Electronic viral load (VL) Test Ordering and Result Reporting System (ETORRS) was introduced to create data exchange between the existing VL database and the electronic medical record (EMR) system, with the aim of reducing laboratory test results turnaround time (TAT), improving data quality, and supporting timely clinical response for patients with high VL. This use case is an illustrative example of initiating and adopting the principles of health information exchange for a priority health program.

INTRODUCTION: Malaria, a devastating febrile illness caused by protozoan parasites, sickened 247,000,000 people in 2021 and killed 619,000, mostly children and pregnant women in sub-Saharan Africa. A highly effective vaccine is urgently needed, especially for Plasmodium falciparum (Pf), the deadliest human malaria parasite. AREAS COVERED: Sporozoites (SPZ), the parasite stage transmitted by Anopheles mosquitoes to humans, are the only vaccine immunogen achieving > 90% efficacy against Pf infection. This review describes > 30 clinical trials of PfSPZ vaccines in the U.S.A., Europe, Africa, and Asia, based on first-hand knowledge of the trials and PubMed searches of 'sporozoites,' 'malaria,' and 'vaccines.' EXPERT OPINION: First generation (radiation-attenuated) PfSPZ vaccines are safe, well tolerated, 80-100% efficacious against homologous controlled human malaria infection (CHMI) and provide 18-19 months protection without boosting in Africa. Second generation chemo-attenuated PfSPZ are more potent, 100% efficacious against stringent heterologous (variant strain) CHMI, but require a co-administered drug, raising safety concerns. Third generation, late liver stage-arresting, replication competent (LARC), genetically-attenuated PfSPZ are expected to be both safe and highly efficacious. Overall, PfSPZ vaccines meet safety, tolerability, and efficacy requirements for protecting pregnant women and travelers, with licensure for these populations possible within five years. Protecting children and mass vaccination programs to block transmission and eliminate malaria are long-term objectives.

Since the Global Polio Eradication Initiative (GPEI) began in 1988, the number of wild poliovirus (WPV) cases has declined by >99.99%. Five of the six World Health Organization (WHO) regions have been certified free of indigenous WPV, and WPV serotypes 2 and 3 have been declared eradicated globally (1). WPV type 1 (WPV1) remains endemic only in Afghanistan and Pakistan (2,3). Before the outbreak described in this report, WPV1 had not been detected in southeastern Africa since the 1990s, and on August 25, 2020, the WHO African Region was certified free of indigenous WPV (4). On February 16, 2022, WPV1 infection was confirmed in one child living in Malawi, with onset of paralysis on November 19, 2021. Genomic sequence analysis of the isolated poliovirus indicated that it originated in Pakistan (5). Cases were subsequently identified in Mozambique. This report summarizes progress in the outbreak response since the initial report (5). During November 2021-December 2022, nine children and adolescents with paralytic polio caused by WPV1 were identified in southeastern Africa: one in Malawi and eight in Mozambique. Malawi, Mozambique, and three neighboring countries at high risk for WPV1 importation (Tanzania, Zambia, and Zimbabwe) responded by increasing surveillance and organizing up to six rounds of national and subnational polio supplementary immunization activities (SIAs).* Although no cases of paralytic WPV1 infection have been reported in Malawi since November 2021 or in Mozambique since August 2022, undetected transmission might be ongoing because of poliovirus surveillance gaps and testing delays. Efforts to further enhance poliovirus surveillance sensitivity, improve SIA quality, and strengthen routine immunization are needed to ensure that WPV1 transmission has been interrupted within 12 months of the first case, thereby preserving the WHO African Region's WPV-free status.

Purpose: Sexual violence (SV) and adolescent relationship abuse (ARA) are common in the U. S. and have strong associations with negative health and wellbeing outcomes. Manhood 2.0 is the first U.S. program designed for community settings to build bystander skills while also challenging harmful gender norms. A cluster-randomized trial comparing Manhood 2.0 to Job Skills, a job readiness training control condition, demonstrated that it is a promising strategy to prevent sexual violence and adolescent relationship abuse. Such community-based interventions may be particularly relevant in lower resource urban settings, and the costs of such prevention programs have not been considered previously. Methods: The aim of the present study is to perform systematic and standardized cost calculations associated with implementing Manhood 2.0 among adolescent males. In addition, this study provides detailed cost information of the community-based intervention program, as well as costs associated with implementing the Job Skills control program. Program implementation data were recorded throughout the study period (20152019) by the Manhood 2.0 study team. Results: The cost of implementing Manhood 2.0 is $4,771 per complete round of program delivery and $451 per participant, which is approximately the same cost as the control Job Skills program ($4,432 and $453 per participant). The marginal cost per additional round of Manhood 2.0 program is $3,682. Conclusion: Implementation of a community-based program requires substantial resources and collaborations with community partners especially in economically disadvantaged neighborhoods. This study provides a snapshot of the cost information of a community-based intervention program from the implementing agencys perspective, which is essential in helping decision-makers understand the costs they will incur by implementing prevention programs and ensuring program feasibility and sustainability. 2022, This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

Despite declaration as a national priority disease, dog rabies remains endemic in Liberia, with surveillance systems and disease control activities still developing. The objective of these initial efforts was to establish animal rabies diagnostics, foster collaboration between all rabies control stakeholders, and develop a short-term action plan with estimated costs for rabies control and elimination in Liberia. Four rabies diagnostic tests, the direct fluorescent antibody (DFA) test, the direct immunohistochemical test (dRIT), the reverse transcriptase polymerase chain reaction (RT-PCR) assay and the rapid immunochromatographic diagnostic test (RIDT), were implemented at the Central Veterinary Laboratory (CVL) in Monrovia between July 2017 and February 2018. Seven samples (n=7) out of eight suspected animals were confirmed positive for rabies lyssavirus, and molecular analyses revealed that all isolates belonged to the Africa 2 lineage, subgroup H. During a comprehensive in-country One Health rabies stakeholder meeting in 2018, a practical workplan, a short-term action plan and an accurately costed mass dog vaccination strategy were developed. Liberia is currently at stage 1.5/5 of the Stepwise Approach towards Rabies Elimination (SARE) tool, which corresponds with countries that are scaling up local-level interventions (e.g. dog vaccination campaigns) to the national level. Overall an estimated 5.3 - 8 million USD invested over 13 years is needed to eliminate rabies in Liberia by 2030. Liberia still has a long road to become free from dog-rabies. However, the dialogue between all relevant stakeholders took place, and disease surveillance considerably improved through implementing rabies diagnosis at the CVL. The joint efforts of diverse national and international stakeholders laid important foundations to achieve the goal of zero dog-mediated human rabies deaths by 2030.

IMPORTANCE: Engaging adolescent boys and young men in preventing violence against women is a potentially impactful public health strategy. OBJECTIVE: To evaluate the effectiveness of a community-based, gender-transformative program (ie, Manhood 2.0) on perpetration of gender-based violence by adolescent boys and young men. DESIGN, SETTING, AND PARTICIPANTS: In this unblinded cluster randomized clinical trial, neighborhoods were designated as the unit of clustering (1:1 allocation). Three-month (ie, time point 2 [T2]) and 9-month (ie, time point 3 [T3]) follow-ups were conducted. The trial took place in 20 Pittsburgh, Pennsylvania, neighborhoods and 1 centrally located site with concentrated disadvantage. Pittsburgh-based adolescent boys and young men (ages 13 to 19 years) were recruited between July 27, 2015, and June 5, 2017, through youth-serving organizations and community-based alternatives to residential placement for juvenile justice-involved youth. Intention-to-treat analysis was conducted from June 2018 to November 2019. INTERVENTIONS: Manhood 2.0, an international program adapted for adolescent boys and young men in US urban communities, encourages these individuals to challenge gender norms that foster violence against women and unhealthy sexual relationships. Individuals in the control population received job-readiness training. Each program was 18 hours. MAIN OUTCOMES AND MEASURES: The primary outcome was change in participant-level perpetration of sexual violence (SV) or adolescent relationship abuse (ARA) at T3. RESULTS: Among 866 participants, 465 individuals (54%) enrolled in 11 intervention clusters and 401 individuals (46%) enrolled in 10 control clusters. In the intervention group, 325 participants (70%) were analyzed at T2 and 334 participants (72%) were analyzed at T3; in the control group, 262 participants (65%) were analyzed at T2 and 301 participants (75%) were analyzed at T3. Mean (SD) age was 15.5 (1.6) years; 609 participants (70%) self-identified as non-Hispanic Black, and 178 (20%) self-identified as Hispanic, multiracial, or other race/ethnicity other than White. Among individuals in the intervention group, 296 participants (64%) reported any SV or ARA perpetration at baseline, and 173 participants (52%) reported any SV or ARA perpetration at T3. Among individuals in the control group, 213 participants (53%) reported any SV or ARA perpetration at baseline, and 124 participants (41%) reported any SV or ARA perpetration at T3). The difference in reduction between groups was not significant. There was no evidence of an intervention effect for the primary outcome (adjusted odds ratio [OR], 1.32; 95% CI, 0.86-2.01; P = .20). CONCLUSIONS AND RELEVANCE: The findings from this evaluation of a community-based gender-transformative program for adolescent boys and young men did not show a significant intervention effect in reducing SV or ARA perpetration between Manhood 2.0 and a job-readiness control program. Combining gender-transformative approaches with job-readiness programs may be relevant for violence prevention in low-resource urban settings. Attention to improving implementation and strategies to sustain such community-based efforts are needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02427061.

PfSPZ Vaccine, composed of radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, is administered by direct venous inoculation (DVI) for maximal efficacy against malaria. A critical issue for advancing vaccines that are administered intravenously is the ability to efficiently administer them across multiple age groups. As part of a pediatric safety, immunogenicity, and efficacy trial in western Kenya, we evaluated the feasibility and tolerability of DVI, including ease of venous access, injection time, and crying during the procedure across age groups. Part 1 was an age de-escalation, dose escalation trial in children aged 13 months-5 years and infants aged 5-12 months; part 2 was a vaccine efficacy trial including only infants, using the most skilled injectors from part 1. Injectors could use a vein viewer, if needed. A total of 1222 injections (target 0.5 mL) were initiated by DVI in 511 participants (36 were 5-9-year-olds, 65 were 13-59-month-olds, and 410 infants). The complete volume was injected in 1185/1222 (97.0%) vaccinations, 1083/1185 (91.4%) achieved with the first DVI. 474/511 (92.8%) participants received only complete injections, 27/511 (5.3%) received at least one partial injection (<0.5 mL), and in 10/511 (2.0%) venous access was not obtained. The rate of complete injections by single DVI for infants improved from 77.1% in part 1 to 92.8% in part 2. No crying occurred in 51/59 (86.4%) vaccinations in 5-9-year-olds, 25/86 (29.1%) vaccinations in 13-59-month-olds and 172/1067 (16.1%) vaccinations in infants. Mean administration time ranged from 2.6 to 4.6 minutes and was longer for younger age groups. These data show that vaccination by DVI was feasible and well tolerated in infants and children in this rural hospital in western Kenya, when performed by skilled injectors. We also report that shipping and storage in liquid nitrogen vapor phase was simple and efficient. (Clinicaltrials.gov NCT02687373).

INTRODUCTION: This study analyzed the associations among male adolescents' gender attitudes, intentions to intervene, witnessing peers' abusive behaviors, and multiple forms of adolescent violence perpetration. This community-based evaluation aims to inform future youth violence prevention efforts through the identification of potential predictors of interpersonal violence perpetration. METHODS: Cross-sectional data were from baseline surveys conducted with 866 male adolescents, aged 13-19 years, from community settings in 20 lower-resource neighborhoods in Pittsburgh, PA (August 2015 - June 2017), as part of a cluster RCT to evaluate a sexual violence prevention program. Participants completed in-person, anonymous electronic surveys about gender attitudes, bystander intentions, witnessing peers' abusive behaviors, violence perpetration, and demographics. The analysis was conducted between 2018 and 2019. RESULTS: The youth identified mostly as African American (70%) or Hispanic, multiracial, or other (21%). Most (88%) were born in the U.S., and 85% were in school. Youth with more equitable gender attitudes had lower odds of self-reported violence perpetration across multiple domains, including dating abuse (AOR=0.46, 95% CI=0.29, 0.72) and sexual harassment (AOR=0.50, 95% CI=0.37, 0.67). The relationship between intentions to intervene and violence perpetration was inconclusive. Witnessing peers engaged in abusive behaviors was associated with increased odds of multiple types of violence perpetration, such as dating abuse (witnessed 3 or more behaviors, AOR=2.41, 95% CI=1.31, 4.44). CONCLUSIONS: This is the first U.S.-based study to elicit information from male adolescents in community-based settings (rather than schools or clinics) about multiple types of interpersonal violence perpetration. Findings support violence prevention strategies that challenge harmful gender and social norms while simultaneously increasing youths' skills in interrupting peers' disrespectful and harmful behaviors.

BACKGROUND: The whole sporozoite PfSPZ Vaccine is being evaluated for malaria prevention. The vaccine is administered intravenously for maximal efficacy. Direct venous inoculation (DVI) with PfSPZ Vaccine has been safe, tolerable, and feasible in adults, but safety data for children and infants are limited. METHODS: We conducted an age de-escalation, dose-escalation randomized controlled trial in Siaya County, western Kenya. Children and infants (5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants and randomized 2:1 to vaccine or normal saline placebo in escalating doses: 1.35x105, 2.7x105, 4.5x105, 9.0x105, and 1.8x106Plasmodium falciparum sporozoites (PfSPZ), with the two highest doses given twice, 8 weeks apart. Solicited adverse events (AEs) were monitored for eight days after vaccination; unsolicited AEs for 29 days; and serious AEs (SAEs) throughout the study. Blood taken pre-vaccination and one-week post-vaccination was tested for IgG antibodies to Pf circumsporozoite protein (PfCSP) using enzyme-linked immunosorbent assay (ELISA). RESULTS: Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs. 41.5%) and unsolicited (83.9% vs. 92.5%) AEs, respectively. No related grade 3 AEs, SAEs, or grade 3 laboratory abnormalities occurred. Most (79.0%) vaccinations were administered by a single DVI. Among those in the 9.0x105 and 1.8x106 PfSPZ groups, 36/45 (80.0%) vaccinees and 4/21 (19.0%) placebo controls developed antibodies to PfCSP, p<0.001. CONCLUSIONS: PfSPZ Vaccine in doses as high as 1.8x106 can be administered to infants and children by DVI, and was safe, well tolerated, and immunogenic.

Background: Under-five and maternal mortality were halved in the Millennium Development Goals (MDG) era, with slower reductions for 2.6 million neonatal deaths and 2.6 million stillbirths. The Every Newborn Action Plan aims to accelerate progress towards national targets, and includes an ambitious Measurement Improvement Roadmap. Population-based household surveys, notably Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys, are major sources of population-level data on child mortality in countries with weaker civil registration and vital statistics systems, where over two-thirds of global child deaths occur. To estimate neonatal/child mortality and pregnancy outcomes (stillbirths, miscarriages, birthweight, gestational age) the most common direct methods are: (1) the standard DHS-7 with Full Birth History with additional questions on pregnancy losses in the past 5 years (FBH(+)) or (2) a Full Pregnancy History (FPH). No direct comparison of these two methods has been undertaken, although descriptive analyses suggest that the FBH(+) may underestimate mortality rates particularly for stillbirths. Methods: This is the protocol paper for the Every Newborn-INDEPTH study (INDEPTH Network, International Network for the Demographic Evaluation of Populations and their Health Every Newborn, Every Newborn Action Plan), aiming to undertake a randomised comparison of FBH(+) and FPH to measure pregnancy outcomes in a household survey in five selected INDEPTH Network sites in Africa and South Asia (Bandim in urban and rural Guinea-Bissau; Dabat in Ethiopia; IgangaMayuge in Uganda; Kintampo in Ghana; Matlab in Bangladesh). The survey will reach >68 000 pregnancies to assess if there is >/=15% difference in stillbirth rates. Additional questions will capture birthweight, gestational age, birth/death certification, termination of pregnancy and fertility intentions. The World Bank's Survey Solutions platform will be tailored for data collection, including recording paradata to evaluate timing. A mixed methods assessment of barriers and enablers to reporting of pregnancy and adverse pregnancy outcomes will be undertaken. Conclusions: This large-scale study is the first randomised comparison of these two methods to capture pregnancy outcomes. Results are expected to inform the evidence base for survey methodology, especially in DHS, regarding capture of stillbirths and other outcomes, notably neonatal deaths, abortions (spontaneous and induced), birthweight and gestational age. In addition, this study will inform strategies to improve health and demographic surveillance capture of neonatal/child mortality and pregnancy outcomes.

BACKGROUND: Building on the declining trend of malaria in Ethiopia, the Federal Ministry of Health aims to eliminate malaria by 2030. As Plasmodium falciparum and Plasmodium vivax are co-endemic in Ethiopia, the use of primaquine is indicated for both transmission interruption and radical cure, respectively. However, the limited knowledge of the local prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and its associated variants has hindered the use of primaquine. METHODS: Some 11,138 dried blood spot (DBS) samples were collected in 2011 as part of a national, household Malaria Indicator Survey, a multi-stage nationally representative survey of all malaria-endemic areas of Ethiopia. A randomly selected sub-set of 1414 DBS samples was successfully genotyped by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) technique. Considering the geographical position and ethnic mix of the country, three common variants: G6PD*A (A376G), G6PD*A- (G202A) and Mediterranean (C563T) were investigated. RESULTS: Of the 1998 randomly selected individuals, 1429 (71.5%) DBS samples were genotyped and merged to the database, of which 53.5% were from females. G6PD*A (A376G) was the only genotype detected. No sample was positive for either G6PD*A- (G202A) or Mediterranean (C563T) variants. The prevalence of G6PD*A (A376G) was 8.9% [95% confidence interval (CI) 6.7-11.2] ranging from 12.2% in the Southern Nations, Nationalities and Peoples' (95% CI 5.7-18.7) to none in Dire Dawa/Harari Region. CONCLUSION: The common G6PD*A- (G202A) or Mediterranean (C563T) variants were not observed in this nationwide study. The observed G6PD*A (A376G) mutation has little or no clinical significance. These findings supported the adoption of primaquine for P. falciparum transmission interruption and radical cure of P. vivax in Ethiopia. As the presence of other clinically important, less common variants cannot be ruled out, the implementation of radical cure will be accompanied by active haematological and adverse events monitoring in Ethiopia.

BACKGROUND: The HIV-1 epidemic in Ethiopia has been shown to be dominated by two phylogenetically distinct subtype C clades, the Ethiopian (C'-ET) and East African (C-EA) clades, however, little is known about the temporal dynamics of the HIV epidemic with respect to subtypes and distinct clades. Moreover, there is only limited information concerning transmission of HIV-1 drug resistance (TDR) in the country. METHODS: A cross-sectional survey was conducted among young antiretroviral therapy (ART)-naive individuals recently diagnosed with HIV infection, in Gondar, Ethiopia, 2011-2013 using the WHO recommended threshold survey. A total of 84 study participants with a median age of 22 years were enrolled. HIV-1 genotyping was performed and investigated for drug resistance in 67 individuals. Phylogenetic analyses were performed on all available HIV sequences obtained from Gondar (n = 301) which were used to define subtype C clades, temporal trends and local transmission clusters. Dating of transmission clusters was performed using BEAST. RESULT: Four of 67 individuals (6.0%) carried a HIV drug resistance mutation strain, all associated with non-nucleoside reverse transcriptase inhibitors (NNRTI). Strains of the C-EA clade were most prevalent as we found no evidence of temporal changes during this time period. However, strains of the C-SA clade, prevalent in Southern Africa, have been introduced in Ethiopia, and became more abundant during the study period. The oldest Gondar transmission clusters dated back to 1980 (C-EA), 1983 (C-SA) and 1990 (C'-ET) indicating the presence of strains of different subtype C clades at about the same time point in Gondar. Moreover, some of the larger clusters dated back to the 1980s but transmissions within clusters have been ongoing up till end of the study period. Besides being associated with more sequences and larger clusters, the C-EA clade sequences were also associated with clustering of HIVDR sequences. One cluster was associated with the G190A mutation and showed onward transmissions at high rate. CONCLUSION: TDR was detected in 6.0% of the sequenced samples and confirmed pervious reports that the two subtype C clades, C-EA and C'-ET, are common in Ethiopia. Moreover, the findings indicated an increased diversity in the epidemic as well as differences in transmission clusters sizes of the different clades and association with resistance mutations. These findings provide epidemiological insights not directly available using standard surveillance and may inform the adjustment of public health strategies in HIV prevention in Ethiopia.

BACKGROUND: Yellow fever (YF) is a viral hemorrhagic fever, endemic in the tropical forests of Africa and Central and South America. The disease is transmitted by mosquitoes infected with the yellow fever virus (YFV). Ethiopia was affected by the largest YF outbreak since the vaccination era during 1960-1962. The recent YF outbreak occurred in 2013 in Southern part of the country. The current survey of was carried out to determine the YF seroprevalence so as to make recommendations from YF prevention and control in Ethiopia. METHODOLOGY: A multistage cluster design was utilized. Consequently, the country was divided into 5 ecological zones and two sampling towns were picked per zone randomly. A total of 1643 serum samples were collected from human participants. The serum samples were tested for IgG antibody against YFV using ELISA. Any serum sample testing positive by ELISA was confirmed by plaque reduction neutralization test (PRNT). In addition, differential testing was performed for other flaviviruses, namely dengue, Zika and West Nile viruses. RESULT: Of the total samples tested, 10 (0.61%) were confirmed to be IgG positive against YFV and confirmed with PRNT. Nine (0.5%) samples were antibody positive for dengue virus, 15(0.9%) forWest Nile virus and 7 (0.4%) for Zika virus by PRNT. Three out of the five ecological zones namely zones 1, 3 and 5 showed low levels (< 2%) of IgG positivity against YFV. A total of 41(2.5%) cases were confirmed to be positive for one of flaviviruses tested. CONCLUSION: Based on the seroprevalence data, the level of YFV activity and the risk of a YF epidemic in Ethiopia are low. However additional factors that could impact the likelihood of such an epidemic occurring should be considered before making final recommendations for YF prevention and control in Ethiopia. Based on the results of the serosurvey and other YF epidemic risk factors considered, a preventive mass vaccination campaign is not recommended, however the introduction of YF vaccine in routine EPI is proposed nationwide, along with strong laboratory based YF surveillance.

Violence against women and girls is an important global health concern. Numerous health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health prevention strategy. Adapted from an international setting for use in the US, "Manhood 2.0" is a "gender transformative" program that involves challenging harmful gender and sexuality norms that foster violence against women while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce the perpetration of sexual violence (SV) and adolescent relationship abuse (ARA). Manhood 2.0 is being rigorously evaluated in a community-based cluster-randomized trial in 21 lower resource Pittsburgh neighborhoods with 866 adolescent males ages 13-19. The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation. This study will provide urgently needed information about the effectiveness of a gender transformative program, which combines healthy sexuality education, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males. In this manuscript, we outline the rationale for and evaluation design of Manhood 2.0. Clinical Trials #: NCT02427061.

BACKGROUND: With declining malaria prevalence and improved use of malaria diagnostic tests, an increasing proportion of children seen by community health workers (CHWs) have unclassified fever. Current community management guidelines by WHO advise that children seen with non-severe unclassified fever (on day 1) should return to CHWs on day 3 for reassessment. We compared the safety of conditional follow-up reassessment only in cases where symptoms do not resolve with universal follow-up on day 3. METHODS AND FINDINGS: We undertook a 2-arm cluster-randomised controlled non-inferiority trial among children aged 2-59 months presenting with fever and without malaria, pneumonia, diarrhoea, or danger signs to 284 CHWs affiliated with 25 health centres (clusters) in Southern Nations, Nationalities, and Peoples' Region, Ethiopia. The primary outcome was treatment failure (persistent fever, development of danger signs, hospital admission, death, malaria, pneumonia, or diarrhoea) at 1 week (day 8) of follow-up. Non-inferiority was defined as a 4% or smaller difference in the proportion of treatment failures with conditional follow-up compared to universal follow-up. Secondary outcomes included the percentage of children brought for reassessment, antimicrobial prescription, and severe adverse events (hospitalisations and deaths) after 4 weeks (day 29). From December 1, 2015, to November 30, 2016, we enrolled 4,595 children, of whom 3,946 (1,953 universal follow-up arm; 1,993 conditional follow-up arm) adhered to the CHW's follow-up advice and also completed a day 8 study visit within +/-1 days. Overall, 2.7% had treatment failure on day 8: 0.8% (16/1,993) in the conditional follow-up arm and 4.6% (90/1,953) in the universal follow-up arm (risk difference of treatment failure -3.81%, 95% CI -infinity, 0.65%), meeting the prespecified criterion for non-inferiority. There were no deaths recorded by day 29. In the universal follow-up arm, 94.6% of caregivers reported returning for reassessment on day 3, in contrast to 7.5% in the conditional follow-up arm (risk ratio 22.0, 95% CI 17.9, 27.2, p < 0.001). Few children sought care from another provider after their initial visit to the CHW: 3.0% (59/1,993) in the conditional follow-up arm and 1.1% (22/1,953) in the universal follow-up arm, on average 3.2 and 3.4 days later, respectively, with no significant difference between arms (risk difference 1.79%, 95% CI -1.23%, 4.82%, p = 0.244). The mean travel time to another provider was 2.2 hours (95% CI 0.01, 5.3) in the conditional follow-up arm and 2.6 hours (95% CI 0.02, 4.5) in the universal follow-up arm (p = 0.82); the mean cost for seeking care after visiting the CHW was 26.5 birr (95% CI 7.8, 45.2) and 22.8 birr (95% CI 15.6, 30.0), respectively (p = 0.69). Though this study was an important step to evaluate the safety of conditional follow-up, the high adherence seen may have resulted from knowledge of the 1-week follow-up visit and may therefore not transfer to routine practice; hence, in an implementation setting it is crucial that CHWs are well trained in counselling skills to advise caregivers on when to come back for follow-up. CONCLUSIONS: Conditional follow-up of children with non-severe unclassified fever in a low malaria endemic setting in Ethiopia was non-inferior to universal follow-up through day 8. Allowing CHWs to advise caregivers to bring children back only in case of continued symptoms might be a more efficient use of resources in similar settings. TRIAL REGISTRATION: www.clinicaltrials.gov, identifier NCT02926625.

BACKGROUND: The Akaki River in Ethiopia has been found to contain elevated levels of several metals. Our objectives were to characterize metals exposures of residents living near the Akaki River and to assess metal levels in their drinking water. METHODS: In 2011, we conducted a cross-sectional study of 101 households in Akaki-Kality subcity (near the Akaki River) and 50 households in Yeka subcity (distant to the Akaki River). One willing adult in each household provided urine, blood, and drinking water sample. RESULTS: Urinary molybdenum (p < 0.001), tungsten (p < 0.001), lead (p < 0.001), uranium (p < 0.001), and mercury (p = 0.049) were higher in Akaki-Kality participants compared to Yeka participants. Participants in both subcities had low urinary iodine; 45% met the World Health Organization (WHO) classification for being at risk of moderate iodine deficiency. In Yeka, 47% of households exceeded the WHO aesthetic-based reference value for manganese; in Akaki-Kality, only 2% of households exceeded this value (p < 0.001). There was no correlation between metals levels in water samples and clinical specimens. CONCLUSIONS: Most of the exposures found during this investigation seem unlikely to cause acute health effects based on known toxic thresholds. However, toxicity data for many of these metals are very limited.

In 2009, basic care packages (BCP) containing health products were distributed to HIV-infected persons in Ethiopia who were clients of antiretroviral therapy clinics. To measure health impact, we enrolled clients from an intervention hospital and comparison hospital, and then conducted a baseline survey, and 7 bi-weekly home visits. We enrolled 405 intervention group clients and 344 comparison clients. Intervention clients were more likely than comparison clients to have detectable chlorine in stored water (40% vs. 1%, p<0.001), soap (51% vs. 36%, p<0.001), and a BCP water container (65% vs. 0%, p<0.001) at every home visit. Intervention clients were less likely than comparison clients to report illness (44% vs. 67%, p<0.001) or health facility visits for illness (74% vs. 95%, p<0.001), and had lower median illness scores (1.0 vs. 3.0, p<0.05). Participation in the BCP program appeared to improve reported health outcomes.

BACKGROUND: Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain. METHODS: We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants. RESULTS: A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03). CONCLUSIONS: Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669 .).

Properly functioning laboratory equipment is a critical component for strengthening health systems in developing countries. The laboratory can be an entry point to improve population health and care of individuals for targeted diseases - prevention, care, and treatment of TB, HIV/AIDS, and malaria, plus maternal and neonatal health - as well as those lacking specific attention and funding. We review the benefits and persistent challenges associated with sustaining laboratory equipment maintenance. We propose equipment management policies as well as a comprehensive equipment maintenance strategy that would involve equipment manufacturers and strengthen local capacity through pre-service training of biomedical engineers. Strong country leadership and commitment are needed to assure development and sustained implementation of policies and strategies for standardization of equipment, and regulation of its procurement, donation, disposal, and replacement. (Journal of Public Health Policy advance online publication, 10 November 2011; doi:10.1057/jphp.2011.57).

Severe rotavirus diarrhea in children <5 years of age is a major public health problem; however, limited regional and country specific data on rotavirus disease burden are available from sub-Saharan Africa. In June 2006, the World Health Organization Regional Office for Africa initiated rotavirus surveillance in selected African countries. With use of standardized methodology developed by the World Health Organization, children <5 years of age who were hospitalized with severe diarrhea were enrolled, and stool specimens were collected for detection of rotavirus strains with use of a commercial enzyme immunoassay. Rotavirus strains were further characterized for G and P types with use of a reverse-transcriptase polymerase chain reaction. From June 2006 through December 2008, rotavirus surveillance was established at 14 sites in 11 African countries. Of 5461 stool samples collected from children enrolled in 8 countries with 1 or 2 complete years of data, 2200 (40%) were positive for rotavirus. Ninety percent of all rotavirus hospitalizations occurred among children aged 3-12 months. Predominant types included G1P[8] (21%), G2P[4] (7%), and P [8] (29%); however, unusual types were also detected, including G8P[6] (5%), G8P[8] (1%), G12P[6] (1%), and G12P[6] (1%). A high percentage of mixed rotavirus infections was also detected. These preliminary results indicate that rotavirus is a major cause of severe diarrheal disease in African children.