Follow-up care of infants born in a prevention of mother-to-child transmission programme in an urban hospital in KwaZulu-Natal, South Africa.

Thesis (M.Med.)-University of KwaZulu-Natal, Durban, 2011.Introduction. The Human Immunodeficiency Virus (HIV) is the main contributor to rising child mortality in South Africa. Although prevention of mother-to-child transmission programmes have been implemented in the country, little is known about the clinical and loss to follow-up outcomes of infants born to HIV-infected women attending these programmes. Purpose. The purpose of the study was to describe the clinical and loss to follow-up outcomes of HIV-exposed infants whose mothers had received antiretroviral therapy or prophylaxis during their pregnancy at the Prevention of Mother-to-Child Transmission programme at McCord Hospital. Furthermore, maternal socio-demographic characteristics associated with these outcomes were determined. Methods. An observational retrospective cohort study design was used. The study population consisted of infants whose mothers had received antiretroviral prophylaxis or therapy at McCord Hospital, and were delivered at McCord Hospital, and/or were brought back to McCord Hospital, following delivery from 1 May 2008 to 31 May 2009. Results. Data on 265 infants was analysed. Of the 220 infants who were tested, the HIV transmission risk was 2.7% (n=6; 95% Cl: 1.0% to 5.8%) at 6 weeks of age. Overall, 40.4% of infants in the cohort were lost to follow-up (n=105, 95% Cl: 34.4 to 46.6). In the multivariable model (n=253), late booking for first antenatal visit at or after 28 weeks of gestation (adjusted hazard ratio (AHR) 2.3; 95% Cl: 1.0 to 5.1, p=0.044) was a risk factor for loss to follow-up. Compared to having an emergency caesarean section, having an elective caesarean section (AHR 1.9; 95% Cl: 1.1 to 3.5) or normal vaginal delivery (AHR 2.5; 95% Cl: 1.4 to 4.5) was significantly associated with loss to follow-up of infants. Discussion. The substantial attrition of infants born to HIV-infected mothers in the Prevention of Mother-to-Child Transmission programme at McCord Hospital undermined the goals of the programme, and underestimated the effect of infectious disease morbidity, mortality and HIV transmission risk associated with these infants. Recommendations. Counselling mothers on the health benefits to their HIV-exposed infants of attending the follow-up clinic and tracing of infants who have been lost to follow-up is vital to the operational effectiveness of the Prevention of Mother-to-Child Transmission programme at McCord Hospital

HIV status, breastfeeding modality at 5 months and postpartum maternal weight changes over 24 months in rural South Africa

ObjectiveTo determine the effect of infant feeding practices on postpartum weight change among HIV-infected and -uninfected women in South Africa.MethodsIn a non-randomised intervention cohort study of antiretroviral therapy-naïve women in South Africa, infants were classified as exclusive (EBF), mixed (MF) or non-breastfed (NBF) at each visit. We analysed infant feeding cumulatively from birth to 5 months using 24-hour feeding history (collected weekly for each of the preceding 7 days). Using generalised estimating equation mixed models, allowing for repeated measures, we compared postpartum weight change (kg) from the first maternal postpartum weight within the first 6 weeks (baseline weight) to each subsequent visit through 24 months among 2340 HIV-infected and -uninfected women with live births and at least two postpartum weight measurements.ResultsHIV-infected (?0.2 kg CI: ?1.7 to 1.3 kg; P = 0.81) and -uninfected women (?0.5 kg; 95% CI: ?2.1 to 1.2 kg; P = 0.58) had marginal non-significant weight loss from baseline to 24 months postpartum. Adjusting for HIV status, socio-demographic, pregnancy-related and infant factors, 5-month feeding modality was not significantly associated with postpartum weight change: weight change by 24 months postpartum, compared to the change in the reference EBF group, was 0.03 kg in NBF (95% CI: ?2.5 to +2.5 kg; P = 0.90) and 0.1 kg in MF (95% CI: ?3.0 to +3.2 kg; P = 0.78).ConclusionHIV-infected and -uninfected women experienced similar weight loss over 24 months. Weight change postpartum was not associated with 5-month breastfeeding modality among HIV-infected and -uninfected women.ObjectifDéterminer l'effet des pratiques d'alimentation des nourrissons sur la variation du poids postpartum chez les femmes infectées et non infectées par le VIH en Afrique du Sud.MéthodesDans une étude de cohorte d'intervention non randomisée sur la thérapie aux antirétroviraux, les nourrissons de femmes naïves pour le traitement en Afrique du Sud, ont été classés comme allaités exclusivement au sein (EBF), recevant une alimentation mixte (MF) ou non allaités au sein (NBF), à chaque visite. Nous avons analysé l'alimentation du nourrisson cumulativement de la naissance à cinq mois, en utilisant l'historique de l'alimentation sur 24 heures (recueillies hebdomadairement pour chacun des sept jours précédents). En utilisant l’équation d'estimation des modèles mixtes généralisés, permettant des mesures répétées, nous avons comparé les changements de poids (kg) postpartum de la première mesure du poids postpartum de la mère endéans les six premières semaines (poids de base) au poids à chaque visite subséquente durant 24 mois chez 2340 femmes infectées et non infectées par le VIH, ayant eu des naissances vivantes et au moins deux mesures du poids postpartum.RésultatsLa perte de poids des femmes infectées (-0,2 kg; IC: -1,7 à 1,3 kg; P = 0,81) et non infectées (0,5 kg, IC95%: -2,1 à 1,2 kg; P = 0,58) par le VIH était marginalement non significative de la base à 24 mois postpartum. En ajustant pour le statut VIH et sociodémographique, pour les facteurs liés à la grossesse et infantiles, le mode d'alimentation sur cinq mois n’étaient pas significativement associé à la variation du poids postpartum; la variation de poids sur 24 mois postpartum comparée à celle dans le groupe EBF de référence, était de 0,03 kg chez les NBF (IC95%: -2,5 à 2,5 kg; P = 0,90) et 0,1 kg chez les MF (IC95%: -3,0 à 3,2 kg; P = 0,78).ConclusionLes femmes infectées et non infectées par le VIH connaissent une perte de poids similaire sur 24 mois. La variation du poids postpartum n'a pas été associée au mode d'allaitement à cinq mois chez les femmes infectées et non infectées par le VIH.ObjetivoDeterminar el efecto de las prácticas de alimentación de los bebés en la variación del peso materno postparto entre mujeres infectadas y no infectadas con VIH en Sudáfrica.MétodosEn una intervención en Sudáfrica no aleatorizada, dentro de un estudio de cohortes de mujeres que no habían recibido anteriormente terapia antirretroviral (naive) – los bebés de se clasificaron como recibiendo exclusivamente el pecho (EP), alimentación mixta (AM), o que no eran amamantados (NA) en cada visita. Hemos analizado la alimentación acumulativa del bebé, desde el nacimiento hasta los cinco meses de edad, utilizando un historial de alimentación de 24 horas (recogido semanalmente para los 7 días anteriores). Utilizando modelos mixtos de ecuaciones de estimación generalizadas, permitiendo medidas repetidas, hemos comparado el cambio de peso (kg) durante el postparto - desde la primera pesada dentro de las primeras seis semanas postparto (peso inicial) con cada visita subsiguiente, durante los 24 meses posteriores, para 2340 mujeres - infectadas con VIH y sin infectar – que dieron a luz bebés nacidos vivos y que tenían recogidas al menos dos pesadas postparto.ResultadosLas mujeres infectadas con VIH (-0.2 kg IC: -1.7 – 1.3 kg; P = 0.81) y aquellas no infectadas (-0.5kg; 95% IC: -2.1 – 1.2 kg; P =0.58) tenían una pérdida de peso marginal y no significativa entre el comienzo del estudio hasta los 24 meses después del parto. Ajustando para el estatus de VIH, los factores sociodemográficos y relacionados con el embarazo y el bebé, la modalidad de alimentación del bebé durante sus cinco primeros meses no estaba significativamente asociada con el cambio de peso postparto: el cambio de peso 24 meses después del parto, comparada con el cambio en referencia al grupo EP, era de 0.03 kg en NA (IC 95%: -2.5 – +2.5 kg; P = 0.90) y 0.1 kg en AM (IC 95%: -3.0 – +3.2 kg; P = 0.78).ConclusiónLas mujeres infectadas con VIH y aquellas sin infección experimentaron una pérdida de peso similar en los 24 meses postparto. El cambio de peso no estaba asociado con la modalidad de amamantamiento entre las mujeres VIH positivas y VIH negativas

Intervention in mothers and newborns to reduce maternal and perinatal mortality in 3 provinces in South Africa using a quality improvement approach: Protocol for a mixed method type 2 hybrid evaluation

The COVID-19 pandemic undermined gains in reducing maternal and perinatal mortality in South Africa. The Mphatlalatsane Initiative is a health system intervention to reduce mortality and morbidity in women and newborns to desired levels. Our evaluation aims to determine the effect of various exposures, including the COVID-19 pandemic, and a system-level, complex, patient-centered quality improvement (QI) intervention (the Mphatlalatsane Initiative) on maternal and neonatal health services at 21 selected South African facilities. The objectives are to determine whether Mphatlalatsane reduces the institutional maternal mortality ratio, neonatal mortality rate, and stillbirth rate (objective 1) and improves patients’ experiences (objective 2) and quality of care (objective 3). Objective 4 assesses the contextual and implementation process factors, including the COVID-19 pandemic, that shape Mphatlalatsane uptake and variation

Preventing Unintended Pregnancy and HIV Transmission: Effects of the HIV Treatment Cascade on Contraceptive Use and Choice in Rural KwaZulu-Natal

Background: For women living with HIV, contraception using condoms is recommended because it prevents not only unintended pregnancy but also acquisition of other sexually transmitted infections and onward transmission of HIV. Dual-method dual-protection contraception (condoms with other contraceptive methods) is preferable over single-method dual-protection contraception (condoms alone) because of its higher contraceptive effectiveness. We estimate the effect of progression through the HIV treatment cascade on contraceptive use and choice among HIV-infected women in rural South Africa. Methods: We linked population-based surveillance data on contraception collected by the Wellcome Trust Africa Centre for Health and Population Studies to data from the local antiretroviral treatment (ART) program in Hlabisa subdistrict, KwaZulu-Natal. In bivariate probit regression, we estimated the effects of progressing through the cascade on contraceptive choice among HIV-infected sexually active women aged 15–49 years (N = 3169), controlling for a wide range of potential confounders. Findings: Contraception use increased across the cascade from 70% among women who have been on ART for 4–7 years. Holding other factors equal (1) awareness of HIV status, (2) ART initiation, and (3) being on ART for 4–7 years increased the likelihood of single-method/dual-method dual protection by the following percentage points (pp), compared with women who were unaware of their HIV status: (1) 4.6 pp (P = 0.030)/3.5 pp (P = 0.001), (2) 10.3 pp (P = 0.003)/5.2 pp (P = 0.007), and (3) 21.6 pp (P < 0.001)/11.2 pp (P < 0.001). Conclusions: Progression through the HIV treatment cascade significantly increased the likelihood of contraception in general and contraception with condoms in particular. ART programs are likely to contribute to HIV prevention through the behavioral pathway of changing contraception use and choice

Southern African Treatment Resistance Network (SATuRN) RegaDB HIV drug resistance and clinical management database: supporting patient management, surveillance and research in southern Africa

Substantial amounts of data have been generated from patient management and academic exercises designed to better understand the human immunodeficiency virus (HIV) epidemic and design interventions to control it. A number of specialized databases have been designed to manage huge data sets from HIV cohort, vaccine, host genomic and drug resistance studies. Besides databases from cohort studies, most of the online databases contain limited curated data and are thus sequence repositories. HIV drug resistance has been shown to have a great potential to derail the progress made thus far through antiretroviral therapy. Thus, a lot of resources have been invested in generating drug resistance data for patient management and surveillance purposes. Unfortunately, most of the data currently available relate to subtype B even though >60% of the epidemic is caused by HIV-1 subtype C. A consortium of clinicians, scientists, public health experts and policy markers working in southern Africa came together and formed a network, the Southern African Treatment and Resistance Network (SATuRN), with the aim of increasing curated HIV-1 subtype C and tuberculosis drug resistance data. This article describes the HIV-1 data curation process using the SATuRN Rega database. The data curation is a manual and time-consuming process done by clinical, laboratory and data curation specialists. Access to the highly curated data sets is through applications that are reviewed by the SATuRN executive committee. Examples of research outputs from the analysis of the curated data include trends in the level of transmitted drug resistance in South Africa, analysis of the levels of acquired resistance among patients failing therapy and factors associated with the absence of genotypic evidence of drug resistance among patients failing therapy. All these studies have been important for informing first- and second-line therapy. This database is a free password-protected open source database available on www.bioafrica.net

Intervention in mothers and newborns to reduce maternal and perinatal mortality in 3 provinces in South Africa using a quality improvement approach : protocol for a mixed method Type 2 hybrid evaluation

BACKGROUND : The COVID-19 pandemic undermined gains in reducing maternal and perinatal mortality in South Africa. The Mphatlalatsane Initiative is a health system intervention to reduce mortality and morbidity in women and newborns to desired levels. OBJECTIVE : Our evaluation aims to determine the effect of various exposures, including the COVID-19 pandemic, and a system-level, complex, patient-centered quality improvement (QI) intervention (the Mphatlalatsane Initiative) on maternal and neonatal health services at 21 selected South African facilities. The objectives are to determine whether Mphatlalatsane reduces the institutional maternal mortality ratio, neonatal mortality rate, and stillbirth rate (objective 1) and improves patients’ experiences (objective 2) and quality of care (objective 3). Objective 4 assesses the contextual and implementation process factors, including the COVID-19 pandemic, that shape Mphatlalatsane uptake and variation. METHODS : This study is an implementation science type 2 hybrid effectiveness, controlled before-and-after design with quantitative and qualitative components. The Mphatlalatsane intervention commenced at the end of 2019. For objective 1, intervention and control facility-level data from the District Health Information System are compared for changes in institutional maternal and neonatal mortality and stillbirth rates and associations with QI, the COVID-19 pandemic, and both. This first analysis includes data from 18 facilities, regardless of their allocation to intervention or comparison, to obtain a general idea of the effect of the COVID-19 pandemic. For objectives 2 to 3, data collectors abstract data from maternal and neonatal records, interview participants, and conduct neonatal facility assessments. For objective 4, interviews, program documentation, surveys, and observations are used to assess how contextual factors at the macro-, meso-, and microlevels explain variation in intervention uptake and outcome. The intervention dose is measured at the microlevel only in the intervention facilities. The study assesses the Mphatlalatsane Initiative from 2020 to 2022. RESULTS : From preliminary analysis, across the 3 provinces, maternal and neonatal deaths increased during the COVID-19 pandemic, whereas stillbirths remained unchanged. Maternal satisfaction with quality of care was >90%. The COVID-19 pandemic severely disrupted the QI teams functioning. However, the QI teams regained their pre–COVID-19 momentum by adapting the QI model, with advisers providing mentoring and support. Variation in adoption at the mesolevel was related to stable and motivated leadership (particularly at the facility level), poor integration into routine processes, and buy-in from senior district managers who were affected by competing priorities. Varying referral and specialist outreach systems, staff availability and development, and service delivery infrastructure are plausible factors in variable outcomes. CONCLUSIONS : Few evaluations rigorously evaluated the effect of health system interventions on improving health services and outcomes. Results will inform the scaling up of successful intervention components and strategies to mitigate the effects of the COVID-19 pandemic or similar emerging epidemics on maternal and neonatal mortality.http://www.researchprotocols.org/Paediatrics and Child HealthStatistic

Early reflections on Mphatlalatsane, a maternal and neonatal quality improvement initiative implemented during COVID-19 in South Africa

Despite global progress in reducing maternal and neonatal mortality and stillbirths, much work remains to be done to achieve the Sustainable Development Goals. Reports indicate that coronavirus disease (COVID-19) disrupts the provision and uptake of routine maternal and neonatal health care (MNH) services and negatively impacts cumulative pre-COVID-19 achievements. We describe a multipartnered MNH quality improvement (QI) initiative called Mphatlalatsane, which was implemented in South Africa before and during the COVID-19 pandemic. The initiative aimed to reduce the maternal mortality ratio, neonatal mortality rate, and stillbirth rate by 50% between 2018 and 2022. The multifaceted design comprises QI and other intervention activities across micro-, meso-, and macrolevels, and its area-based approach facilitates patients’ access to MNH services. The initiative commenced 6 months pre-COVID-19, with subsequent adaptation necessitated by COVID-19. The initial focus on a plan-dostudy- act QI model shifted toward meeting the immediate needs of health care workers (HCWs), the health system, and health care managers arising from COVID-19. Examples include providing emotional support to staff and streamlining supply chain management for infection control and personal protection materials. As these needs were addressed, Mphatlalatsane gradually refocused HCWs’ and managers’ attention to recognize the disruptions caused by COVID-19 to routine MNH services. This gradual reprioritization included the development of a risk matrix to help staff and managers identify specific risks to service provision and uptake and develop mitigating measures. Through this approach, Mphatlalatsane led to an optimization case using existing resources rather than requesting new resources to build an investment case, with a responsive design and implementation approach as the cornerstone of the initiative. Further, Mphatlalatsane demonstrates that agile and context-specific responses to crises such as the COVID-19 pandemic can mitigate such threats and maintain interventions to improve MNH services.Mphatlalatsane is funded by ELMA Philanthropies, an anonymous donor, and the South African Medical Research Council, with additional in-kind programmatic implementation funding by the South African National Department of Health.https://www.ghspjournal.orgam2023Obstetrics and GynaecologyPaediatrics and Child Healt

The MONARCH intervention to enhance the quality of antenatal and postnatal primary health services in rural South Africa: protocol for a stepped-wedge cluster-randomised controlled trial

Background: Gaps in maternal and child health services can slow progress towards achieving the Sustainable Development Goals. The Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health &amp; HIV Care (MONARCH) study will evaluate a Continuous Quality Improvement (CQI) intervention targeted at improving antenatal and postnatal health service outcomes in rural South Africa where HIV prevalence among pregnant women is extremely high. Specifically, it will establish the effectiveness of CQI on viral load (VL) testing in pregnant women who are HIV-positive and repeat HIV testing in pregnant women who are HIV-negative. Methods: This is a stepped-wedge cluster-randomised controlled trial (RCT) of 7 nurse-led primary healthcare clinics to establish the effect of CQI on selected routine antenatal and postnatal services. Each clinic was a cluster, with the exception of the two smallest clinics, which jointly formed one cluster. The intervention was applied at the cluster level, where staff received training on CQI methodology and additional mentoring as required. In the control exposure state, the clusters received the South African Department of Health standard of care. After a baseline data collection period of 2 months, the first cluster crossed over from control to intervention exposure state; subsequently, one additional cluster crossed over every 2 months. The six clusters were divided into 3 groups by patient volume (low, medium and high). We randomised the six clusters to the sequences of crossing over, such that both the first three and the last three sequences included one cluster with low, one with medium, and one with high patient volume. The primary outcome measures were (i) viral load testing among pregnant women who were HIV-positive, and (ii) repeat HIV testing among pregnant women who were HIV-negative. Consenting women ≥18 years attending antenatal and postnatal care during the data collection period completed outcome measures at delivery, and postpartum at three to 6 days, and 6 weeks. Data collection started on 15 July 2015. The total study duration, including pre- and post-exposure phases, was 19 months. Data will be analyzed by intention-to-treat based on first booked clinic of study participants. Discussion: The results of the MONARCH trial will establish the effectiveness of CQI in improving antenatal and postnatal clinic processes in primary care in sub-Saharan Africa. More generally, the results will contribute to our knowledge on quality improvement interventions in resource-poor settings. Trial registration: This trial was registered on 10 December 2015: www.clinicaltrials.gov, identifier NCT02626351

The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: results of a stepped-wedge cluster-randomised controlled implementation trial

Background: Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa. Methods and findings: We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics—combined into 6 clusters—over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic–time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p &lt; 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention. Conclusions: We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success. Trial registration: This trial is registered at ClinicalTrials.gov under registration number NCT02626351