstrate the application of this novel technique.

Editorial on "What is a potentially damaging vaccination delay in children younger than 2 years?"

Control of hepatitis B through routine infant immunization in more than 95% of countries has reduced the prevalence of chronic hepatitis carriers to less than 1%-2% in immunized cohorts of children even in high endemicity countries. In that context the authors of this editorial found the results of a paper by Gras et al in this issue concerning. They performed a Delphi survey of 37 French immunization experts and the results concluded that delayed hepatitis B immunization would cause "potential damage" only after 11 years. Large cohorts of French children and adolescents remain susceptible to hepatitis B infection. Given the high rates of immigration to France from areas of higher endemicity, the higher birth rate and degree of integration of these groups into the health system, plus the lower age of sexual debut and the use of injectable drugs in the general population, we cannot agree that a delay of 11 years is acceptable. Rates of adolescent immunization are quite low so relying on protection at this age will yield little in terms of population protection. Loss of confidence in Hepatitis B vaccine following disproved allegations that the vaccine caused Multiple Sclerosis persists in France, and we believe the results of this paper sends a damaging message to health workers and parents in France and beyond.

Utilizing optical tomography with ultrasound localization to image heterogeneous hemoglobin distribution in large breast cancers.

PURPOSE: Angiogenesis in advanced breast cancers is highly distorted and heterogeneous. Noninvasive imaging that can monitor angiogenesis may be invaluable initially for diagnosis and then for assessing tumor response to treatment. By combining ultrasound (US) and near-infrared (NIR) optical imaging, a reliable new technique has emerged for localizing and characterizing tumor angiogenesis within the breast. METHODS: This new technique employs a commercial US transducer coupled with an array of NIR optical fibers mounted on a hand-held probe. The US image is used for lesion localization and for guiding optical imaging reconstruction. Optical sensors are used for imaging tumor total hemoglobin distribution, which is directly related to tumor angiogenesis. RESULTS: Six large breast carcinomas were studied and microvessel density count was then performed on tissue samples obtained from these cancers. Two patients had locally advanced breast cancers and received neoadjuvant chemotherapy for 3 months. In one patient, before chemotherapy, the total hemoglobin distribution showed a high concentration at the cancer periphery; the distribution was later confined to the core area after 3 months of treatment. In another patient, as treatment progressed, the maximum hemoglobin concentration decreased from 255.3, to 147.5, to 76.9 micromol/l with an associated reduction in spatial extension. The other four patients had cancers of 2.0 to 3.0 cm in size and were imaged either at the time of core biopsy or definitive surgery. The histologic microvessel density counts from these tumor samples correlate to hemoglobin distributions with a correlation coefficient of 0.64 (P < .05). CONCLUSION: These initial results suggest that this new imaging technique may have great potential in imaging the heterogeneous vascular distribution of larger breast cancers in vivo and in monitoring treatment-related changes in angiogenesis during chemotherapy.

Ultrasound-guided optical tomographic imaging of malignant and benign breast lesions: initial clinical results of 19 cases.

The diagnosis of solid benign and malignant tumors presents a unique challenge to all noninvasive imaging modalities. Ultrasound is used in conjunction with mammography to differentiate simple cysts from solid lesions. However, the overlapping appearances of benign and malignant lesions make ultrasound less useful in differentiating solid lesions, resulting in a large number of benign biopsies. Optical tomography using near-infrared diffused light has great potential for imaging functional parameters of 1) tumor hemoglobin concentration, 2) oxygen saturation, and 3) metabolism, as well as other tumor distinguishing characteristics. These parameters can differentiate benign from malignant lesions. However, optical tomography, when used alone, suffers from low spatial resolution and target localization uncertainty due to intensive light scattering. Our aim is to combine diffused light imaging with ultrasound in a novel way for the detection and diagnosis of solid lesions. Initial findings of two early-stage invasive carcinomas, one combined fibroadenoma and fibrocystic change with scattered foci of lobular neoplasia/lobular carcinoma in situ, and 16 benign lesions are reported in this paper. The invasive cancer cases reveal about two-fold greater total hemoglobin concentration (mean 119 micromol) than benign cases (mean 67 micromol), and suggest that the discrimination of benign and malignant breast lesions might be enhanced by this type of achievable optical quantification with ultrasound localization. Furthermore, the small invasive cancers are well localized and have wavelength-dependent appearance in optical absorption maps, whereas the benign lesions appear diffused and relatively wavelength-independent.

Effects of a carbohydrate-protein beverage on cycling endurance and muscle damage.

INTRODUCTION: The purpose of this study was to determine whether endurance cycling performance and postexercise muscle damage were altered when consuming a carbohydrate and protein beverage (CHO+P; 7.3% and 1.8% concentrations) versus a carbohydrate-only (CHO; 7.3%) beverage. METHODS: Fifteen male cyclists (mean (.-)VO(2peak) = 52.6 +/- 10.3 mL x kg x min) rode a cycle ergometer at 75% (.-)VO(2peak) to volitional exhaustion, followed 12 - 15 h later by a second ride to exhaustion at 85% (.-)VO(2peak). Subjects consumed 1.8 mL x kg BW of randomly assigned CHO or CHO+P beverage every 15 min of exercise, and 10 mL x kg BW immediately after exercise. Beverages were matched for carbohydrate content, resulting in 20% lower total caloric content per administration of CHO beverage. Subjects were blinded to treatment beverage and repeated the same protocol seven to 14 d later with the other beverage. RESULTS: In the first ride (75% (.-)VO(2peak)), subjects rode 29% longer (P < 0.05) when consuming the CHO+P beverage (106.3 +/- 45.2 min) than the CHO beverage (82.3 +/- 32.6 min). In the second ride (85% (.-)VO(2peak)), subjects performed 40% longer when consuming the CHO+P beverage (43.6 +/- 12.5 min) than when consuming the CHO beverage (31.2 +/- 8.7 min). Peak postexercise plasma CPK levels, indicative of muscle damage, were 83% lower after the CHO+P trial (216.3 +/- 122.0 U x L) than the CHO trial (1318.1 +/- 1935.6 U x L). There were no significant differences in exercising levels of (.-)VO(2), ventilation, heart rate, RPE, blood glucose, or blood lactate between treatments in either trial. CONCLUSION: A carbohydrate beverage with additional protein calories produced significant improvements in time to fatigue and reductions in muscle damage in endurance athletes. Further research is necessary to determine whether these effects were the result of higher total caloric content of the CHO+P beverage or due to specific protein-mediated mechanisms.

Key outcomes and addressing remaining challenges--perspectives from a final evaluation of the China GAVI project.

During the China GAVI project, implemented between 2002 and 2010, more than 25 million children received hepatitis B vaccine with the support of project, and the vaccine proved to be safe and effective. With careful consideration for project savings, China and GAVI continually adjusted the budget, additionally allowing the project to spend operational funds to support demonstration projects to improve timely birth dose (TBD), conduct training of EPI staff, and to monitor the project impact. Results from the final evaluation indicated the achievement of key outcomes. As a result of government co-investment, human resources at county level engaged in hepatitis B vaccination increased from 29 per county on average in 2002 to 66 in 2009. All project counties funded by the GAVI project use auto-disable syringes for hepatitis B vaccination and other vaccines. Surveyed hepatitis B vaccine coverage increased from 71% in 2002 to 93% in 2009 among infants. The HBsAg prevalence declined from 9.67% in 1992 to 0.96% in 2006 among children under 5 years of age. However, several important issues remain: (1) China still accounts for the largest annual number of perinatal HBV infections (estimated 84,121) in the WHO WPR region; (2) China still lacks a clear national policy for safe injection of vaccines; (3) vaccination of high risk adults and protection of health care workers are still not implemented; (4) hepatitis B surveillance needs to be refined to more accurately monitor acute hepatitis B; and (5) a program for treatment of persons with chronic HBV infection is needed. Recommendations for future hepatitis B control include: using the lessons learned from the China GAVI project for future introductions of new vaccines; addressing unmet needs with a second generation hepatitis B program to reach every infant, including screening mothers, and providing HBIG for infants born to HBsAg positive mothers; expanding vaccination to high risk adults; addressing remaining unsafe injection issues; and improving monitoring of acute hepatitis B. This paper describes findings and discusses perspectives from a final project evaluation, a national stratified validated cross-sectional survey done in October 2010.

Origins, design and implementation of the China GAVI project.

China received GAVI support for hepatitis B vaccination in 2001 because of high disease burden and strong government will to protect infants at risk. The China/GAVI project, implemented since 2002, was funded 50% by GAVI and 50% by the Government of China. The purpose of the project was to increase coverage of hepatitis B vaccine through a pro-poor approach targeting all counties of the 12 Western provinces and poverty counties of the 10 Central provinces, to accelerate integration of hepatitis B vaccine into routine immunization, and assure immunization injection safety. The mechanism of internal coordination among multiple government entities and international cooperation was established and comprehensive strategies were used to improve vaccine coverage and injection safety. After 8 years of implementation, 193,000 health care workers in 118,316 health care facilities participated in the project, mostly at the township hospitals level (55,051) and in community centres (104,547). Through the China GAVI project, the 85% HepB3 coverage goal was reached in 98% of GAVI China project counties, the 75% timely birth dose (TBD) coverage goal was reached in 80% of GAVI project counties, and AD syringes were introduced into 100% of GAVI-supported areas. Additionally, the GAVI project was instrumental in convincing the Chinese Government to sustainably introduce and fully fund HepB vaccine for all newborns in China. The impact of hepB vaccination on HBsAg prevalence was observed throughout China, as HBsAg prevalence (previously ~10%) is now less than 1% among children under 5 years of age.

Evaluation of policies and practices to prevent mother to child transmission of hepatitis B virus in China: results from China GAVI project final evaluation.

BACKGROUND: Mother to Child Transmission (MTCT) has remained a leading cause of HBV infection in China, accounting for 40% of total infections. Providing hepatitis B vaccine (HepB) to all infants within 24h of birth (Timely Birth Dose, TBD), and subsequent completion of at least 3 vaccine doses is key to preventing perinatal HBV infection. In 2002, with the financial support of the Global Alliance on Vaccine and Immunization (GAVI) targeted to Western region and 223 poverty-affected counties in Central region, hepatitis B vaccine was provided for free. In 2010, we evaluated the China GAVI project in terms of its activities to prevent perinatal infections. OBJECTIVE: The objectives of the evaluation were to (1) measure achievements in the China GAVI project in terms of TBD coverage, and (2) describe practices for HBsAg screening of pregnant women and HBIG use outside the GAVI China project. METHODS: We used the methods recommended by WHO to select a cluster sample of health care facilities for the purpose of an injection safety assessment. We stratified China into three regions based on economic criteria, and selected eight counties with a probability proportional to population size in each region. In each selected county, we selected (a) 10 townships at random among the list of townships of the county and (b) the one county level hospital. In each hospital, we abstracted 2002 through 2009 records to collect information regarding birth cohorts, hospitals deliveries, vaccine management, hepatitis B vaccination delivery, HBsAg screening practices and results, and HBIG administration. In addition, in all hospitals, we abstracted records regarding the delivery of TBD. RESULTS: We visited 244 facilities in the three regions, including 24 county hospitals and 220 township hospitals. We reviewed 837,409 birth summary records, 699,249 for infants born at county or township hospitals. Hospital delivery rates increased from 58% in 2002 to 93% in 2009. Surveyed TBD coverage increased from 60% in 2002 to 91% in 2009 (+31%). Surveyed TBD coverage among children born in hospitals increased from 73% in 2002 to 98% in 2009. Between 2002 and 2009, the proportion of pregnant women screened for HBsAg increased from 64% in 2002 to 85% in 2009. In 2009, the proportion of infants born to women screened and found to be HBsAg positive who did not receive any immunization within 24h after birth ranged from 0% to 0.7% across regions. CONCLUSIONS: Increased availability of hepatitis B vaccine, along with efforts to improve hospital deliveries, increased TBD coverage in China. This decreased perinatal HBV transmission and will reduce disease burden in the future. Screening for HBsAg to guide HBIG administration has begun, but with heterogeneous immuno-prophylaxis practices and a poor system for follow up.