Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy.

BACKGROUND: The World Health Organization recommends 1500 to 2000 mg of calcium daily as supplementation, divided into three doses, for pregnant persons in populations with low dietary calcium intake in order to reduce the risk of preeclampsia. The complexity of the dosing scheme, however, has led to implementation barriers. METHODS: We conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess the noninferiority of a 500-mg daily dose to a 1500-mg daily dose of calcium supplementation. In each trial, the two primary outcomes were preeclampsia and preterm birth, and the noninferiority margins for the relative risks were 1.54 and 1.16, respectively. RESULTS: A total of 11,000 nulliparous pregnant women were included in each trial. The cumulative incidence of preeclampsia was 3.0% in the 500-mg group and 3.6% in the 1500-mg group in the India trial (relative risk, 0.84; 95% confidence interval [CI], 0.68 to 1.03) and 3.0% and 2.7%, respectively, in the Tanzania trial (relative risk, 1.10; 95% CI, 0.88 to 1.36) - findings consistent with the noninferiority of the lower dose in both trials. The percentage of live births that were preterm was 11.4% in the 500-mg group and 12.8% in the 1500-mg group in the India trial (relative risk, 0.89; 95% CI, 0.80 to 0.98), which was within the noninferiority margin of 1.16; in the Tanzania trial, the respective percentages were 10.4% and 9.7% (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin. CONCLUSIONS: In these two trials, low-dose calcium supplementation was noninferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was noninferior with respect to the risk of preterm live birth in the trial in India but not in the trial in Tanzania. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03350516; Clinical Trials Registry-India number, CTRI/2018/02/012119; and Tanzania Medicines and Medical Devices Authority Trials Registry number, TFDA0018/CTR/0010/5).

The influence of depressive symptoms and school-going status on risky behaviors: a pooled analysis among adolescents in six sub-Saharan African countries.

Background: Evidence from sub-Saharan Africa (SSA) regarding risky behaviors among adolescents remains scarce, despite the large population (approximately 249 million out of 1.2 billion globally in 2019) of adolescents in the region. We aimed to examine the potential influence of depressive symptoms and school-going status on risky behaviors among adolescents in six SSA countries. Methods: We used individual cross-sectional data from adolescents aged 10-19 based in eight communities across six SSA countries, participating in the ARISE Network Adolescent Health Study (N = 7,661). Outcomes of interest were cigarette or tobacco use, alcohol use, other substance use, getting into a physical fight, no condom use during last sexual intercourse, and suicidal behavior. We examined the proportion of adolescents reporting these behaviors, and examined potential effects of depressive symptoms [tertiles of 6-item Kutcher Adolescent Depression Scale (KADS-6) score] and school-going status on these behaviors using mixed-effects Poisson regression models. We also assessed effect modification of associations by sex, age, and school-going status. Results: The proportion of adolescents reporting risky behaviors was varied, from 2.2% for suicidal behaviors to 26.2% for getting into a physical fight. Being in the higher tertiles of KADS-6 score was associated with increased risk of almost all risky behaviors [adjusted risk ratio (RR) for highest KADS-6 tertile for alcohol use: 1.70, 95% confidence interval (95% CI): 1.48-1.95, p < 0.001; for physical fight: 1.52, 95% CI: 1.36-1.70, p < 0.001; for suicidal behavior: 7.07, 95% CI: 2.69-18.57, p < 0.001]. Being in school was associated with reduced risk of substance use (RR for alcohol use: 0.73, 95% CI: 0.53-1.00, p = 0.047), and not using a condom (RR: 0.81, 95% CI: 0.66-0.99, p = 0.040). There was evidence of modification of the effect of school-going status on risky behaviors by age and sex. Conclusion: Our findings reinforce the need for a greater focus on risky behaviors among adolescents in SSA. Addressing depressive symptoms among adolescents, facilitating school attendance and using schools as platforms to improve health may help reduce risky behaviors in this population. Further research is also required to better assess the potential bidirectionality of associations.

Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania.

BACKGROUND: Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organization currently recommends that pregnant women receive high-dose calcium supplementation (1500-2000 mg elemental calcium) for prevention of preeclampsia in populations with low dietary calcium intake. Trials of low-dose calcium supplementation (< 1000 mg elemental calcium/day) during pregnancy have also shown similar reductions in the risk of preeclampsia; however, no trials to date have directly compared low-dose to the standard high-dose calcium supplementation. Our objective is to assess the non-inferiority of low-dose as compared to standard high-dose calcium supplementation in pregnancy. METHODS/DESIGN: We will conduct two independent trials in Bangalore, India (n = 11,000 pregnancies), and Dar es Salaam, Tanzania (n = 11,000 pregnancies). The trial designs are individually randomized, parallel group, quadruple-blind, non-inferiority trials of low-dose calcium supplementation (500 mg elemental calcium/day) as compared to standard high-dose calcium supplementation (1500 mg elemental calcium/day) among nulliparous pregnant women. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized calcium regimen from randomization until the time of delivery. The co-primary outcomes are (i) preeclampsia and (ii) preterm birth; we will test non-inferiority of the primary outcomes for low-dose as compared to the standard high-dose supplementation regimen in each trial. The trials' secondary outcomes include gestational hypertension, severe features of preeclampsia, pregnancy-related death, third trimester severe anemia, fetal death, stillbirth, low birthweight, small-for-gestational age birth, and infant death. DISCUSSION: The trials will provide causal evidence on the non-inferiority of low-dose as compared to the standard high-dose supplementation in India and Tanzania. A single tablet, low-dose calcium supplementation regimen may improve individual-level adherence, reduce programmatic costs, and ultimately expand implementation of routine calcium supplementation in pregnancy in populations with low dietary calcium intake. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03350516 ; registered on 22 November 2018. Clinical Trials Registry-India identifier: CTRI/2018/02/012119 ; registered on 23 February 2018. Tanzania Medicines and Medical Devices Authority Trials Registry identifier: TFDA0018/CTR/0010/5 ; registered on 20 December 2018.

Design and field methods of the ARISE Network Adolescent Health Study.

The ARISE Network Adolescent Health Study is an exploratory, community-based survey of 8075 adolescents aged 10-19 in 9 communities in 7 countries: Burkina Faso, Eswatini, Ethiopia, Ghana, Nigeria, Tanzania and Uganda. Communities were selected opportunistically and existing population cohorts maintained by health and demographic surveillance systems (HDSSs). The study is intended to serve as a first round of data collection for African adolescent cohorts, with the overarching goal of generating community-based data on health-related behaviours and associated risk factors in adolescents, to identify disease burdens and health intervention opportunities. Household-based sampling frames were used in each community to randomly select eligible adolescents (aged 10-19 years). Data were collected between July 2015 and December 2017. Consenting participants completed face-to-face interviews with trained research assistants using a standardised questionnaire, which covered physical activity, cigarette and tobacco use, substance and drug use, mental health, sexual behaviours and practices, sexually transmitted infections, pregnancy, food security and food diversity, teeth cleaning and hand washing, feelings and friendship, school and home activities, physical attacks and injuries, health care, health status assessment and life satisfaction, as well as media and cell phone use and socio-demographic and economic background characteristics. Results from this multi-community study serve to identify major adolescent health risks and disease burdens, as well as opportunities for interventions and improvements through policy changes.

L'étude ARISE du réseau sur la santé des adolescents est une étude exploratoire de surveillance basée sur la communauté portant sur 8.075 adolescents âgés de 10 à 19 ans dans 9 communautés de 7 pays: Burkina Faso, Eswatini, Ethiopie, Ghana, Nigéria, Tanzanie et Ouganda. Les communautés ont été sélectionnés de manière opportuniste et les cohortes de population existantes maintenues par des systèmes de surveillance de la santé et démographique (SSSD). L'étude est destinée à servir comme premier cycle de collecte de données pour les cohortes d'adolescents africains, dans le but primordial de générer des données communautaires sur les comportements liés à la santé et les facteurs de risque associés chez les adolescents, afin d'identifier la charge de morbidité et les opportunités d'intervention en matière de santé. Des cadres d'échantillonnage basés sur le ménage ont été utilisés dans chaque communauté pour sélectionner au hasard les adolescents admissibles (âgés de 10-19 ans). Les données ont été collectées entre juillet 2015 et décembre 2017. Les participants consentants ont participé à des entretiens de face à face avec des assistants de recherche formés, à l'aide d'un questionnaire standardisé couvrant l'activité physique, l'usage de la cigarette ou la consommation de tabac, l'usage de drogues et autres substances, la santé mentale, les comportements et pratiques sexuels, les infections sexuellement transmissibles, la grossesse, la sécurité et la diversité alimentaire, le nettoyage des dents et le lavage des mains, les sentiments et les amitiés, les activités scolaires et à domicile, les attaques et les blessures physiques, les soins de santé, l'évaluation de l'état de santé et la satisfaction à l'égard de la vie, l'utilisation des médias et du téléphone portable ainsi que les caractéristiques sociodémographiques et économiques. Les résultats de cette étude portant sur plusieurs communautés permettent d'identifier les principaux risques pour la santé des adolescents et les charges de morbidité, ainsi que les opportunités d'interventions et d'amélioration par le biais de changements de politiques.

The age of opportunity: prevalence of key risk factors among adolescents 10-19 years of age in nine communities in sub-Saharan Africa.

OBJECTIVE: To measure health-related behaviours and risk factors among sub-Saharan African adolescents. METHODS: Cross-sectional study in nine communities in Burkina Faso, Ethiopia, Eswatini, Ghana, Nigeria, Tanzania and Uganda between 2015 and 2017. Community-representative samples of males and females 10-19 years of age were selected. All communities used a uniform questionnaire that was adapted from the WHO Global School-based Student Health Survey. Weighted prevalence estimates and 95% confidence intervals were calculated for each indicator and stratified by age and sex using SAS version 9.4. All prevalence estimates were pooled across communities through random-effects meta-analyses in Stata version 14. RESULTS: A total of 8075 adolescents participated in the study. We observed a high prevalence of inadequate fruit consumption (57-63%) and low physical activity (82-90%); a moderate prevalence of inadequate vegetable consumption (21-31%), unprotected last sex (38-45%), age at first sex <15 years (21-28%) and bullying and physical fighting (12-35%); and a low prevalence of mental health risk factors (1-11%) and alcohol and substance use risk factors (0-6%). We observed a moderate to high prevalence of daily soft drink consumption (21-31%) for all adolescents. Among sexually active adolescents 15-19 years, 37% of females reported ever being pregnant and 8% of males reported to have ever made someone pregnant. Bullying (23%) and physical fighting (35%) were more common among younger male adolescents . The prevalence of low mood was generally higher among older (15-19 years) than younger adolescents (10-14 years). The proportion of adolescents reporting alcohol, drug or cigarette use was very small, with the exception of khat use in Ethiopia. CONCLUSION: Overall, diet and physical activity, violence, sexual and reproductive health, and depression are important risk factors for these sub-Saharan African communities. These findings suggest that more evidence is needed including novel efforts for the collection of sensitive information, as well as a need to move towards community-tailored interventions to reach adolescent populations with varying needs.

OBJECTIF: Mesurer les comportements liés à la santé et les facteurs de risque chez les adolescents africains subsahariens. MÉTHODES: Etude transversale dans neuf communautés au Burkina Faso, en Ethiopie, à Eswatini, au Ghana, au Nigéria, en Tanzanie et en Ouganda entre 2015 et 2017. Des échantillons représentatifs de la communauté composés d'hommes et de femmes âgés de 10 à 19 ans ont été sélectionnés. Toutes les communautés ont utilisé un questionnaire uniforme adapté de l'Enquête Mondiale sur la Santé des Elèves de l'OMS. Les estimations de prévalence pondérée et les intervalles de confiance à 95% ont été calculés pour chaque indicateur et stratifiées par âge et sexe à l'aide de la version 9.4 de SAS. Toutes les estimations de prévalence ont été poolées dans les communautés via des méta-analyses à effets aléatoires dans Stata, version 14. RÉSULTATS: 8.075 adolescents ont participé à l'étude. Nous avons observé une prévalence élevée de consommation insuffisante de fruits (57-63%) et de faible activité physique (82-90%); une prévalence modérée de consommation insuffisante de légumes (21-31%), du dernier rapport sexuel non protégé (38-45%), du premier rapport sexuel à moins de 15 ans (21-28%) et de l'intimidation et des combats physiques (12-35%), une faible prévalence de facteurs de risque pour la santé mentale (1-11%) et de facteurs de risque pour la consommation d'alcool et de substances (0-6%). Nous avons observé une prévalence modérée à élevée de consommation quotidienne de boissons gazeuses (21-31%) chez tous les adolescents. Parmi les adolescents sexuellement actifs âgées de 15 à 19 ans, 37,0% des femmes ont déclaré avoir déjà été enceintes et 8,0% des hommes ont rapporté avoir déjà enceinté une femme. L'intimidation (23%) et les combats physiques étaient plus fréquents chez les adolescents plus jeunes (35%). La prévalence de la mauvaise humeur était généralement plus élevée chez les adolescents d'âge plus élevé (de 15 à 19 ans) que chez les plus jeunes (de 10 à 14 ans). La proportion d'adolescents déclarant avoir consommé de l'alcool, des drogues ou des cigarettes était très faible, à l'exception de la consommation de khat en Ethiopie. CONCLUSION: Dans l'ensemble, le régime alimentaire et l'activité physique, la violence, la santé sexuelle et reproductive et la dépression sont des facteurs de risque importants pour ces communautés d'Afrique subsaharienne. Ces résultats suggèrent que davantage de données sont nécessaires, notamment de nouveaux efforts pour la collecte d'informations sensibles, ainsi que la nécessité de passer à des interventions adaptées aux communautés pour atteindre les populations adolescentes avec des besoins variés.

Maternal mortality among HIV-infected pregnant women in Tanzania.

OBJECTIVE: To investigate risk factors for maternal mortality among HIV-infected women in Tanzania. DESIGN: Prospective cohort study. SETTING: HIV care and treatment clinics in Dar es Salaam, Tanzania. POPULATION: HIV-infected pregnant women. METHODS: Data were collected for all patients enrolled in an HIV/AIDS care and treatment program. Between November 2004 and September 2011, there were 18 917 women pregnant at least once during the follow-up. Thirteen percent of these women had more than one pregnancy, with 21 645 pregnancies occurring. Logistic regression was used to explore the predictors of maternal death among these women. MAIN OUTCOME MEASURES: Maternal mortality. RESULTS: During the study period, 363 maternal deaths occurred, giving a maternal mortality ratio of 1729 [95% confidence interval (CI) 1553-1905] per 100 000 live births. Being wasted [odds ratio (OR) 3.38, 95% CI 2.58-4.45] or anemic (OR 2.26, 95% CI 1.70-3.00) was associated with a higher risk of maternal mortality. Women who were initiated on antiretroviral therapy before their pregnancy had a 55% decreased risk of maternal mortality (95% CI 0.29-0.70) compared with women who were not. The risk of maternal mortality decreased with the length of time on antiretroviral therapy during pregnancy, by 8% for each additional month (OR 0.92, 95% CI 0.88-0.96). CONCLUSIONS: Maternal mortality was high among HIV-infected women. Initiating women on antiretroviral therapy as early as possible and providing nutritional interventions during pregnancy should be considered as means to reduce the maternal mortality among these women.