Browsing by Author "Kalk, Emma"
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- ItemOpen AccessA longitudinal analysis of neonatal and infant diagnostic HIV-PCR uptake and associations during three sequential policy periods in Mitchell’s Plain, Cape Town(2018) Kalk, Emma; Davies, Mary-AnnBackground: Despite technological and programmatic advances in the prevention of vertical transmission of HIV and early infant diagnosis (EID), paediatric HIV continues to have a significant impact on infant and child survival in low- and middle-income countries. Many EID programmes follow the WHO recommendation of initial infant HIV testing with a nucleic acid assay at 4-6 weeks old. In general this strategy has been poorly implemented with substantial attrition after birth such that, according to UNAIDS, only 51% of HIV-exposed infants received a virological test in the first two months of life in 2015. In addition, there is concern about the sensitivity of the nucleic acid assays at six weeks in the context of exposure to prolonged multidrug antiretroviral therapy as infant post-exposure prophylaxis, and in breast milk. HIV-PCR testing at birth has been promoted as a means of maximizing the number of infants who receive an HIV test as well as identifying in utero-infected infants in whom HIV infection may follow an aggressive course. Evidence from pilot studies and modelling data was sufficiently compelling for the WHO to include a conditional recommendation for the addition of a birth HIV-PCR (either routine or targeted at high risk groups) to its EID algorithms in 2015. The Western Cape introduced targeted birth HIV testing for high risk infants in August 2014 and expanded this in line with the South African National Prevention of Mother-to-Child Transmission Guidelines, to include all HIV-exposed infants in December 2015. Methods: Between 2013 and 2016 we conducted an implementation science project to iteratively assess the implementation and effectiveness of the vertical transmission prevention of HIV in a chain of referral facilities in Cape Town (i.e. from primary to tertiary care). The e-register provided a single longitudinal record for each woman (linked to her infant after birth) and enabled assessment of HIV testing and treatment from first antenatal visit through delivery to infant HIV testing. Using a cohort of HIV-exposed live infants from this database, a protocol was designed (Section A: Protocol) to assess the implementation and outcome of effectively three different EID policy periods in the facility chain. i.e. an initial period of birth HIV-PCR at the clinician’s discretion if evidence of HIV infection; a period of targeted birth testing of high risk infants and lastly, of routine birth HIV-PCR for all HIV-exposed infants. A critical review of the literature appraised published assessments of birth HIV testing programmes in low- and middle-income countries (Section B: Literature Review) with the aim of assessing in utero transmission rates, follow-up testing and transmission rates and the resources required for implementation. Studies that modelled the impact of birth HIV testing were specifically reviewed. The manuscript (Section C: Manuscript) presented an analysis of the HIV-infected/exposed mother/infant dyads from the e-register of the Closing the Gaps study. Using this database adherence to guidelines in each period was assessed as well as the outcome of HIV-PCR at four delivery sites and the impact of the policies on return for follow-up EID. Results: South Africa is the first country in sub-Saharan Africa to implement birth HIV testing and most of the studies in support of this strategy were generated here. There was limited literature which highlighted the need for further investigation into the implementation and effectiveness of such programmes. No prospective data addressed targeted birth testing and those reporting on more routine birth HIV-PCR demonstrated success in timeous diagnosis and treatment although significant additional project resources were required. The retrospective laboratory data indicated that receipt of a birth HIV-PCR reduced the likelihood for follow-up at later testing time-points. This is important as the modelling studies suggested that the clinical and financial benefits of adding birth testing to existing algorithms would be lost if follow-up was poor. In the cohort of 2012 HIV-exposed infants in the study presented in the manuscript, the proportion who received birth testing increased with the progression of the EID policies but guideline implementation was poor, especially in primary care, with only 60% of infants being tested as recommended. The proportion of infants with positive HIV-PCR decreased as the pool of HIV-exposed infants undergoing testing expanded, being highest during the periods of targeted birth testing. In concurrence with the South African literature, receipt of a birth HIV-PCR decreased the likelihood of follow-up testing at 6-10 weeks. Among infants tested at 6-10 weeks old, the proportion who were positive for the first time at this time- point increased with the introduction of routine birth testing for all HIV-exposed infants, emphasizing the importance of the follow-up EID time-points. Conclusion: Virological testing at birth effectively increased the number of HIV-exposed infants who received an HIV test and was effective in identifying in utero infection in high risk infants (who could start treatment early with the attendant benefits.) The Western Cape EID policies were incompletely implemented in the study facilities over this time with many infants not being tested as indicated. Birth HIV-PCR decreased follow-up testing, an unintended consequence of serious concern. Adherence to the provincial and national guidelines needs to be re-enforced at delivery sites and at the primary care facilities where follow-up EID occurs.
- ItemOpen AccessA longitudinal analysis of the completeness of maternal HIV testing, including repeat testing, during pregnancy, and the predictors thereof, in Mitchell’s Plain, Cape Town(2019) De Beer, Shani; Davies, Mary-Ann; Kalk, EmmaHIV testing during pregnancy is the gateway to the HIV-related services that are part of the prevention of mother-to-child transmission (PMTCT) cascade. The virtual elimination of vertical HIV transmission cannot be achieved without universal antenatal care (ANC) HIV testing. Furthermore, women are at an increased risk of HIV infection and subsequent mother-to-child transmission (MTCT) during pregnancy. Emphasis has thus been placed on repeat testing during pregnancy among women who have a HIV-negative result at their first ANC test. Very little has been published on the current uptake and adherence to antenatal and repeat HIV testing in sub-Saharan Africa (SSA) countries. In line with the World Health Organization Guidelines, the Western Cape Prevention of Mother-to-Child Transmission of HIV (PMTCT) Clinical Guidelines in 2014 recommended a repeat HIV test between 32 - 34 weeks gestation and again at delivery in addition to testing at “booking” (< 20 weeks gestation), meaning that there were three “testing windows” during which pregnant women not previously diagnosed as HIV-infected should undergo testing. Between 2013 and 2016 the Closing the Gaps study established an electronic PMTCT register (e-register) that consolidated routine care data from a primary healthcare facility and its secondary and tertiary referral sites in Cape Town, South Africa. This provided a single longitudinal record, from antenatal care to delivery, for each pregnant woman which enabled the longitudinal assessment of maternal HIV testing uptake and treatment. Utilizing these data, we conducted a retrospective sub-analysis investigating the implementation of PMTCT HIV testing guidelines (until delivery), in Cape Town, for the period 1 July 2014 - 31 December 2016. The main objectives of the study were to assess the coverage and timing of initial HIV testing during pregnancy, the completion of HIV testing at “booking” and within the recommended testing windows (including delivery), HIV prevalence and incidence at the recommended testing windows, and the predictors of missed testing opportunities. The research protocol (Part A) was designed to describe the proposed significance, objectives and methodology of the study. The literature review (Part B) critically evaluated available literature on: antenatal and repeat HIV testing proportions, HIV positivity, the feasibility and acceptability of repeat iv testing, and the predictors of testing completeness within different SSA countries, for the period 2010 - June 2018. Its aim was to inform this study. The need for post-Option B+ implementation, longitudinal studies that analyze antenatal and repeat HIV testing coverage and implementation within SSA was identified. In Part C I present the methods, results and interpretation thereof for the analysis of individual-level, longitudinal, maternal HIV-testing patient data from the Closing the Gaps study e-register as a manuscript to be submitted for publication. Among 8558 women who delivered at either the primary care facility or its referral sites, 7213 were not diagnosed HIV-positive prior to their first visit and thus eligible for testing in pregnancy. Among these women, 91% received ≥1 HIV test and 85% “booked” >5 days before delivery with 98% testing completeness at “booking”. Only 49% of women eligible for testing “booked” ≤22 weeks gestation. Among women that “booked” ≤22 weeks gestation who weren’t diagnosed HIV-positive before delivery and delivered >5 days after the start of the third trimester, 10% received tests in all three recommended windows. Thirty-one percent of women that had not been diagnosed HIV-positive before delivery had an uncertain (i.e. last tested ≥3 months before delivery) or unknown (i.e. never tested) HIV status after delivery. Out of the women that had a known HIV status at delivery, 21% were HIV-positive of whom 95% were known HIV-positive before current pregnancy and 4% were diagnosed at “booking”. Overall, HIV incidence in those with ≥2 HIV tests during pregnancy/at delivery was estimated to be 0.2% between “booking” and delivery. Women who enrolled after 2014 were less likely to miss ≥1 of the three recommended tests (aOR: 0.70; CI: 0.55 - 0.90) and not test at delivery (aOR: 0.63; CI: 0.55 - 0.71) compared to those who enrolled in 2014. Conclusion: In our study, HIV testing completion at “booking” was high, but women tended to “book” late during pregnancy resulting in late initial testing and missed opportunities for early HIV diagnosis. Implementation of repeat HIV testing is poor, particularly at delivery. HIV incidence between first negative ANC test and delivery is very low and therefore future studies to assess the most cost-effective number and timing of HIV tests, and feasibility of implementation, should be considered. Overall, maternal HIV testing within the PMTCT programme in Cape Town has matured post 2014 with improved implementation over time.
- ItemOpen AccessAssociation between infant feeding practices and infant growth by maternal HIV and antiretroviral therapy status: A prospective study in Cape Town, South Africa(2024) Rhoda, Janice; Kalk, EmmaBackground Infants who are HIV-Exposed Uninfected (HEU) may experience adverse growth outcomes compared to those who are HIV Unexposed Uninfected (HUU). Breastfeeding (BF) provides infants with the necessary nutrients to grow optimally irrespective of maternal HIV status. The initiation and duration of BF may also be related to infant growth. We compared growth parameters from birth up to 12 months old in infants who were HEU and HUU, investigating associations with types of infant feeding practices (BF and complementary feeding) and Household Food Security Status (HFSS) under the current era of universal Antiretroviral therapy (ART) in pregnancy policies in South Africa. Methods Pregnant women living with and without HIV were enrolled at their first antenatal visit. Feeding data and infant anthropometry were collected at birth, 7 days, 10 weeks, 6 months, and 12 months postpartum. Infant weight and length at birth were converted to weight-for-age (WAZ) and length-forage (LAZ) using Intergrowth-21st software, and the World Health Organization (WHO)-Anthro survey analyzer tool was used to obtain these and weight-for-length z-scores (WLZ) from 10 weeks old. Linear mixed effects (LME) models were fit to compare WAZ, LAZ and WLZ between infants who were HEU and HUU controlling for a priori selected variables. Results Overall, 796 mother-infant pairs were included, 400 (50%) were HUU and 396 (50%) were HEU. A high proportion of all infants had ever breastfed, although this was lower in infants who were HEU compared to HUU (90% vs 93%; p = 0.118). Infants who were HEU vs HUU had a significantly shorter median duration of BF [73 days; IQR 12-222 vs 209 days; IQR 72-365 [p < 0.001]). There were no differences between the two groups regarding the types of complementary feeding. By 12 months, both infants who were HEU vs HUU had high proportions of overweight (17% vs 21%; p 0.22). WAZ and LAZ on average were lower in infants HEU than HUU [β = -0.147; 95% CI: -0.327, 0.033] and [β = - 0.146; 95% CI: -0.339, 0.471] keeping age at visit, maternal age, duration of BF, HFSS, employment and marital status constant. Conclusion Infants who were HEU had lower WAZ and LAZ compared to those who were HUU after adjusting for covariates. At 12 months, high proportions among both groups were overweight; which may be partly related to sub-optimal complementary feeding practices. Public health interventions need to be aimed at strengthening BF practices among the population of infants who are HEU and improving complementary feeding practices for all infants.
- ItemOpen AccessCohort Profile: The Western Cape Pregnancy Exposure Registry (WCPER)(2022-06) Kalk, Emma; Heekes, Alexa; Slogrove, Amy; Phelanyane, Florence; Davies, Mary-Ann; Myer, Landon; Euvrard, Jonathan; Kroon, Max; Petro, Greg; Fieggen, Karen; Stewart, Chantal; Rhoda, Natasha; Gebhardt, Stefan; Osman, Ayesha; Anderson, Kim; Boulle, Andrew; Mehta, UshmaPurpose: The Western Cape Pregnancy Exposure Registry (PER) was established at two public sector healthcare sentinel sites in the Western Cape province, South Africa, to provide ongoing surveillance of drug exposures in pregnancy and associations with pregnancy outcomes. Participants: Established in 2016, all women attending their first antenatal visit at primary care obstetric facilities were enrolled and followed to pregnancy outcome regardless of the site (ie, primary, secondary, tertiary facility). Routine operational obstetric and medical data are digitised from the clinical stationery at the healthcare facilities. Data collection has been integrated into existing services and information platforms and supports routine operations. The PER is situated within the Provincial Health Data Centre, an information exchange that harmonises and consolidates all health-related electronic data in the province. Data are contributed via linkage across a unique identifier. This relationship limits the missing data in the PER, allows validation and avoids misclassification in the population-level data set. Findings to date: Approximately 5000 and 3500 pregnant women enter the data set annually at the urban and rural sites, respectively. As of August 2021, >30 000 pregnancies have been recorded and outcomes have been determined for 93%. Analysis of key obstetric and neonatal health indicators derived from the PER are consistent with the aggregate data in the District Health Information System. Future plans: This represents significant infrastructure, able to address clinical and epidemiological concerns in a low/middle-income setting.
- ItemOpen AccessComparison of three levels of ascertainment of antenatal medication use at Gugulethu Midwife Obstetric Unit(2022) van Der Hoven, Jani; Kalk, Emma; Allen, ElizabethBackground The use of medicines and/or remedies among pregnant women is common. Pregnant women are generally excluded from clinical trials due to ethical reasons. There are therefore minimal data available about the safety of most drugs during pregnancy by the time they come to the market, and post-marketing evaluation of medicine use during pregnancy is required. In South-Africa, with mass treatment campaigns for Tuberculosis (TB) and Human Immunodeficiency Virus (HIV), the introduction of new therapeutic agents and frequent self-medication, it is important for reliable methods to determine medicine exposures, including the frequency and timing of use, to support such evaluations. Databases about medication exposures are promising resources for pharmaco-epidemiological investigations, however the optimal method of ascertainment of medicine use during pregnancy is uncertain. Different data sources could also be better for different types of medication. To improve the quality of data, a combination of data sources may be ideal but time-consuming and expensive. By looking at and comparing three data sources: 1) self-report, 2) clinician records and 3) electronic dispensing systems, we aimed to identify the optimal method of ascertainment of antenatal medicine use for multiple medication types. Methods The aim of this investigation was to provide a more comprehensive reflection of the drug exposures during pregnancy and to make recommendations to strengthen routine clinical data capturing to improve maternity case reporting. The data of 988 pregnant women seeking antenatal care at Gugulethu Midwife Obstetric Unit (GMOU) in Cape Town between 2016 and 2018 were used. The three data sources consisted of self-reports gathered by an interviewer administered questionnaire at up to three antenatal visits to the GMOU; clinical records as recorded in the Pregnancy Exposure Registry (PER); and linked electronic dispensing data obtained from the Provincial Health Data Centre (PHDC) of the Western Cape Department of Health. Medication exposure data were coded using the Anatomical Therapeutic Chemical (ATC) Classification system, an internationally acknowledged system to classify medicine maintained by the WHO. ATC codes were assigned to active ingredients, depending on the therapeutic indication. The three data sources were then assessed in terms of missing or overlapping information and evaluated on the level of agreement between sources using Spearman's rank coefficient and Cohen's Kappa. Results According to the Spearman rank test, the PER and PHDC datasets as a whole showed the highest correlation both at 1st and 5th ATC level. The overlaps between the datasets were poor and the Kappa agreement between the sources was low for most therapeutic classes, except for HIV treatments. An “almost perfect” Kappa agreement existed between anti-diabetic medication (ATC A10) reported in the self-report and PHDC datasets. Traditional, herbal, complementary and home remedies were only reported in the self-report dataset. Conclusion We found an overall poor agreement between data sources, with one alone not able to effectively capture all data. The datasets should thus be used in conjunction to ensure accurate and reliable record of exposure. Self-report was the best data source for traditional, home, herbal and complementary medicine exposures while the PER provided a better and more complete reflection of influenza vaccines and vitamins. The best method of ascertaining antenatal medicine exposure therefore depends on the type of medicine being investigated, and choice of data source depends on the objectives of the investigation. This study suggests that PER, PHDC and self-report should ideally be used together since each is critical to ensure accurate, reliable and effective exposure data, although this will have resource and cost implications.
- ItemOpen AccessPrevention of mother-to-child-transmission of HIV in Khayelitsha: a contemporary review of services 20 years later(2021) Phelanyane, Florence Malehlabathe; Kalk, EmmaBackground: It's been 20 years since the Western Cape (WC) province of South Africa launched its first Prevention of Mother-To-Child-Transmission of HIV(PMTCT) pilot programme in Khayelitsha. The programme evolved alongside the World Health Organization (WHO) guidelines; in 2013 the recommended guidelines in the province was WHO Option B+( life-long antiretroviral therapy (ART) irrespective of CD4 count, and exclusive breastfeeding for the first 6 months of life). Alongside the explanation of the PMTCT programme, the province gradually implemented patient administrative systems in all fixed public health facilities; these systems all shared a unique patient identifier called the folder number. The digitization of folder number lead to the establishment of the Provincial Health Data Centre (PHDC), an African health information exchange (HIE) developed and hosted in the WC Department of Health. The HIE also integrated data from disease management information systems (Three Interlinked Electronic Registers (TIER) and the Electronic Tuberculosis Register (ETR)), allowing the ability to track the cohort of pregnant women living with HIV who attend public health services across the Western Cape. Here we report the latest analysis of vertical HIV transmission in the era of WHO Option B+ with the advantage of a maturing consolidated African HIE. The primary aim of the study was to describe coverage of the PMTCT care cascade, including the implementation of maternal viral load monitoring and early infant diagnosis, among HIV positive women who presented antenatal care, or delivered in the absence of antenatal care, at a public health facility in Khayelitsha subdistrict in 2017; and to quantify MTCT risk factors and outcomes among this cohort up to 12 months post-partum. Methods: Patient-level consolidated PHDC data were used to draw an observational cohort consisting of all live-born and linked mother-infant pairs in which the mother was HIV positive, at any point prior to her first antenatal visit up to 12 months post-partum and attended antenatal care, or in the absence of antenatal care delivered in Khayelitsha in 2017. The PHDC provided a single summative record per pregnancy for each woman (linked to her infant after birth) which enabled the assessment of PMTCT uptake from her first antenatal visit through delivery to infant early infant diagnosis (EID) of HIV-PCR testing and PHDC ascertainment of HIV up to the end of the index period (i.e. 12 months post-partum). iii Using this cohort of HIV-exposed infants, a protocol was designed (Section A: Protocol) to assess the outcomes of the implementation of WHO Option B+(lifelong ART for all HIV positive pregnant women; and periodic re-testing of HIV negative women) under the latest EID guidelines of routine birth HIV-PCR (within 1 week of birth), and repeat testing at 10 weeks (between 2 and 14 weeks of birth) or a first HIV-test at 10 weeks if the infant had not been tested at birth. Continuous variables were converted to categorical variables according to pre-set thresholds, all categorical variables were described using proportions, and frequency tables were used for comparison. Timing of ART initiation was categorized as a binary variable which was assigned 1 if the mother started ART before the first antenatal visits, and 0 of she started ART at the first antenatal visit or anytime during the pregnancy. Viral load was categorised according to coverage and suppression status; virologic suppression was defined as having a viral load of 1000 copies/ml or less after 3 months on ART. Analysis was performed in using R studio; descriptive statistics were used to assess coverage along the PMTCT care cascade, and logistic regression was run to quantify a priori defined risk factors associated with MTCT. Results: The study cohort of 2 576 mother-infant pairs (2548 women living with HIV (WLHIV)) presented in the manuscript was a young cohort with a median age of 30 years (interquartile range of 26 – 34), in which most women delivered vaginally (70.5%), and 78.3% attended at least one antenatal visit before delivery. Most WLHIV (88.3%) presented to their first pregnancy related visit (antenatal care or delivery) already knowing their status, of whom 77.9% were already on ART. 94.5% of women diagnosed prior to birth were initiated on ART prior; 85.0% of these women received a viral load test antenatally, of whom 88.0% were virologically suppressed. Early infant diagnosis coverage was sub-optimal with birth HIV-PCR (within 7 days of birth) coverage of 79.21% among HIV exposed infants (HEI); an even lower proportion (57.9%) of HEI who tested negative at birth had a repeat test around 10-weeks. HIV-PCR ascertained MTCT was 0.8% at 10 weeks, consolidated data from the PHDC suggested an MTCT of 1.8% by the end of the index period (the PHDC HIV episode identified an additional 16 HIVexposed (HEI) infants with HIV who were not detected by laboratory tests). PWLHIV who started ART prior to the first antenatal visit had 50% reduced risk of MTCT compared to those who started ART during the pregnancy. Women who were not suppressed antenatally had a 5- fold (aOR = 5.3, 95% CI: 2.5 – 12.3) increased MTCT risk compared to those were suppressed antenatally. Women who did not attend ANC were at highest risk of transmission (aOR=1.6,95%CI: 0.7 – 3.6). iv Conclusion: Although women most women present to care already knowing their HIV status, ART initiation and uptake of viral load testing is very low at presentation but improved significantly during pregnancy, evidence of maturing PMCT services. National and Provincial MTCT is likely to be underestimated as it relies solely on PCR results; the uptake of the birth PCR among HIV-exposed infants is still not 100% (where it should be) and the uptake of a repeat tests among infants that tested negative is even lower. PHDC data, which consolidates HIV data from multiple sources, revealed a higher MTCT than HIV-PCR testing alone.
- ItemOpen AccessProvider-initiated HIV testing and counselling for children(Public Library of Science, 2014) Davies, Mary-Ann; Kalk, EmmaMary-Ann Davies and Emma Kalk reflect on recent research by Rashida Ferrand and colleagues into barriers to provider-initiated HIV testing for older children in Zimbabwe. Please see later in the article for the Editors' Summary