Vaccines have played a critical role in controlling disease outbreaks, hence the proliferation of the development and testing of multiple vaccine candidates during the COVID-19 pandemic. Randomised trials are gold standards for evaluating the safety and efficacy of pharmaceutical interventions such as COVID-19 vaccines. However, contextual differences may attenuate effects of COVID-19 vaccines. Thus, the need to conduct COVID-19 vaccine trials in all settings, including in Africa. We conducted a cross-sectional analysis of planned, ongoing, and completed COVID-19 vaccine trials in Africa. We searched the South African National Clinical Trials Register, Pan African Clinical Trials Registry, and International Clinical Trials Registry Platform (ICTRP) on 12 January and 30 April 2022; and complemented this with a search of ClinicalTrials.gov on 17 May 2022. We screened the search output and included randomised trials with at least one recruitment site in Africa. We identified only 108 eligible trials: 90 (83%) evaluating candidate COVID-19 vaccines, 11 (10%) assessing if existing vaccines could prevent SARS-CoV-2 infection, and 7 (7%) evaluating interventions for improving COVID-19 vaccination coverage. South Africa had the highest number of trials at 58 (54%). Beyond South Africa, countries with more than 10 trial sites include Kenya, Ghana, Egypt, Uganda, and Zimbabwe. Among the trials, 14 (13%) do not have principal investigators based in Africa, 39 (30%) are funded by industry, and 91 (84%) are funded by institutions based outside the host country. COVID-19 vaccine trials with recruitment sites in Africa represented only 7% of the 1453 COVID-19 vaccine trials in the ICTRP. The paucity of COVID-19 vaccine trials conducted on the African continent is a cause for concern. This has implications for the role that Africa may play in future pandemics. SIGNIFICANCE: • There are generally very few vaccine trials conducted in Africa, relative to the rest of the world. • The limited vaccine trials in Africa could be attributed to limited expertise and resources, both human and material, as well as lack of perceived market. • It is reassuring that many COVID-19 vaccines are planned, being conducted, or have been conducted in multiple African countries; but there is a need for more African public sector funding for vaccine trials on the continent.

BACKGROUND: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question OBJECTIVES: To describe the challenges to adolescent research and suggest strategies to address these METHOD: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum RESULTS: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research CONCLUSION: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant

BACKGROUND: Accurate record-keeping is important for continuity and quality of care. Completing a child's Road-to-Health Booklet (RTHB), or the older, less detailed, Road-to-Health Card/Chart (RTHC), immediate interpretation thereof and appropriate action facilitates comprehensive care, which could contribute to a decline in child morbidity and mortality. OBJECTIVE: This study aimed to assess the extent to which healthcare personnel working in catchment clinics of Kalafong Provincial Tertiary Hospital (KPTH), Tshwane district, South Africa, complete HIV-related, sociodemographic, neonatal, growth and immunisation information in the RTHC and/or RTHB. METHODS: A cross-sectional, quantitative record review was conducted. Data were extracted from 318 RTHCs and/or RTHBs of children attending KPTH for paediatric care. Data extraction focused on six main areas, namely documentation of HIV-related, neonatal, sociodemographic, anthropometric, immunisation and vitamin A-related information. During data analysis, age-appropriate completeness scores were generated for each area and completeness of documentation in the RTHB and RTHC was assessed. RESULTS: Data demonstrate significantly less unrecorded HIV-related information (maternal HIV status, timing of maternal HIV testing, timing of maternal antiretroviral therapy [ART] initiation, current maternal ART use and infant feeding decisions) in RTHBs compared with RTHCs (p < 001). Despite this, 24% of all RTHBs had no record of maternal HIV status and 67% of RTHBs from documented HIV-exposed infants had no record of maternal ART duration. Neonatal information completeness was similar between RTHBs and RTHCs, but socio-demographic completeness was significantly better in RTHBs compared with RTHCs (p = 0.006). Growth (especially weight), immunisation and vitamin A completeness was > 80% and similar between RTHBs and RTHCs. Length-for-age, weight-for-length and head circumference were plotted in < 5% of RTHBs and none of the RTHCs. CONCLUSION: Although completeness of key HIV-related information was better in RTHBs compared with RTHCs, RTHB completeness was suboptimal. Healthcare personnel need reminders to utilise the RTHB optimally to improve continuity and quality of child healthcare.

In January 2015, the South African National Department of Health released new consolidated guidelines for the prevention of mother to child transmission (PMTCT) of HIV, in line with the World Health Organization's (WHO) PMTCT Option B+. Implementing these guidelines should make it possible to eliminate mother to child transmission (MTCT) of HIV and improve long-term maternal and infant outcomes. The present article summarises the key recommendations of the 2015 guidelines and highlights current gaps that hinder optimal implementation; these include late antenatal booking (as a result of poor staff attitudes towards 'early bookers' and foreigners, unsuitable clinic hours, lack of transport to facilities, quota systems being applied to antenatal clients and clinic staff shortages); poor compliance with rapid HIV testing protocols; weak referral systems with inadequate follow-up; inadequate numbers of laboratory staff to handle HIV-related monitoring procedures and return of results to the correct facility; and inadequate supply chain management, leading to interrupted supplies of antiretroviral drugs. Additionally, recommendations are proposed on how to address these gaps. There is a need to evaluate the implementation of the 2015 guidelines and proactively communicate with ground-level implementers to identify operational bottlenecks, test solutions to these bottlenecks, and develop realistic implementation plans.

PROBLEM: The World Health Organization has produced clear guidelines for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV). However, ensuring that all PMTCT programme components are implemented to a high quality in all facilities presents challenges. APPROACH: Although South Africa initiated its PMTCT programme in 2002, later than most other countries, political support has increased since 2008. Operational research has received more attention and objective data have been used more effectively. LOCAL SETTING: In 2010, around 30% of all pregnant women in South Africa were HIV-positive and half of all deaths in children younger than 5 years were associated with the virus. RELEVANT CHANGES: Between 2008 and 2011, the estimated proportion of HIV-exposed infants younger than 2 months who underwent routine polymerase chain reaction (PCR) tests to detect early HIV transmission increased from 36.6% to 70.4%. The estimated HIV transmission rate decreased from 9.6% to 2.8%. Population-based surveys in 2010 and 2011 reported transmission rates of 3.5% and 2.7%, respectively. LESSONS LEARNT: Critical actions for improving programme outcomes included: ensuring rapid implementation of changes in PMTCT policy at the field level through training and guideline dissemination; ensuring good coordination with technical partners, such as international health agencies and international and local nongovernmental organizations; and making use of data and indicators on all aspects of the PMTCT programme. Enabling health-care staff at primary care facilities to initiate antiretroviral therapy and expanding laboratory services for measuring CD4+ T-cell counts and for PCR testing were also helpful.

SITUACIÓN: La Organización Mundial de la Salud ha presentado unas directrices claras para la prevención de la transmisión del virus de la inmunodeficiencia humana (VIH) de la madre al niño. No obstante, habrá que superar algunos desafios para asegurar la puesta en marcha de todos los elementos del programa de prevención a fin de alcanzar un nivel de calidad elevado en todas las instalaciones. ENFOQUE: Aunque Sudáfrica inició su programa de prevención en el ano 2002, más tarde que la mayoria de los paises, el apoyo politico ha aumentado desde 2008. Se ha prestado más atención a las investigaciones operativas y los datos objetivos se han utilizado con mayor eficacia. MARCO REGIONAL: En 2010, alrededor del 30% de las mujeres embarazadas en Sudáfrica eran seropositivas, y la mitad de todas las muertes en niños menores de cinco anos estuvieron asociadas al virus. CAMBIOS IMPORTANTES: Entre los anos 2008 y 2011, la proporción estimada de niños menores de dos meses expuestos al VIH que se sometió a las pruebas rutinarias de reacción en cadena de la polimerasa aumentó del 36,6% al 70,4%, y la tasa estimada de transmisión del VIH se redujo del 9,6% al 2,8%. Las encuestas de población de los anos 2010 y 2011 reflejaron unas tasas de transmisión del 3,5% y el 2,7%, respectivamente LECCIONES APRENDIDAS: Las actividades fundamentales para mejorar los resultados del programa incluyeron: garantizar la implementación rápida de los cambios en la polÃtica de prevención de la transmisión a nivel de campo mediante cursos formativos y la difusión de las directrices; garantizar una coordinación adecuada entre los socios técnicos, tales como las agencias sanitarias internacionales y las ONG locales e internacionales; y utilizar los datos e indicadores acerca de todos los aspectos del programa de prevención de la transmisión del VIH de la madre al niño. También resultó muy útil permitir al personal sanitario de los centros de atención primaria iniciar terapias antirretrovirales y ampliar los servicios de laboratorio para realizar los recuentos de linfocitos T CD4+ y las pruebas de reacción en cadena de la polimerasa.

PROBLÈME: L'Organisation mondiale de la Santé a élaboré des lignes directrices claires pour la prévention de la transmission mère-enfant (PTME) du virus de l'immunodéficience humaine (VIH). S'assurer que tous les éléments du programme de PTME soient mis en œuvre de manière qualitative dans tous les établissements présente cependant des défis. APPROCHE: Bien que l'Afrique du Sud ait lancé son programme de PTME en 2002, plus tard que la plupart des autres pays, le soutien politique a augmenté depuis 2008. La recherche opérationnelle a reçu davantage d'attention, et les données objectives ont été utilisées plus efficacement. ENVIRONNEMENT LOCAL: En 2010, environ 30% de toutes les femmes enceintes en Afrique du Sud étaient séropositives, et la moitié de tous les décès dénfants de moins de 5 ans étaient associée au virus. CHANGEMENTS SIGNIFICATIFS: Entre 2008 et 2011, la proportion estimée de nourrissons de moins de 2 mois exposés au VIH, ayant subi une réaction en chaîne par polymérase (PCR) de routine visant à détecter la transmission précoce du VIH, est passée de 36,6% à 70,4%. Le taux estimé de transmission du VIH a diminué, passant de 9,6% à 2,8%. Les enquêtes basées sur la population en 2010 et 2011 ont signalé des taux de transmission de 3,5% et 2,7%, respectivement. LEÇONS TIRÉES: Voici certaines actions essentielles pour améliorer les résultats du programme: assurer la mise en œuvre rapide des changements de politique de PTME sur le terrain, grâce à la formation et à la diffusion des lignes directrices; assurer une bonne coordination avec les partenaires techniques, comme les agences de santé internationales et locales et les organisations non gouvernementales; et utiliser les données et les indicateurs relatifs à tous les aspects du programme de PTME. Il est aussi utile de permettre au personnel soignant des établissements de soins de santé primaires d'initier un traitement antirétroviral et de développer les services de laboratoire pour les décomptes de cellules CD4 + T et les tests PCR.

The World Health Organization released revised principles and recommendations for HIV and infant feeding in November 2009. The recommendations are based on programmatic evidence and research studies that have accumulated over the past few years within African countries. This document urges national or subnational health authorities to decide whether health services should mainly counsel and support HIV-infected mothers to breastfeed and receive antiretroviral interventions, or to avoid all breastfeeding, based on estimations of which strategy is likely to give infants in those communities the greatest chance of HIV-free survival. South Africa has recently revised its clinical guidelines for prevention of mother-to-child HIV transmission, adopting many of the recommendations in the November 2009 World Health Organization's rapid advice on use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants. However, one aspect of the new South African guidelines gives cause for concern: the continued provision of free formula milk to HIV-infected women through public health facilities. This paper presents the latest evidence regarding mortality and morbidity associated with feeding practices in the context of HIV and suggests a modification of current policy to prioritize child survival for all South African children.

La Organización Mundial de la Salud publicó en noviembre de 2009 una revisión de sus principios y recomendaciones relacionados con el VIH y la lactancia. Las recomendaciones se basan en evidencias sistemáticas y en estudios de investigación que se han realizado en los últimos años en el continente africano. Este documento insta a las autoridades sanitarias nacionales o regionales a decidir con carácter urgente si los servicios sanitarios deben asesorar y apoyar a las madres con el VIH para que den el pecho a sus bebés y reciban tratamientos con antirretrovíricos, o si deben evitar cualquier tipo de lactancia materna, en función de las estimaciones sobre qué estrategia permitirá que los lactantes de esas comunidades tengan más posibilidades de sobrevivir sin contagiarse con el VIH. Sudáfrica acaba de revisar sus directrices clínicas para evitar que las madres transmitan el VIH a sus hijos, adoptando muchas de las recomendaciones incluidas en la orientación de noviembre de 2009 de la Organización Mundial de la Salud sobre el uso de antirretrovíricos para el tratamiento temprano de embarazadas y para evitar que los niños de pecho se contagien con el VIH. No obstante, un aspecto de las nuevas directrices sudafricanas resulta especialmente preocupante: el suministro continuado, a través de los sistemas de salud públicos, de leche de inicio gratuita para las mujeres infectadas por el VIH. Este artículo presenta los últimos datos relacionados con la mortalidad y la morbilidad asociadas a la lactancia en los casos de madres con VIH y sugiere una modificación de la política actual para dar prioridad a la supervivencia infantil de todos los niños sudafricanos.

L'Organisation mondiale de la Santé a publié des recommandations et des principes révisés pour le VIH et la nutrition infantile en novembre 2009. Ces recommandations reposent sur des preuves programmatiques et des études de recherche rassemblées ces dernières années dans des pays africains. Ce document conseille vivement aux autorités sanitaires nationales ou sous-nationales de décider si leurs services de soins de santé doivent essentiellement soutenir et encourager les mères séropositives à allaiter et à recevoir des traitements antirétroviraux, ou à éviter l'allaitement au sein, selon les estimations de la meilleure stratégie à adopter pour augmenter les chances de survie sans VIH des nourrissons de ces communautés. L'Afrique du Sud a récemment révisé ses lignes directrices cliniques en matière de prévention de la transmission VIH mère enfant, en adoptant les conseils rapides de novembre 2009 de l'Organisation mondiale de la Santé relatives à l'utilisation des antirétroviraux pour le traitement des femmes enceintes et la prévention de la transmission du VIH aux enfants. Toutefois, l'un des aspects que présentent ces nouvelles lignes directrices sud-africaines est préoccupant. Il s'agit de la distribution permanente et gratuite de lait infantile aux femmes séropositives dans les centres de santé publics. Cet article présente les derniers éléments probants en matière de mortalité et de morbidité associées à ces pratiques nutritionnelles dans le contexte du VIH et suggère une modification de la politique actuelle de façon à placer la survie de tous les enfants sud-africains au cœur de ses priorités.

BACKGROUND: Malaria rapid diagnostic tests (MRDTs) are quick and easy to perform and useful for diagnosing malaria in primary health care settings. In South Africa most malaria infections are due to Plasmodium falciparum, and HRPII-based MRDTs have been used since 2001. Previous studies in Africa showed variability in sensitivity and specificity of HRPIIbased MRDTs; hence, we conducted a field evaluation in Limpopo province to determine the accuracy of the MRDT currently used in public sector clinics and hospitals. METHODS: A cross-sectional observational study was conducted to determine the sensitivity and specificity of an ICT Pf MRDT. We tested 405 patients with fever with ICT Pf MRDT and compared the results with blood film microscopy (the gold standard). RESULTS: The overall sensitivity of the ICT Pf MRDT was 99.48% (95% confidence interval (CI) 96.17 - 100%), while specificity was 96.26% (95% CI 94.7 - 100%). The positive predictive value of the test was 98.48 (99% CI 98.41 - 100%), and the negative predictive value was 99.52% (95% CI 96.47 - 100%). CONCLUSIONS: The ICT Pf MRDT is an appropriate test to use in the field in South Africa where laboratory facilities are not available. It has a high degree of sensitivity and acceptable level of specificity in accordance with the World Health Organization criteria. However, sensitivity of MRDT at low levels of parasitaemia (<100 parasites/µl of blood) in field conditions must still be established.

OBJECTIVE: To determine the operational effectiveness of the South African programme for preventing mother-to-child transmission (PMTCT) of HIV in reducing rates of early transmission of infection. METHODS: Participants were mother-infant pairs who participated in the South African PMTCT programme between October 2002 and November 2004. This was a prospective cohort study. Three sites in different provinces were selected to represent differences in socioeconomic status and HIV prevalence. Data on antenatal care and labour ward care were obtained from maternal interviews and from reviews of medical records. A total of 665 mother-infant pairs in which the mother was HIV-positive were recruited and 588 (88.4%) were followed up at 3 or 4 weeks postpartum to determine the HIV status and vital status of the infant. FINDINGS: Rural participants were significantly poorer and their health care was significantly worse. Women of higher socioeconomic status and those who received better counselling were more likely to be treated with nevirapine. Rates of early HIV transmission ranged from 8.6% to 13.7%. Maternal viral load was the only statistically significant risk factor for transmission. After adjusting for maternal viral load and prevalence of low birth weight, the odds of transmission were 1.8 times higher at the rural site. Controlling for having had > 4 antenatal visits and any delivery complication reduced the odds of transmission to 1.5 higher at the rural site. CONCLUSION: Rates of early transmission of HIV in an operational setting using single-dose nevirapine administered both to mother and child are similar to those obtained in clinical trials. Scaling up access to antiretroviral regimens for women will further reduce transmission to infants.

OBJETIVO: Determinar la eficacia operacional del programa sudafricano de prevención de la transmisión de la madre al niño (PTMN) del VIH en lo que respecta a la reducción de las tasas de transmisión temprana de la infección. MÉTODOS: Se analizó la evolución de pares de madre y lactante que participaron en el programa de PTMN de Sudáfrica entre octubre de 2002 y noviembre de 2004. En este estudio prospectivo de cohortes se seleccionaron tres sitios de diferentes provincias para que estuvieran representados los distintos estatus socioeconómicos y prevalencias de la infección por VIH. Los datos sobre la atención prenatal y en las salas de parto proceden de entrevistas maternas e historias clínicas. Se reclutó a un total de 665 pares de madre y lactante en que la madre era VIH-positiva, lográndose someter a seguimiento a 588 (88,4%) de ellas a las 3 o 4 semanas tras el parto para determinar su serología VIH y el estado del lactante. RESULTADOS: Las participantes rurales eran significativamente más pobres y la atención sanitaria que recibieron fue significativamente peor. Las mujeres de estatus socioeconómico más alto y las que recibieron mejor asesoramiento presentaron una mayor probabilidad de ser tratadas con nevirapina. Las tasas de transmisión temprana del VIH se situaron entre el 8,6% y el 13,7%. La carga viral materna fue el único factor de riesgo de transmisión estadísticamente significativo. Después de ajustar los datos en función de la carga viral materna y de la prevalencia de peso bajo al nacer, la probabilidad de transmisión resultó ser 1,8 veces mayor en el sitio rural. Controlando el número de visitas prenatales (> 4) y las posibles complicaciones del parto, el factor de aumento de la probabilidad de transmisión en el sitio rural se reducía a 1,5. CONCLUSIÓN: Las tasas de transmisión temprana de la infección por VIH en un entorno operacional de administración de una sola dosis de nevirapina a ambos, madre y niño, son similares a las observadas en ensayos clínicos. La expansión del acceso a los regímenes antirretrovirales para las mujeres reducirá aún más la transmisión a los lactantes.

OBJETIF: Déterminer l’efficacité opérationnelle du programme de prévention de la transmission de la mère à l’enfant du VIH (PTME) mené en Afrique du Sud dans la réduction des taux de transmission précoce de l’infection. MÉTHODES: On a choisi comme sujets de l’étude des couples mères-enfants ayant bénéficié du programme PTME pour l’Afrique du Sud entre octobre 2002 et novembre 2004. Ces couples ont fait l’objet d’une étude prospective de cohorte. On a sélectionné trois sites dans des provinces différentes afin de prendre en compte les écarts de statut socioéconomique et de prévalence du VIH. Des entretiens avec les mères et une analyse des dossiers médicaux ont permis d’obtenir des données sur les soins anténatals et ceux dispensés en salle de travail. On a recruté au total 665 couples mères-enfants comprenant une mère séropositive, parmi lesquels 588 (88,4 %) ont été suivis 3 à 4 semaines après l’accouchement pour déterminer le statut vital et le statut à l’égard du VIH du nourrisson. RÉSULTATS: Les sujets de l’étude vivant en milieu rural étaient nettement plus pauvres et leur état de santé sensiblement plus dégradé par rapport aux sujets de milieux urbains. La probabilité de recevoir un traitement par la névirapine était plus forte chez les femmes de statut socioéconomique élevé et chez celles ayant été bien conseillées. Les taux de transmission précoce du VIH se situaient entre 8,6 et 13,7 %. La charge virale maternelle s’est révélée le seul facteur de risque ayant une influence statistiquement significative. Après ajustement pour la charge virale et la prévalence des faibles poids à la naissance, la probabilité de transmission du virus pour le site rural était 1,8 fois supérieure à celle en milieu urbain. En contrôlant pour les femmes du site rural ayant bénéficié de 4 visites anténatales au moins et dont l’accouchement s’était opéré sans aucune complication, la probabilité de transmission pour ce site est passée à 1,5 fois celle du site urbain. CONCLUSION: Les taux de transmission précoce du VIH obtenus dans un contexte opérationnel en administrant une dose unique de névirapine à la mère et à l’enfant sont similaires à ceux enregistrés dans des essais cliniques. L’élargissement de l’accès pour les femmes au traitement antirétroviral permettra de réduire davantage la transmission du VIH aux nourrissons.