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Background: Integrated community case management (CCM) has led to reductions in child mortality in Malawi resulting from illnesses such as malaria, pneumonia, and diarrhea. However, adherence to CCM guidelines is often poor, potentially leading to inappropriate clinical decisions and poor outcomes. We determined the impact of an e-CCM app on the referral, reconsultation, and hospitalization rates of children presenting to village clinics in Malawi.Objective: We determined the impact of an electronic version of a smartphone-based CCM (e-CCM) app on the referral, reconsultation, and hospitalization rates of children presenting to village clinics in Malawi.Methods: We used a stepped-wedge, cluster-randomized trial to compare paper-based CCM (control) with and without the use of an e-CCM app on smartphones from November 2016 to February 2017. A total of 102 village clinics from 2 districts in northern Malawi were assigned to 1 of 6 clusters, which were randomized on the sequencing of the crossover from the control phase to the intervention phase as well as the duration of exposure in each phase. Children aged ≥2 months to <5 years who presented with acute illness were enrolled consecutively by health surveillance assistants. The primary outcome of urgent referrals to higher-level facilities was evaluated by using multilevel mixed effects models. A logistic regression model with the random effects of the cluster and the fixed effects for each step was fitted. The adjustment for potential confounders included baseline factors, such as patient age, sex, and the geographical location of the village clinics. Calendar time was adjusted for in the analysis.Results: A total of 6965 children were recruited-49.11% (3421/6965) in the control phase and 50.88% (3544/6965) in the intervention phase. After adjusting for calendar time, children in the intervention phase were more likely to be urgently referred to a higher-level health facility than children in the control phase (odds ratio [OR] 2.02, 95% CI 1.27-3.23; P=.003). Overall, children in the intervention arm had lower odds of attending a repeat health surveillance assistant consultation (OR 0.45, 95% CI 0.34-0.59; P<.001) or being admitted to a hospital (OR 0.75, 95% CI 0.62-0.90; P=.002), but after adjusting for time, these differences were not significant (P=.07 for consultation; P=.30 for hospital admission).Conclusions: The addition of e-CCM decision support by using smartphones led to a greater proportion of children being referred to higher-level facilities, with no apparent increase in hospital admissions or repeat consultations in village clinics. Our findings provide support for the implementation of e-CCM tools in Malawi and other low- and middle-income countries with a need for ongoing assessments of effectiveness and integration with national digital health strategies.Trial Registration: ClinicalTrials.gov NCT02763345; https://clinicaltrials.gov/ct2/show/NCT02763345. [ABSTRACT FROM AUTHOR]

Background: Malawi introduced an ambitious public health program known as "Option B+" which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. Methods/design: PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. Results: Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17-51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75-100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22-31) years. All women have ≥20 months of possible follow-up time; 96% ≥ 2 years (24-32 months). Conclusion: The PURE Malawi study showed that 3 implementing partner organizations could successfully recruit a complex cohort of pregnant and lactating women across 3 geographical zones in Malawi within a reasonable timeline. Trial registration: This study is registered at clinicaltrials.gov - ID Number NCT02005835. Registered 4 December, 2013. [ABSTRACT FROM AUTHOR]

Background Understanding the cost-effectiveness and affordability of interventions to reduce maternal and newborn deaths is critical to persuading policymakers and donors to implement at scale. The effectiveness of community mobilisation through women's groups and health facility quality improvement, both aiming to reduce maternal and neonatal mortality, was assessed by a cluster randomised controlled trial conducted in rural Malawi in 2008-2010. In this paper, we calculate intervention cost-effectiveness and model the affordability of the interventions at scale. Methods Bayesian methods are used to estimate the incremental cost-effectiveness of the community and facility interventions on their own (CI, FI), and together (FICI), compared to current practice in rural Malawi. Effects are estimated with Monte Carlo simulation using the combined full probability distributions of intervention effects on stillbirths, neonatal deaths and maternal deaths. Cost data was collected prospectively from a provider perspective using an ingredients approach and disaggregated at the intervention (not cluster or individual) level. Expected Incremental Benefit, Cost-effectiveness Acceptability Curves and Expected Value of Information (EVI) were calculated using a threshold of $780 per disability-adjusted life-year (DALY) averted, the per capita gross domestic product of Malawi in 2013 international $. Results The incremental cost-effectiveness of CI, FI, and combined FICI was $79, $281, and $146 per DALY averted respectively, compared to current practice. FI is dominated by CI and FICI. Taking into account uncertainty, both CI and combined FICI are highly likely to be cost effective (probability 98% and 93%, EVI $210,423 and $598,177 respectively). Combined FICI is incrementally cost effective compared to either intervention individually (probability 60%, ICER $292, EIB $9,334,580 compared to CI). Future scenarios also found FICI to be the optimal decision. Scaling-up to the whole of Malawi, CI is of greatest value for money, potentially averting 13.0% of remaining annual DALYs from stillbirths, neonatal and maternal deaths for the equivalent of 6.8% of current annual expenditure on maternal and neonatal health in Malawi. Conclusions Community mobilisation through women's groups is a highly cost-effective and affordable strategy to reduce maternal and neonatal mortality in Malawi. Combining community mobilisation with health facility quality improvement is more effective, more costly, but also highly cost-effective and potentially affordable in this context. [ABSTRACT FROM AUTHOR]

The article investigates into the adoption of mobile money services in Malawi through a randomized controlled trial conducted among microentrepreneurs from 2017-2018. Topics discussed include economic impact of mobile money services, use of the mobile money accounts for the purpose of saving more than money transfers, and effects on labor supply, expenditures, and interpersonal transfers.

Background: People living with HIV (PLHIV) have to take lifelong antiretroviral treatment, which is often challenging. Young people living with HIV (YPLHIV) have the lowest viral load suppression rates in Malawi and globally, mostly due to poor treatment adherence. This is a result of complex interactions of multiple factors unique to this demographic group. The use of digital health interventions, such as real-time medication monitor (RTMM)-based digital adherence tools (DATs), could improve ART adherence in YPLHIV and subsequently improve viral load suppression which in turn could lead to reduced HIV-associated morbidity and mortality. Aim: To provide the evidence base for a digital adherence intervention to improve treatment outcomes in YPLHIV on ART. Objectives: 1. The primary objective is to determine the efficacy of a customised DAT compared to the standard of care in improving ART adherence in YPLHIV. 2. The secondary objective is to determine the efficacy of the customised DAT compared to the standard of care in improving viral load suppression in YPLHIV. Methodology: This will be a parallel open-label randomised control controlled two-arm trial in which non-adherent YPLHIV in selected ART facilities in Blantyre will be randomised in a 1:1 ratio to a customised DAT and standard care arms and followed up for 9 months. The primary outcome is the proportion adherent at 9 months (> = 95% by pill count), and the secondary outcome is the proportion with viral load suppressed at 9 months (< 200 copies/ml). Discussion: There is a paucity of good quality evidence on effective digital health interventions to improve ART adherence and viral load suppression in YPLHIV globally and particularly in HIV high-burden settings like Malawi. This study will provide good-quality evidence on the effectiveness of a customised DAT in improving ART adherence and viral load suppression in this important demographic. Trial registration: The trial has been registered in the Pan African Clinical Trials Registry number: PACTR202303867267716 on 23 March 2023 and can be accessed through the following URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25424. All items from the WHO Trial Registration Data Set are described in this manuscript. [ABSTRACT FROM AUTHOR]

Background: A randomized controlled trial in South Africa found a beneficial effect of acyclovir on genital ulcer healing, but no effect was seen in trials in Ghana, Central African Republic and Malawi. The aim of this paper is to assess whether the variation in impact of acyclovir on ulcer healing in these trials can be explained by differences in the characteristics of the study populations. Methodology/Principal Findings: Pooled data were analysed to estimate the impact of acyclovir on the proportion of ulcers healed seven days after randomisation by HIV/CD4 status, ulcer aetiology, size and duration before presentation; and impact on lesional HIV-1. Risk ratios (RR) were estimated using Poisson regression with robust standard errors. Of 1478 patients with genital ulcer, most (63%) had herpetic ulcers (16% first episode HSV-2 ulcers), and a further 3% chancroid, 2% syphilis, 0.7% lymphogranuloma venereum and 31% undetermined aetiology. Over half (58%) of patients were HIV-1 seropositive. The median duration of symptoms before presentation was 6 days. Patients on acyclovir were more likely to have a healed ulcer on day 7 (63% vs 57%, RR = 1.08, 95% CI 0.98-1.18), shorter time to healing (p = 0.04) and less lesional HIV-1 RNA (p = 0.03). Small ulcers (<50 mm2), HSV-2 ulcers, first episode HSV-2 ulcers, and ulcers in HIV-1 seropositive individuals responded best but the better effectiveness in South Africa was not explained by differences in these factors. Conclusions/Significance: There may be slight benefit in adding acyclovir to syndromic management in settings where most ulcers are genital herpes. The stronger effect among HIV-1 infected individuals suggests that acyclovir may be beneficial for GUD/HIV-1 co-infected patients. The high prevalence in this population highlights that genital ulceration in patients with unknown HIV status provides a potential entry point for provider-initiated HIV testing. [ABSTRACT FROM AUTHOR]

Introduction: Ready-to-use therapeutic foods (RUTFs) have successfully promoted recovery from severe wasting and increased treatment coverage. However, RUTFs do not sufficiently improve linear growth, leaving many survivors of severe wasting at risk of persistent stunting, which is associated with high mortality risk, poor child development and non-communicable diseases in adulthood. High protein quantity and quality can stimulate linear growth. Aim: The trial aims to assess whether higher-protein-RUTF leads to higher concentrations of markers of linear growth compared to standard RUTF among 6–23 months old children with severe wasting. Methods: We designed a higher protein quantity and quality RUTF for a proof-of-concept (PoC) double-blind randomized controlled trial. Outcomes: The primary outcome is a change in insulin-like growth factor-1 (IGF-1), a hormone positively associated with linear growth after four weeks of treatment. Secondary outcomes include changes in ponderal and linear growth and in body composition from baseline to eight weeks later; plasma amino acid profile at four weeks; acceptability and safety. Implications: These findings will help in informing the potential impact of increased protein in RUTF on linear growth when treating severe wasting towards conducting a larger clinical trial. Trial registration: The trial has been registered on clinicaltrial.gov (NCT05737472). [ABSTRACT FROM AUTHOR]

Background: HIV testing among the sexual partners of HIV–positive clients is critical for case identification and reduced transmission in southern and eastern Africa. HIV self-testing (HIVST) may improve uptake of HIV services among sexual partners of antiretroviral therapy (ART) clients, but the impact of HIVST on partner testing and subsequent ART initiation remains unclear. Methods and findings: We conducted an individually randomized, unblinded trial to assess if an index HIVST intervention targeting the partners of ART clients improves uptake of testing and treatment services in Malawi. The trial was conducted at 3 high-burden facilities in central and southern Malawi. ART clients attending HIV treatment clinics were randomized using simple randomization 1:2·5 to: (1) standard partner referral slip (PRS) whereby ART clients were given facility referral slips to distribute to their primary sexual partners; or (2) index HIVST whereby ART clients were given HIVST kits + HIVST instructions and facility referral slips to distribute to their primary sexual partners. Inclusion criteria for ART clients were: ≥15 years of age, primary partner with unknown HIV status, no history of interpersonal violence (IPV) with partner, and partner lives in facility catchment area. The primary outcome was partner testing 4-weeks after enrollment, reported by ART clients using endline surveys. Medical chart reviews and tracing activities with partners with a reactive HIV test measured ART initiation at 12 months. Analyses were conducted based on modified intention-to-treat principles, whereby we excluded individuals who did not have complete endline data (i.e., were loss to follow up from the study). Adjusted models controlled for the effects of age and marital status. A total of 4,237 ART clients were screened and 484 were eligible and enrolled (77% female) between March 28, 2018 and January 5, 2020. A total of 365 participants completed an endline survey (257/34 index HIVST arm; 107/13 PRS arm) and were included in the final analysis (78% female). Testing coverage among sexual partners was 71% (183/257) in the index HIVST arm and 25% (27/107) in the PRS arm (aRR: 2·77, 95% CI [2·56 to 3·00], p ≤ 0.001). Reported HIV positivity rates did not significantly differ by arm (16% (30/183) in HIVST versus 15% (4/27) in PRS; p = 0.99). ART initiation at 12 months was 47% (14/30) in HIVST versus 75% (3/4) in PRS arms; however, index HIVST still resulted in a 94% increase in the proportion of all partners initiating ART due to higher HIV testing rates in the HIVST arm (5% partners initiated ART in HVIST versus 3% in PRS). Adverse events including IPV and termination of the relationship did not vary by arm (IPV: 3/257 index HIVST versus 4/10 PRS; p = 0.57). Limitations include reliance on secondary report by ART clients, potential social desirability bias, and not powered for sex disaggregated analyses. Conclusions: Index HIVST significantly increased HIV testing and the absolute number of partners initiating ART in Malawi, without increased risk of adverse events. Additional research is needed to improve linkage to HIV treatment services after HIVST use. Trial registration: ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316. Author summary: Why was this study done?: Undiagnosed and untreated HIV remains a barrier to sustained epidemic control, particularly among men. HIV self-testing (HIVST) improves HIV testing coverage and can be distributed through sexual networks of antiretroviral therapy (ART) clients (i.e., index HIVST) who are at increased risk of HIV infection. A key innovation for this study is to understand the acceptability and impact of index HIVST among sexual partners of index ART clients and ART initiation rates among partners with reactive HIVST results. What did the researchers do and find?: We conducted an individually randomized, unblinded trial with 365 participants in Malawi (n = 257 index HIVST arm; n = 107 partner referral slip (PRS) arm) to assess the impact of index HIVST on HIV testing and uptake of ART among partners of ART clients. Index HIVST increased HIV testing among partners (71% with index HIVST versus 25% with standard of care), was cost-efficient, and was acceptable and feasible to both ART clients and their partners. ART initiation among those with a reactive HIV test was lower in the index HIVST arm compared to standard of care (47% versus 75%), but the proportion of all partners who initiated ART was higher because testing uptake was substantially higher in the index HIVST arm (5% versus 3% of all partners). What do these findings mean?: Index HIVST is a useful tool to increase HIV testing among sexual partners of ART clients in Malawi, where the majority ART clients were married and already disclosed their HIV status to their partners. Index HIVST may be most successful for treatment uptake when implemented alongside other strategies to increase access and demand for treatment services. Our sample size was not powered on secondary outcomes and did not allow for disagregatted findings by key variables such as relationship status or status disclosure. Additional research is needed to assess if index HIVST is acceptable and impactful in settings with less stable relationships and lower rates of status disclosure. In a randomized controlled trial from Malawi, Kathryn Dovel and colleagues, investigate the impact of HIV self-testing in partners of people taking antiretroviral therapy. [ABSTRACT FROM AUTHOR]

Simple Summary: Our study evaluated which of two HPV-based cervical cancer screening–family planning integration models would result in a higher proportion of eligible women ever being screened for cervical cancer in our targeted communities in Malawi. We found that the model that offered HPV self-collection in both the local health clinic and through community health workers resulted in a significantly higher proportion of eligible women ever being screened in that model's targeted communities, when compared to the model that only offered HPV self-collection at the local health clinic. In addition, women in the clinic–community integration model were more likely to be using modern family planning services. Therefore, we recommend that countries and programs aiming to increase the proportion of eligible women ever screened for cervical cancer integrate HPV self-collection with family planning services in both clinic- and community-based settings to reach women that have never been screened for cervical cancer. We conducted a cluster randomized trial of two models for integrating HPV self-collection into family-planning (FP) services at 16 health facilities in Malawi between March 2020–December 2021. Model 1 involved providing only clinic-based HPV self-collection, whereas Model 2 included both clinic-based and community-based HPV self-collection. An endline household survey was performed in sampled villages and households between October-December 2021 in the catchment areas of the health facilities. We analyzed 7664 surveys from 400 villages. Participants from Model 2 areas were more likely to have ever undergone cervical cancer screening (CCS) than participants from Model 1 areas, after adjusting for district, facility location (urban versus rural), and facility size (hospital versus health center) (adjusted odds ratio = 1.73; 95% CI: 1.29, 2.33). Among participants who had ever undergone CCS, participants from Model 2 were more likely to report having undergone HPV self-collection than participants from Model 1 (50.5% versus 22.8%, p = 0.023). Participants from Model 2 were more likely to be using modern FP (adjusted odds ratio = 1.01; 95% CI: 1.41, 1.98) than Model 1 participants. The integration of FP and HPV self-collection in both the clinic and community increases CCS and modern FP uptake more than integration at the clinic-level alone. [ABSTRACT FROM AUTHOR]

This study examines evidence from a randomized controlled trial of a novel financial services intervention designed to spur savings uptake in rural areas of the developing world. The sample includes more than 2,000 households from 325 villages in rural Malawi. Results show that an information treatment consisting of periodic village visits from a trained bank staff person significantly increased adoption and use of savings accounts. The findings also show important impact heterogeneities along dimensions such as education level, remoteness of village, and gender of household head, as well as positive spillover effects onto account uptake at other financial institutions. Further analysis reveals active account use among adopters. These findings confirm recent suggestions from survey evidence on an important role played by "soft" barriers to financial inclusion (e.g., low information and trust) and provide insights on how such barriers can be overcome. [ABSTRACT FROM AUTHOR]

Encouraging HIV-infected pregnant women to recruit male partners for couple HIV testing and counselling (CHTC) is promoted by the World Health Organization, but remains challenging. Formal strategies for recruiting the male partners of pregnant women have not been explored within an Option B+ programme. Our objective was to learn about experiences surrounding CHTC recruitment within a formal CHTC recruitment study. A randomised controlled trial comparing two CHTC recruitment strategies was conducted among HIV-infected pregnant women presenting to Bwaila Antenatal Unit in 2014. Women were randomised to receive an invitation to attend the clinic as a couple or this invitation plus clinic-led phone and community tracing. A qualitative study was conducted with a subset of participants to learn about recruitment. This paper describes experiences of a subset of HIV-infected pregnant women (N= 20) and male partners (N= 17). One on one in-depth interviews were audio-recorded, transcribed, translated, and coded using content analysis. Nearly all women presented the invitation and disclosed their HIV-positive status to their partners on the day of HIV diagnosis, often to facilitate pill-taking. Men and women in both arms perceived the messages to be more compelling since they came from the clinic, rather than the woman herself. Couples who attended CHTC displayed greater care for one another and mutual support for HIV-related behaviours. Facilitating CHTC with invitations and tracing can support CHTC uptake and support for HIV-affected couples. In an Option B+ context, inviting partners for CHTC can facilitate male involvement and have important benefits for families. [ABSTRACT FROM PUBLISHER]

Background: The Nutrition Embedded Evaluation Programme Impact Evaluation (NEEP-IE) study is a cluster randomised controlled trial designed to evaluate the impact of a childcare centre-based integrated nutritional and agricultural intervention on the diets, nutrition and development of young children in Malawi. The intervention includes activities to improve nutritious food production and training/behaviour-change communication to improve food intake, care and hygiene practices. This paper presents the rationale and study design for this randomised control trial.Methods: Sixty community-based childcare centres (CBCCs) in rural communities around Zomba district, Malawi, were randomised to either (1) a control group where children were attending CBCCs supported by Save the Children's Early Childhood Health and Development (ECD) programme, or (2) an intervention group where nutritional and agricultural support activities were provided alongside the routine provision of the Save the Children's ECD programme. Primary outcomes at child level include dietary intake (measured through 24-h recall), whilst secondary outcomes include child development (Malawi Development Assessment Tool (MDAT)) and nutritional status (anthropometric measurements). At household level, primary outcomes include smallholder farmer production output and crop-mix (recall of last production season). Intermediate outcomes along theorised agricultural and nutritional pathways were measured. During this trial, we will follow a mixed-methods approach and undertake child-, household-, CBCC- and market-level surveys and assessments as well as in-depth interviews and focus group discussions with project stakeholders.Discussion: Assessing the simultaneous impact of preschool meals on diets, nutrition, child development and agriculture is a complex undertaking. This study is the first to explicitly examine, from a food systems perspective, the impact of a preschool meals programme on dietary choices, alongside outcomes in the nutritional, child development and agricultural domains. The findings of this evaluation will provide evidence to support policymakers in the scale-up of national programmes.Trial Registration: ISRCTN registry, ID: ISRCTN96497560 . Registered on 21 September 2016. [ABSTRACT FROM AUTHOR]

Objective: The benefit of male circumcision is greatest among men who are most at risk of HIV infection. Encouraging this population of men to get circumcised maximizes the benefit that can be achieved through the scale-up of circumcision programs. This paper examines how the price of circumcision affects the risk profile of men who receive a voluntary medical circumcision.Methods: In 2010, 1649 uncircumcised adult men in urban Malawi were interviewed and provided a voucher for a subsidized voluntary medical male circumcision, at randomly assigned prices. Clinical data were collected indicating whether the men in the study received a circumcision.Results: Men who took-up circumcision with a zero-priced voucher were 25 percentage points less likely than those who took-up with a positive-price voucher, to be from a tribe that traditionally circumcises (p=0.101). Zero-priced vouchers also brought in men with more sexual partners in the past year (p=0.075) and past month (p=0.003). None of the men who were most at risk of HIV at baseline (those with multiple partners and who did not use a condom the last time they had sex) received a circumcision if they were offered a positive-priced voucher. Lowering the price to zero increased circumcision take-up to 25% for men of this risk group. The effect of price on take-up was largest among those at highest risk (p=0.096).Conclusions: Reducing the price of circumcision surgery to zero can increase take-up among those who are most at risk of HIV infection. [ABSTRACT FROM AUTHOR]

Background: Source data verification (SDV) is a data monitoring procedure which compares the original records with the Case Report Form (CRF). Traditionally, on-site SDV relies on monitors making multiples visits to study sites requiring extensive resources. The Cooking And Pneumonia Study (CAPS) is a 24- month village-level cluster randomized controlled trial assessing the effectiveness of an advanced cook-stove intervention in preventing pneumonia in children under five in rural Malawi (). CAPS used smartphones to capture digital images of the original records on an electronic CRF (eCRF). In the present study, descriptive statistics are used to report the experience of electronic data capture with remote SDV in a challenging research setting in rural Malawi. Methods: At three monthly intervals, fieldworkers, who were employed by CAPS, captured pneumonia data from the original records onto the eCRF. Fieldworkers also captured digital images of the original records. Once Internet connectivity was available, the data captured on the eCRF and the digital images of the original records were uploaded to a web-based SDV application. This enabled SDV to be conducted remotely from the UK. We conducted SDV of the pneumonia data (occurrence, severity, and clinical indicators) recorded in the eCRF with the data in the digital images of the original records. Result: 664 episodes of pneumonia were recorded after 6 months of follow-up. Of these 664 episodes, 611 (92%) had a finding of pneumonia in the original records. All digital images of the original records were clear and legible. Conclusion: Electronic data capture using eCRFs on mobile technology is feasible in rural Malawi. Capturing digital images of the original records in the field allows remote SDV to be conducted efficiently and securely without requiring additional field visits. We recommend these approaches in similar settings, especially those with health endpoints. [ABSTRACT FROM AUTHOR]

Background: Evidence from low‐income settings around early education interventions that can improve young children's development is sparse, particularly with regard to the most marginalized children. This study used a two‐arm parallel cluster randomized control design to evaluate the impact of an adapted staff training programme on the developmental outcomes of children attending community‐based early learning centres in Thyolo district, rural Malawi. Methods: At baseline we randomly selected 48 centres, from each of which 20 children were randomly selected, although data from one centre was incomplete resulting in 932 children from 47 centres. Centres were randomly allocated to either the intervention or control arm. Twelve months later, follow‐up data were collected from 44 centres. At baseline and endline, community‐based childcare centre (CBCC) managers provided information about the centre, and parents/guardians provided information on the children, including the primary outcomes of age‐standardized development scores in the language and social domains, measured using the Malawi Developmental Assessment Tool. Children in the bottom 2.5 percentile of either domain were considered to have a delay; a third outcome variable, Any Delay, was developed to indicate children with a delay in either or both domains. Centre‐level mean scores were calculated, and linear regression models were constructed to assess differences between baseline and endline and between allocation groups. Results: Analysis of the difference between baseline and endline measures in the allocation groups shows a non‐significant reduction in delay associated with the study intervention across all domains. Adjustment for baseline characteristics within the CBCCs showed little impact on the magnitude of the observed effect, and the difference remained non‐significant. Conclusions: Despite no observed differences between allocation groups, the data did indicate a positive change in the intervention groups in both domains, particularly language. Community‐based early learning in Malawi holds tremendous potential for promoting inclusive development and learning. [ABSTRACT FROM AUTHOR]

Background: The SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention is a pragmatic randomised controlled trial, testing the effectiveness of brief text messaging for improving clinical outcomes and medication adherence. The intervention did not impact glycaemic control. We conducted a pre-and post-trial process evaluation alongside the StAR2D study in Malawi and South Africa, exploring the experiences and perceptions of patient participants, to better understand potential underlying reasons for the trial outcomes.Methods: We employed a qualitative research design, including conducting semi structured in-depth interviews and focus groups at both trial sites. Purposive sampling was used to ensure representation of a wide range of patients with type 2 diabetes with regards to age, gender, ethnicity, language, and duration of diabetes. We interviewed the same participants at baseline and at the end of the trial. We used within-case and across-case thematic analysis to identify key themes.Results: Brief messages delivered by text were acceptable and useful for addressing informational and support needs for participants. Some participants reported behaviour changes because of the text reminders and advice on a healthy lifestyle. Both participating in the trial and the messages were experienced as a source of support, caring, and motivation. Participants' ability to act on the messages was limited. A common theme was frustration over the lack of ability to effectively control one's blood glucose level. They reported a range of routinised, partial diabetes care adherence behaviours, shaped by complex and interacting individual, social, and health service factors. Participant responses and intervention impact were similar across sites, despite differences in health services.Conclusion: This process evaluation provided context and insight into the factors influencing participants' engagement with the text messaging intervention. The complex context in which patients take their diabetes medication, may explain in part, why brief text messaging may have been insufficient to bring about changes in health outcomes. The scale of need for self-management and health service support, suggests that health system strengthening, and other forms of self-management support should accompany digital communication interventions. (Current Controlled Trials ISRCTN70768808 , registered 03/08/2015.). [ABSTRACT FROM AUTHOR]

Eggs are a rich source of multiple nutrients that support child growth and development. Provision of eggs as a complementary food may improve dietary adequacy among young children at risk for undernutrition. Our objective was to test the impact of an egg intervention on the adequacy of total nutrient intakes and micronutrient density among 6‐ to 15‐month‐old Malawian children. Children 6 to 9 months old, living in Mangochi District, Malawi, were randomly assigned to the intervention group (n = 331) receiving an egg per day or a control group (n = 329) consuming their usual diet. Dietary intakes of macronutrients, vitamins and minerals were assessed using 24‐h recalls at baseline, 3‐month midline and 6‐month endline, with repeat recalls in a subsample. Usual nutrient intake and micronutrient density distributions were modelled to estimate group means and prevalence of inadequacy. Group differences at midline and endline were tested using unequal variance t tests with bootstrapped standard errors. The egg intervention resulted in higher intakes of fat and protein and lower intakes of carbohydrates. The egg group had lower prevalence of inadequacy for selenium, vitamin A, riboflavin, vitamin B5, vitamin B12 and choline. Micronutrient density inadequacy was lower in the egg group for vitamin A and choline at midline and endline, riboflavin at midline and vitamin B5 at endline. Inadequacy of nutrient intakes or density remained highly prevalent in both groups for multiple micronutrients. Though the egg intervention increased intakes of protein and several micronutrients, total intakes and micronutrient density of multiple micronutrients remained far below recommendations. [ABSTRACT FROM AUTHOR]

Aim: This study was designed to determine whether faecal regenerating 1B protein (REG1B) concentration is associated with physical growth among 6–30‐month‐old children in rural Malawi. Methods: This was a secondary analysis from a randomised controlled trial in rural Malawi in which we followed‐up 790 live‐born infants from birth to 30 months of age. We collected anthropometric data at the age of 6, 12, 18, 24 and 30 months. We measured faecal REG1B concentration by enzyme‐linked immunosorbent assay (ELISA) technique using stool samples collected at 6, 18 and 30 months of age. We assessed the association between faecal REG1B concentration and children's physical growth using linear regression and longitudinal data analysis. Results: Of 790 live‐born infants enrolled, 694 (87%) with at least one faecal REG1B concentration measurement were included in the analysis. Faecal REG1B concentration was not associated with the children's concurrent length‐for‐age z‐score (LAZ), weight‐for‐age z‐score (WAZ), weight‐for‐length z‐score (WLZ) and mid‐upper arm circumference‐for‐age z‐score (MUACZ) at any time point (P > 0.05), nor with a change in their anthropometric indices in the subsequent 6‐month period (P > 0.05). Conclusions: Faecal REG1B concentration is not associated with LAZ, WAZ, WLZ and MUACZ among 6–30‐month‐old infants and children in rural Malawi. [ABSTRACT FROM AUTHOR]

Complementary feeding diets in low‐ and middle‐income countries are generally inadequate to meet requirements for growth and development. Food‐based interventions may prevent nutrient inadequacies provided that they do not displace other nutrient‐rich foods. We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were provided an egg a day for 6 months or assigned to a control group. Dietary intake of complementary foods and drinks was assessed at baseline, 3‐month midline and 6‐month endline visits using a tablet‐based multipass 24‐h recall. Up to two repeat recalls were collected at each time point in a subsample of 100 children per treatment group. At midline and endline, usual energy intake from eggs was about 30 kcal/day higher in the egg group compared with controls (p < 0.0001). Compared with controls, children in the egg group were over nine times more likely to consume eggs at midline and endline. There was a comparable, but nonsignificant, greater total usual energy intake from complementary foods of 30 kcal/day at midline (p = 0.128) and 36 kcal/day at endline (p = 0.087). There also was a displacement of 7 kcal/day in legumes and nuts in children at endline (p = 0.059). At midline and endline, more than 80% of children in the egg group consumed a minimally diverse diet compared with 53% at midline and 60% at endline in the control group. This study illustrates that mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other complementary foods. [ABSTRACT FROM AUTHOR]

Poor mental health is a pressing global health problem, with high prevalence among poor populations from low-income countries. Existing studies of conditional cash transfer (CCT) effects on mental health have found positive effects. However, there is a gap in the literature on population-wide effects of cash transfers on mental health and if and how these vary by the severity of mental illness. We use the Malawian Longitudinal Study of Family and Health containing 790 adult participants in the Malawi Incentive Programme, a year-long randomized controlled trial. We estimate average and distributional quantile treatment effects and we examine how these effects vary by gender, HIV status and usage of the cash transfer. We find that the cash transfer improves mental health on average by 0.1 of a standard deviation. The effect varies strongly along the mental health distribution, with a positive effect for individuals with worst mental health of about four times the size of the average effect. These improvements in mental health are associated with increases in consumption expenditures and expenditures related to economic productivity. Our results show that CCTs can improve adult mental health for the poor living in low-income countries, particularly those with the worst mental health. [ABSTRACT FROM AUTHOR]

There are no guidelines for the optimal protein quality of ready‐to‐supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double‐blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein‐optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6–59 months of age treated with 75 kcal/kg/day of either control or protein quality‐optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein‐optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, −2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness. [ABSTRACT FROM AUTHOR]

Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of many adverse sexual and reproductive health outcomes. Small-group interventions addressing underlying vulnerabilities may influence risky sexual behaviors associated with these adverse outcomes. Girl Power-Malawi assessed whether a facilitator-led, curriculum-driven small-group behavioral intervention impacted risky sexual behaviors among AGYW in Lilongwe, Malawi. Four Health Centers were selected; two were randomly assigned to provide the intervention. Two-hundred fifty AGYW 15–24 years old were enrolled in each clinic (N = 1000 total), followed for 1 year, and interviewed at baseline and endline. At both time points participants reported on two behaviors in the last month (vaginal sex and ≥ 2 sexual partners) and two behaviors in the last year (age-disparate relationships and transactional relationships). In intervention clinics, there were no declines in risk behaviors between baseline and endline. Endline behaviors were not less risky in intervention clinics than control clinics. This intervention did not have a positive effect on four risk behaviors over a 1-year period. [ABSTRACT FROM AUTHOR]

Background: Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART.Methods: This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses.Discussion: This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes.Trial Registration: ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018. [ABSTRACT FROM AUTHOR]

Aim: Intermittent preventive treatment in pregnancy (IPTp) with azithromycin and monthly sulfadoxine-pyrimethamine increased the mean child weight, mid-upper arm and head circumference at four weeks of age in a rural low-income setting. Now we assess for how long these gains were sustained during 0–5 years of age. Methods: We enrolled 1320 pregnant Malawian women in a randomized trial and treated them with two doses of sulfadoxine-pyrimethamine (control) or monthly sulfadoxine-pyrimethamine as IPTp against malaria, or monthly sulfadoxine-pyrimethamine and two doses of azithromycin (AZI-SP) as IPTp against malaria and reproductive tract infections. Child weight, mid-upper arm circumference, head circumference and weight-for-height Z-score were recorded at one, six, 12, 24, 36, 48, and 60 months. Results: Throughout follow-up, the mean child weight was approximately 100 g higher (difference in means 0.12 kg, 95% CI 0.04–0.20, P = 0.003 at one month; 0.19 kg, 95% CI 0.05–0.33, P = 0.007, at six months), mean head circumference 2 mm larger (0.3 cm, 95% CI 0.1 to 0.5, P = 0.004 at one month) and the cumulative incidence of underweight by five years of age was lower (hazard ratio 0.74, 95% CI 0.60 to 0.90, P = 0.002) in the AZI-SP group than in the control group. The 2 mm difference in the mean mid-upper arm circumference at one month (0.2 cm, 95% CI 0.0 to 0.3, P = 0.007) disappeared after three years of age. There was no difference in mean weight-for-height Z-score at any time point. Conclusion: In Malawi, IPTp with azithromycin and monthly sulfadoxine-pyrimethamine has a modest, 3-5-year positive impact on child weight, mid-upper arm circumference and head circumference, but not on weight-for-height Z-score. [ABSTRACT FROM AUTHOR]

Background Typhoid fever is an acute infection characterized by prolonged fever following the ingestion and subsequent invasion of Salmonella enterica serovar Typhi (S. Typhi), a human-restricted pathogen. The incidence of typhoid fever has been most reported in children 5–15 years of age, but is increasingly recognized in children younger than 5 years old. There has been a recent expansion of multidrug-resistant typhoid fever globally. Prior typhoid vaccines were not suitable for use in the youngest children in countries with a high burden of disease. This study aims to determine the efficacy of a typhoid conjugate vaccine (TCV) that was recently prequalified by the World Health Organization, by testing it in children 9 months through 12 years of age in Blantyre, Malawi. Methods In this Phase III, individually randomized, controlled, double-blind trial of the clinical efficacy of TCV, 28 000 children 9 months through 12 years of age will be enrolled and randomized in a 1:1 ratio to receive either Vi-TCV or a meningococcal serogroup A conjugate vaccine. A subset of 600 of these children will be further enrolled in an immunogenicity and reactogenicity sub-study to evaluate the safety profile and immune response elicited by Vi-TCV. Recruiting began in February 2018. Results All children will be under passive surveillance for at least 2 years to determine the primary outcome, which is blood culture–confirmed S. Typhi illness. Children enrolled in the immunogenicity and reactogenicity sub-study will have blood drawn before vaccination and at 2 timepoints after vaccination to measure their immune response to vaccination. They will also be followed actively for adverse events and serious adverse events. Conclusions The introduction of a single-dose, efficacious typhoid vaccine into countries with high burden of disease or significant antimicrobial resistance could have a dramatic impact, protecting children from infection and reducing antimicrobial usage and associated health inequity in the world's poorest places. This trial, the first of a TCV in Africa, seeks to demonstrate the impact and programmatic use of TCVs within an endemic setting. Clinical Trials Registration NCT03299426. [ABSTRACT FROM AUTHOR]

Background: Socioeconomic inequalities in neonatal mortality are substantial in many developing countries. Little is known about how to address this problem. Trials in Asia and Africa have shown strong impacts on neonatal mortality of a participatory learning and action intervention with women's groups. Whether this intervention also reduces mortality inequalities remains unknown. We describe the equity impact of this women's groups intervention on the neonatal mortality rate (NMR) across socioeconomic strata.Methods: We conducted a meta-analysis of all four participatory women's group interventions that were shown to be highly effective in cluster randomized trials in India, Nepal, Bangladesh and Malawi. We estimated intervention effects on NMR and health behaviours for lower and higher socioeconomic strata using random effects logistic regression analysis. Differences in effect between strata were tested.Results: Analysis of 69120 live births and 2505 neonatal deaths shows that the intervention strongly reduced the NMR in lower (50-63% reduction depending on the measure of socioeconomic position used) and higher (35-44%) socioeconomic strata. The intervention did not show evidence of 'elite-capture': among the most marginalized populations, the NMR in intervention areas was 63% lower [95% confidence interval (CI) 48-74%] than in control areas, compared with 35% (95% CI: 15-50%) lower among the less marginalized in the last trial year (P-value for difference between most/less marginalized: 0.009). The intervention strongly improved home care practices, with no systematic socioeconomic differences in effect.Conclusions: Participatory women's groups with high population coverage benefit the survival chances of newborns from all socioeconomic strata, and perhaps especially those born into the most deprived households. [ABSTRACT FROM AUTHOR]

Background: Typhoid fever is an acute infection characterized by prolonged fever following the ingestion and subsequent invasion of Salmonella enterica serovar Typhi (S. Typhi), a human-restricted pathogen. The incidence of typhoid fever has been most reported in children 5–15 years of age, but is increasingly recognized in children younger than 5 years old. There has been a recent expansion of multidrug-resistant typhoid fever globally. Prior typhoid vaccines were not suitable for use in the youngest children in countries with a high burden of disease. This study aims to determine the efficacy of a typhoid conjugate vaccine (TCV) that was recently prequalified by the World Health Organization, by testing it in children 9 months through 12 years of age in Blantyre, Malawi. Methods: In this Phase III, individually randomized, controlled, double-blind trial of the clinical efficacy of TCV, 28 000 children 9 months through 12 years of age will be enrolled and randomized in a 1:1 ratio to receive either Vi-TCV or a meningococcal serogroup A conjugate vaccine. A subset of 600 of these children will be further enrolled in an immunogenicity and reactogenicity sub-study to evaluate the safety profile and immune response elicited by Vi-TCV. Recruiting began in February 2018. Results: All children will be under passive surveillance for at least 2 years to determine the primary outcome, which is blood culture–confirmed S. Typhi illness. Children enrolled in the immunogenicity and reactogenicity sub-study will have blood drawn before vaccination and at 2 timepoints after vaccination to measure their immune response to vaccination. They will also be followed actively for adverse events and serious adverse events. Conclusions: The introduction of a single-dose, efficacious typhoid vaccine into countries with high burden of disease or significant antimicrobial resistance could have a dramatic impact, protecting children from infection and reducing antimicrobial usage and associated health inequity in the world's poorest places. This trial, the first of a TCV in Africa, seeks to demonstrate the impact and programmatic use of TCVs within an endemic setting. Clinical Trials Registration: NCT03299426. [ABSTRACT FROM AUTHOR]

Fortifying complementary foods with lipid-based nutrient supplements (LNS) may improve energy and nutrient intakes of infants at risk for undernutrition. We aimed to determine the relative validity of an interactive 24-h recall (i-24-HR) for assessing the impact of an LNS intervention on dietary intakes of energy and nutrients among rural Malawian 9–10-month-old infants (n 132) participating in the International Lipid‐Based Nutrient Supplements Dose (iLiNS-DOSE) trial. Dietary data were collected for the same day via i-24-HR and weighed food records. Inter-method agreements were estimated overall and by intervention group, using Bland–Altman plots and paired t tests; measurement error models (differential error); and percentage of food omissions and intrusions were estimated. Overall, inter-method differences in mean intakes of energy and most nutrients were not significant. When stratified by group, recalled energy intakes were under-estimated (−368 kJ; P =0·01) in the control but not in the intervention group (−42 kJ; P =0·6). This differential reporting error was related to an over-estimation of recalled LNS (8·1 v. 4·5 g; P <0·001) in the intervention group, compensating for an under-estimation of energy and nutrient intakes from complementary foods. Sources of measurement error in the i-24-HR were under-estimations of starchy staples, meat/fish/eggs and legumes/nuts/seeds (overall percentage agreement between 38 and 89 %; P <0·028); and over-estimations of added sugar, soups/broths and LNS (overall percentage agreement between 138 and 149 %; P <0·001). Common (>30 % eating occasions) omissions were milk/fish/eggs, starchy roots/vegetables and sweetened snacks. Common intrusions were milk/yogurt. Starchy staples and LNS were recalled when consumed (>85 %) (i.e. matched). These results emphasise the importance of considering differential error when interpreting dietary results in LNS trials. [ABSTRACT FROM AUTHOR]

Abstract: We examined the effect of three types of prenatal supplements containing different amounts of iron on haemoglobin (Hb) and iron status (zinc protoporphyrin [ZPP] and soluble transferrin receptor [sTfR]) in late pregnancy among 1,379 women in rural Malawi. Participants were recruited at ≤20 gestational weeks (gw) and randomly assigned to consume daily (1) 60‐mg iron and folic acid (IFA); (2) 20‐mg iron plus 17 micronutrients in a capsule (MMN); or (3) lipid‐based nutrient supplement (LNS; 118 kcal) with 20‐mg iron plus 21 micronutrients, protein, and fat. We analysed differences between intervention groups in mean Hb, ZPP, and sTfR at 36 gw, and the proportion with anaemia (Hb < 100 g L−1) and iron deficiency (ZPP > 60 μmol mol−1 haem or sTfR > 6 mg L−1) at 36 gw. Women in the IFA group had higher Hb at 36 gw than women in the LNS group (P = 0.030) and higher iron status (lower ZPP and sTfR) than women in both the LNS (P < 0.001 for both ZPP and sTfR) and MMN (P = 0.025 and P = 0.046) groups. Results for anaemia and iron deficiency showed similar trends. Further research is needed to elucidate the appropriate amount of iron to improve Hb and iron status, while improving birth outcomes. [ABSTRACT FROM AUTHOR]

Background: Ready-to-use therapeutic food (RUTF) is used to treat children suffering from severe acute malnutrition (SAM). Standard RUTF uses milk as the primary protein source, which makes the product expensive, and given the high worldwide SAM burden, having a less expensive effective alternative is a public health priority. Objective: The objective of this study was to evaluate whether newly developed amino acid-enriched milk-free RUTF (FSMS-RUTF) or amino acid-enriched low-milk RUTF (MSMS-RUTF) treatment could replenish plasma amino acids to levels comparable to those following standard peanut-milk RUTF (PM-RUTF) treatment and to improve understanding of the effects of treatment on anthropometric measurements. A secondary analysis was performed to test the noninferiority hypothesis of plasma essential amino acid (EAA) levels. Methods: Plasma EAA levels were measured in a nonblinded, 3-arm, parallel-group simple randomized controlled trial conducted in Malawi to examine the efficacy of FSMS-RUTF, MSMS-RUTF and PM-RUTF in the treatment of SAM in 2 groups of children aged 6–23 and 24–59 months (mo). Sample size calculations were performed based on the previous our study. A noninferiority margin was set at -25% of the PM-RUTF arm at discharge. Results: The relative values of the differences (95% CI) in plasma EAA levels between PM-RUTF treatment and FSMS-RUTF and MSMS-RUTF treatments at discharge were -7.9% (-18.6, 2.8) and 9.8% (0.2, 19.5), respectively, in children aged 6–23 mo, while in those aged 24–59 mo, the difference values were 17.8% (1.6, 34.1) and 13.6% (-2.8, 29.9), respectively. Conclusion: At discharge, the plasma EAA concentrations in 6-59-mo-old SAM children treated with FSMS-RUTF and MSMS-RUTF were not less than those of children treated with PM-RUTF. These findings indicate that treatment with either of the 3 RUTFs was associated with adequate protein synthesis and that all the formulations provided sufficient functional metabolites of plasma amino acids to support nutritional recovery from SAM. [ABSTRACT FROM AUTHOR]

Abstract: World Health Organization recommends exclusive breastfeeding for infants for the first 6 months of life, followed by introduction of nutritious complementary foods alongside breastfeeding. Breast milk remains a significant source of nourishment in the second half of infancy and beyond; however, it is not clear whether more breast milk is always better. The present study was designed to determine the association between amount of breast milk intake at 9–10 months of age and infant growth and development by 12–18 months of age. The study was nested in a randomized controlled trial conducted in Malawi. Regression analysis was used to determine associations between breast milk intake and growth and development. Mean (SD) breast milk intake at 9–10 months of age was 752 (244) g/day. Mean (SD) length‐for‐age z‐score at 12 months and change in length‐for‐age z‐score between 12 and 18 months were −1.69 (1.0) and −0.17 (0.6), respectively. At 18 months, mean (SD) expressive vocabulary score was 32 (24) words and median (interquartile range) skills successfully performed for fine, gross, and overall motor skills were 21 (19–22), 18 (16–19), and 38 (26–40), respectively. Breast milk intake (g/day) was not associated with either growth or development. Proportion of total energy intake from breast milk was negatively associated with fine motor (β = −0.18, p = .015) but not other developmental scores in models adjusted for potential confounders. Among Malawian infants, neither breast milk intake nor percent of total energy intake from breast milk at 9–10 months was positively associated with subsequent growth between 12 and 18 months, or development at 18 months. [ABSTRACT FROM AUTHOR]

Background: The use of herbal medicines during pregnancy is very high globally and previous studies have pointed out possible associations with adverse pregnancy outcomes. Nevertheless, the safety of herbal medicines in pregnancy is under-explored in low-income countries experiencing high maternal and neonatal complications. We investigated the associations between self-reported use of Mwanamphepo (a group of herbal medicines commonly used to induce or hasten labour) and adverse maternal and neonatal outcomes in rural Malawi. Methods: We conducted a cross-sectional analysis of secondary household data relating to 8219 births that occurred between 2005 and 2010 in Mchinji district, Malawi. The data were collected as part of a cluster-randomised controlled trial (RCT) that evaluated community interventions designed to reduce maternal and neonatal mortality. Data were gathered on maternity history, demographic characteristics, pregnancy outcomes and exposure to Mwanamphepo. Associations between self-reported use of Mwanamphepo and maternal morbidity as well as neonatal death or morbidity were examined using mixed-effects models, adjusted for relevant covariates. All analyses were also adjusted for the clustered nature of the survey. Results: Of the 8219 births, Mwanamphepo was used in 2113 pregnancies, representing an estimated prevalence of 25.7%. The self-reported use of Mwanamphepo was significantly associated with increased occurrence of maternal morbidity and neonatal death or morbidity. Specifically, the odds of maternal morbidity were 28% higher among self-reported users than non-users of Mwanamphepo (AOR = 1.28; 95% CI = 1.09–1.50) and the probabilities of neonatal death or morbidity were 22% higher (AOR =1.22; 95% CI = 1.06–1.40) among neonates whose mother reportedly used Mwanamphepo than those who did not. Conclusion: The use of Mwanamphepo was associated with adverse pregnancy outcomes in rural Malawi. Thus, herbal medicines may not be safe in pregnancy. Where possible, pregnant women should be discouraged from using herbal medicines of unconfirmed safety and those who report to have used should be closely monitored by health professionals. The study was limited by the self-report of exposure and unavailability of data relating to some possible confounders. [ABSTRACT FROM AUTHOR]

Factors associated with relapse among children who are discharged after reaching a threshold denoted 'recovered' from moderate acute malnutrition (MAM) are not well understood. The aim of this study was to identify factors associated with sustained recovery, defined as maintaining a mid-upper-arm circumference≥12·5 cm for 1 year after release from treatment. On the basis of an observational study design, we analysed data from an in-depth household (HH) survey on a sub-sample of participants within a larger cluster randomised controlled trial (cRCT) that followed up children for 1 year after recovery from MAM. Out of 1497 children participating in the cRCT, a subset of 315 children participated in this sub-study. Accounting for other factors, HH with fitted lids on water storage containers (P= 0·004) was a significant predictor of sustained recovery. In addition, sustained recovery was better among children whose caregivers were observed to have clean hands (P= 0·053) and in HH using an improved sanitation facility (P =0·083). By contrast, socio-economic status and infant and young child feeding practices at the time of discharge and HH food security throughout the follow-up period were not significant. Given these results, we hypothesise that improved water, sanitation and hygiene conditions in tandem with management of MAM through supplemental feeding programmes have the possibility to decrease relapse following recovery from MAM. Furthermore, the absence of associations between relapse and nearly all HH-level factors indicates that the causal factors of relapse may be related mostly to the child's individual, underlying health and nutrition status. [ABSTRACT FROM AUTHOR]

Objective: The present study examined the impacts of training on nutrition, hygiene and food safety designed by the Nutrition Working Group, Child Survival Collaborations and Resources Group (CORE).Design: Adapted from the 21d Positive Deviance/Hearth model, mothers were trained on the subjects of appropriate complementary feeding, water, sanitation and hygiene (WASH) practices, and aflatoxin contamination in food. To assess the impacts on child undernutrition, a randomised controlled trial was implemented on a sample of 179 mothers and their children (<2 years old) in two districts of Malawi, namely Mzimba and Balaka. Settings A 21d intensive learning-by-doing process using the positive deviance approach.Subjects: Malawian children and mothers.Results: Difference-in-difference panel regression analysis revealed that the impacts of the comprehensive training were positive and statistically significant on the Z-scores for wasting and underweight, where the effects increased constantly over time within the 21d time frame. As for stunting, the coefficients were not statistically significant during the 21d programme, although the level of significance started increasing in 2 weeks, indicating that stunting should also be alleviated in a slightly longer time horizon.Conclusions: The study clearly suggests that comprehensive training immediately guides mothers into improved dietary and hygiene practices, and that improved practices take immediate and progressive effects in ameliorating children's undernutrition. [ABSTRACT FROM AUTHOR]

Abstract: Pregnant and post‐partum women require increased nutrient intake and optimal cognition, which depends on adequate nutrition, to enable reasoning and learning for caregiving. We aimed to assess (a) differences in maternal cognition and caregiving between women in Malawi who received different nutritional supplements, (b) 14 effect modifiers, and (c) associations of cognition and caregiving with biomarkers of iron, Vitamin A, B‐vitamin, and fatty acid status. In a randomized controlled trial (n = 869), pregnant women daily received either multiple micronutrients (MMN), 20 g/day lipid‐based nutrient supplements (LNS), or a control iron/folic acid (IFA) tablet. After delivery, supplementation continued in the MMN and LNS arms, and the IFA control group received placebo until 6 months post‐partum, when cognition (n = 712), caregiving behaviour (n = 669), and biomarkers of nutritional status (n = 283) were assessed. In the full group, only one difference was significant: the IFA arm scored 0.22 SD (95% CI [0.01, 0.39], p = .03) higher than the LNS arm in mental rotation. Among subgroups of women with baseline low hemoglobin, poor iron status, or malaria, those who received LNS scored 0.4 to 0.7 SD higher than the IFA arm in verbal fluency. Breastmilk docosahexaenoic acid and Vitamin B12 concentrations were positively associated with verbal fluency and digit span forward (adjusting for covariates ps < .05). In this population in Malawi, maternal supplementation with MMN or LNS did not positively affect maternal cognition or caregiving. Maternal docosahexaenoic acid and B12 status may be important for post‐partum attention and executive function. [ABSTRACT FROM AUTHOR]

Abstract: We evaluated effects of antiretroviral (ARV) therapy and lipid‐based nutrient supplements (LNSs) on iron, copper, and zinc in milk of exclusively breastfeeding HIV‐infected Malawian mothers and their correlations with maternal and infant biomarkers. Human milk and blood at 2, 6, and 24 weeks post‐partum and blood during pregnancy (≤30 weeks gestation) were collected from 535 mothers/infant‐pairs in the Breastfeeding, Antiretrovirals, and Nutrition study. The participants received ARV, LNS, ARV and LNS, or no intervention from 0 to 28 weeks post‐partum. ARVs negatively affected copper and zinc milk concentrations, but only at 2 weeks, whereas LNS had no effect. Among all treatment groups, approximately 80–90% of copper and zinc and <50% of iron concentrations met the current adequate intake for infants at 2 weeks and only 1–19% at 24 weeks. Pregnancy haemoglobin was negatively correlated with milk iron at 2 and 6 weeks (r = −.18, p < .02 for both). The associations of the milk minerals with each other were the strongest correlations observed (r = .11–.47, p < .05 for all); none were found with infant biomarkers. At 2 weeks, moderately anaemic women produced milk higher in iron when ferritin was higher or TfR lower. At 6 weeks, higher maternal α‐1‐acid glycoprotein and C‐reactive protein were associated with higher milk minerals in mildly anaemic women. Infant TfR was lower when milk mineral concentrations were higher at 6 weeks and when mothers were moderately anaemic during pregnancy. ARV affects copper and zinc milk concentrations in early lactation, and maternal haemoglobin during pregnancy and lactation could influence the association between milk minerals and maternal and infant iron status and biomarkers of inflammation. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization recommends participatory learning and action (PLA) in women's groups to improve maternal and newborn health, particularly in rural settings with low access to health services. There have been calls to understand the pathways through which this community intervention may affect neonatal mortality. We examined the effect of women's groups on key antenatal, delivery, and postnatal behaviours in order to understand pathways to mortality reduction.Methods and Findings: We conducted a meta-analysis using data from 7 cluster-randomised controlled trials that took place between 2001 and 2012 in rural India (2 trials), urban India (1 trial), rural Bangladesh (2 trials), rural Nepal (1 trial), and rural Malawi (1 trial), with the number of participants ranging between 6,125 and 29,901 live births. Behavioural outcomes included appropriate antenatal care, facility delivery, use of a safe delivery kit, hand washing by the birth attendant prior to delivery, use of a sterilised instrument to cut the umbilical cord, immediate wrapping of the newborn after delivery, delayed bathing of the newborn, early initiation of breastfeeding, and exclusive breastfeeding. We used 2-stage meta-analysis techniques to estimate the effect of the women's group intervention on behavioural outcomes. In the first stage, we used random effects models with individual patient data to assess the effect of groups on outcomes separately for the different trials. In the second stage of the meta-analysis, random effects models were applied using summary-level estimates calculated in the first stage of the analysis. To determine whether behaviour change was related to group attendance, we used random effects models to assess associations between outcomes and the following categories of group attendance and allocation: women attending a group and allocated to the intervention arm; women not attending a group but allocated to the intervention arm; and women allocated to the control arm. Overall, women's groups practising PLA improved behaviours during and after home deliveries, including the use of safe delivery kits (odds ratio [OR] 2.92, 95% CI 2.02-4.22; I2 = 63.7%, 95% CI 4.4%-86.2%), use of a sterile blade to cut the umbilical cord (1.88, 1.25-2.82; 67.6%, 16.1%-87.5%), birth attendant washing hands prior to delivery (1.87, 1.19-2.95; 79%, 53.8%-90.4%), delayed bathing of the newborn for at least 24 hours (1.47, 1.09-1.99; 68.0%, 29.2%-85.6%), and wrapping the newborn within 10 minutes of delivery (1.27, 1.02-1.60; 0.0%, 0%-79.2%). Effects were partly dependent on the proportion of pregnant women attending groups. We did not find evidence of effects on uptake of antenatal care (OR 1.03, 95% CI 0.77-1.38; I2 = 86.3%, 95% CI 73.8%-92.8%), facility delivery (1.02, 0.93-1.12; 21.4%, 0%-65.8%), initiating breastfeeding within 1 hour (1.08, 0.85-1.39; 76.6%, 50.9%-88.8%), or exclusive breastfeeding for 6 weeks after delivery (1.18, 0.93-1.48; 72.9%, 37.8%-88.2%). The main limitation of our analysis is the high degree of heterogeneity for effects on most behaviours, possibly due to the limited number of trials involving women's groups and context-specific effects.Conclusions: This meta-analysis suggests that women's groups practising PLA improve key behaviours on the pathway to neonatal mortality, with the strongest evidence for home care behaviours and practices during home deliveries. A lack of consistency in improved behaviours across all trials may reflect differences in local priorities, capabilities, and the responsiveness of health services. Future research could address the mechanisms behind how PLA improves survival, in order to adapt this method to improve maternal and newborn health in different contexts, as well as improve other outcomes across the continuum of care for women, children, and adolescents. [ABSTRACT FROM AUTHOR]

Background: The links between empowerment and a number of health-related outcomes in sub-Saharan Africa have been documented, but empowerment related to pregnancy is under-investigated. Antenatal care (ANC) is the entry point into the healthcare system for most women, so it is important to understand how ANC affects aspects of women's sense of control over their pregnancy. We compare pregnancy-related empowerment for women randomly assigned to the standard of care versus CenteringPregnancy-based group ANC (intervention) in two sub-Saharan countries, Malawi and Tanzania.Methods: Pregnant women in Malawi (n = 112) and Tanzania (n = 110) were recruited into a pilot study and randomized to individual ANC or group ANC. Retention at late pregnancy was 81% in Malawi and 95% in Tanzania. In both countries, individual ANC, termed focused antenatal care (FANC), is the standard of care. FANC recommends four ANC visits plus a 6-week post-birth visit and is implemented following the country's standard of care. In group ANC, each contact included self- and midwife-assessments in group space and 90 minutes of interactive health promotion. The number of contacts was the same for both study conditions. We measured pregnancy-related empowerment in late pregnancy using the Pregnancy-Related Empowerment Scale (PRES). Independent samples t-tests and multiple linear regressions were employed to assess whether group ANC led to higher PRES scores than individual ANC and to investigate other sociodemographic factors related to pregnancy-related empowerment.Results: In Malawi, women in group ANC had higher PRES scores than those in individual ANC. Type of care was a significant predictor of PRES and explained 67% of the variation. This was not so in Tanzania; PRES scores were similar for both types of care. Predictive models including sociodemographic variables showed religion as a potential moderator of treatment effect in Tanzania. Muslim women in group ANC had a higher mean PRES score than those in individual ANC; a difference not observed among Christian women.Conclusions: Group ANC empowers pregnant women in some contexts. More research is needed to identify the ways that models of ANC can affect pregnancy-related empowerment in addition to perinatal outcomes globally. [ABSTRACT FROM AUTHOR]

Background: Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women.Methods: A phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic (ANC) days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing) or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders. Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity.Discussion: This trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying particular attention to safety concerns. Contamination may occur if women in the intervention arms share their self-test kits with women in the SOC arm.Trial Registration: ISRCTN, ID: 18421340 . Registered on 31 March 2016. [ABSTRACT FROM AUTHOR]

Background: The case fatality rate of severely malnourished children during inpatient treatment is high and mortality is often associated with diarrhea. As intestinal carbohydrate absorption is impaired in severe acute malnutrition (SAM), differences in dietary formulations during nutritional rehabilitation could lead to the development of osmotic diarrhea and subsequently hypovolemia and death. We compared three dietary strategies commonly used during the transition of severely malnourished children to higher caloric feeds, i.e., F100 milk (F100), Ready-to-Use Therapeutic Food (RUTF) and RUTF supplemented with F75 milk (RUTF + F75).Methods: In this open-label pilot randomized controlled trial, 74 Malawian children with SAM aged 6-60 months, were assigned to either F100, RUTF or RUTF + F75. Our primary endpoint was the presence of low fecal pH (pH ≤ 5.5) measured in stool collected 3 days after the transition phase diets were introduced. Secondary outcomes were duration of hospital stay, diarrhea and other clinical outcomes. Chi-square test, two-way analysis of variance and logistic regression were conducted and, when appropriate, age, sex and initial weight for height Z-scores were included as covariates.Results: The proportion of children with acidic stool (pH ≤5.5) did not significantly differ between groups before discharge with 30, 33 and 23% for F100, RUTF and RUTF + F75, respectively. Mean duration of stay after transitioning was 7.0 days (SD 3.4) with no differences between the three feeding strategies. Diarrhea was present upon admission in 33% of patients and was significantly higher (48%) during the transition phase (p < 0.05). There was no significant difference in mortality (n = 6) between diets during the transition phase nor were there any differences in other secondary outcomes.Conclusions: This pilot trial does not demonstrate that a particular transition phase diet is significantly better or worse since biochemical and clinical outcomes in children with SAM did not differ. However, larger and more tightly controlled efficacy studies are needed to confirm these findings.Trial Registration: ISRCTN13916953 Registered: 14 January 2013. [ABSTRACT FROM AUTHOR]

Objectives Undernutrition during early life contributes to more than 200 million children globally not fulfilling their developmental potential. Our objective was to determine whether dietary supplementation with several formulations of lipid-based nutrient supplements (LNS), which differed in dose per day and milk content, positively affect infant development in Malawi. Methods We randomly assigned 1932 infants age 6 months to receive one of the following for 12 months: 10, 20 g, or 40 g/day milk-containing LNS, 20 g or 40 g/day milk-free LNS, or no supplement until 18 months of age (control group). We assessed motor, language, socio-emotional, and executive function at age 18 months. Primary analysis was by intention-to-treat and we also examined 13 potential effect modifiers, including the child's initial nutritional status and level of developmental stimulation. The study is registered as clinical trial NCT00945698. Results We found no significant differences between intervention groups in any scores. The difference in mean z-scores between children in the control group and children in the intervention groups ranged from −0.08 to 0.04 for motor development ( p = 0.76), −0.05 to 0.01 for language development ( p = 0.97), −0.15 to 0.11 for socio-emotional development ( p = 0.22), and −0.02 to 0.20 for executive function ( p = 0.24). We did not find that initial nutritional status, developmental stimulation, or other factors modified the effect LNS versus control group. Conclusions for Practice Our results suggest that in a population such as this one, provision of LNS from age 6 to 18 months would not affect motor, language, socio-emotional, or executive function skills at age 18 months. [ABSTRACT FROM AUTHOR]

Background: Supplementing pregnant and lactating mothers with small quantity lipid-based nutrient supplements (SQ-LNS) has resulted in improvements in birth outcomes in some low-income settings. In order to be effective, SQ-LNS must be consumed regularly over sustained periods.Methods: The objective was to assess and compare acceptability of and adherence to SQ-LNS consumption among pregnant and lactating women in Ghana and Malawi throughout 12 months of supplementation. We enrolled women before 20 gestation weeks into randomized trials in Ghana (n = 1320) and Malawi (n = 869). In the SQ-LNS group participants received a 20 g sachet of supplement per day during pregnancy and the first 6 months of lactation. In the control groups participants received multiple micronutrients (MMN) during pregnancy and lactation or iron and folic acid (IFA) during pregnancy and calcium during lactation. We used questionnaires to collect data on self-reported adherence to daily use of supplements and conducted in-depth interviews with women in the SQ-LNS group to examine acceptability.Results: The mean self-reported adherence during the supplementation period was lower in Ghana (79.9 %) than in Malawi (91.7 %) for all supplements (difference 11.8 %, P < 0.001). Over time, adherence increased in Malawi but decreased in Ghana. In both countries, adherence in the SQ-LNS group was non-inferior to that in the control groups. Participants typically reported consuming SQ-LNS as instructed but when interviewers queried about experiences, most of the women described incidents of non-adherence. A usual reason for not consuming SQ-LNS was nausea and vomiting during pregnancy. Especially in Malawi, women reported sharing SQ-LNS with families and friends. Sustained use of SQ-LNS was attributed to expected health benefits and favorable sensory attributes. Often women compared their pregnancy to previous ones, and were of the view that SQ-LNS made a positive difference.Conclusion: Self-reported sustained adherence to consume SQ-LNS daily was high in both sites but lower in Ghana than in Malawi. In Ghana, adherence decreased over time whereas in Malawi adherence increased. Acceptability and adherence appeared interlinked, complex and context-related. Sustained consumption of SQ-LNS may require tailoring interventions by context.Trial Registration: The Ghana trial was registered at clinicaltrials.gov as NCT00970866 , and the Malawi trial as NCT01239693 . [ABSTRACT FROM AUTHOR]

Background: Before antiretroviral therapy (ART) became widely available in sub-Saharan Africa, several studies demonstrated that daily trimethoprim-sulfamethoxazole (TS) prophylaxis reduced morbidity and mortality among HIV-infected adults. As a result, the World Health Organization (WHO) recommended administering TS prophylaxis to this group. However, the applicability of the results to individuals taking ART and living in sub-Saharan Africa has not been definitively evaluated. This study aims to determine if TS prophylaxis benefits HIV-infected Malawian adults after a good response to ART. If TS prophylaxis does indeed show benefit, it is important to determine if this is due to its antibacterial and/or antimalarial properties.Methods/design: A randomized, controlled, open-label, phase III trial of continued standard of care prophylaxis with daily trimethoprim-sulfamethoxazole (TS) compared to discontinuation of standard of care TS prophylaxis and starting weekly chloroquine (CQ) prophylaxis or discontinuation of standard of care TS prophylaxis. The study will randomize 1400-1500 HIV-infected adults (equally divided over the three study arms) with a nondetectable viral load and a CD4 count of 250/mm(3) or more from antiretroviral therapy clinics in Blantyre and Zomba. The expected rate of primary endpoint events of death and WHO stage 3 and 4 events is 6.8 per 100 person-years of follow-up in all participants. Assuming the number of events follows a Poisson distribution and average participant follow-up after 10 % loss to follow-up is 41.6 months, the study will have approximately 85 % power to rule out a reduction of 35 % or more in primary endpoint events in the TS or CQ arms compared to discontinuation of TS prophylaxis-i.e., to show that discontinuation of TS prophylaxis is noninferior to either TS or CQ, with a noninferiority margin of 35 %. Ethical and regulatory approvals were obtained from the University of Malawi College of Medicine Research Ethics Committee; the Malawi Pharmacy, Medicines and Poisons Board; and the University of Maryland Baltimore Institutional Review Board.Discussion: The study began recruitment activities at the Ndirande site in November 2012. The sponsor agreed to extend and expand the study in early 2015, and a second site, Zomba, was added for recruitment and follow-up in mid-2015.Trial Registration: ClinicalTrials.gov Identifier: NCT01650558 (registered on 6 July 2012).Protocol Version: Letter of amendment #1 to the DAIDS-ES 10822 TSCQ Malawi Protocol, Version 4.0, 16 December 2014. [ABSTRACT FROM AUTHOR]

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Objective: Safety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children.Design: Randomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %.Setting: Namwera and Mangochi catchment areas in rural Malawi.Subjects: Infants aged 6 months (n 1932).Results: The enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups.Conclusions: Provision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits. [ABSTRACT FROM AUTHOR]

The Cooking and Pneumonia Study (CAPS) is a pragmatic cluster-level randomized controlled trial of the effect of an advanced cookstove intervention on pneumonia in children under the age of 5 years (under 5s) in Malawi (). The primary outcome of the trial is the incidence of pneumonia during a two-year follow-up period, as diagnosed by healthcare providers who are using the World Health Organization (WHO) integrated management of childhood illnesses (IMCI) pneumonia assessment protocol and who are blinded to the trial arms. We evaluated the quality of pneumonia assessment in under 5s in this setting via a cross-sectional study of provider-patient encounters at nine outpatient clinics located within the catchment area of 150 village-level clusters enrolled in the trial across the two study locations of Chikhwawa and Karonga, Malawi, between May and June 2015 using the IMCI guidelines as a benchmark. Data were collected using a key equipment checklist, an IMCI pneumonia knowledge test, and a clinical evaluation checklist. The median number of key equipment items available was 6 (range 4 to 7) out of a possible 7. The median score on the IMCI pneumonia knowledge test among 23 clinicians was 75% (range 60% to 89%). Among a total of 176 consultations performed by 15 clinicians, a median of 9 (range 3 to 13) out of 13 clinical evaluation tasks were performed. Overall, the clinicians were adequately equipped for the assessment of sick children, had good knowledge of the IMCI guidelines, and conducted largely thorough clinical evaluations. We recommend the simple pragmatic approach to quality assurance described herein for similar studies conducted in challenging research settings. [ABSTRACT FROM AUTHOR]

Nutritional supplementation during pregnancy is increasingly recommended especially in low‐resource settings, but its oral health impacts have not been studied. Our aim was to examine whether supplementation with multiple micronutrients (MMN) or small‐quantity lipid‐based nutrient supplements affects dental caries development or periodontal health in a rural Malawian population. The study was embedded in a controlled iLiNS‐DYAD trial that enrolled 1391 pregnant women <20 gestation weeks. Women were provided with one daily iron–folic acid capsule (IFA), one capsule with 18 micronutrients (MMN) or one sachet of lipid‐based nutrient supplements (LNS) containing protein, carbohydrates, essential fatty acids and 21 micronutrients. Oral examination of 1024 participants was conducted and panoramic X‐ray taken within 6 weeks after delivery. The supplement groups were similar at baseline in average socio‐economic, nutritional and health status. At the end of the intervention, the prevalence of caries was 56.7%, 69.1% and 63.3% (P = 0.004), and periodontitis 34.9%, 29.8% and 31.2% (P = 0.338) in the IFA, MMN and LNS groups, respectively. Compared with the IFA group, women in the MMN group had 0.60 (0.18–1.02) and in the LNS group 0.59 (0.17–1.01) higher mean number of caries lesions. In the absence of baseline oral health data, firm conclusions on causality cannot be drawn. However, although not confirmatory, the findings are consistent with a possibility that provision of MMN or LNS may have increased the caries incidence in this target population. Because of the potential public health impacts, further research on the association between gestational nutrient interventions and oral health in low‐income settings is needed. [ABSTRACT FROM AUTHOR]

Background: Prenatal micronutrient supplements have been found to increase birth weight, but mechanisms for increased growth are poorly understood. Our hypotheses were that 1) women who receive lipid-based nutrient supplements (LNS) during pregnancy would have lower mean salivary cortisol concentration at 28 wk and 36 wk gestation compared to the multiple micronutrient (MMN) and iron-folic acid (IFA) supplement groups and 2) both salivary cortisol and perceived stress during pregnancy would be associated with shorter duration of gestation and smaller size at birth.Methods: Women were enrolled in the trial in early pregnancy and randomized to receive LNS, MMN, or iron-folic acid (IFA) supplements daily throughout pregnancy. At enrollment, 28 wk and 36 wk gestation, saliva samples were collected and their cortisol concentration was measured. Self-report of perceived stress was measured using questionnaires. Gestation duration was indicated by ultrasound dating and newborn anthropometric measurements (weight, length, head circumference) provided indicators of intrauterine growth.Results: Of the 1391 women enrolled in the trial, 1372, 906 and 1049 saliva samples were collected from women at baseline, 28 wk and 36 wk, respectively. There were no significant differences in mean cortisol concentrations by intervention group at 28 wk or 36 wk gestation. Cortisol concentrations were negatively associated with duration of gestation (Baseline: β = -0.05, p = 0.039; 36 wk: β = -0.04, p = 0.037) and birth weight (28 wk: β = -0.08, p = 0.035; 36 wk: β = -0.11, p = 0.003) but not associated with length-for-age or head circumference-for-age z-scores. Perceived stress at 36 wk was significantly associated with shorter newborn LAZ (p = 0.001). There were no significant associations with the risk of small for gestational age, preterm birth, or low birth weight.Conclusions: Maternal salivary cortisol concentration was strongly associated with birth weight and duration of gestation in rural Malawi, but these data do not support the hypothesis that LNS provision to pregnant women would influence their salivary cortisol concentrations.Trial Registration: Clinicaltrials.gov identifier NCT01239693. [ABSTRACT FROM AUTHOR]

Low nutritional value of complementary foods is associated with high incidence of childhood growth stunting in low‐income countries. This study was done to test a hypothesis that dietary complementation with lipid‐based nutrient supplements (LNS) promotes linear growth and reduces the incidence of severe stunting among at‐risk infants. A total of 840 6‐month‐old healthy infants in rural Malawi were enrolled to a randomised assessor‐blinded trial. The participants received 12‐month supplementation with nothing, milk–LNS, soy–LNS, or corn–soy blend (CSB). Supplements provided micronutrients and approximately 280 kcal energy per day. Outcomes were incidence of severe and very severe stunting [length‐for‐age z‐score, (LAZ) < −3.00 and <−3.50, respectively], and change in LAZ. The incidence of severe stunting was 11.8%, 8.2%, 9.1% and 15.5% (P = 0.098) and that of very severe stunting 7.4%, 2.9%, 8.0% and 6.4% (P = 0.138) in control, milk–LNS, soy–LNS and CSB groups, respectively. Between 9 and 12 months of age, the mean change in LAZ was −0.15, −0.02, −0.12 and −0.18 (P = 0.045) for control, milk–LNS, soy–LNS and CSB groups, respectively. There was no significant between‐group difference in linear growth during other age‐intervals. Although participants who received milk–LNS had the lowest incidence of severe and very severe stunting, the differences between the groups were smaller than expected. Thus, the results do not provide conclusive evidence on a causal association between the LNS supplementation and the lower incidence of stunting. Exploratory analyses suggest that provision of milk–LNS, but not soy–LNS promotes linear growth among at‐risk infants mainly between 9 and 12 months of age. [ABSTRACT FROM AUTHOR]

Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy‐dense foods on dietary intake. This substudy aimed at assessing the effect of supplementation with corn–soy blend (CSB) or lipid‐based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8–18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control). An interactive 24‐h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37–250; P < 0.001) and 46 (1.5–7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non‐supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non‐supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001). This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings. [ABSTRACT FROM AUTHOR]