Questioning the ethics of international research on formula milk supplementation in low-income African countries

Over the past three decades, the increase in funding for priority public health issues largely affecting low/middle-income countries (LMICs) has led to the growth in international research involving researchers or research sponsors from a high-income country (HIC) conducting research in LMICs. The ethical considerations in such international research were raised in the 1990s and several ethical guidelines specifically addressing international research were published.1 2 However, in 2022, we still find examples of research undertaken by HIC principal investigators and funders, with no benefit and large potential for harm, being undertaken in LMICs

The Potential Role of Mother-in-Law in Prevention of Mother-to-Child Transmission of HIV: A Mixed Methods Study from the Kilimanjaro Region, Northern Tanzania.

In the Kilimanjaro region the mother-in-law has traditionally had an important role in matters related to reproduction and childcare. The aim of this study was to explore the role of the mothers-in-law in prevention of mother-to-child transmission (PMTCT) service utilization and adherence to infant feeding guidelines. The study was conducted during 2007-2008 in rural and urban areas of Moshi district in the Kilimanjaro region of Tanzania. Mixed methods were used and included focus group discussions with mothers-in-law, mothers and fathers; in-depth interviews with mothers-in-law, mothers, fathers and HIV-infected mothers, and a survey of 446 mothers bringing their four-week-old infants for immunisation at five reproductive and child health clinics. The study demonstrated that the mother-in-law saw herself as responsible for family health issues in general and child care in particular. However she received limited trust, and couples, in particular couples living in urban areas, tended to exclude her from decisions related to childbearing and infant feeding. Mothers-in-law expected their daughters-in-law to breastfeed in a customary manner and were generally negative towards the infant feeding methods recommended for HIV-infected mothers; exclusive replacement feeding and exclusive breastfeeding. Decreasing influence of the mother-in-law and increasing prominence of the conjugal couples in issues related to reproduction and child care, reinforce the importance of continued efforts to include male partners in the PMTCT programme. The potential for involving mothers-in-law in the infant feeding component, where she still has influence in some areas, should be further explored

Low adherence to exclusive breastfeeding in Eastern Uganda: A community-based cross-sectional study comparing dietary recall since birth with 24-hour recall

BACKGROUND: Exclusive breastfeeding is recommended as the best feeding alternative for infants up to six months and has a protective effect against mortality and morbidity. It also seems to lower HIV-1 transmission compared to mixed feeding. We studied infant feeding practices comparing dietary recall since birth with 24-hour dietary recall. METHODS: A cross-sectional survey on infant feeding practices was performed in Mbale District, Eastern Uganda in 2003 and 727 mother-infant (0–11 months) pairs were analysed. Four feeding categories were made based on WHO's definitions: 1) exclusive breastfeeding, 2) predominant breastfeeding, 3) complementary feeding and 4) replacement feeding. We analyzed when the infant fell into another feeding category for the first time. This was based on the recall since birth. Life-table analysis was made for the different feeding categories and Cox regression analysis was done to control for potential associated factors with the different practices. Prelacteal feeding practices were also addressed. RESULTS: Breastfeeding was practiced by 99% of the mothers. Dietary recall since birth showed that 7% and 0% practiced exclusive breastfeeding by 3 and 6 months, respectively, while 30% and 3% practiced predominant breastfeeding and had not started complementary feeding at the same points in time. The difference between the 24-hour recall and the recall since birth for the introduction of complementary feeds was 46 percentage points at two months and 59 percentage points at four months. Prelacteal feeding was given to 57% of the children. High education and formal marriage were protective factors against prelacteal feeding (adjusted OR 0.5, 0.2 – 1.0 and 0.5, 0.3 – 0.8, respectively). CONCLUSION: Even if breastfeeding is practiced at a very high rate, the use of prelacteal feeding and early introduction of other food items is the norm. The 24-hour recall gives a higher estimate of exclusive breastfeeding and predominant breastfeeding than the recall since birth. The 24-hour recall also detected improper infant feeding practices especially in the second half year of life. The dietary recall since birth might be a feasible alternative to monitor infant feeding practices in resource-poor settings. Our study reemphasizes the need for improving infant feeding practices in Eastern Uganda

Malaria Parasitaemia among Infants and Its Association with Breastfeeding Peer Counselling and Vitamin A Supplementation: A Secondary Analysis of a Cluster Randomized Trial

Background: Malaria is the second highest contributor to the disease burden in Africa and there is a need to identify low cost prevention strategies. The objectives of this study were to estimate the prevalence of malaria parasitaemia among infants and to measure the association between peer counselling for exclusive breastfeeding (EBF), vitamin A supplementation, anthropometric status (weight and length) and malaria parasitaemia. Methods: A cluster randomized intervention trial was conducted between 2006 and 2008 where 12 of 24 clusters, each comprising one or two villages, in Eastern Uganda were allocated to receive peer counselling for EBF. Women in their third trimester of pregnancy (based on the last normal menstrual period) were recruited in all 24 clusters and followed up until their children’s first birthday. Blood was drawn from 483 infants between 3 and 12 months of age, to test for malaria parasitaemia. Results: The prevalence of malaria parasitaemia was 11% in the intervention areas and 10% in the control areas. The intervention did not seem to decrease the prevalence of malaria (PR 1.7; 95% CI: 0.9, 3.3). After controlling for potential confounders, infants not supplemented with Vitamin A had a higher prevalence for malaria compared to those who had been supplemented (PR 6.1; 95% CI: 2.1, 17.6). Among children supplemented with vitamin A, every unit increase in lengthfor- age Z (LAZ) scores was associated with a reduced prevalence in malaria (PR 0.5; 95% CI:0.4, 0.6). There was no association between LAZ scores and malaria among children that had not been supplemented. Conclusion: Peer counselling for exclusive breastfeeding did not decrease the prevalence of malaria parasitaemia. Children that had not received Vitamin A supplementation had a higher prevalence of malaria compared to children that had been supplemented

Efficacy of processed amaranth-containing bread compared to maize bread on hemoglobin, anemia and iron deficiency anemia prevalence among two-to-five year-old anemic children in Southern Ethiopia: A cluster randomized controlled trial.

BACKGROUND: Few studies have evaluated iron-rich plant-based foods, such as amaranth grain, to reduce anemia and iron deficiency anemia. Amaranth is rich in nutrients, but with high level of phytate. The objective of this trial was to evaluate the efficacy of home processed amaranth grain containing bread in the treatment of anemia, hemoglobin concentration and iron deficiency anemia among two-to-five year-old children in Southern Ethiopia. METHOD: Children with anemia (hemoglobin concentration <110.0g/L) (N = 100) were identified by random sampling and enrolled in a 1:1 cluster randomized controlled trial for six months in 2017. The amaranth group (N = 50), received 150g bread containing 70% amaranth and 30% chickpea, the amaranth grain was processed at home (soaking, germinating, and fermenting) to decrease the phytate level. The maize group (N = 50), received 150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread. Hemoglobin, ferritin, and CRP were measured at baseline and at the end of intervention. Hemoglobin and ferritin values were adjusted for altitude and infection, respectively. Generalized estimating equation and generalized linear model were used to analyze the data. RESULT: In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR: 0.39 (95%CI: 0.16-0.77)]. Hemoglobin concentration estimate of beta coefficient was significantly higher in the amaranth group compared with the maize group [aβ 8.9g/L (95%CI: 3.5-14.3)], p-value <0.01. The risk of iron deficiency anemia is significantly lower in the amaranth group [aRR: 0.44 (95%CI: 0.23-0.83)] in the intention to treat analysis but not significant in the complete case analysis. There was no significant difference between groups in iron deficiency [aRR: 0.81 (95%CI: 0.55-1.19)]. CONCLUSION: Processed amaranth bread had favorable effects on hemoglobin concentration and has the potential to minimize anemia prevalence. CLINICAL TRIAL REGISTRATION: Trial registry number: PACTR201705002283263 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2283

Are we doing enough? Improved breastfeeding practices at 14 weeks but challenges of non-initiation and early cessation of breastfeeding remain: Findings of two consecutive cross-sectional surveys in KwaZulu-Natal, South Africa

Background KwaZulu-Natal (KZN) Initiative for breastfeeding support (KIBS) was a multipronged intervention to support the initiation and sustaining of breastfeeding, implemented between 2014 and 2017. We present results of two surveys conducted before and after KIBS implementation to assess changes in infant feeding practices in KZN over this time period. Methods Two cross-sectional surveys were conducted in primary health care clinics. Multistage stratified random sampling was used to select clinics and participants. Sample size was calculated to provide district estimates of 14-week exclusive breastfeeding (EBF) rates at baseline (KIBS1), and provincial estimates at endpoint (KIBS2). At KIBS1 the sample required was nine participating clinics in each of 11 districts (99 clinics) with 369 participants per district (N = 4059), and at KIBS2 was 30 clinics in KZN with 30 participants per clinic (N = 900). All caregivers aged ≥15 years attending the clinic with infants aged 13- < 16 weeks were eligible to participate. Data was collected using structured interviews on android devices. Multi-variable logistic regression was used to adjust odds ratios for differences between time points. Results At KIBS1 (May2014- March2015), 4172 interviews were conducted with carers, of whom 3659 (87.6%) were mothers. At KIBS2 (January–August 2017), 929 interviews were conducted which included 788 (84.8%) mothers. Among all carers the proportion exclusively breastfeeding was 44.6 and 50.5% (p = 0.1) at KIBS1 and KIBS2 respectively, but greater improvements in EBF were shown among mothers (49.9 vs 59.1: p = 0.02). There were reductions in mixed breastfeeding among all infants (23.2% vs 16.3%; p = 0.016). Although there was no change in the proportion of carers who reported not breastfeeding (31.9% vs 32.8%; p = 0.2), the duration of breastfeeding among mothers who had stopped breastfeeding was longer at KIBS2 compared to KIBS1 (p = 0.0015). Mothers who had returned to work or school were less likely to be breastfeeding (adjusted odds ratio [AOR] 3.76; 95% CI 3.1–4.6), as were HIV positive mothers (AOR 2.1; 95% CI 1.7–2.6). Conclusion Despite improvements to exclusive breastfeeding, failure to initiate and sustain breastfeeding is a challenge to achieving optimal breastfeeding practices. Interventions are required to address these challenges and support breastfeeding particularly among working mothers and HIV positive mothers.publishedVersio

Association of maternal HIV‐1 severity with dental caries: an observational study of uninfected 5‐ to 7‐yr‐old children of HIV‐1‐infected mothers without severe immune suppression

Treatment programs to prevent perinatal and postnatal HIV-1 transmission have become available in sub-Saharan Africa, leading to an emerging population of HIV-1 exposed uninfected (HEU) children. Exposure to HIV-1 in utero and during breastfeeding may increase the risk of morbidity and mortality in HEU children. This study estimated the association of the severity of maternal HIV-1 infection as assessed by CD4 count and viral load at baseline (7 d postpartum), with dmft count of their 5- to 7-yr-old HEU offspring. A follow-up study was conducted of HIV-1-infected mother–HEU children pairs (n = 164) from the Ugandan site of the ANRS 12341-PROMISE- PEP trial (ClinicalTrials.gov, number NCT00640263). HIV-1-infected mothers were interviewed and the HEU children were examined for caries using the World Health Organization's survey methods for field conditions and the dmft index. Directed acyclic graphs and negative binomial regression were used for analyses. The prevalence of 1 or more dmft was 48%. Negative binomial regression showed no association between the dmft count and maternal CD4 counts 7 d postpartum but a 10% lower dmft count with longer breastfeeding duration was found. Maternal CD4 count at birth was not associated with the dental caries experience in uninfected children born to women without severe immune suppression, while there appeared to be a protective effect of high viral load and breastfeeding duration.publishedVersio

Effects of complementary feeding on attained height among lower primary school-aged children in Eastern Uganda: A nested prospective cohort study

Background: Despite the fact that Uganda has been a signatory to the global strategy for Infant and Young Children Feeding practices (IYCF) for nearly a decade, the prevalence of stunting among children under five years of age remains tragically high at 17% in Eastern Uganda and twofold higher countrywide. Only 6% of all children aged 6–23 months feed adequately. This study aimed to establish the covariates of complementary feeding (CF) and its effect on attained height among primary school-aged children in Mbale district (Eastern Uganda). Methods: This was a community-based prospective cohort study using data from the PROMISE EBF trial. The main exposure variable was adequate complementary feeding (CF) measured in a parent questionnaire at 18–24 months of age. We defined adequate CF as having received animal food, cereals and fruit, juice and/or vegetables during the 24 hours preceding the interview. An adapted minimum acceptable diet was defined as having been given milk or milk products at least twice a day, an adapted meal frequency of two and solid or semi-solid food from at least four food groups on a 24-hour dietary recall based on modified IYCF criteria. The main outcome variable was attained height [(height-for-age Z score (HAZ)] measured between five and eight years of age using the WHO growth standards. Effects of CF on HAZ were estimated using linear regression analyses with cluster-robust standard errors. Results: A total of 506 children were studied. The majority (85%) were from rural areas and the average age at the end of the study was 6.9 (standard deviation: 0.63) years. Of these, 23.9% were adequately fed and 2.3% received the adapted minimum acceptable diet. Adequate CF was not associated with HAZ (adjusted β = -0.111; 95% CI: -0.363, 0.141; p = 0.374). Factors significantly associated with attained height were baseline HAZ (0.262; 0.152, 0.374; p<0.001) and WHZ (-0.147; -0.243, -0.051; p = 0.004), child’s age (0.454; -0.592, -0.315; p<0.001) and maternal education (0.030; 95% CI: 0.003, 0.057; p = 0.034). Conclusion: Adequate CF at age 18–24 months was worryingly insufficient and not associated with attained HAZ at age 5–8 years. Further strategies need to be considered to improve child nutrition and linear growth in resource-constrained settings.publishedVersio

“I feel good when I drink”—detecting childhood-onset alcohol abuse and dependence in a Ugandan community trial cohort

Background Alcohol, substance use, and mental health disorders constitute major public health issues worldwide, including in low income and lower middle-income countries, and early initiation of use is an important predictor for developing substance use disorders in later life. This study reports on the existence of childhood alcohol abuse and dependence in a sub-study of a trial cohort in Eastern Uganda. Methods The project SeeTheChild—Mental Child Health in Uganda (STC) included a sub-study of the Ugandan site of the study PROMISE SB: Saving Brains in Uganda and Burkina Faso. PROMISE SB was a follow-up study of a trial birth cohort (PROMISE EBF) that estimated the effect that peer counselling for exclusive breast-feeding had on the children’s cognitive functioning and mental health once they reached 5–8 years of age. The STC sub-study (N = 148) used the diagnostic tool MINI-KID to assess mental health conditions in children who scored medium and high (≥ 14) on the Strengths and Difficulties Questionnaire (SDQ) in the PROMISE SB cohort N = (119/148; 80.4%). Another 29/148 (19.6%) were recruited from the PROMISE SB cohort as a comparator with low SDQ scores (< 14). Additionally, the open-ended questions in the diagnostic history were analysed. The MINI-KID comprised diagnostic questions on alcohol abuse and dependence, and descriptive data from the sub-study are presented in this paper. Results A total of 11/148 (7.4%) children scored positive for alcohol abuse and dependence in this study, 10 of whom had high SDQ scores (≥ 14). The 10 children with SDQ-scores ≥ 14 had a variety of mental health comorbidities of which suicidality 3/10 (30.0%) and separation anxiety disorder 5/10 (50.0%) were the most common. The one child with an SDQ score below 14 did not have any comorbidities. Access to homemade brew, carer’s knowledge of the drinking, and difficult household circumstances were issues expressed in the children’s diagnostic histories. Conclusions The discovery of alcohol abuse and dependence among 5–8 year olds in clinical interviews from a community based trial cohort was unexpected, and we recommend continued research and increased awareness of these conditions in this age group. Trial registration Trial registration for PROMISE SB: Saving Brains in Uganda and Burkina Faso: Clinicaltrials.gov (NCT01882335), 20 June 2013. Regrettably, there was a 1 month delay in the registration compared to the commenced re-inclusion in the follow-up study: https://clinicaltrials.gov/ct2/show/NCT01882335?term=saving+brains&draw=2&rank=1publishedVersio

‘As soon as they can hold a glass, they begin taking alcohol’: a qualitative study on early childhood substance use in Mbale District, Uganda

Background Globally, substance use is a leading contributor to the burden of disease among young people, with far reaching social, economic and health effects. Following a finding of harmful alcohol use among 5-8-year-old children in Mbale District, Uganda, this study aims to investigate community members’ views on early childhood substance use among children below the age of 10 years. Methods In 2016, we conducted eight focus group discussions with 48 parents and 26 key informant interviews with teachers, health workers, alcohol distributors, traditional healers, religious leaders, community leaders and youth workers. We used thematic content analysis. Four participants and two research assistants reviewed and confirmed the findings. Results Alcohol in everyday life: ‘Even children on laps taste alcohol’: Almost all participants confirmed the existence of and concern for substance use before age 10. They described a context where substance use was widespread in the community, especially intake of local alcoholic brews. Children would access substances in the home or buy it themselves. Those living in poor neighbourhoods or slums and children of brewers were described as particularly exposed. Using substances to cope: ‘We don’t want them to drink’: Participants explained that some used substances to cope with a lack of food and resources for childcare, as well as traumatic experiences. This made children in deprived families and street-connected children especially vulnerable to substance use. Participants believed this was a result of seeing no alternative solution. Conclusions To our knowledge, this is the first study to describe the context and conditions of childhood substance use before age 10 in Mbale District, Uganda. The study shows that community members attributed early childhood substance use to a social context of widespread use in the community, which was exacerbated by conditions of material and emotional deprivation. These social determinants for this practice deserve public health attention and intervention.publishedVersio