Infants born to pregnant women living with HIV (WLHIV) are at greater risk for morbidity and mortality and may also have poorer developmental outcomes as compared with infants who are not exposed to HIV. Nutrition interventions in pregnancy may affect developmental outcomes.

This study evaluated the effect of maternal vitamin D supplementation on infant development outcomes.

We conducted a secondary analysis of a randomised, triple-blind, placebo-controlled trial of maternal vitamin D supplementation from June 2015 to October 2019.

Antenatal care clinics in Dar es Salaam, Tanzania.

Pregnant WLHIV and their offspring.

Daily 3000 IU vitamin D₃ or placebo supplements taken during pregnancy and lactation.

Infants were assessed for cognitive, language and motor development at 1 year of age with the Caregiver Reported Early Development Instruments (CREDI).

A total of 2167 infants were eligible, and 1312 of them completed CREDI assessments at 1 year of age. Vitamin D supplementation had no effect on overall CREDI z-scores (standardised mean difference (SMD) 0.03, 95% CI –0.09, 0.15, p value 0.66). There was also no evidence of a difference between vitamin D and placebo groups in language (SMD 0.06, 95% CI –0.08, 0.21, p value 0.40), motor (SMD 0.02, 95% CI –0.09, 0.14, p value 0.69) or cognitive domain z-scores (SMD 0.05, 95% CI –0.08, 0.17, p 0.48).

Maternal vitamin D supplementation during pregnancy and lactation did not affect infant development outcomes.

ClinicalTrials.gov identifier: NCT02305927.

There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.

This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.

This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.

NCT06360783.