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Background: World Health Organization (WHO) developed the Safe Childbirth Checklist as an intervention to improve care and outcomes in maternal and newborn health. In the primary BetterBirth traditional trial analysis, the intervention did not significantly improve . However, a novel subgroup-based analysis could identify subpopulations that benefited from the intervention. Methods: In this work, we employ data-driven analysis methods to identify differentiated subgroups with unexpected characteristics compared to the average population. Specifically, we aim to identify: 1) vulnerable subgroups and 2) subpopulation in the intervention arm with significantly reduced outcome. The method utilizes the existing subset scanning literature that searches over a combination of features to identify the differentiated groups. Findings: We found that low birthweight (

Frequent coaching was associated with increased adherence to evidence-based essential birth practices among birth attendants but not with improved maternal and perinatal health outcomes in the BetterBirth Trial, which assessed the impact of a complex intervention to implement the World Health Organization's Safe Childbirth Checklist. To promote sustainable behavior change, future coaching-based interventions may need to explore cost-effective, feasible mechanisms for providing more frequent coaching delivered with high coverage among health care workers for longer durations., Background: Coaching can improve the quality of care in primary-level birth facilities and promote birth attendant adherence to essential birth practices (EBPs) that reduce maternal and perinatal mortality. The intensity of coaching needed to promote and sustain behavior change is unknown. We investigated the relationship between coaching intensity, EBP adherence, and maternal and perinatal health outcomes using data from the BetterBirth Trial, which assessed the impact of a complex, coaching-based implementation of the World Health Organization's Safe Childbirth Checklist in Uttar Pradesh, India. Methods: For each birth, we defined multiple coaching intensity metrics, including coaching frequency (coaching visits per month), cumulative coaching (total coaching visits accrued during the intervention), and scheduling adherence (coaching delivered as scheduled). We considered coaching delivered at both facility and birth attendant levels. We assessed the association between coaching intensity and birth attendant adherence to 18 EBPs and with maternal and perinatal health outcomes using regression models. Results: Coaching frequency was associated with modestly increased EBP adherence. Delivering 6 coaching visits per month to facilities was associated with adherence to 1.3 additional EBPs (95% confidence interval [CI]=0.6, 1.9). High-frequency coaching delivered with high coverage among birth attendants was associated with greater improvements: providing 70% of birth attendants at a facility with at least 1 visit per month was associated with adherence to 2.0 additional EBPs (95% CI=1.0, 2.9). Neither cumulative coaching nor scheduling adherence was associated with EBP adherence. Coaching was generally not associated with health outcomes, possibly due to the small magnitude of association between coaching and EBP adherence. Conclusions: Frequent coaching may promote behavior change, especially if delivered with high coverage among birth attendants. However, the effects of coaching were modest and did not persist over time, suggesting that future coaching-based interventions should explore providing frequent coaching for longer periods.

IntroductionPreterm birth is the leading cause of child mortality. This study aimed to develop and validate programmatically feasible and accurate approaches to estimate newborn gestational age (GA) in low resource settings.MethodsThe WHO Alliance for Maternal and Newborn Health Improvement (AMANHI) study recruited pregnant women from population-based cohorts in five countries (Bangladesh, Ghana, Pakistan, Tanzania and Zambia). Women Results7428 liveborn infants were included (n=536 preterm, ConclusionThe best machine-learning model (10 neonatal characteristics and LMP) estimated GA within ±15.7 days of early ultrasound dating. Simpler models performed reasonably well with marginal increases in prediction error. These models hold promise for newborn GA estimation when ultrasound dating is unavailable.

Background Accurate assignment of the gestational age of newborns is important for the identification of prematurity. The Dubowitz assessment is the gold standard among postnatal examinations used to assign gestational age, but implementation has been limited because of examination complexity and training requirements. The objective of this study was to explore factors related to teaching and implementing the Dubowitz examination that may influence its uptake in India and Malawi. Methods This cross-sectional study was conducted in India and Malawi during the preparation for a low-birthweight infant feeding exploratory study. Twenty trainees participated in a Dubowitz examination training workshop that occurred over two half-day sessions. Trainees completed pretraining and posttraining surveys related to their perceptions of the Dubowitz training, the examination, and factors affecting the administration of the examination in their setting. Results All survey respondents expressed confidence in their ability to perform the Dubowitz examination after the training. Less than a third expressed concerns about the time required to learn (30%) or perform the examination (25%). Eighty-five percent of trainees identified concerns related to parental perception of the examination that may inhibit implementation. Trainees averaged 14 minutes (standard deviation: 4.5 minutes) to complete the examination. More than 80% of trainee answers were within one point of the trainer for 16 of the 22 Dubowitz signs. Trainee composite scores were within ±3 weeks of the trainer for 95% of assessments based on Bland-Altman analysis. Conclusions The Dubowitz examination at birth is a method to improve identification of premature infants in the absence of prenatal dating. We found widespread acceptance for the Dubowitz assessment among participants in training workshops in India and Malawi, despite the complexity and length of the examination. The high level of trainee-trainer concordance on individual examination signs suggests that an acceptable level of competence is feasible after a short, concentrated workshop. Further investigation into barriers that hinder implementation such as negative parental perceptions is warranted. Registration details Clinical Trials Registration: NCT04002908 (www.clinicaltrials.gov) and CTRI/2019/02/017475 (Clinical Trial Registry of India - http://ctri.nic.in).

OBJECTIVE To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India. DESIGN Secondary analysis of a cluster-randomised controlled trial. SETTING Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017. POPULATION Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation. METHODS The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not. MAIN OUTCOME MEASURES Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask. RESULTS We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P

Background Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa. Methods and findings This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman’s self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes. Conclusions Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths. Trial registration The study is not a clinical trial., Author summary Why was this study done? Estimates of severe direct maternal morbidity are largely based on hospital-based studies with inconsistent definitions and varying selection criteria. Limited data are available from South Asia and sub-Saharan Africa, the 2 regions with the highest maternal and newborn morbidity and mortality, where a larger proportion of births occur at home. What did the researchers do and find? We collected data on maternal morbidities from a cohort of women in the community in multiple sites in sub-Saharan Africa and in South Asia. Out of a cohort of >114,000 women, we found that about 1 in 3 women suffer a maternal morbidity, which was notably higher than the previously reported data. We found that the prevalence of preeclampsia and eclampsia was about 1%, which was lower than previously reported. About 11% of women reported having prolonged or obstructed labour, which was somewhat higher than published estimates. The burden of pregnancy-related infection in postpartum period was higher in South Asia than in sub-Saharan Africa. This is the first study, to our knowledge, to describe the burden of antepartum haemorrhage and late antepartum infection and to clearly demonstrate the association of direct maternal morbidity with adverse pregnancy outcomes. What do these findings mean? Higher burden of direct maternal morbidity and its association with adverse outcomes highlights the need for improving health of women and mothers, including promotion of preconception health and nutrition, and high-quality antepartum, intrapartum and postpartum care.

Background Neonatal infection, a leading cause of neonatal death in low- and middle-income countries, is often caused by pathogens acquired during childbirth. Clean delivery kits (CDKs) have shown efficacy in reducing infection-related perinatal and neonatal mortality. However, there remain gaps in our current knowledge, including the effect of individual components, the timeline of protection, and the benefit of CDKs in home and facility deliveries. Methods and findings A post hoc secondary analysis was performed using nonrandomized data from the Zambia Chlorhexidine Application Trial (ZamCAT), a community-based, cluster-randomized controlled trial of chlorhexidine umbilical cord care in Southern Province of Zambia from February 2011 to January 2013. CDKs, containing soap, gloves, cord clamps, plastic sheet, razor blade, matches, and candle, were provided to all pregnant women. Field monitors made a home-based visit to each participant 4 days postpartum, during which CDK use and newborn outcomes were ascertained. Logistic regression was used to study the association between different CDK components and neonatal mortality rate (NMR). Of 38,579 deliveries recorded during the study, 36,996 newborns were analyzed after excluding stillbirths and those with missing information. Gloves, cord clamps, and plastic sheets were the most frequently used CDK item combination in both home and facility deliveries. Each of the 7 CDK components was associated with lower NMR in users versus nonusers. Adjusted logistic regression showed that use of gloves (odds ratio [OR] 0.33, 95% CI 0.24–0.46), cord clamp (OR 0.51, 95% CI 0.38–0.68), plastic sheet (OR 0.46, 95% CI 0.34–0.63), and razor blade (OR 0.69, 95% CI 0.53–0.89) were associated with lower risk of newborn mortality. Use of gloves and cord clamp were associated with reduced risk of immediate newborn death (, Jason Park and co-workers assess components of clean delivery kits for possible contributions to reduced newborn mortality in a trial done in Zambia., Author summary Why was this study done? Infection during childbirth is a major cause of newborn mortality and morbidity in rural and resource-limited settings. Clean delivery kits can prevent pathogen transmission during infection by providing sterile equipment and encouraging hygienic behaviors. A more nuanced understanding of the benefits of clean delivery kits and their components would aid global implementation to help reduce newborn mortality. What did the researchers do and find? We analyzed the data from the Zambia Chlorhexidine Application Trial (ZamCAT), a cluster-randomized controlled trial conducted in Zambia in 2011–2013. During ZamCAT, we provided clean delivery kits to all mothers in the community and tracked the health outcomes of all women and newborns through the neonatal period. Analysis of 38,579 deliveries showed us that use of gloves, cord clamps, plastic sheets, and razor blades during intrapartum care were associated with lower newborn mortality, in both home and facility deliveries. Components of clean delivery kits were associated with lower risk of perinatal and newborn mortality in the first 7 days of life, but not with mortality between 7 and 28 days of life. What do these findings mean? Components of clean delivery kits that showed highest usage and association with newborn mortality reduction should be included in future clean delivery kit interventions. As this is a post hoc secondary data analysis and the trial was not meant to specifically study the impact of clean delivery kits, causality cannot be inferred. Nevertheless, the large sample size, variation in component use, and study design focused on community settings provide support for clean delivery kits as an intervention that may improve newborn health outcomes in both home and facility deliveries.

Objective To evaluate changes in quality of care after implementing an adapted safe childbirth checklist (SCC) in Chiapas, Mexico. Methods A convergent mixed-methods study was conducted among 447 women in labor who attended a rural community hospital between September 1, 2016, and June 30, 2017. Logistic regression analysis was used to evaluate adherence to evidence-based practices over time, adjusting for provider. Participants were surveyed about their perceptions of care after hospital discharge. A purposefully sampled subgroup also completed in-depth interviews. Thematic analysis was performed to evaluate perceptions of care. Results 384 (85.9%) women were attended by staff that used the adapted SCC during delivery. Of these, 221 and 28 completed the hospital discharge survey and in-depth interview, respectively. Adherence with offering a birth companion (odds ratio [OR] 3.06, 95% CI 1.40-6.68), free choice of birth position (2.75, 1.21-6.26), and immediate skin-to-skin contact (4.53, 1.97-10.39) improved 6-8 months after implementation. Participants' perceived quality of care improved over time. Provider communication generated positive perceptions. Reprimanding women for arriving in early labor or complaining of pain generated negative perceptions. Conclusion Use of the adapted SCC improved quality of care through increased adherence with essential and respectful delivery practices.

Approximately 15% of infants worldwide are born with low birthweight (

BackgroundEvidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality.MethodsWithin the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants’ practice adherence to perinatal mortality.FindingsAcross 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality.InterpretationAdherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex.FundingBill & Melinda Gates Foundation.Trial registration detailsClinicalTrials.gov:NCT02148952; Universal Trial Number: U1111-1131-5647.

Worldwide, many newborns die in the first month of life, with most deaths happening in low/middle-income countries (LMICs). Families’ use of evidence-based newborn care practices in the home and timely care-seeking for illness can save newborn lives. Postnatal education is an important investment to improve families’ use of evidence-based newborn care practices, yet there are gaps in the literature on postnatal education programees that have been evaluated to date. Recent findings from a 13 000+ person survey in 3 states in India show opportunities for improvement in postnatal education for mothers and families and their use of newborn care practices in the home. Our survey data and the literature suggest the need to incorporate the following strategies into future postnatal education programming: implement structured predischarge education with postdischarge reinforcement, using a multipronged teaching approach to reach whole families with education on multiple newborn care practices. Researchers need to conduct robust evaluation on postnatal education models incorporating these programee elements in the LMIC context, as well as explore whether this type of education model can work for other health areas that are critical for families to survive and thrive.

Objective Omphalitis, or umbilical cord infection, is an important cause of newborn morbidity and mortality in low-resource settings. We tested an algorithm that task-shifts omphalitis diagnosis to community-level workers in sub-Saharan Africa. Methods Community-based field monitors and Zambian paediatricians independently evaluated newborns presenting to health facilities in Southern Zambia using a signs and symptoms checklist. Responses were compared against the paediatrician's gold standard clinical diagnosis. Results Of 1009 newborns enrolled, 6.2% presented with omphalitis per the gold standard clinical diagnosis. Paediatricians' signs and symptoms with the highest sensitivity were presence of pus (79.4%), redness at the base (50.8%) and newborn flinching when cord was palpated (33.3%). The field monitor's signs and symptoms answers had low correlation with paediatrician's answers; all signs and symptoms assessed had sensitivity Conclusion Despite extensive training, field monitors could not consistently identify signs and symptoms associated with omphalitis in the sub-Saharan African setting.

IntroductionEnding preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, Methods and analysisLIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants.Ethics and disseminationThis study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities.Trial registration numbersNCT04002908and CTRI/2019/02/017475.

Background Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: -1% to 62%). Conclusion Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale.Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth intervention were pending publication in another journal. After the impact findings have been published, we will update this article on the effect of the intervention on birth practices with a reference to the impact findings.

Background: Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the effect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods: We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facility-based clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratified, restricted randomisation to divide clusters into urban or two rural groups (located

Background In 2014, Vietnam was the first Southeast Asian country to commit to achieving the World Health Organization’s 90–90-90 global HIV targets (90% know their HIV status, 90% on sustained treatment, and 90% virally suppressed) by 2020. This pledge represented further confirmation of Vietnam’s efforts to respond to the HIV epidemic, one feature of which has been close collaboration with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Starting in 2004, PEPFAR supported community outreach programs targeting high-risk populations (people who inject drugs, men who have sex with men, and sex workers). To provide early evidence on program impact, in 2007–2008 we conducted a nationwide evaluation of PEPFAR-supported outreach programs in Vietnam. The evaluation focused on assessing program effect on HIV knowledge, high-risk behaviors, and HIV testing among high-risk populations—results relevant to Vietnam’s push to meet global HIV goals. Methods We used a mixed-methods cross-sectional evaluation design. Data collection encompassed a quantitative survey of 2199 individuals, supplemented by 125 in-depth interviews. Participants were members of high-risk populations who reported recent contact with an outreach worker (intervention group) or no recent contact (comparison group). We assessed differences in HIV knowledge, risky behaviors, and HIV testing between groups, and between high-risk populations. Results Intervention participants knew significantly more about transmission, prevention, and treatment than comparison participants. We found low levels of injection drug-use-related risk behaviors and little evidence of program impact on such behaviors. In contrast, a significantly smaller proportion of intervention than comparison participants reported risky sexual behaviors generally and within each high-risk population. Intervention participants were also more likely to have undergone HIV testing (76.1% vs. 47.0%, p

Background The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants—nurses and auxiliary nurse midwives (ANMs)—during and after a peer coaching intervention for the WHO Safe Childbirth Checklist. Methods This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point). Results Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68). Conclusions Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency. Trial registration ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111–1131-5647.

BACKGROUND Early initiation of combination antiretroviral therapy (cART) for HIV-positive pregnant women can decrease vertical transmission to less than 5%. Programmatic barriers to early cART include decentralized care, disease-stage assessment delays, and loss to follow-up. INTERVENTION Our intervention had 3 components: integrated HIV and antenatal services in 1 location with 1 provider, laboratory courier to expedite CD4 counts, and community-based follow-up of women-infant pairs to improve prevention of mother-to-child transmission attendance. Preintervention HIV-positive pregnant women were referred to HIV clinics for disease-stage assessment and cART initiation for advanced disease (CD4 count 2). METHODS We used a quasi-experimental design with preintervention/postintervention evaluations at 6 government antenatal clinics (ANCs) in Southern Province, Zambia. Retrospective clinical data were collected from clinic registers during a 7-month baseline period. Postintervention data were collected from all antiretroviral therapy-naive, HIV-positive pregnant women and their infants presenting to ANC from December 2011 to June 2013. RESULTS Data from 510 baseline women-infant pairs were analyzed and 624 pregnant women were enrolled during the intervention period. The proportion of HIV-positive pregnant women receiving CD4 counts increased from 50.6% to 77.2% [relative risk (RR) = 1.81; 95% confidence interval (CI): 1.57 to 2.08; P < 0.01]. The proportion of cART-eligible pregnant women initiated on cART increased from 27.5% to 71.5% (RR = 2.25; 95% CI: 1.78 to 2.83; P < 0.01). The proportion of eligible HIV-exposed infants with documented 6-week HIV PCR test increased from 41.9% to 55.8% (RR = 1.33; 95% CI: 1.18 to 1.51; P < 0.01). CONCLUSIONS Integration of HIV care into ANC and community-based support improved uptake of CD4 counts, proportion of cART-eligible women initiated on cART, and infants tested.

Background: Research demonstrates that coaching is an effective method for promoting behavior change, yet little is known about which attributes of a coach make them more or less effective. This post hoc, sub-analysis of the BetterBirth trial used observational data to explore whether specific coaches’ and team leaders' characteristics were associated with improved adherence to essential birth practices listed on the World Health Organization Safe Childbirth Checklist. Methods: A descriptive analysis was conducted on the coach characteristics from the 50 BetterBirth coaches and team leaders. Data on adherence to essential birth practices by birth attendants who received coaching were collected by independent observers. Bivariate linear regression models were constructed, accounting for clustering by site, to examine the association between coach characteristics and attendants’ adherence to practices. Results: All of the coaches were female and the majority were nurses. Team leaders were comprised of both males and females; half had clinical backgrounds. There was no association between coaches’ or team leaders’ characteristics, namely gender, type of degree, or years of clinical training, and attendants’ adherence to essential birth practices. However, a significant inverse relationship was detected between the coach or team leader’s age and years of experience and the birth attendants’ adherence to the checklist. Conclusion: Younger, less experienced coaches were more successful in promoting essential birth practices adherence in this population. More data is needed to fully understand the relationship between coaches and birth attendants.

OBJECTIVE: The objective of the Alliance for Maternal and Newborn Health Improvement (AMANHI) gestational age study is to develop and validate a programmatically feasible and simple approach to accurately assess gestational age of babies after they are born. The study will provide accurate, population-based rates of preterm birth in different settings and quantify the risks of neonatal mortality and morbidity by gestational age and birth weight in five South Asian and sub-Saharan African sites. METHODS: This study used on-going population-based cohort studies to recruit pregnant women early in pregnancy (

Conducting research in areas with diverse cultures requires attention to community sensitization and involvement. The process of community engagement is described for a large community-based, cluster-randomized, controlled trial comparing daily 4% chlorhexidine umbilical cord wash to dry cord care for neonatal mortality prevention in Southern Province, Zambia. Study preparations required baseline formative ethnographic research, substantial community sensitization, and engagement with three levels of stakeholders, each necessitating different strategies. Cluster-specific birth notification systems developed with traditional leadership and community members using community-selected data collectors resulted in a post-natal home visit within 48 hours of birth in 96% of births. Of 39,679 pregnant women enrolled (93% of the target of 42,570), only 3.7% were lost to follow-up or withdrew antenatally; 0.2% live-born neonates were lost by day 28 of follow-up. Conducting this trial in close collaboration with traditional, administrative, political, and community stakeholders facilitated excellent study participation, despite structural and sociocultural challenges.

INTRODUCTION: Access to lifesaving prevention of mother-to-child transmission (PMTCT) services is problematic in rural Zambia. The simplest intervention used in Zambia has been 2-dose nevirapine (NVP) administration in the peripartum period a regimen of 1 NVP tablet to the mother at the onset of labor and 1 dose in the form of syrup to the newborn within 4 to 72 hours after birth. This 2-dose regimen has been shown to reduce MTCT by nearly 50%. We set out to demonstrate that in-home HIV testing and NVP dosing by traditional birth attendants (TBAs) is feasible and acceptable by women in rural Zambia. METHODS: This was a pilot program using TBAs to perform rapid saliva-based HIV testing and administer single-dose NVP in tablet form to the mother at the onset of labor and syrup to the infant after birth. RESULTS: A total of 280 pregnant women were consented and enrolled into the program of whom 124 (44.3%) gave birth at home with the assistance of a trained TBA. Of those 16 (12.9%) were known to be HIV positive and 101 of the remaining 108 (93.5%) accepted a rapid HIV test. All these women tested HIV negative. In the subset of 16 mothers who were HIV positive 13 (81.3%) took single-dose NVP administered by a TBA between 1 and 24 hours prior to birth and 100% of exposed newborns (16 of 16) received NVP syrup within 72 hours after birth 80% of whom were dosed in the first 24 hours of life. DISCUSSION: With the substantial shortage of human resources in public health care throughout sub-Saharan Africa it is extremely valuable to utilize lay health care workers to help extended services beyond the level of the facility. Given the high uptake of PMTCT services we believe that TBAs with proper training and support can successfully provide country-approved PMTCT. (c) 2013 by the American College of Nurse-Midwives.

Mastitis and abscess in HIV-infected women increase the risk of breastfeeding transmission of HIV. Guidelines encourage women to stop breastfeeding on the affected breast and feed on the contralateral breast. However, impact of breast pathology on breast milk HIV dynamics is unknown.HIV RNA was quantified in 211 breast milk samples collected before, during, and after a clinical mastitis or an abscess diagnosis from 38 HIV-infected women participating in a Zambian breastfeeding study. HIV RNA quantity was compared between affected and unaffected breasts over time using generalized estimating equation models. A sample of 115 women without breast pathology was selected as a control group.In the affected breast, breast milk HIV RNA quantity increased from the pre- to during-pathology period by log(10) 0.45 copies per milliliter [95% confidence interval (CI): 0.16 to 0.74], and after symptom resolution, HIV RNA levels were no different from prepathology levels (log10 -0.04 copies per milliliter 95% CI: -0.33 to 0.25). In the contralateral, unaffected breast, HIV RNA quantity did not significantly increase (log(10) 0.15 copies per milliliter, 95% CI: -0.41 to 0.10). Increase was more marked in women with abscess or with a greater number of mastitis symptoms. HIV RNA was not significantly different between affected and unaffected women, except at the time of diagnosis.Breast milk HIV RNA increased modestly in the affected breast with unilateral mastitis or abscess and returned to prepathology levels with symptom resolution. Contralateral HIV RNA was not affected. Results support guidelines encouraging feeding from the contralateral breast to minimize the risk of HIV transmission associated with unilateral breast pathology.

To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries.We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality.Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality.Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings.Estimer la mortalité néonatale, en particulier dans les 24 heures suivant la naissance, dans six pays à revenu faible et intermédiaire - tranche inférieure.Nous avons analysé des données épidémiologiques portant sur un total de 149 570 naissances vivantes qui avaient été recueillies entre 2007 et 2013 lors de six essais prospectifs randomisés et d'une étude de cohorte réalisés dans des zones majoritairement rurales du Bangladesh, du Ghana, d'Inde, du Pakistan, de Tanzanie et de Zambie. Le taux de mortalité néonatale ainsi que la mortalité dans les 24 heures suivant la naissance ont été estimés pour tous ces pays; la mortalité dans les 6 heures suivant la naissance a été estimée pour quatre pays sur lesquels nous avions des données. Les résultats ont été comparés aux estimations de la mortalité néonatale publiées, qui ont été établies d'après des modèles.Globalement, le taux de mortalité néonatale observé sur les sites étudiés dans les six pays était de 30,5 pour 1000 naissances vivantes (de 13,6 en Zambie à 47,4 au Pakistan). La mortalité globale dans les 24 heures suivant la naissance était de 14,1 pour 1000 naissances vivantes (de 5,1 en Zambie à 20,1 en Inde) et 46,3% de l'ensemble des décès néonataux étaient survenus dans les 24 heures (de 36,2% au Pakistan à 65,5% en Tanzanie). Le taux de mortalité dans les 6 heures suivant la naissance était de 8,3 pour 1000 naissances vivantes, soit 31,9% de la mortalité néonatale totale.La mortalité néonatale dans les 24 heures suivant la naissance dans des zones majoritairement rurales de six pays à revenu faible et intermédiaire-tranche inférieure était supérieure aux estimations établies d'après des modèles pour ces pays. Un peu moins de la moitié des décès néonataux étaient survenus dans les 24 heures suivant la naissance et environ un tiers dans les 6 heures. La mise en place de soins obstétriques et néonataux efficaces et de haute qualité devrait être une priorité dans ces pays.Calcular la mortalidad neonatal, especialmente durante las 24 horas posteriores al nacimiento, en países con ingresos bajos y países con ingresos medios más bajos.Se analizaron datos epidemiológicos de un total de 149 570 nacidos vivos recopilados entre 2007 y 2013 en seis ensayos aleatorizados prospectivos y un estudio de cohortes de zonas principalmente rurales de Bangladesh, Ghana, India, Pakistán, la República Unida de Tanzanía y Zambia. Se calculó la tasa de mortalidad neonatal y la mortalidad durante las 24 horas posteriores al nacimiento en todos los países y se estimó la tasa de mortalidad en 6 horas en cuatro países con información disponible. Los resultados se compararon con estimaciones publicadas basadas en modelos de mortalidad neonatal.En general, la tasa de mortalidad neonatal observada en los lugares de estudio de los seis países fue de 30,5 por cada 1 000 nacidos vivos (alcance: 13,6 en Zambia a 47,4 en Pakistán). En conjunto, la mortalidad durante las primeras 24 horas fue de 14,1 por cada 1 000 nacidos vivos (alcance: 5,1 en Zambia a 20,1 en India) y el 46,3% de todas las muertes neonatales se produjo durante las primeras 24 horas (alcance: 36,2% en Pakistán a 65,5% en la República Unida de Tanzanía). La mortalidad en las primeras 6 horas fue de 8,3 por cada 1 000 nacidos vivos, es decir, un 31,9% de mortalidad neonatal.La mortalidad neonatal durante las 24 horas posteriores al nacimiento en zonas principalmente rurales de seis países con ingresos bajos y países con ingresos medios más bajos fue superior a las estimaciones basadas en modelos realizadas para estos países. Algo menos de la mitad de todas las muertes neonatales se produjeron durante las 24 horas posteriores al nacimiento y cerca de un tercio durante las primeras 6 horas de vida. En estos lugares, la implementación de obstetricia eficaz y de alta calidad y la atención a recién nacidos debería ser una prioridad.تقدير معدل وفيات الأطفال حديثي الولادة، وبالأخص في غضون 24قمنا بتحليل البيانات الوبائية لإجمالي 149,570عمومًا، كان معدل وفيات الأطفال حديثي الولادة الذي لوحظ في مواقع الدراسة في ستة بلدان يبلغ 30.5 لكل 1000 من المواليد على قيد الحياة (نطاق القياس: 13.6 في زامبيا إلى 47.4إن معدل الوفيات للأطفال حديثي الولادة في غضون 24旨在评估 6 个中低收入国家的新生儿死亡率、尤其是出生后 24 小时内的死亡率。.我们一共对 149 570 名新出生婴儿的流行病学数据进行了分析，该数据来自于 2007 年至 2013 年对巴基斯坦、印度、加纳、孟加拉国、坦桑尼亚联合共和国及赞比亚主要乡村地区进行的 6 项前瞻性随机试验和一项队列研究。 我们对所有国家的新生儿死亡率以及新生儿出生后 24 小时内的死亡率进行了评估，并对拥有可用数据的 4 个国家的新生儿出生后 6 小时内的死亡率进行了评估。 我们将调查结果与已发布的、基于模型的新生儿死亡率估算结果进行了比较。.总体而言， 6 个国家的研究地的实际新生儿死亡率为每 1000 名新出生婴儿中有 30.5 名死亡（范围： 从赞比亚的 13.6 到巴基斯坦的 47.4）。 新生儿出生后 24 小时内死亡率为每 1000 名新出生婴儿中共有 14.1 名死亡（范围： 从赞比亚的 5.1 到印度的 20.1），且 46.3% 的新生儿死亡案例发生在婴儿出生后 24 小时内（范围： 从巴基斯坦的 36.2% 到坦桑尼亚联合共和国的 65.5%）。 婴儿出生后 6 小时内的死亡率为每 1000 名新出生婴儿中有 8.3 名死亡，即新生儿死亡率为 31.9%。.6 个中低收入国家主要乡村地区的新生儿出生后 24 小时内的死亡率均高于这些国家的基于模型的估算结果。 略低于一半的新生儿死亡案例发生在婴儿出生后 24 小时内，而大约三分之一的案例发生在婴儿出生后 6 小时内。 上述国家应将实施优质、有效的产科护理和早期新生儿护理视为工作重点。.Дать оценку смертности новорожденных, особенно в первые 24 часа жизни, в шести странах с низким уровнем дохода и уровнем дохода ниже среднего.Проведен анализ эпидемиологических данных, полученных в результате рождения 149 570 живых детей в промежутке с 2007 по 2013 год, на основании шести проспективных рандомизированных исследований и одного когортного исследования в преимущественно сельских регионах Бангладеша, Ганы, Замбии, Индии, Объединенной Республики Танзании и Пакистана. Были рассчитаны показатели смертности новорожденных в первые 24 часа для всех стран, а оценка смертности в первые шесть часов была получена для четырех стран с доступными данными. Результаты сравнили с опубликованными показателями смертности новорожденных, рассчитанными на основе моделирования.В целом показатель смертности новорожденных, наблюдаемый в центрах проведения исследования шести стран, составил 30,5 на 1000 рождений живых детей (от 13,6 в Замбии до 47,4 в Пакистане). Смертность в течение первых суток в целом составляла 14,1 на 1000 рождений живых детей (диапазон: от 5,1 в Замбии до 20,1 в Индии) или 46,3% от всех смертей новорожденных (от 36,2% в Пакистане до 65,5% в Объединенной Республике Танзания). Смертность в первые шесть часов составляла 8,3 на 1000 рождений живых детей или 31,9% от всех смертей новорожденных.Смертность новорожденных в первые 24 часа в преимущественно сельских регионах шести стран с низким уровнем дохода и уровнем дохода ниже среднего была выше, чем показатели, рассчитанные на основе моделирования для этих же стран. Чуть менее половины всех смертей новорожденных произошли в течение 24 часов после рождения, и около трети произошли в течение первых шести часов. Поэтому внедрение высококачественной эффективной акушерской помощи и ухода за новорожденными должно стать первостепенной задачей.

Objective To see if, in the diagnosis of infant infection with human immunodeficiency virus (HIV) in Zambia, turnaround times could be reduced by using an automated notification system based on mobile phone texting. Methods In Zambia’s Southern province, dried samples of blood from infants are sent to regional laboratories to be tested for HIV with polymerase chain reaction (PCR). Turnaround times for the postal notification of the results of such tests to 10 health facilities over 19 months were evaluated by retrospective data collection. These baseline data were used to determine how turnaround times were affected by customized software built to deliver the test results automatically and directly from the processing laboratory to the health facility of sample origin via short message service (SMS) texts. SMS system data were collected over a 7.5-month period for all infant dried blood samples used for HIV testing in the 10 study facilities. Findings Mean turnaround time for result notification to a health facility fell from 44.2 da ys pre-implementation to 26.7 da ys postimplementation. The reduction in turnaround time was statistically significant in nine (90%) facilities. The mean time to notification of a caregiver also fell significantly, from 66.8 da ys pre-implementation to 35.0 da ys post-implementation. Only 0.5% of the texted reports investigated differed from the corresponding paper reports. Conclusion The texting of the results of infant HIV tests significantly shortened the times between sample collection and results notification to the relevant health facilities and caregivers.

Objectives: To assess the quality and safety of having community health workers (CHWs) in rural Zambia use rapid diagnostic tests (RDTs) and provide integrated management of malaria and pneumonia. Design/methods: In the context of a cluster-randomized controlled trial of two models for community-based management of malaria and/or non-severe pneumonia in children under 5 years old, CHWs in the intervention arm were trained to use RDTs, follow a simple algorithm for classification and treat malaria with artemether–lumefantrine (AL) and pneumonia with amoxicillin. CHW records were reviewed to assess the ability of the CHWs to appropriately classify and treat malaria and pneumonia, and account for supplies. Patients were also followed up to assess treatment safety. Results: During the 12-month study, the CHWs evaluated 1017 children with fever and/or fast/difficult breathing and performed 975 RDTs. Malaria and/or pneumonia were appropriately classified 94–100% of the time. Treatment based on disease classification was correct in 94–100% of episodes. Supply management was excellent with over 98% of RDTs, amoxicillin, and AL properly accounted for. The use of RDTs, amoxicillin, and AL was associated with few minor adverse events. Most febrile children (90%) with negative RDT results recovered after being treated with an antipyretic alone. Conclusions: Volunteer CHWs in rural Zambia are capable of providing integrated management of malaria and pneumonia to children safely and at high quality.

Background: Reducing maternal and neonatal mortality is essential to improving population health. Demand-side interventions are designed to increase uptake of critical maternal health services, but associated change in service uptake and outcomes is varied. We undertook a literature review to understand current evidence of demand-side intervention impact on improving utilization and outcomes for mothers and newborn children. Methods: We completed a rapid review of literature in PubMed. Title and abstracts of publications identified from selected search terms were reviewed to identify articles meeting inclusion criteria: demand-side intervention in low or middle-income countries (LMIC), published after September 2004 and before March 2014, study design describing and reporting on >1 priority outcome: utilization (antenatal care visits, facility-based delivery, delivery with a skilled birth attendant) or health outcome measures (maternal mortality ratio (MMR), stillbirth rate, perinatal mortality rate (PMR), neonatal mortality rate (NMR)). Bibliographies were searched to identify additional relevant papers. Articles were abstracted using a standardized data collection template with double extraction on a sample to ensure quality. Quality of included studies was assessed using McMaster University’s Quality Assessment Tool from the Effective Public Health Practice Project (EPHPP). Results: Five hundred and eighty two articles were screened with 50 selected for full review and 16 meeting extraction criteria (eight community mobilization interventions (CM), seven financial incentive interventions (FI), and one with both). We found that demand-side interventions were effective in increasing uptake of key services with five CM and all seven FI interventions reporting increased use of maternal health services. Association with health outcome measures were varied with two studies reporting reductions in MMR and four reporting reduced NMR. No studies found a reduction in stillbirth rate. Only four of the ten studies reporting on both utilization and outcomes reported improvement in both measures. Conclusions: We found strong evidence that demand-side interventions are associated with increased utilization of services with more variable evidence of their impact on reducing early neonatal and maternal mortality. Further research is needed to understand how to maximize the potential of demand-side interventions to improve maternal and neonatal health outcomes including the role of quality improvement and coordination with supply-side interventions.

Implementation of the WHO Safe Childbirth Checklist with peer coaching resulted in >90% adherence to 35 of 39 essential birth practices among birth attendants after 8 months, but adherence to some practices was lower when the coach was absent., Background: Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods: We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results: Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: −1% to 62%). Conclusion: Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale. (After publication of this article, the impact results of the BetterBirth intervention were published in the New England Journal of Medicine [volume 377, pages 2313-2324, doi: 10.1056/NEJMoa1701075]. The results showed that the intervention had no significant effect on maternal or perinatal mortality or maternal morbidity, despite having positive effects on essential birth practices.)

BACKGROUND: Early weaning has been recommended to reduce postnatal human immunodeficiency virus (HIV) transmission. We evaluated the safety of stopping breast-feeding at different ages for mortality of uninfected children born to HIV-infected mothers. METHODS: During a trial of early weaning 958 HIV-infected mothers and their infants were recruited and followed up from birth to 24 months postpartum in Lusaka Zambia. One-half of the cohort was randomized to wean abruptly at 4 months and the other half of the cohort was randomized to continue breast-feeding. We examined associations between uninfected child mortality and actual breast-feeding duration and investigated possible confounding and effect modification. RESULTS: The mortality rate among 749 uninfected children was 9.4% by 12 months of age and 13.6% by 24 months of age. Weaning during the interval encouraged by the protocol (4-5 months of age) was associated with a 2.03-fold increased risk of mortality (95% confidence interval [CI] 1.13-3.65) weaning at 6-11 months of age was associated with a 3.54-fold increase (95% CI 1.68-7.46) and weaning at 12-18 months of age was associated with a 4.22-fold increase (95% CI 1.59-11.24). Significant effect modification was detected such that risks associated with weaning were stronger among infants born to mothers with higher CD4(+) cell counts (>350 cells/microL). CONCLUSION: Shortening the normal duration of breast-feeding for uninfected children born to HIV-infected mothers living in low-resource settings is associated with significant increases in mortality extending into the second year of life. Intensive nutritional and counseling interventions reduce but do not eliminate this excess mortality.

OBJECTIVES: Single-dose nevirapine (SDNVP) for prevention of mother-to-child HIV transmission selects mutations conferring resistance to nonnucleoside reverse transcriptase inhibitor (NNRTI)-based therapy. We investigated mortality and virologic and clinical outcomes after introduction of antiretroviral treatment (ART) among a cohort of women given SDNVP. METHODS: When ART programs were introduced in 2004 in Lusaka Zambia we were completing a trial of infant feeding which involved following HIV-infected women who received SDNVP between 2001 and 2005. Women still in follow-up or who could be contacted were evaluated for eligibility for ART (CD4 count or=3) and started on NNRTI-based therapy if eligible. We compared mortality in the cohort of women before and after ART access and examined among women initiating ART whether virologic response was better allowing a longer time to elapse between SDNVP and treatment initiation. RESULTS: In the cohort of 872 women mortality more than halved after ART became available (relative hazard = 0.46 95% confidence interval: 0.23 to 0.91 P = 0.03). Of 161 SDNVP-exposed women followed on NNRTI-based ART 70.8% suppressed (viral load 24 months after exposure (chi2 trend P = 0.01). CONCLUSIONS: Most SDNVP-exposed women respond well to NNRTI-based therapy but there was an attenuation of therapy efficacy that persisted to 12 months after exposure. Women should be screened for ART eligibility during pregnancy and started on effective regimens before delivery.

Background Reducing maternal and neonatal deaths are important global health priorities. We have previously shown that up to a country-level caesarean delivery rate (CDRs) of roughly 19·0%, cesarean delivery rates and maternal mortality ratio (MMR) and neonatal mortality rate (NMR) were inversely correlated. We investigated the absolute reductions in maternal and neonatal deaths if countries with low CDR increased their rates to a range of greater than 7·2% but less than or equal to 19·1%. Methods We calculated maternal and neonatal deaths in 2013 and 2012, respectively, for countries with CDR 7·2% or less (N=45) with available data from the World Bank Development Indicators. We modelled the expected reduction in deaths in these countries if they had the 25th and 75th MMR and NMR percentiles observed for countries (N=48) with CDRs ranging from greater than 7·2% but less than or equal to 19·1%. This model assumes that if countries with low CDRs increased their rates of caesarean delivery to greater than 7·2% but less than or equal to 19·1%, they would achieve levels of MMR and NMR observed in countries with those CDRs. Findings We estimate 176 078 (95% CI 163 258–188 898) maternal and 1 117 257 (95% CI 1 033 611–1 200 902) neonatal deaths occurred in 45 countries with low CDRs in 2013 and 2012, respectively. If these countries had the 25th and 75th MMR and NMR percentiles (MMR, IQR 36–190; NMR, 9–24) observed in countries (N=48) with a CDR ranging from greater than 7·2% but less than or equal to 19·1%, there would be a potential reduction of 109 762–163 513 and 279 584–803 129 maternal and neonatal deaths, respectively. Interpretation Increasing caesarean delivery in countries with low CDRs could avert as many as 163 513 maternal deaths and 803 129 neonatal deaths annually. These findings assume that as health systems develop the capacity to deliver surgical care, there is a concurrent improvement in the quality of care and in the ability to rescue women and neonates who would otherwise die. Improving access to safe caesarean delivery should be a central focus in surgical care globally. Funding None.

Purpose The aim of the current study is to test the validity and reliability of the Shame Questionnaire among traumatized girls in Lusaka, Zambia. Methods The Shame Questionnaire was validated through both classical test and item response theory methods. Internal reliability, criterion validity and construct validity were examined among a sample of 325 female children living in Zambia. Sub-analyses were conducted to examine differences in construct validity among girls who reported sexual abuse and girls who did not. Results All girls in the sample were sexually abused, but only 61.5% endorsed or reported that sexual abuse had occurred. Internal consistency was very good among the sample with alpha = .87. Criterion validity was demonstrated through a significant difference of mean Shame Questionnaire scores between girls who experienced 0–1 trauma events and more than one traumatic event, with higher mean Shame Questionnaire scores among girls who had more than one traumatic event (p = .004 for 0–1 compared to 2 and 3 events and p = .016 for 0–1 compared to 4+ events). Girls who reported a history of witnessing or experiencing physical abuse had a significantly higher mean Shame Questionnaire score than girls who did not report a history of witnessing or experiencing physical abuse (p

HIV and violence are two major public health problems increasingly shown to be connected and relevant to international mental health issues and HIV-related services. Qualitative research is important due to the dearth of literature on this association in developing countries, cultural influences on mental health syndromes and presentations, and the sensitive nature of the topic. The study presented in this paper sought to investigate the mental health issues of an HIV-affected population of women and children in Lusaka, Zambia, through a systematic qualitative study. Two qualitative methods resulted in the identification of three major problems for women: domestic violence (DV), depression-like syndrome, and alcohol abuse; and children: defilement, DV, and behavior problems. DV and sexual abuse were found to be closely linked to HIV and alcohol abuse. This study shows the local perspective of the overlap between violence and HIV. Results are discussed in relation to the need for violence and abuse to be addressed as HIV services are implemented in sub-Saharan Africa.

We present the rationale and design of the Zambian Exclusive Breast-feeding Study (ZEBS), a randomized trial evaluating the efficacy of short-duration exclusive breast-feeding (EBF) as a strategy to reduce postnatal human immunodeficiency virus (HIV) transmission while preserving the other health benefits of this important mode of infant feeding.One thousand two hundred HIV-positive pregnant women were recruited in Lusaka, Zambia, and followed with their infants for 24 months. In addition to Nevirapine (NVP), all women received intensive and frequent clinic- and home-based counseling to support exclusive breast-feeding. When the infant was 1 week of age, half of the women were randomly assigned to a group encouraged to abruptly (24 h) cease all breast-feeding at 4 months. The primary outcome of the experimental (randomized) comparison is HIV-free survival at 24 months. The design is also observational and will compare HIV transmission rates between those who do and do not adhere to the counseling intervention promoting exclusive breast-feeding.Our study aims to quantify the benefit-risk ratio of early cessation of exclusive breast-feeding to interrupt mother-to-child transmission of HIV with an intensive behavioral intervention and has both observational and experimental analytic approaches. Our study design assesses efficacy and also has a prominent applied component that if the intervention is effective, it will permit rapid and sustainable adoption within low-resource communities.

Objective To evaluate the capacity of health facilities in Southern Province, Zambia, to perform routine obstetric care and emergency obstetric and neonatal care (EmONC). Methods Surveys were completed at 90 health centers and 10 hospitals between September 1, 2011, and February 28, 2012. An expanded set of signal functions for routine care and EmONC was used to assess the facilities’ capacity to provide obstetric and neonatal care. Results Interviews were completed with 172 health workers. Comprehensive EmONC was available in only six of 10 hospitals; the remaining four hospitals did not perform all basic EmONC signal functions. None of the 90 health centers performed the basic set of EmONC signal functions. Performance of routine obstetric care functions, health worker EmONC training, and facility infrastructure and staffing varied. Conclusion Assessment of the indicators for routine care revealed that several low-cost interventions are currently underused in Southern Province. There is substantial room for improvement in emergency and routine obstetric and neonatal care at the surveyed facilities. Efforts should focus on improving infrastructure and supplies, EmONC training, and adherence to the UN guidelines for routine and emergency obstetric care.

In Vietnam, despite the possibility of living healthy sexual lives and bearing children due to the increasing availability of antiretroviral therapy and prevention of mother-to-child transmission services, HIV programming has given little attention to the sexual and reproductive health of people living with HIV. Our study explored factors influencing sexual and reproductive health decision-making, needs, rights and access to services for women living with HIV in Hai Phong and Ho Chi Minh City. Nearly half of the women were sexually active at the time of the study and 15% reported wanting a child or another child. Only 14% of women who did not want a child used contraceptive services in the last six months. More than 40% of women reported being advised, primarily by health care providers and family members, to abstain from sex, and more than 13% who were pregnant at the time of the study said that they had been advised to have an abortion. As with all women, women living with HIV must be informed of their sexual and reproductive rights and must have access to medically sound counseling and services to facilitate informed reproductive health decision-making. Sexual and reproductive health services are urgently needed for this population.

Street children, or children who live and/or spend time on the streets, are a vulnerable group of considerable concern to the global public health community. This paper describes the results of two linked qualitative studies conducted with children living or spending time on the street and in orphanages in and around urban areas in the Republic of Georgia between 2005 and 2006. The studies examined perceived causes of children going to the street, as well as indicators of healthy functioning and psychosocial problems among these children. Results on causes indicated a range of “push” factors leading children to the street and “pull” factors that keep children living on the street. Findings also showed a range of internalizing and externalizing mental health symptoms among children on the street and within orphanages. Some differences in responses were found between children living on the street and in institutions. It is important to understand the perspectives of these vulnerable populations to guide decisions on appropriate interventions that address their primary problems.

Importance Based on older analyses, the World Health Organization (WHO) recommends that cesarean delivery rates should not exceed 10 to 15 per 100 live births to optimize maternal and neonatal outcomes. Objectives To estimate the contemporary relationship between national levels of cesarean delivery and maternal and neonatal mortality. Design, Setting, and Participants Cross-sectional, ecological study estimating annual cesarean delivery rates from data collected during 2005 to 2012 for all 194 WHO member states. The year of analysis was 2012. Cesarean delivery rates were available for 54 countries for 2012. For the 118 countries for which 2012 data were not available, the 2012 cesarean delivery rate was imputed from other years. For the 22 countries for which no cesarean rate data were available, the rate was imputed from total health expenditure per capita, fertility rate, life expectancy, percent of urban population, and geographic region. Exposures Cesarean delivery rate. Main Outcomes and Measures The relationship between population-level cesarean delivery rate and maternal mortality ratios (maternal death from pregnancy related causes during pregnancy or up to 42 days postpartum per 100 000 live births) or neonatal mortality rates (neonatal mortality before age 28 days per 1000 live births). Results The estimated number of cesarean deliveries in 2012 was 22.9 million (95% CI, 22.5 million to 23.2 million). At a country-level, cesarean delivery rate estimates up to 19.1 per 100 live births (95% CI, 16.3 to 21.9) and 19.4 per 100 live births (95% CI, 18.6 to 20.3) were inversely correlated with maternal mortality ratio (adjusted slope coefficient, −10.1; 95% CI, −16.8 to −3.4; P = .003) and neonatal mortality rate (adjusted slope coefficient, −0.8; 95% CI, −1.1 to −0.5; P P P = .004). Conclusions and Relevance National cesarean delivery rates of up to approximately 19 per 100 live births were associated with lower maternal or neonatal mortality among WHO member states. Previously recommended national target rates for cesarean deliveries may be too low.

BackgroundPneumonia, diarrhea and measles are the leading causes of death in children worldwide, but have a disproportionately low share of international funding and media attention. In comparison, AIDS, tuberculosis and malaria--diseases that also significantly affect children--receive considerably more funding and have relatively high media coverage. This study investigates the potential relationship between media agenda setting and funding levels in the context of the actual burden of disease.MethodsThe news databases Lexis Nexis, Factiva, and Google News Archive were searched for the diseases AIDS, TB and Malaria and for lower funded pediatric diseases: childhood pneumonia, diarrhea, and measles. A sample of news articles across geographic regions was also analyzed using a qualitative narrative frame analysis of how the media stories were told.ResultsThere were significantly more articles addressing the Global Fund diseases compared to the lower funded pediatric diseases between 1981 and 2008 (1,344,150 versus 291,865 articles). There were also notable differences in the framing of media narratives: 1) There was a high proportion of articles with the primary purpose of raising awareness for AIDS, TB and malaria (46.2%) compared with only 17.9% of the pediatric disease articles. 2) Nearly two-thirds (61.5%) of the AIDS, tuberculosis and malaria articles used a human rights, legal or social justice frame, compared with 46.2% for the lower funded pediatric disease articles, which primarily used an ethical or moral frame.ConclusionThis study demonstrates that lower funded pediatric diseases are presented differently in the media, both quantitatively and qualitatively, than higher funded, higher profile diseases.

In a cluster randomized trial, Kojo Yeboah-Antwi and colleagues find that integrated management of malaria and pneumonia in children under five by community health workers is both feasible and effective., Background Pneumonia and malaria, two of the leading causes of morbidity and mortality among children under five in Zambia, often have overlapping clinical manifestations. Zambia is piloting the use of artemether-lumefantrine (AL) by community health workers (CHWs) to treat uncomplicated malaria. Valid concerns about potential overuse of AL could be addressed by the use of malaria rapid diagnostics employed at the community level. Currently, CHWs in Zambia evaluate and treat children with suspected malaria in rural areas, but they refer children with suspected pneumonia to the nearest health facility. This study was designed to assess the effectiveness and feasibility of using CHWs to manage nonsevere pneumonia and uncomplicated malaria with the aid of rapid diagnostic tests (RDTs). Methods and Findings Community health posts staffed by CHWs were matched and randomly allocated to intervention and control arms. Children between the ages of 6 months and 5 years were managed according to the study protocol, as follows. Intervention CHWs performed RDTs, treated test-positive children with AL, and treated those with nonsevere pneumonia (increased respiratory rate) with amoxicillin. Control CHWs did not perform RDTs, treated all febrile children with AL, and referred those with signs of pneumonia to the health facility, as per Ministry of Health policy. The primary outcomes were the use of AL in children with fever and early and appropriate treatment with antibiotics for nonsevere pneumonia. A total of 3,125 children with fever and/or difficult/fast breathing were managed over a 12-month period. In the intervention arm, 27.5% (265/963) of children with fever received AL compared to 99.1% (2066/2084) of control children (risk ratio 0.23, 95% confidence interval 0.14–0.38). For children classified with nonsevere pneumonia, 68.2% (247/362) in the intervention arm and 13.3% (22/203) in the control arm received early and appropriate treatment (risk ratio 5.32, 95% confidence interval 2.19–8.94). There were two deaths in the intervention and one in the control arm. Conclusions The potential for CHWs to use RDTs, AL, and amoxicillin to manage both malaria and pneumonia at the community level is promising and might reduce overuse of AL, as well as provide early and appropriate treatment to children with nonsevere pneumonia. Trial registration ClinicalTrials.gov NCT00513500 Please see later in the article for the Editors' Summary, Editors' Summary Background Every year, about 11 million children die before their fifth birthday. Most of these deaths are in developing countries and most are due to a handful of causes—pneumonia (lung inflammation usually caused by an infection), malaria (a parasitic disease spread by mosquitoes), measles, diarrhea, and birth-related problems. In sub-Saharan Africa, pneumonia and malaria alone are responsible for nearly a third of deaths in young children. Both these diseases can be treated if caught early—pneumonia with antibiotics such as amoxicillin and malaria with artemisinin-based combination therapy (ACT), a treatment that contains several powerful antimalarial drugs. Unfortunately, parents in rural areas in sub-Saharan Africa rarely have easy access to health facilities and sick children are often treated at home by community health workers (CHWs, individuals with some medical training who provide basic health care to their communities), drug sellers, and traditional healers. This situation means that ongoing global efforts to reduce child mortality will require innovative community level interventions if they are to succeed. Why Was This Study Done? One community level intervention that the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recently recommended is integrated management of malaria and pneumonia in countries where these diseases are major childhood killers. One such country is Zambia. In rural areas of Zambia, CHWs treat suspected cases of uncomplicated (mild) malaria with artemether-lumefantrine (AL, an ACT) or with sulfadoxine-pyrimethamine (a non-ACT antimalarial drug combination) and refer children with suspected pneumonia to the nearest health facility. However, because uncomplicated malaria and pneumonia both cause fever, many children are treated inappropriately. This misdiagnosis is worrying because giving antimalarial drugs to children with pneumonia delays their treatment with more appropriate drugs and increases the risk of drug-resistant malaria emerging. The use of rapid diagnostic tests (RDTs) for malaria might be one way to improve the treatment of malaria and pneumonia by CHWs in Zambia. Here, the researchers investigate the feasibility and effectiveness of this approach in a cluster randomized controlled trial, a study that compares the outcomes of groups (clusters) of patients randomly allocated to different interventions. What Did the Researchers Do and Find? The researchers randomly allocated 31 community health posts (fixed locations where CHWs provide medical services to several villages) to the study's intervention and control arms. CHWs in the intervention arm did RDTs for malaria on all the children under 5 years old who presented with fever and/or difficult or fast breathing (symptoms of pneumonia), treated test-positive children with AL, and treated those with nonsevere pneumonia (an increased breathing rate) with amoxicillin. CHWs in the control arm did not use RDTs but treated all children with fever with AL and referred those with signs of pneumonia to the nearest health facility. About 3,000 children with fever were treated during the 12-month study. 99.1% of the children in the control arm received AL compared with 27.5% of the children in the intervention arm, a 4-fold reduction in treatment for malaria. Importantly, the CHWs in the intervention arm adhered to treatment guidelines and did not give AL to children with negative RDT results. Of the children classified with nonsevere pneumonia, 13.3% of those in the control arm received early and appropriate treatment with amoxicillin compared to 68.2% of those in the intervention arm, a 5-fold increase in the timely treatment for pneumonia. What Do These Findings Mean? These findings indicate that CHWs in Zambia are capable of using RDTs, AL, and amoxicillin to manage malaria and pneumonia. They show that the intervention tested in this study has the potential to reduce the overuse of AL and to provide early and appropriate treatment for nonsevere pneumonia. Although this approach needs to be tested in other settings, these findings suggest that the use of CHWs might be a feasible and effective way to provide integrated management of pneumonia and malaria at the community level in developing countries. Importantly, these results also support the evaluation of the treatment by CHWs of other major childhood diseases and raise the possibility of saving the lives of many children in sub-Saharan Africa and other developing regions of the world through community level interventions. Additional Information Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000340. WHO provides information on malaria, on rapid diagnostic tests for malaria, on artemisinin-combination therapy, and on global child mortality and efforts to reduce it (in several languages); WHO also provides a country health profile for Zambia The US Centers for Disease Control and Prevention provide information on malaria (in English and Spanish) Kidshealth, a resource maintained by the not-for-profit Nemours Foundation (a not-for-profit organization for children's health), provides information for parents on pneumonia (in English and Spanish) MedlinePlus provides links to additional information on malaria and on pneumonia (in English and Spanish) More information about the Zambia Integrated Management of Malaria and Pneumonia Study is available

Background Breast milk transmission of HIV-1 remains a major route of pediatric infection. Defining the characteristics of viral variants to which breastfeeding infants are exposed is important for understanding the genetic bottleneck that occurs in the majority of mother-to-child transmissions. The blood-milk epithelial barrier markedly restricts the quantity of HIV-1 in breast milk, even in the absence of antiretroviral drugs. The basis of this restriction and the genetic relationship between breast milk and blood variants are not well established. Methodology/Principal Findings We compared 356 HIV-1 subtype C gp160 envelope (env) gene sequences from the plasma and breast milk of 13 breastfeeding women. A trend towards lower viral population diversity and divergence in breast milk was observed, potentially indicative of clonal expansion within the breast. No differences in potential N-linked glycosylation site numbers or in gp160 variable loop amino acid lengths were identified. Genetic compartmentalization was evident in only one out of six subjects in whom contemporaneously obtained samples were studied. However, in samples that were collected 10 or more days apart, six of seven subjects were classified as having compartmentalized viral populations, highlighting the necessity of contemporaneous sampling for genetic compartmentalization studies. We found evidence of CXCR4 co-receptor using viruses in breast milk and blood in nine out of the thirteen subjects, but no evidence of preferential localization of these variants in either tissue. Conclusions/Significance Despite marked restriction of HIV-1 quantities in milk, our data indicate intermixing of virus between blood and breast milk. Thus, we found no evidence that a restriction in viral genotype diversity in breast milk accounts for the genetic bottleneck observed following transmission. In addition, our results highlight the rapidity of HIV-1 env evolution and the importance of sample timing in analyses of gene flow.

Objective. To improve care of sexually abused children by establishment of a “One Stop Centre” at the University Teaching Hospital.Methodology. Prior to opening of the One Stop Centre, a management team comprising of clinical departmental heads and a technical group of professionals (health workers, police, psychosocial counselors lawyers and media) were put in place. The team evaluated and identified gaps and weaknesses on the management of sexually abused children prevailing in Zambia. A manual was produced which would be used to train all professionals manning a One Stop Centre. A team of consultants from abroad were identified to offer need based training activities and a database was developed.Results. A multidisciplinary team comprising of health workers, police and psychosocial counselors now man the centre. The centre is assisted by lawyers as and when required. UTH is offering training to other areas of the country to establish similar services by using a Trainer of Trainers model. A comprehensive database has been established for Lusaka province.Conclusion. For establishment of a One Stop Centre, there needs to be a core group comprising of managers as well as a technical team committed to the management and protection of sexually abused children.

BACKGROUND:We previously reported no benefit of early weaning for HIV-free survival of children born to HIV-infected mothers in intent-to-treat analyses. Since early weaning was poorly accepted, we conducted a secondary analysis to investigate whether beneficial effects may have been hidden. METHODS:958 HIV-infected women in Lusaka, Zambia, were randomized to abrupt weaning at 4 months (intervention) or to continued breastfeeding (control). Children were followed to 24 months with regular HIV PCR tests and examinations to determine HIV infection or death. Detailed behavioral data were collected on when all breastfeeding ended. Most participants were recruited before antiretroviral treatment (ART) became available. We compared outcomes among mother-child pairs who weaned earlier or later than intended by study design adjusting for potential confounders. RESULTS:Of infants alive, uninfected and still breastfeeding at 4 months in the intervention group, 16.1% who weaned as instructed acquired HIV or died by 24 months compared to 16.0% who did not comply (p = 0.98). Children of women with less severe disease during pregnancy (not eligible for ART) had worse outcomes if their mothers weaned as instructed (RH = 2.60 95% CI: 1.06-6.36) compared to those who continued breastfeeding. Conversely, children of mothers with more severe disease (eligible for ART but did not receive it) who weaned early had better outcomes (p-value interaction = 0.002). In the control group, weaning before 15 months was associated with 3.94-fold (95% CI: 1.65-9.39) increase in HIV infection or death among infants of mothers with less severe disease. CONCLUSION:Incomplete adherence did not mask a benefit of early weaning. On the contrary, for women with less severe disease, early weaning was harmful and continued breastfeeding resulted in better outcomes. For women with more advanced disease, ART should be given during pregnancy for maternal health and to reduce transmission, including through breastfeeding. TRIAL REGISTRATION:(ClinicalTrials.gov) NCT00310726.

In low-resource settings, many programs recommend that women who are infected with the human immunodeficiency virus (HIV) stop breast-feeding early. We conducted a randomized trial to evaluate whether abrupt weaning at 4 months as compared with the standard practice has a net benefit for HIV-free survival of children.We enrolled 958 HIV-infected women and their infants in Lusaka, Zambia. All the women planned to breast-feed exclusively to 4 months; 481 were randomly assigned to a counseling program that encouraged abrupt weaning at 4 months, and 477 to a program that encouraged continued breast-feeding for as long as the women chose. The primary outcome was either HIV infection or death of the child by 24 months.In the intervention group, 69.0% of the mothers stopped breast-feeding at 5 months or earlier; 68.8% of these women reported the completion of weaning in less than 2 days. In the control group, the median duration of breast-feeding was 16 months. In the overall cohort, there was no significant difference between the groups in the rate of HIV-free survival among the children; 68.4% and 64.0% survived to 24 months without HIV infection in the intervention and control groups, respectively (P=0.13). Among infants who were still being breast-fed and were not infected with HIV at 4 months, there was no significant difference between the groups in HIV-free survival at 24 months (83.9% and 80.7% in the intervention and control groups, respectively; P=0.27). Children who were infected with HIV by 4 months had a higher mortality by 24 months if they had been assigned to the intervention group than if they had been assigned to the control group (73.6% vs. 54.8%, P=0.007).Early, abrupt cessation of breast-feeding by HIV-infected women in a low-resource setting, such as Lusaka, Zambia, does not improve the rate of HIV-free survival among children born to HIV-infected mothers and is harmful to HIV-infected infants.(ClinicalTrials.gov number, NCT00310726.)

Adequate adherence is required for prevention of mother-to-child transmission of HIV (pMTCT) programs to be effective. We investigated predictors and extent of nonadherence to singledose nevirapine. Data on nevirapine intake and possible predictors were collected among 760 HIV-positive women with liveborn babies enrolled in a study in Lusaka Zambia. Most (94%) women took nevirapine before delivery and most (91%) newborns received it soon after delivery. Maternal nonadherence was associated with home births (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.3 to 7.4) no high school education (OR: 2.4; 95% CI: 1.1 to 5.3) and low newborn birth weight (OR: 4.6; 95% CI: 1.3 to 20.1). Disclosure of HIV status and couples counseling was only associated with adherence among home births. Failure to administer nevirapine to the newborn was associated with birth at the tertiary hospital (OR: 7.2; 95% CI: 3.7 to 13.8) lower 5-minute Apgar scores (OR: 0.5; 95% CI: 0.4 to 0.7) and neonatal death (OR: 5.8; 95% CI: 2.0 to 16.3). Excellent adherence to single-dose nevirapine for pMTCT can be achieved. Nonadherence seems to be affected by place of birth and by poor health status of the newborn. Procedures to ensure that viable yet ill neonates receive nevirapine should be part of clinical protocols and training within pMTCT programs. (authors)

A previously reported association between prolonged lactation and maternal mortality has generated concern that breast-feeding may be detrimental for HIV-positive women. As part of a trial conducted in Lusaka Zambia 653 HIV-positive women were randomly assigned either to a counseling program that encouraged abrupt cessation of breast-feeding at 4 months (group A) or to a program that encouraged prolonged breast-feeding for the duration of the woman’s own informed choice (group B). We examined whether mortality up to 2 years post-partum increased with breastfeeding for a longer duration. There was no difference in mortality 12 months after delivery between 326 HIV-positive women randomly assigned to short breast-feeding [group A: 4.93%; 95% confidence interval (CI) 2.42–7.46] versus 327 women assigned to long breast-feeding (group B: 4.89%; 95% CI 2.38–7.40). Analysis based on actual practice rather than random assignment also demonstrated no increased mortality due to breast-feeding. Although HIV-related mortality was high in this cohort of untreated HIV positive women prolonged lactation was not associated with increased mortality. (authors)

Infants born to HIV-infected mothers are at risk of acquiring HIV infection. The risk is serious, but it can be substantially reduced with antiretroviral drugs [1–3]. Yet, even in the absence of interventions, the majority of infants born to HIV-infected mothers do not acquire infection. However, these infants risk losing their mother (and father) to HIV infection during childhood, with the social dislocation of orphanhood posing obvious dangers to their well-being [4–6]. But do HIV-uninfected children have other risks associated with having an HIV-infected mother? There is surprisingly little known about morbidity and mortality among HIV-exposed, HIV-uninfected infants. Demographic studies estimate that mortality among children born to HIV-infected mothers is higher than that among children born to mothers without HIV infection, but interpretation is limited because the proportion of HIV-infected children is not known [6–9]. Factors affecting morbidity and mortality in general (e.g., lack of breastfeeding, unhygienic living conditions, and malaria exposure) are also likely to be important among HIV–exposed, HIV-uninfected infants. In addition, HIV exposure directly or indirectly in utero, intrapartum, and during breastfeeding may confer risks to infants, even in the absence of vertical transmission. Perinatal transmission and disease progression among infected infants are higher among those born to mothers with more advanced HIV disease [10–12]. The effect, if any, on uninfected offspring is unclear. Here, we investigate whether advanced HIV disease and/or immune dysfunction among HIV-infected mothers increases mortality and morbidity among their uninfected infants. Any effect will have substantial public health consequences, because the absolute number of reproductive-aged women with HIV infection continues to increase.

Couple counseling has been promoted as a strategy to improve uptake of interventions to prevent mother-to-child HIV transmission (pMTCT) and to minimize adverse social outcomes associated with disclosure of HIV status.We tested whether women counseled antenatally as part of a couple were more likely to accept HIV testing and nevirapine in a pMTCT program, and whether they would be less likely to experience later adverse social events than women counseled alone.A pMTCT program that included active community education and outreach to encourage couple counseling and testing was implemented in two antenatal clinics in Lusaka, Zambia. A subset of HIV-positive women was asked to report their experience of adverse social events 6 months after delivery. Couple-counseled women were compared with individual-counseled women stratified by whether or not they had disclosed their HIV status to their partners.Nine percent (868) of 9409 women counseled antenatally were counseled with their husband. Couple-counseled women were more likely to accept HIV testing (96%) than women counseled alone (79%); however uptake of nevirapine was not improved. Six months after delivery, 28% of 324 HIV-positive women reported at least one adverse social event (including physical violence, verbal abuse, divorce or separation). There were no significant differences in reported adverse social events between couple- and individual-counseled women.Couple counseling did not increase the risk of adverse social events associated with HIV disclosure. Support services and interventions to improve social situations for people living with HIV need to be further evaluated.

Objective The objective of the study was to examine the relationship between breastfeeding patterns, markers of maternal human immunodeficiency virus (HIV) disease, and woman's breast pathology. Study Design Secondary data analysis from a randomized breastfeeding trial including 947 HIV-infected women (n = 5982 visits) from breastfeeding initiation until 6 months postpartum; 1 month after breastfeeding cessation; or loss to follow-up or death. Generalized estimating equations assessed the effects of breastfeeding pattern and maternal HIV status on breast pathology. Results One hundred ninety women (20.1%) had a breast problem; 86 (9.1%) had mastitis; and 31 (3.3%) had abscess. After confounder adjustment, nonexclusively breastfeeding women had an increased risk of breast problems (odds ratio, 1.98; 95% confidence interval, 1.33–2.95) and mastitis (odds ratio, 2.87, 95% confidence interval, 1.69–4.88) compared with exclusive breastfeeders. Women with a CD4 count less than 200 cells/μL tended to have an increased risk of abscess. Conclusion Nonexclusive breastfeeding significantly increased the risk of breast pathology. Exclusive breastfeeding is not only optimal for infant health but it also benefits mothers by reducing breast problems.