Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1-11-month-old infants in Mali.

Background: The Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin (LAKANA) trial in Mali aims to evaluate the efficacy and safety of azithromycin (AZI) mass drug administration (MDA) to 1-11-month-old infants as well as the impact of the intervention on antimicrobial resistance (AMR) and mechanisms of action of azithromycin. To improve the transparency and quality of this clinical trial, we prepared this statistical analysis plan (SAP).

Methods/design: LAKANA is a cluster randomized trial that aims to address the mortality and health impacts of biannual and quarterly AZI MDA.

Testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1-11-month-old infants in Mali (LAKANA): study protocol for a cluster-randomized, placebo-controlled, double-blinded, parallel-group, three-arm clinical trial.

Background: Mass drug administration (MDA) of azithromycin (AZI) has been shown to reduce under-5 mortality in some but not all sub-Saharan African settings. A large-scale cluster-randomized trial conducted in Malawi, Niger, and Tanzania suggested that the effect differs by country, may be stronger in infants, and may be concentrated within the first 3 months after treatment. Another study found no effect when azithromycin was given concomitantly with seasonal malaria chemoprevention (SMC).

Association between prenatal provision of lipid-based nutrient supplements and caesarean delivery: Findings from a randomised controlled trial in Malawi.

In populations with a high prevalence of childhood and adolescent undernutrition, supplementation during pregnancy aiming at improving maternal nutritional status and preventing fetal growth restriction might theoretically lead to cephalopelvic disproportion and delivery complications. We investigated whether the prenatal provision of small-quantity lipid-based nutrient supplements (SQ-LNS) was associated with an increased risk of caesarean section (CS) or other delivery complications. Pregnant Malawian women were randomised to receive daily i) iron-folic acid (IFA) capsule (control), ii) multiple micronutrient (MMN) capsule of 18 micronutrients (second control), or iii) SQ-LNS with similar micronutrients as MMN, plus four minerals and macronutrients contributing 118 kcal.

SARS-CoV-2 infection and antibody seroprevalence in routine surveillance patients, healthcare workers and general population in Kita region, Mali: an observational study 2020-2021.

Objective: To estimate the degree of SARS-CoV-2 transmission among healthcare workers (HCWs) and general population in Kita region of Mali.

Design: Routine surveillance in 12 health facilities, HCWs serosurvey in five health facilities and community serosurvey in 16 villages in or near Kita town, Mali.

Setting: Kita region, western Mali; local health centres around the central (regional) referral health centre.

Evaluation of an unconditional cash transfer program targeting children's first-1,000-days linear growth in rural Togo: A cluster-randomized controlled trial.

Background: In 2014, the government of Togo implemented a pilot unconditional cash transfer (UCT) program in rural villages that aimed at improving children's nutrition, health, and protection. It combined monthly UCTs (approximately US$8.40 /month) with a package of community activities (including behavior change communication [BCC] sessions, home visits, and integrated community case management of childhood illnesses and acute malnutrition [ICCM-Nut]) delivered to mother-child pairs during the first "1,000 days" of life.

Conditional cash transfer and/or lipid-based nutrient supplement targeting the first 1000 d of life increased attendance at preventive care services but did not improve linear growth in young children in rural Mali: results of a cluster-randomized controlled trial.

Background: In 2014, the World Food Programme added to an ongoing health and nutrition program named "Santé Nutritionnelle à Assise Communautaire dans la région de Kayes" (SNACK), the distribution of cash to mothers and/or lipid-based nutrient supplement (LNS) to children aged 6-23 mo, conditional upon attendance at community health centers (CHCs) during the first 1000 d of life.

Objective: We evaluated the additional impact of the distribution of cash and/or LNS on mean height-for-age z scores (HAZ; primary outcome), stunting (HAZ < -2), and on intermediate outcomes along the program impact pathways.

Methods: In a cluster-randomized controlled trial using a 2 × 2 factorial design, 76 CHCs were randomly assigned to deliver either SNACK, SNACK + Cash, SNACK + LNS, or SNACK + Cash + LNS.

The Minimum Dietary Diversity for Women of Reproductive Age (MDD-W) Indicator Is Related to Household Food Insecurity and Farm Production Diversity: Evidence from Rural Mali.

Background: The popularity of nutrition-sensitive interventions calls for high-quality monitoring and evaluation tools. In this context, the Minimum Dietary Diversity for Women of Reproductive Age (MDD-W), validated as a proxy of micronutrient adequacy, does fill a gap. However, because it is a newly endorsed indicator, information on its linkages with other dimensions of food and nutrition security is still scarce.