COVID-19 testing acceptance among symptomatic individuals screened for a randomized clinical trial in The Gambia.

Background: Testing is a critical component to control disease outbreaks. The screening process required to enrol study participants from individuals with suspected COVID-19 disease in a clinical trial, presented an opportunity to explore factors that influence the willingness to be tested for COVID-19.

Methods: We analyzed data from individuals with symptoms suggestive of mild-moderate COVID-19 in two different health facilities in Western Gambia.

Effect of intrapartum azithromycin on early childhood gut mycobiota development: post hoc analysis of a double-blind randomized trial.

Intrapartum azithromycin prophylaxis reduced maternal infections but showed no effect on neonatal sepsis and mortality. Although antibiotic exposure may indirectly alter the mycobiota (community of fungi that live in a given environment), there is no data available on how intrapartum azithromycin impacts gut mycobiota development. We hereby assess the impact of intrapartum azithromycin on gut mycobiota development from birth to the age of three years, by ITS2 gene profiling of rectal samples from 102 healthy Gambian infants selected from a double-blind randomized placebo-controlled clinical trial (PregnAnZI-2 - ClinicalTrials.

Effect of the 13-valent pneumococcal conjugate vaccine on pneumococcal carriage in rural Gambia 10 years after its introduction: A population-based cross-sectional study.

Background: Sub-Saharan Africa has a high burden of pneumococcal diseases. Pneumococcal carriage precedes invasive disease and transmission. The introduction of pneumococcal conjugate vaccines (PCVs) has significantly reduced global vaccine-type (VT) pneumococcal disease, but data on PCVs' long-term impact on VT serotypes in Africa are limited.

The effect of pertussis vaccination in pregnancy on the immunogenicity of acellular or whole-cell pertussis vaccination in Gambian infants (GaPS): a single-centre, randomised, controlled, double-blind, phase 4 trial.

Background: Vaccinating women against pertussis in pregnancy protects young infants from severe disease and death. Vaccination-induced maternally derived antibodies, however, might subsequently modulate (and specifically blunt) the infant's serological response to their primary series of pertussis vaccinations. We examined the effect of pertussis immunisation in pregnancy on the immunogenicity of primary acellular or whole-cell pertussis vaccines in a west African cohort.

The association between 25-hydroxyvitamin D and parathyroid hormone in adolescents living with HIV in southern Africa: a cross-sectional study.

Low vitamin D associated with high parathyroid hormone (PTH) is common in HIV infection. We determined the association between total 25(OH)D and PTH in adolescents living with HIV, in Zambia and Zimbabwe. Adolescents (11-19 years) perinatally infected with HIV and established on antiretroviral therapy for ≥ 6 months were recruited into a cross-sectional study.

Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials.

Background: Guidance exists to inform the content of statistical analysis plans in clinical trials. Though not explicitly stated, this guidance is generally focused on clinical trials in which the randomization units are individual patients and not groups of patients. There are critical considerations for the analysis of cluster randomized trials, such as accounting for clustering, the risk of imbalances between the arms due to post-randomization recruitment, and the need to use small sample corrections when the number of clusters is small.

Patterns of linear growth among children and adolescents living with HIV on antiretroviral therapy in Zimbabwe and Zambia.

Background: Adolescents with HIV (AWH) frequently exhibit impaired growth, which manifests as stunting and wasting. We studied trajectories in leg-length (appendicular), sitting (axial), and standing height among AWH on antiretroviral therapy (ART), determining peak height velocity (PHV) and age at PHV (aPHV).

Methods: Analyses used VITALITY trial data from Zimbabwe and Zambia (PACTR20200989766029), which recruited AWH (11-19 years) established on ART to determine whether vitamin D/calcium supplementation improves bone health.

Social contacts and mixing patterns in rural Gambia.

Background: Close contact between an infectious and susceptible person is an important factor in respiratory disease transmission. Information on social contacts and mixing patterns in a population is crucial to understanding transmission patterns and informing transmission models of respiratory infections. Although West Africa has one of the highest burdens of respiratory infections, there is a lack of data on interpersonal contact and mixing patterns in this region.

Interactions between live attenuated influenza vaccine and nasopharyngeal microbiota among children aged 24-59 months in The Gambia: a phase 4, open-label, randomised controlled trial.

Background: Live attenuated influenza vaccines (LAIVs) alter nasopharyngeal microbiota in adults. It is poorly understood why LAIV immunogenicity varies across populations, but it could be linked to the microbiome. We aimed to investigate the interactions between intranasal immunisation with LAIV and nasopharyngeal microbiota composition in children from The Gambia.

Immunogenicity of yellow fever vaccine co-administered with 13-valent pneumococcal conjugate vaccine in rural Gambia: A cluster-randomised trial.

Introduction: Because booster doses of pneumococcal conjugate vaccine (PCV) may be given at a similar time to yellow fever vaccine (YF), it is important to assess the immune response to YF when co-administered with PCV. This has been investigated during a reduced-dose PCV trial in The Gambia.

Methods: In this phase 4, parallel-group, cluster-randomized trial, healthy infants aged 0-10 weeks were randomly allocated to receive either a two-dose schedule of PCV13 with a booster dose co-administered with YF vaccine at age 9 months (1 + 1 co-administration) or YF vaccine administered separately at age 10 months (1 + 1 separate) or the standard three early doses of PCV13 with YF vaccine at age 9 months (3 + 0 separate).

The role of vitamin D metabolism in regulating bone turnover in adolescents with perinatally-acquired HIV in Southern Africa: a cross-sectional study in Zimbabwe and Zambia.

Vitamin D dysregulation can occur in people living with HIV, disrupting calcium homeostasis, and bone turnover. We aimed to investigate the potential mechanisms by which vitamin D regulates bone turnover in adolescents living with perinatally-acquired HIV (ALWH) in Southern Africa. A pre-planned secondary analysis was performed of baseline data from the vitamin D for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology trial (PACTR20200989766029) which enrolled ALWH (11-19 yr) taking antiretroviral therapy for ≥6 mo, and recorded socio-demographic, clinical and dietary data.

Directly observed social contact patterns among school children in rural Gambia.

Introduction: School-aged children play a major role in the transmission of many respiratory pathogens due to high rate of close contacts in schools. The validity and accuracy of proxy-reported contact data may be limited, particularly for children when attending school. We observed social contacts within schools and assessed the accuracy of proxy-reported versus observed physical contact data among students in rural Gambia.

Risk factors for non-participation in ivermectin and dihydroartemisinin-piperaquine mass drug administration for malaria control in the MASSIV trial.

Background: Mass Drug Administration (MDA) has become a mainstay for the control of several diseases over the last two decades. Successful implementation of MDA programmes requires community participation and can be threatened by systematic non-participation. Such concerns are particularly pertinent for MDA programmes against malaria, as they require multi-day treatment over several consecutive months.

Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.

A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g.

Burden and causes of pregnancy-related mortality in The Gambia: evidence from census and health and demographic surveillance data.

Background: The Gambia lacks capacity to estimate its burden and causes of pregnancy-related mortality (PRM) to guide reproductive health programming. We used census and Health and Demographic Surveillance System (HDSS) data from Farafenni and Basse to establish levels and causes of PRM in The Gambia.

Methods: Using reported deaths and births in the 2013 Gambian census, national and regional pregnancy-related mortality ratios (PRMRatios) were derived as the ratio of pregnancy-related deaths (PRDs) per 100 000 live births (lbs).

Evaluating the sensitivity and specificity of Determine™ HIV-1/2 rapid test using a 0.01M phosphate-buffered saline produced at the Medical Research Council Unit The Gambia for the diagnosis of HIV.

Background: Human immunodeficiency virus (HIV) rapid diagnostic tests (RDTs) are widely used. However, buffer stockouts commonly lead to utilising non-approved liquids, resulting in errors. Our aim was to evaluate the diagnostic accuracy of an alternative buffer.

SARS-CoV-2 seroprevalence in pregnant women during the first three COVID-19 waves in The Gambia.

Objectives: SARS-CoV-2 transmission in sub-Saharan Africa has probably been underestimated. Population-based seroprevalence studies are needed to determine the extent of transmission in the continent.

Methods: Blood samples from a cohort of Gambian pregnant women were tested for SARS-CoV-2 total receptor binding domain (RBD) immunoglobulin (Ig) M/IgG before (Pre-pandemic: October-December 2019) and during the pandemic (Pre-wave 1: February-June 2020; Post-wave 1: October-December 2020, Post-wave 2: May-June 2021; and Post-wave 3: October-December 2021).

Circulation of respiratory viruses during the COVID-19 pandemic in The Gambia.

In many countries, non-pharmaceutical interventions to limit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission resulted in significant reductions in other respiratory viruses. However, similar data from Africa are limited. We explored the extent to which viruses such as influenza and rhinovirus co-circulated with SARS-CoV-2 in The Gambia during the COVID-19 pandemic.

Asymptomatic Plasmodium falciparum carriage and clinical disease: a 5-year community-based longitudinal study in The Gambia.

Background: Carriers of persistent asymptomatic Plasmodium falciparum infections constitute an infectious reservoir that maintains malaria transmission. Understanding the extent of carriage and characteristics of carriers specific to endemic areas could guide use of interventions to reduce infectious reservoir.

Methods: In eastern Gambia, an all-age cohort from four villages was followed up from 2012 to 2016.

A novel nano-iron supplement versus standard treatment for iron deficiency anaemia in children 6-35 months (IHAT-GUT trial): a double-blind, randomised, placebo-controlled non-inferiority phase II trial in The Gambia.

Background: Iron deficiency anaemia (IDA) is the leading cause of years lost to disability in most sub-Saharan African countries and is especially common in young children. The IHAT-GUT trial assessed the efficacy and safety of a novel nano iron supplement, which is a dietary ferritin analogue termed iron hydroxide adipate tartrate (IHAT), for the treatment of IDA in children under 3 years of age.

Methods: In this single-country, randomised, double-blind, parallel, placebo-controlled, non-inferiority Phase II study in The Gambia, children 6-35 months with IDA (7≤Hb < 11 g/dL and ferritin<30 μg/L) were randomly assigned (1:1:1) to receive either IHAT, ferrous sulphate (FeSO) or placebo daily for 3 months (85 days).