Search

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. [ABSTRACT FROM AUTHOR]

Objective: This study investigated whether young women's participation in a combination HIV-prevention intervention was associated with accessing and using condoms and other contraceptives.Study Design: A cross-sectional household survey was conducted from 2017 to 2018 among a representative sample of young women aged 15-24 years old living in six South African districts in which the intervention was implemented. Cross-tabulations and multivariate regression analyses of weighted data were performed to examine access to and use of condoms and other contraceptives.Results: In total 4399 young women participated, representing a 60.6% response rate. Of participants, 61.0% (n = 2685) reported accessing condoms and other contraceptives in the past year. Among those who ever had sex (n = 3009), 51.0% used condoms and 37.4% other contraceptives at last sex. Among 15-19 year old, participation in the combination intervention was positively associated with reporting contraceptive use other than condoms at last sex (Prevalence Ratio (PR): 1.36; 95% CI: 1.21-1.53) and reporting use of both condoms and other contraceptives at last sex (PR: 1.45; 95% CI: 1.26-1.68). No associations were observed in the age group 20-24.Conclusion: Our findings suggest that combination HIV prevention interventions may lead to increased access and use of condoms and other methods of contraception among adolescent women, but this needs to be confirmed in experimental studies. We need to test different or more intensive interventions to increase contraceptive use in young women aged 20-24.Implications: Participating in combination HIV prevention interventions that are delivered via multiple approaches may promote access to, and use of condoms and other methods of contraceptives among adolescent women, and thereby help reduce unintended pregnancies. [ABSTRACT FROM AUTHOR]

Background: Community health workers (CHWs) are increasingly providing task-shared psychological interventions for depression and alcohol use in primary health care in low-income and middle-income countries. We aimed to compare the effectiveness of CHWs dedicated to deliver care with CHWs designated to deliver care over and above their existing responsibilities and with treatment as usual for patients with a chronic physical disease.Methods: We did a three-arm, cluster randomised, multicentre, open-label trial done in 24 primary health-care clinics (clusters) within the Western Cape province of South Africa. Clinics were randomly assigned (1:1:1) to implement dedicated care, designated care, or treatment as usual, stratified by urban-rural status. Patients with HIV or type 1 or type 2 diabetes were eligible if they were 18 years old or older, taking antiretroviral therapy for HIV or medication to manage their diabetes, had an Alcohol Use Disorders Identification Test (AUDIT) score of eight or more or a Center for Epidemiologic Studies Depression Scale score of 16 or more, and were not receiving mental health treatment. In the intervention arms, all participants were offered three sessions of an evidence-based psychological intervention, based on motivational interviewing and problem-solving therapy, delivered by CHWs. Our primary outcomes were depression symptom severity and alcohol use severity, which we assessed separately for the intention-to-treat populations of people with HIV and people with diabetes cohorts and in a pooled cohort, at 12 months after enrolment. The Benjamini-Hochberg procedure was used to adjust for multiple testing. The trial was prospectively registered with the Pan African Clinical Trials Registry, PACTR201610001825403.Findings: Between May 1, 2017, and March 31, 2019, 1340 participants were recruited: 457 (34·1%) assigned to the dedicated group, 438 (32·7%) assigned to the designated group, and 445 (33·2%) assigned to the treatment as usual group. 1174 (87·6%) participants completed the 12 month assessment. Compared with treatment as usual, the dedicated group (people with HIV adjusted mean difference -5·02 [95% CI -7·51 to -2·54], p<0·0001; people with diabetes -4·20 [-6·68 to -1·72], p<0·0001) and designated group (people with HIV -6·38 [-8·89 to -3·88], p<0·0001; people with diabetes -4·80 [-7·21 to -2·39], p<0·0001) showed greater improvement on depression scores at 12 months. By contrast, reductions in AUDIT scores were similar across study groups, with no intervention effects noted.Interpretation: The dedicated and designated approaches to delivering CHW-led psychological interventions were equally effective for reducing depression, but enhancements are required to support alcohol reduction. This trial extends evidence for CHW-delivered psychological interventions, offering insights into how different delivery approaches affect patient outcomes.Funding: British Medical Research Council, Wellcome Trust, UK Department for International Development, the Economic and Social Research Council, and the Global Challenges Research Fund. [ABSTRACT FROM AUTHOR]

Aim: In view of the current context of poverty and socio-economic inequalities and the high and rising burdens of HIV infection and non-communicable diseases in South Africa, this study aims to describe the distribution of adverse life events (ALEs) by age and gender, and examine the socio-demographic characteristics, psychosocial coping mechanisms, risky lifestyle behaviours and family burden of HIV-related ill-health associated with ALEs in 25-74-year-old black residents of Cape Town. Materials and methods: In a random cross-sectional sample, 12 ALEs, tobacco and alcohol use, sense of coherence (SOC), locus of control (LOC) and impact of HIV in the family were determined by administered questionnaires. Data analyses included descriptive statistics adjusted for the realised sample. Multivariable linear regression models assessed the independent associations of increasing number of ALEs. Results: Among 1099 participants, mean lifetime score of ALE categories examined was 6.1 ±2.1 (range 0–12) with men reporting significantly higher number of events compared with women (p<0.001). The most frequent ALE was the death of a loved one (88.5%) followed by a major financial crisis (81.2%) with no trend across gender or age group. In the multivariable linear regression model, increasing ALEs were significantly associated with male gender, unemployment, having spent >50% of life in urban areas, >7 years of education, problematic alcohol use and poorer psychosocial coping mechanisms defined by low SOC and LOC. All four variables pertaining to HIV-related burden of ill-health in the family were significantly associated with increasing ALEs. Conclusions: Considering that lower SOC and LOC and problem drinking were significantly linked to ALEs, policymakers need to formulate strategies that improve coping mechanisms and promote problem-solving behaviours, target the high burden of alcohol misuse and address unemployment. [ABSTRACT FROM AUTHOR]

Background: Studies determining the reliability of the World Heart Federation (WHF) anterior mitral valve leaflet (AMVL) measurement are limited by the introduction of bias in their test‐retest analyses. This study sought to determine the reliability of the current AMVL measurement while controlling for systematic bias. Methods: Retrospective analysis of echocardiographic data from 16 patients with previous acute rheumatic fever was performed. Included in this study was an optimized cine loop of the mitral valve (MV) [reader‐optimized measurement (ROM]) in the parasternal long‐axis view and an optimized still image of the MV obtained from the same cine loop [specialist‐optimized image (SOI)]. Each still image and associated cine loop was quadruplicated and randomized to determine intra‐ and inter‐rater agreement and quantify the impact of zoom on AMVL measurement. Results: Specialist‐optimized image without zoom reflected the highest degree of agreement in both cohorts with an ICC of 0.29 and 0.46. The agreement in ROM images without zoom was ICC of 0.23 and 0.45. The addition of zoom to SOI decreased agreement further to an ICC of 0.20 and 0.36. The setting associated with the poorest agreement profile was ROI with zoom with an ICC of 0.13 and 0.34, respectively. The intra‐rater agreement between readers in both cohorts was moderate across all settings with an ICC ranging between 0.64 and 0.86. Conclusions: The WHF AMVL measurement is only moderately repeatable within readers and demonstrates poor reproducibility that was not improved by the addition of a zoom‐optimized protocol. Given our study findings, we cannot advocate the current WHF AMVL measurement as a reliable assessment for RHD. [ABSTRACT FROM AUTHOR]

Background: The use of waist-to-height ratio has been suggested as a better proxy indicator of central obesity.Objective: To compare the utility of waist-to-height ratio with commonly used adiposity indices of body mass index, waist circumference and waist-to-hip ratio to identify cardio-metabolic diseases in 25-74-year-old black residents of Cape Town.Methods: This cross-sectional study, stratified for age and gender, determined cardio-metabolic abnormalities by administered questionnaires, clinical measurements and biochemical analyses, including oral glucose tolerance tests. Correlations between adiposity indices with cardio-metabolic components were examined. Age- and gender-adjusted logistic regression analyses determined the associations of obesity by these adiposity indices with cardio-metabolic abnormalities.Results: The study comprised 392 men and 707 women. Compared with other adiposity indices, waist-to-height ratio in men correlated most closely with fasting (0.360) and 2-hour (0.388) glucose levels, total cholesterol (0.267), low-density lipoprotein cholesterol (0.351) and triglycerides (0.400). In women, waist-to-height ratio correlated the best with systolic blood pressure (0.254) and diastolic blood pressure (0.287). Of the adiposity indices, waist circumference was most strongly associated with diabetes (odds ratio 4.27, 95% confidence interval: 2.39-7.62), low high-density lipoprotein cholesterol (2.84, 1.90-4.26) and hypertriglyceridaemia (3.60, 2.03-6.40), whereas raised waist-to-height ratio was most closely related to hypertension (1.61, 1.07-2.42), hypercholesterolaemia (1.72, 1.04-2.83) and raised low-density lipoprotein cholesterol (2.46, 1.70-3.55).Conclusions: Compared with other adiposity indices, the better correlation of waist-to-height ratio with many cardio-metabolic components, particularly in men, and the stronger association of raised waist-to-height ratio with hypertension, hypercholesterolaemia and raised low-density lipoprotein cholesterol support the utility of waist-to-height ratio in routine assessments of adiposity in this population, which may improve the identification of cardio-metabolic risk. [ABSTRACT FROM AUTHOR]

Objectives To determine the level and evaluate factors affecting the participation of laboratory professionals in continuous professional development (CPD) programs in eastern and southern Africa. Methods A survey was conducted among laboratory professionals from 14 countries. The CPD participation was defined as low if it was fewer than 2 CPD trainings in the past 2 years. Associations between categorical variables were tested for significance using Fisher exact test. Results Of the expected 400, 283 (70% response rate) individuals participated in the survey. Of these, 153 (54%) had low CPD participation and 199 (70%) were aware of CPD educational activities in their respective country. Those with diploma certificates attended more CPD programs (P <.001) than those with undergraduate and master's degrees. Awareness of CPD programs was associated with a higher level of CPD participation (P =.0001). Job satisfaction was significantly associated with high levels of CPD participation (P =.02). Other factors associated with high level of participation in CPD programs included affordability (P =.03), funding by employer (P =.0005), and awareness of legal CPD requirements (P =.002). Conclusions The CPD programs are considered useful to an individual's professional development, although there was low participation. It is recommended that different formats and platforms be used to expand CPD programs. [ABSTRACT FROM AUTHOR]

Background: Young women in southern Africa have substantial risk of HIV acquisition. Female-controlled biomedical interventions are needed to mitigate this risk. We aimed to assess the safety and efficacy of a pericoitally applied tenofovir 1% gel.Methods: We did a phase 3, double-blind, randomised, placebo-controlled trial at nine community-based clinical trial sites in South Africa to evaluate the safety and efficacy of tenofovir 1% gel. Sexually active women who were HIV negative and aged 18-30 years were enrolled. Participants were randomly assigned (1:1) using sequential participant numbers to either tenofovir 1% gel or a placebo gel (one dose within 12 h before sex and one dose within 12 h after sex [BAT-24 regimen]), using dynamic permuted block sizes of 8 and 16 within each site. Women received monthly HIV-1 testing, risk reduction support, physical examinations, and product dispensing for up to 27 months. The primary efficacy outcome was incident HIV infection and the primary safety outcome was occurrence of grade 2-4 adverse events, both analysed in the modified intention-to-treat population. To assess the efficacy of tenofovir gel, the cumulative probability of HIV infection was calculated for each treatment using the Kaplan-Meier method. This trial is registered with ClinicalTrials.gov, number NCT01386294.Findings: From Oct 11, 2011, to Aug 29, 2014, 3844 women were screened, 2059 enrolled, and 2029 included in the primary analysis (1032 in the tenofovir group and 1027 in the placebo group); 39 (4%) in the tenofovir group and 36 (4%) in the placebo group were lost to follow-up. 123 HIV-1 infections occurred over 3036 woman-years of observation; 61 in the tenofovir group (HIV incidence 4·0 per 100 woman-years, 95% CI 3·1-5·2) and 62 in the placebo group (4·0 per 100 woman-years, 3·1-5·2; incidence rate ratio [IRR] 0·98, 95% CI 0·7-1·4). A higher incidence of grade 2 adverse events was observed in the tenofovir group than in the placebo group (IRR 1·09, 95% CI 1·0-1·2; p=0·02). The most common grade 2 or higher product-related adverse events were hypophosphataemia (n=22 for tenofovir vs n=22 for placebo), genital symptoms (n=6 for tenofovir vs n=2 for placebo), or elevated transaminases (n=2 for tenofovir vs n=2 for placebo). No product-related serious adverse events were reported, and no differences in product-related adverse events (p=0·78), grade 3 events (p=0·64), or grade 4 events (p=0·74) were observed between treatment groups.Interpretation: Overall, pericoital tenofovir gel did not prevent HIV-1 acquisition in this population of young women at risk of HIV infection in South Africa. Alternate safe and effective products that are less user dependent than this product or do not require high adherence are needed.Funding: The US Agency for International Development (USAID), the Bill & Melinda Gates Foundation, and the South African Department of Science and Technology and Department of Health. [ABSTRACT FROM AUTHOR]

Fish is a good source of Animal Source Proteins (ASP). Families from low-income countries with limited access to other animal source proteins can utilize it to improve the nutrition status of infants and young children. The objective of the study was to assess if fish fed during the early complementary feeding period had an effect on improved head circumference (HC) and mid-upper arm circumference (MUAC) among infants aged 6–7 months. A randomised controlled trial was conducted from April 2019 to January 2020 in the Samfya district, Luapula Province, Zambia. The infants (238) were randomised to either the fish group (intervention) or the sorghum group (control). Every week for a period of 6 months, infants received seven sachets of fish powder and sorghum powder, respectively. Compliance was also monitored during the fish powder distribution. The head circumference measurements were conducted at baseline and once each follow-up month for a period of six months while the MUAC measurements were conducted twice (at baseline and endline). Using statistical software for data science (STATA) (version 16), a linear mixed effect model was used to analyse the data. The results showed that fish improved head circumference for age z score (HCZ) by 0.53 (95% CI: 0.23–0.82), p-value < 0.001, and MUAC by 0.36 (95% CI: 0.13–0.59) p-value < 0.002. Therefore, fish can be used as the main source of protein in complementary foods for infants and young children in low-income communities with limited access to meat. [ABSTRACT FROM AUTHOR]

Background: South Africa has the highest prevalence of overweight/obesity in Sub-Saharan Africa. Assessing the effect of modifiable factors such as early infant feeding on growth velocity and overweight/obesity is therefore important. This paper aimed to assess the effect of infant feeding in the transitional period (12 weeks) on 12-24 week growth velocity amongst HIV unexposed children using WHO growth velocity standards and on the age and sex adjusted body mass index (BMI) Z-score distribution at 2 years. Methods: Data were from 3 sites in South Africa participating in the PROMISE-EBF trial. We calculated growth velocity Z-scores using the WHO growth standards and assessed feeding practices using 24-hour and 7-day recall data. We used quantile regression to study the associations between 12 week infant feeding and 12-24 week weight velocity (WVZ) with BMI-for-age Z-score at 2 years. We included the internal sample quantiles (70th and 90th centiles) that approximated the reference cut-offs of+2 (corresponding to overweight) and +3 (corresponding to obesity) of the 2 year BMI-for-age Z-scores. Results: At the 2-year visit, 641 children were analysed (median age 22 months, IQR: 17-26 months). Thirty percent were overweight while 8.7% were obese. Children not breastfed at 12 weeks had higher 12-24 week mean WVZ and were more overweight and obese at 2 years. In the quantile regression, children not breastfed at 12 weeks had a 0.37 (95% 0 0.07, 0.66) increment in BMI-for-age Z-score at the 50th sample quantile compared to breast-fed children. This difference in BMI-for-age Z-score increased to 0.46 (95% CI 0.18, 0.74) at the 70th quantile and 0.68 (95% O 0.41, 0.94) at the 90th quantile . The 12-24 week WVZ had a uniform independent effect across the same quantiles. Conclusions: This study demonstrates that the first 6 months of life is a critical period in the development of childhood overweight and obesity. Interventions targeted at modifiable factors such as early infant feeding practices may reduce the risks of rapid weight gain and subsequent childhood overweight/obesity. [ABSTRACT FROM AUTHOR]

Objectives: To ascertain the prevalence and determinants of overweight/obesity in the 25–74-year-old urban black population of Cape Town and examine the changes between 1990 and 2008/09. Methods: In 2008/09, a representative cross-sectional sample, stratified for age and sex, was randomly selected from the same townships sampled in 1990. Data were collected by questionnaires, clinical measurements and biochemical analyses. Gender-specific linear regression models evaluated the associations with overweight/obesity. Results: There were 1099 participants, 392 men and 707 women (response rate 86%) in 2008/09. Mean body mass index (BMI) and waist circumference (WC) were 23.7 kg/m2 (95% confidence interval (CI): 23.1–24.2) and 84.2 cm (95% CI: 82.8–85.6) in men, and 33.0 kg/m2 (95% CI: 32.3–33.7) and 96.8 cm (95% CI: 95.5–98.1) in women. Prevalence of BMI ≥25 kg/m2 and raised WC were 28.9% (95% CI: 24.1–34.3) and 20.1% (95% CI: 15.9–24.9) in men, and 82.8% (95% CI: 79.3–85.9) and 86.0% (95% CI: 82.9–88.6) in women. Among 25–64-year-olds, BMI ≥25 kg/m2 decreased between 1990 (37.3%, 95% CI: 31.7–43.1) and 2008/09 (27.7%, 95% CI: 22.7–33.4) in men but increased from 72.7% (95% CI: 67.6–77.2) to 82.6% (95% CI: 78.8–85.8) in women. In the regression models for men and women, higher BMI was directly associated with increasing age, wealth, hypertension and diabetes but inversely related to daily smoking. Also significantly associated with rising BMI were raised low-density lipoprotein cholesterol and being employed compared to unemployed in men, and having >7 years of education in women. Conclusions: Overweight/obesity, particularly in urban black women, requires urgent action because of the associations with cardiovascular disease risk factors and their serious consequences. [ABSTRACT FROM AUTHOR]

Introduction: To examine the prevalence and determinants of tobacco use in the 25–74-year-old urban Black population of Cape Town and to examine the changes between 1990 and 2008/09 in the 25–64-year-old sample. Methods: In 2008/09 (n = 1,099), a representative cross-sectional sample was randomly selected from the same townships sampled in 1990 (n = 986). Sociodemographic characteristics, tobacco use by the World Health Organization (WHO) STEP-wise questionnaire, and psychosocial stress, including sense of coherence (SOC), locus of control, and adverse life events, were determined. Survey logistic regression analysis assessed the determinants of smoking ≥1 cigarette/day. Results: There were 392 men and 707 women. Age-standardized prevalence of smoking ≥1 cigarette/day was 48.5% (95% confidence interval [CI] = 43.0–54.0) in men and 7.8% (95% CI = 5.8–10.5) in women (p < .001). Prevalence in men was lower in 2008/09 (51.0%, 95% CI = 45.2–56.7) compared with 1990 (59.7%, 95% CI = 53.8–65.4) but unchanged in women (2008/09: 8.0%, 95% CI = 5.9–10.7; 1990: 8.4%, 95% CI = 6.0–11.8). In the logistic model for men, smoking was associated with younger age (p = .005) and being poor (p = .024). In women, spending more than half their lives in the city (p < .001), being poor (p = .002), and coping poorly with stress (defined by lower SOC; OR: 1.04, 95% CI = 1.01–1.08; p = .035) were associated with smoking. Increasing number of adverse events, which replaced SOC in the same models, was significant for women (OR: 1.10, 95% CI = 1.01–1.21; p = .047) but not for men. Education level, employment status, and housing quality were not relevant for men or women. Conclusions: The high smoking prevalence in men and unchanged rate in women require additional interventions to curtail this behavior. [ABSTRACT FROM PUBLISHER]

Introduction: Adolescent girls and young women (AGYW) aged 15–24 years and adolescent boys and young men (ABYM) aged 15–34 years represent one of the populations at highest risk for HIV-infection in South Africa. The National Department of Health adopted the universal test and treat (UTT) strategy in 2016, resulting in increases in same-day antiretroviral therapy initiations and linkage to care. Monitoring progress towards attainment of South Africa's 95-95-95 targets amongst AGYW and ABYM relies on high quality data to identify and address gaps in linkage to care. The aim of this study is to describe the current approaches for engaging AGYW and ABYM in the treatment continuum to generate knowledge that can guide efforts to improve linkage to, and retention in, HIV care among these populations in KwaZulu-Natal, South Africa. Methods and analysis: This is a mixed methods study, which will be conducted in uMgungundlovu district of KwaZulu-Natal, over a 24-month period, in 22 purposively selected HIV testing and treatment service delivery points (SDPs). For the quantitative component, a sample of 1100 AGYW aged 15–24 years and ABYM aged 15–35 years old will be recruited into the study, in addition to 231 healthcare providers (HCPs) involved in the implementation of the UTT program. The qualitative component will include 30 participating patients who were successfully linked to care, 30 who were not, and 30 who have never tested for HIV. Key informant interviews will also be conducted with 24 HCPs. Logistic regression will be used to model the primary outcomes on SDP types, while a time to event analysis will be conducted using a Cox regression model and adjusting the standard errors of the hazard ratio for the clustering of participants within SDPs. For qualitative data, a general inductive approach of analysis will be used. Dissemination: Findings from the study will be communicated to the study population and results will be presented to stakeholders and at appropriate local and international conferences. Outputs will also include a policy brief, peer reviewed journal articles and research capacity building through research degrees. [ABSTRACT FROM AUTHOR]

Background To determine the prevalence and determinants of problematic alcohol use (CAGE ≥2) in 25-74-year-old black population in Cape Town in 2008/2009 and examine the changes in self-reported alcohol consumption between 1990 and 2008/2009 in 25-64-year-olds. Methods In 2008/2009, a representative cross-sectional sample, stratified for age and sex, was randomly selected from the same townships sampled in 1990. Socio-demographic characteristics, the ability to cope with psychosocial stress (sense of coherence) and adverse life events were determined. Ordinal logistic regression analysis assessed the determinants of problem drinking. Results There were 1099 participants, 392 men and 707 women, in 2008/2009. Prevalence of alcohol consumption in 2008/2009 (men: 68.5%, 95% CI 62.7 to 73.7; women: 27.4%, 95% CI 23.7 to 31.5) was higher than in 1990 (men: 56.7%, women: 15.1%). Prevalence of problem drinking was significantly higher in men (49.7%, 95% CI 44.6 to 54.9) than in women (18.1% 95% CI 15.3 to 21.2) ( p<0.001). In men, greater alcohol use was associated with >7 years of education ( p=0.012), being unemployed compared with employed (p=0.008) and coping poorly with stress (OR 1.02, 95% CI 1.01 to 1.05, p=0.042), and in women with spending more than half their life in the city (p<0.001) and coping poorly with stress (OR 1.02, 95% CI 1.01 to 1.04, p=0.039). The odds for greater alcohol use with increasing number of adverse life events, after adjusting for the other factors, was significant in men (OR 1.11, 95% CI 1.02 to 1.19, p=0.010) and women (OR 1.09, 95% CI 1.03 to 1.16, p=0.005). Conclusions Problem drinking is a major problem in this population and requires urgent interventions to curtail the misuse. [ABSTRACT FROM AUTHOR]

Data from a prospective multisite cohort study were used to examine the effect of HIV exposure, untreated HIV infection, and single-dose nevirapine on infant growth velocity. The 2009 WHO growth velocity standards constitute a new tool for this type of investigation and are in need of functional validation. In period 1 (3-24 wk), 65 HIV-infected, 502 HIV-exposed uninfected (HEU), and 216 HIV-unexposed infants were included. In period 2 (25-36 wk), 31 infants moved from the HEU group to the HIV-infected group. We compared weight velocity Z-scores (WVZ) and length velocity Z-scores (LVZ) by HIV group and assessed their independent influences. In period 1, mean WVZ (95% CI) was significantly (P < 0.001) lower in infected [-0.87 (-1.77, 0.04)] than HEU [0.81 (0.67, 0.94)] and unexposed [0.55 (0.33, 0.78)] infants. LVZ showed similar associations. In both periods, sick infants and those exposed to higher maternal viral loads had lower WVZ. Higher mean LVZ was associated with low birth weight. Infants that had received nevirapine had higher LVZ. In conclusion, HIV infection and not exposure was associated with low WVZ and LVZ in period 1. Eliminating infant HIV infection is a critical component in averting HIV-related poor growth patterns in infants in the first 6 mo of life. [ABSTRACT FROM AUTHOR]

Integration of HIV care into primary care is a potential strategy to improve access to antiretroviral therapy (ART) in high-burden countries. This study was conducted to determine the effect of integration of HIV care on the survival of patients needing ART.A questionnaire was used to measure the integration of HIV care into primary care during a randomized controlled trial of task shifting and decentralization of HIV care in South Africa. Cox proportional hazard ratios (HRs) were estimated for the effect of 5 different integration scores (total, pre-ART, ART, mainstreaming HIV, and internal integration) on the survival of patients with CD4 count 350 cells per microliter and not yet on ART.A total of 9252 patients were followed up for 12-18 months. Cox proportional HRs adjusted for patient and clinic characteristics showed decreased risk of mortality in clinics with high scores for total integration [HR, 0.97; 95% confidence interval (CI), 0.95 to 0.98; P < 0.001], ART integration (HR, 0.94; 95% CI, 0.90 to 0.99; P = 0.013), and internal integration (HR, 0.97; 95% CI, 0.95 to 1.00; P = 0.041). Analysis of the effect of component scores adjusted for patient characteristics only showed decreased risk of mortality in clinics with high scores for total integration (HR, 0.97; 95% CI, 0.94 to 1.00; P = 0.032), pre-ART integration (HR, 0.92; 95% CI, 0.85 to 0.99; P = 0.027), ART integration (HR, 0.95; 95% CI, 0.93 to 0.98; P = 0.001), and mainstreaming HIV (HR, 0.90; 95% CI, 0.83 to 0.97; P = 0.007).In a context of task shifting and decentralization of care, integration of HIV care into primary care is associated with improved survival of HIV-positive patients needing ART. [ABSTRACT FROM AUTHOR]

Background and objectives: Many clinical management guidelines for chronic diseases have been published, but they have not been put into practice by busy clinicians at primary care levels. This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record (SR) in Cape Town in a randomised controlled trial (RCT). Methods: Eighteen public sector community health centres (CHC) were randomly selected and allocated as intervention or control CHC. At each clinic, 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline. Questionnaires were completed, blood samples were collected, blood pressure (BP) and anthropometric measures were taken and patient records were audited. SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records. Contact was maintained during the year of intervention with the clinic staff. A follow-up survey was conducted 1 year later to assess BP and HbA1c, and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics. In-depth interviews were conducted with doctors and nurses to record their response to the intervention. Results: The intervention evaluated in this RCT had no impact on either diabetes or hypertension control. In the intervention clinics, less than 60% of the patient folders contained the SR and when present was seldom used. Although the staff were well disposed to the research team, their workload prohibited them from undertaking a true evaluation of the SR, and overall they did not perceive the SR as supporting their current process of patient care. Conclusions: No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT. The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics. [ABSTRACT FROM AUTHOR]

Background: Human immunodeficiency virus (HIV) infected persons on antiretroviral therapy (ART) have been shown to have functionally and structurally altered ventricles and may be related to cardiovascular inflammation. Mounting evidence suggests that the myocardium of HIV infected individuals may be abnormal before ART is initiated and may represent subclinical HIV-associated cardiomyopathy (HIVAC). The influence of ART on subclinical HIVAC is not known. Methods: Newly diagnosed, ART naïve persons with HIV infection were enrolled along with HIV uninfected, age- and sex-matched controls. All participants underwent comprehensive cardiovascular assessment, including contrasted cardiovascular magnetic resonance (CMR) with multiparametric mapping on a 1.5T CMR system. The HIV group was started on ART (tenofovir/lamivudine/dolutegravir) and prospectively evaluated 9 months later. Cardiac tissue characterisation was compared in, and between groups using the appropriate statistical tests for the cross sectional data and the paired, prospective data respectively. Results: Seventy-three ART naïve HIV infected individuals (32 ± 7 years, 45% female) and 22 healthy non-HIV subjects (33 ± 7 years, 50% female) were enrolled. Compared with non-HIV healthy subjects, the global native T1 (1008 ± 31 ms vs 1032 ± 44 ms, p = 0.02), global T2 (46 ± 2 vs 48 ± 3 ms, p = 0.006), and the prevalence of pericardial effusion (18% vs 67%, p < 0.001) were significantly higher in the HIV infected group at diagnosis. Global native T1 (1032 ± 44 to 1014 ± 34 ms, p < 0.001) and extracellular volume (ECV) (26 ± 4% to 25 ± 3%, p = 0.001) decreased significantly after 9 months on ART and were significantly associated with a decrease in the HIV viral load, decreased high sensitivity C-reactive protein, and improvement in the CD4 count (p < 0.001). Replacement fibrosis was significantly higher in the HIV infected group than controls (49% vs 10%, p = 0.02). The prevalence of late gadolinium enhancement did not change significantly over the 9-month study period (49% vs 55%, p = 0.4). Conclusion: Subclinical HIVAC may already be present at the time of HIV diagnosis, as suggested by the combination of subclinical myocardial oedema and fibrosis found to be present before administration of ART. Markers of myocardial oedema on tissue characterization improved on ART in the short term, however, it is unclear if the underlying pathological mechanism is halted, or merely slowed by ART. Mid- to long term prospective studies are needed to evaluate subtle myocardial changes over time and to assess the significance of subclinical myocardial fibrosis. [ABSTRACT FROM AUTHOR]

Background: The relationship between in-utero antiretroviral (ARV) drug exposure and child growth needs further study as current data provide mixed messages. We compared postnatal growth in the first 18-months of life between children who are HIV-exposed uninfected (CHEU) with fetal exposure to ARV drugs (prophylaxis or triple-drug therapy (ART)) and CHEU not exposed to ARVs. We also examined other independent predictors of postnatal growth. Methods: We analysed data from a national prospective cohort study of 2526 CHEU enrolled at 6-weeks and followed up 3-monthly till 18-months postpartum, between October 2012 and September 2014. Infant anthropometry was measured, and weight-for-age (WAZ) and length-for-age (LAZ) Z-scores calculated. Generalized estimation equation models were used to compare Z-scores between groups. Results: Among 2526 CHEU, 617 (24.4%) were exposed to ART since -pregnancy (pre-conception ART), 782 (31.0%) to ART commencing post-conception, 879 (34.8%) to maternal ARV prophylaxis (Azidothymidine (AZT)), and 248 (9.8%) had no ARV exposure. In unadjusted analyses, preterm birth rates were higher among CHEU with no ARV exposure than in other groups. Adjusting for infant age, the mean WAZ profile was lower among CHEU exposed to pre-conception ART [-0.13 (95% confidence interval − 0.26; − 0.01)] than the referent AZT prophylaxis group; no differences in mean WAZ profiles were observed for the post-conception ART (− 0.05 (− 0.16; 0.07)), None (− 0.05 (− 0.26; 0.16)) and newly-infected (− 0.18 (− 0.48; 0.13)) groups. Mean LAZ profiles were similar across all groups. In multivariable analyses, mean WAZ and LAZ profiles for the ARV exposure groups were completely aligned. Several non-ARV factors including child, maternal, and socio-demographic factors independently predicted mean WAZ. These include child male (0.45 (0.35; 0.56)) versus female, higher maternal education grade 7–12 (0.28 (0.14; 0.42) and 12 + (0.36 (0.06; 0.66)) versus ≤ grade7, employment (0.16 (0.04; 0.28) versus unemployment, and household food security (0.17 (0.03; 0.31). Similar predictors were observed for mean LAZ. Conclusion: Findings provide evidence for initiating all pregnant women living with HIV on ART as fetal exposure had no demonstrable adverse effects on postnatal growth. Several non-HIV-related maternal, child and socio-demographic factors were independently associated with growth, highlighting the need for multi-sectoral interventions. Longer-term monitoring of CHEU children is recommended. [ABSTRACT FROM AUTHOR]

To cite this article: Zöllner EW, Lombard C, Galal U, Hough S, Irusen E, Weinberg E. Hypothalamic-pituitary-adrenal axis suppression in asthmatic children on inhaled and nasal corticosteroids: is the early-morning serum adrenocorticotropic hormone (ACTH) a useful screening test? Pediatr Allergy Immunol 2011; 22: 614-620. Abstract Background: Hypothalamic-pituitary-adrenal axis suppression (HPAS) in asthmatic children treated with inhaled corticosteroids (ICS), with or without nasal steroids (NS), may be more common than previously thought. Only dynamic testing will identify children at risk of adrenal crisis. It is impractical to test all asthmatic children for HPAS with a gold standard adrenal function test, i.e. the metyrapone or insulin tolerance test. Objective: To determine which clinical or biochemical parameter is the most useful screening test for HPAS in asthmatic children. Methods: Twenty-six asthmatic children, 5-18 yr old, on ICS ± NS, not treated with oral or topical steroids in the preceding year were recruited. Height, weight, height velocity, weight velocity and a change in systolic blood pressure from the recumbent to the standing position (ΔSBP) were recorded. Early-morning urine for urinary free cortisol (UFC) and urinary cortisol metabolites (UCM) was collected. UFC was analysed by both a chemiluminescent assay and gas chromatography/mass spectrometry (GC-MS). Morning serum cortisol and adrenocorticotropic hormone (ACTH) levels were measured. The overnight metyrapone test was performed if the fasting morning serum cortisol was >83 nmol/l. HPAS was diagnosed if the ACTH failed to rise >100 pg/ml after metyrapone. Spearman correlation coefficients (r) were calculated between the post-metyrapone ACTH and each variable. A receiver-operating characteristics (ROC) curve was drawn for the most promising test, and the diagnostic performance was calculated. Results: All clinical and biochemical parameters investigated were weakly and non-significantly correlated with the post-metyrapone ACTH, except for the morning serum ACTH (r = 0.68; p <0.001). The best discrimination between those who have and those who do not have HPAS is a morning serum ACTH level of 11.7 pg/ml. This corresponds to a sensitivity of 0.89 (0.57-0.98), a specificity of 0.77 (0.53-0.90), a positive predictive value of 0.67 (0.39-0.87), a negative predictive value of 0.93 (0.69-0.99), an accuracy of 0.81 (0.61-0.94), a positive likelihood ratio of 3.78 (1.68-9.49) and a negative likelihood ratio of 0.15 (0.03-0.60). Conclusions: The morning serum ACTH level was found to be the most useful screening test to detect HPAS in this sample of children receiving ICS ± NS. A larger study should be undertaken to refine the diagnostic precision of the morning serum ACTH level. [ABSTRACT FROM AUTHOR]

BACKGROUND: Recent years have seen a growing interest in the impact of infertility on reproductive health in developing countries. Most of the research which has addressed the psychosocial consequences of infertility in African countries has been qualitative in nature and focused on women. It was the aim of this study to assess psychological distress quantitatively in men suffering from couple infertility living in an urban community in South Africa. [ABSTRACT FROM PUBLISHER]

We describe a methodology for analysing self-reported risk behaviour transitional patterns in a binary outcome variable, subject to misclassification and a large loss to follow-up. The motivation stems from the analysis of self-reported transitional patterns in responses to the question 'have you ever smoked a whole cigarette?' in a cohort of South African school children. The partially complete records analysis (PCRA) introduced, estimates the transitional probability as: the ratio of the joint probability of the response at two time points based on the complete records for this time sequence over the marginal probabilities of the response based on the complete records at the first time point, and assumes a non-informative missing pattern. A comparison was made using un-weighted complete records and inverse probability weighted logistic regression. The estimates of the probabilities of reporting ever having smoked a cigarette obtained from the three methods were similar for a particular transition. The PCRA method lacked precision compared with the inverse probability weighted logistic regression. A simulation study indicated an association between bias and reporting error in all three methods. The PCRA method can be considered as a method for the estimation of transition probabilities in a cohort study where there is consistency in the self-reported risk behaviour pattern and the sample size is large at baseline. The inverse probability weighting approach is more precise and is suitable for this setting in order to determine risk factors for the incidence of self-reported substance used in a cohort with a high dropout rate. Copyright © 2008 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Diets of infants across the world are commonly deficient in multiple micronutrients during the period of growth faltering and dietary transition from milk to solid foods. A randomized placebo controlled trial was carried out in Indonesia, Peru, South Africa, and Vietnam, using a common protocol to investigate whether improving status for multiple micronutrients prevented growth faltering and anemia during infancy. The results of the pooled data analysis of the 4 countries for growth, anemia, and micronutrient status are reported. A total of 1134 infants were randomized to 4 treatment groups, with 283 receiving a daily placebo (P), 283 receiving a weekly multiple micronutrient supplement (WMM), 280 received a daily multiple micronutrient (DMM) supplement, and 288 received daily iron (DI) supplements. The DMM group had a significantly greater weight gain, growing at an average rate of 207 g/mo compared with 192 g/mo for the WMM group, and 186 g/mo for the DI and P groups. There were no differences in height gain. DMM was also the most effective treatment for controlling anemia and iron deficiency, besides improving zinc, retinol, tocopherol, and riboflavin status. DI supplementation alone increased zinc deficiency. The prevalence of multiple micronutrient deficiencies at baseline was high, with anemia affecting the majority, and was not fully controlled even after 6 mo of supplementation. These positive results indicate the need for larger effectiveness trials to examine how to deliver supplements at the program scale and to estimate cost benefits. Consideration should also be given to increasing the dosages of micronutrients being delivered in the foodlets. [ABSTRACT FROM AUTHOR]

Objective: To demonstrate the impact on perinatal mortality of inadequate treatment for maternal syphilis despite adequate screening.Method: In 12 clinics providing antenatal care in Hlabisa, South Africa 1783 pregnant women were screened for syphilis at their first antenatal visit between June and October 1998. Pregnancy outcome was determined among those with syphilis.Results: A total of 158 women were diagnosed with syphilis: prevalence 9% (95% CI 8-10%). Mean gestation at first antenatal visit was 24 weeks. Thirty women (19%) received no treatment and 96 (61%) received all three recommended doses of penicillin. Among those receiving at least one dose, mean delay to the first dose was 20 days. Among those fully treated mean delay to treatment completion was 34 days. Pregnancy outcome was known for 142 women (90%) and there were 17 perinatal deaths among 15 women (11%). Eleven of 43 women (26%) who received one or fewer doses of penicillin experienced a perinatal death whilst only four of 99 women (4%) who received two or more doses of penicillin did so (P = 0.0001). Protection from perinatal death increased with the number of doses of penicillin: linear modelling suggests that one dose reduced the risk by 41%, two doses by 65% and three doses by 79%, compared with no doses. A dose-specific, categorical model confirmed reduction in risk by 79% for all three doses.Conclusion: Despite effective screening, many pregnant women with syphilis remain inadequately treated, resulting in avoidable perinatal mortality. Delays in starting and finishing treatment, as well as incomplete treatment occur. Near-patient syphilis testing in the antenatal clinic with early treatment could improve treatment of syphilis and reduce perinatal mortality, and a randomized trial to test this is underway. [ABSTRACT FROM AUTHOR]

Introduction: Altered levels of mitochondrial DNA copy number (mtDNA-CN) have been proposed as a proxy for mitochondrial dysfunction. Following reports of mtDNA depletion in the blood and substantia nigra of Parkinson's disease (PD) cases, mtDNA-CN was also suggested as a possible biomarker for PD. Therefore, this study aimed to investigate whether blood mtDNA-CN levels of African ancestry PD cases would be altered compared to controls, as previously reported in individuals of Asian and European ancestry.Methods: Droplet digital polymerase chain reaction (ddPCR) was performed to quantify blood-derived mtDNA-CN levels as a ratio of a mitochondrial gene (MT-TL1) to a nuclear gene (B2M) in 72 PD cases and 79 controls of African ancestry (i.e. individuals with African mtDNA haplogroups) from South Africa. mtDNA-CN per cell was calculated by the formula 2 × MT-TL1/B2M.Results: Accepting study limitations, we report significantly higher mtDNA-CN in whole blood of our PD cases compared to controls (median difference = 81 copies/cell), independent of age (95% CI [64, 98]; P < 0.001]). These findings contradict previous reports of mtDNA depletion in PD cases.Conclusions: We caution that the observed differences in mtDNA-CN between the present and past studies may be a result of unaccounted-for factors and variability in study designs. Consequently, larger well-designed investigations may help determine whether mtDNA-CN is consistently altered in the blood of PD cases across different ancestries and whether it can serve as a viable biomarker for PD. [ABSTRACT FROM AUTHOR]

Objectives: The UNAIDS 95-95-95 global targets for epidemic control aim to ensure by 2030 that 95% of HIV-positive people know their HIV status, 95% of people diagnosed with HIV receive sustained antiretroviral therapy (ART), and 95% of people on ART have viral suppression. While data on the first and second 95 targets are routinely reported nationally, data on the third 95 target are not available for pregnant women in South Africa. The lack of data on the third 95 target limits the inclusion of low viral suppression as one of the contributing factors in MTCT root cause analyses. This study assessed progress towards the 95-95-95 targets among pregnant women between the ages of 15–49 years attending public health facilities in South Africa. Method: Data were obtained from two consecutive national cross-sectional antenatal HIV sentinel surveys conducted between 1 October and 15 November in both 2017 and 2019. In each survey, data on age, knowledge of HIV status, ART initiation, and geographical location (province) were extracted from medical records. A blood specimen was collected from each woman and tested for HIV. Viral load tests were performed on HIV-positive specimens. Descriptive and multiple logistic regression analyses were performed to examine association between province and viral suppression (defined as viral load <50 copies/mL) using the combined dataset (i.e., both 2017 and 2019 data combined). All analyses considered the survey design. Results: Of 10 065 and 11 321 HIV-positive women included in the 2017 and 2019 surveys, respectively, 96.0% (95% confidence interval (CI): 95.6–96.4%) and 97.6% (95% CI: 97.3–97.8%) knew their HIV-positive status; 86.6% (95% CI: 85.9–87.3%) and 96.0% (95% CI: 95.6–96.4%) of those who knew their HIV status were receiving ART; while 64.2% (95% CI: 63.2–65.2%) and 66.0% (95% CI: 65.1–66.8%) of those receiving ART were virally suppressed. Achievement of the third 95 target significantly varied by province ranging from 33.9–72.6% in 2017 and 43.4–77.3% in 2019. Knowledge of HIV-positive status, ART initiation, and viral suppression increased in both 15–24 and 25–49 year age groups between 2017 and 2019. In a multivariable analysis adjusting for survey year, gravidity, and education, the odds of viral suppression significantly varied by province (except KwaZulu-Natal and Western Cape, other provinces were less likely to attain viral suppression compared to Gauteng), age (adjusted odds ratio (AOR) for 15–24 years vs 25–49 years: 0.7, 95% CI: 0.6–0.8), and timing of ART initiation (AOR for ART initiation during pregnancy vs before pregnancy: 0.4, 95% CI: 0.5–0.6). Conclusion: Although in 2019 the first and second 95 targets were achieved among pregnant women, meeting the third 95 target remains a challenge. This study highlighted the importance of promoting early ART initiation and the need to target young women in efforts to improve progress towards the third 95 target. Additionally, the provincial variation in viral suppression could be further investigated in future studies to identify and address the root causes underlying these differences. [ABSTRACT FROM AUTHOR]

Several studies have reported a possible association between leucocyte telomere length (LTL) and cardio-metabolic diseases (CMDs). However, studies investigating such association are lacking in South Africa despite having a very high prevalence of CMDs. We investigated the association between LTL and CMD risk profile in a black South African population. This was a cross-sectional study with participants > 21 years of age and residing in five townships in Cape Town. CMD markers were compared between men and women and across quartiles of LTL. Linear and logistic regressions relate increasing quartile and Log10LTL with CMD risk profile, with appropriate adjustment. Among 676-participants, diabetes, obesity and hypertension prevalence were 11.5%, 23.1% and 47.5%. Waist-circumference, hip-circumference and highly sensitive c-reactive protein values were significantly higher in women (all p < 0.001), while HDL-C (p = 0.023), creatinine (p = 0.005) and gamma glutamyl transferase (p < 0.001) values were higher in men. In age, sex and BMI adjusted linear regression model, Log10 of LTL was associated with low HDL-C (beta = 0.221; p = 0.041) while logistic regression showed a significant association between Log10LTL and prevalent dyslipidaemia characterised by high LDL-C. In this population, the relationship between LTL and CMD is weak given its association with only HDL-C and LDL-C. [ABSTRACT FROM AUTHOR]

To describe the prevalence of unintended pregnancy and its association with HIV status among pregnant women in South Africa. A cross-sectional survey was conducted between October and mid-November 2019 among pregnant women aged 15–49 years in 1589 selected public antenatal care facilities. Pregnancy intention was assessed using two questions from the London Measure of Unplanned Pregnancy. Survey logistic regression examined factors associated with unintended pregnancy. Among 34,946 participants, 51.6% had an unintended pregnancy. On multivariable analysis, the odds of unintended pregnancy was higher among women who knew their HIV-positive status before pregnancy but initiated treatment after the first antenatal visit (adjusted odds ratio [aOR], 1.5 [95% confidence interval (CI):1.2–1.8]), women who initiated treatment before pregnancy (aOR, 1.3 [95% CI:1.2–1.3]), and women with a new HIV diagnosis during pregnancy (aOR, 1.2 [95% CI:1.1–1.3]) compared to HIV-negative women. Women who were single, in a non-cohabiting or a cohabiting relationship, and young women (15–24 years) had significantly higher risk of unintended pregnancy compared to married women and women aged 30–49 years, respectively. A comprehensive approach, including regular assessment of HIV clients' pregnancy intention, and adolescent and youth-friendly reproductive health services could help prevent unintended pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: Despite the numerous efforts and initiatives, males with HIV are still less likely than women to receive HIV treatment. Across Sub-Saharan Africa, men are tested, linked, and retained in HIV care at lower rates than women, and South Africa is no exception. This is despite the introduction of the universal test-and-treat (UTT) prevention strategy anticipated to improve the uptake of HIV services. The aim of this study was to investigate linkage to and retention in care rates of an HIV-positive cohort of men in a high HIV prevalence rural district in KwaZulu-Natal province, South Africa. Methods: From January 2018 to July 2019, we conducted an observational cohort study in 18 primary health care institutions in the uThukela district. Patient-level survey and clinical data were collected at baseline, 4-months and 12-months, using isiZulu and English REDCap-based questionnaires. We verified data through TIER.Net, Rapid mortality survey (RMS), and the National Health Laboratory Service (NHLS) databases. Data were analyzed using STATA version 15.1, with confidence intervals and p-value of ≤0.05 considered statistically significant. Results: The study sample consisted of 343 male participants diagnosed with HIV and who reside in uThukela District. The median age was 33 years (interquartile range (IQR): 29–40), and more than half (56%; n = 193) were aged 18–34 years. Almost all participants (99.7%; n = 342) were Black African, with 84.5% (n = 290) being in a romantic relationship. The majority of participants (85%; n = 292) were linked to care within three months of follow-up. Short-term retention in care (≤ 12 months) was 46% (n = 132) among men who were linked to care within three months. Conclusion: While the implementation of the UTT strategy has had positive influence on improving linkage to care, men's access of HIV treatment remains inconsistent and may require additional innovative strategies. [ABSTRACT FROM AUTHOR]

Objectives: South Africa has made remarkable progress in increasing the coverage of antiretroviral therapy (ART) among pregnant women; however, viral suppression among pregnant women receiving ART is reported to be low. Access to routine viral load testing is crucial to identify women with unsuppressed viral load early in pregnancy and to provide timely intervention to improve viral suppression. This study aimed to determine the coverage of maternal viral load monitoring nationally, focusing on viral load testing, documentation of viral load test results, and viral suppression (viral load < 50 copies/mL). At the time of this study, the first‐line regimen for women initiating ART during pregnancy was non‐nucleoside reverse transcriptase (NNRTI)‐based regimen. Methods: Between 1 October and 15 November 2019, a cross‐sectional survey was conducted among 15‐ to 49‐year‐old pregnant women attending antenatal care in 1589 nationally representative public health facilities. Data on ART status, viral load testing and viral load test results were extracted from medical records. Logistic regression was used to examine factors associated with coverage of viral load testing. Results: Of 8112 participants eligible for viral load testing, 81.7% received viral load testing, and 94.1% of the viral load test results were documented in the medical records. Of those who had viral load test results documented, 74.1% were virally suppressed. Women initiated on ART during pregnancy and who received ART for three months had lower coverage of viral load testing (73%) and viral suppression (56.8%) compared with women initiated on ART before pregnancy (82.8% and 76.1%, respectively). Initiating ART during pregnancy rather than before pregnancy was associated with a lower likelihood of receiving a viral load test during pregnancy (adjusted odds ratio = 1.6, 95% confidence interval: 1.4–1.8). Conclusions: Viral load result documentation was high; viral load testing could be improved especially among women initiating ART during pregnancy. The low viral suppression among women who initiated ART during pregnancy despite receiving ART for three months highlights the importance of enhanced adherence counselling during pregnancy. Our finding supports the WHO recommendation that a Dolutegravir‐containing regimen be the preferred regimen for women who are newly initiating ART during pregnancy for more rapid viral suppression. [ABSTRACT FROM AUTHOR]

• Glycated albumin (GA) threshold in South Africa was similar to the 15–16% in Asia. • GA and fructosamine can discriminate by glycemic status in black South Africans. • Higher correlations of GA with glucose by obesity suggests better utility in obese. The associations of glycated albumin (GA) and fructosamine (FA) as alternate tests for diabetes screening in South Africans were examined to overcome shortcomings with oral glucose tolerance tests (OGTTs). Based on OGTTs, glycaemic status included 1) normal glucose, 2) dysglycaemia (impaired fasting glucose, impaired glucose tolerance, newly diagnosed diabetes), and 3) known diabetes. Among 1092 participants, >21 years, mean GA (16.9%) and FA (230.2 μmol/l) increased significantly by age and worsening glycaemic status and were significantly higher in women vs. men and BMI (kg/m2) ≥ 30 vs. <30. For dysglycaemia, correlations of GA and FA with fasting and 2-hour glucose levels were higher in obese (0.576 to 0.688) vs. non-obese (−0.010 to 0.522). Optimal GA threshold to identify dysglycaemia was 15.35% and comparable, but with lower sensitivity (0.54) and specificity (0.55) , to Asian studies. For FA, the optimal cut-point of 227.0 μmol/l approximated that described in the literature. Dysglycaemia and known diabetes were associated with GA, while only known diabetes was related to FA, in models adjusted for age, gender and obesity. Potential exists for GA and/or FA as alternative measures of dysglycaemia in clinical practice in Africans, but longitudinal studies are required to clearly elucidate their utility. [ABSTRACT FROM AUTHOR]

Purpose: The objective of the study was to determine whether all patients with spinal non-missile penetrating injuries (NMPIs) need to be managed at a tertiary neurosurgical centre. Methods: A retrospective analysis of clinical, demographic, and imaging records was performed on all NMPI patients referred to the Department of Neurosurgery at Tygerberg Academic Hospital in Cape Town, South Africa, between 1 January 2016 and 31 December 2019. Results: Ninety-six patients were identified (94 males and 2 females) with 35 cervical, 60 thoracic, and 1 lumbar spinal stab. Eighty-six had an incomplete spinal cord injury. Six patients presented with cerebrospinal fluid (CSF) leak, all of which resolved spontaneously. MRI was performed in nine patients. Six patients had retained blades, of which 5 were removed in the emergency room (ER). Surgery was performed in two patients (cervical intramedullary abscess and a retained blade). Two patients developed meningitis, and one an intramedullary abscess. Twenty-two patients had associated injuries (pneumothorax, bowel injury). The average length of stay was 17 days, with 81% being unchanged neurologically. The average time from discharge to leaving the hospital was 11 days. Conclusion: Early management of NMPI should include prophylactic antibiotics and wound debridement and X-ray imaging to exclude retained blades. Bowel and lung injury must be managed accordingly. Tertiary neurosurgical referral is not routinely necessary and is only warranted for deteriorating neurology, retained blades not removable in the ER, and respiratory failure secondary to spinal cord injury. Complications include meningitis and persistent CSF leak, which should be referred timeously. [ABSTRACT FROM AUTHOR]

Introduction: New HIV infection during pre-conception and pregnancy is a significant contributor of mother–to–child transmission of HIV in South Africa. This study estimated HIV incidence (defined as new infection within the last one year from the time of the survey which included both new infections occurred during pregnancy or just before pregnancy) among pregnant women and described the characteristics of recently infected pregnant women at national level. Methods: Between 1 October and 15 November 2017, we conducted a national cross–sectional survey among pregnant women aged 15–49 years old attending antenatal care at 1,595 public facilities. Blood specimens were collected from pregnant women and tested for HIV in a centralised laboratory. Plasma viral load and Limiting Antigen Avidity Enzyme Immunosorbent Assay (LAg) tests were further performed on HIV positive specimens to differentiate between recent and long–term infections. Recent infection was defined as infection that occurred within one year from the date of collection of blood specimen for the survey. Data on age, age of partner, and marital status were collected through interviews. Women whose specimens were classified as recent by LAg assay and with viral loads >1,000 copies/mL were considered as recently infected. The calculated proportion of HIV positive women with recent infection was adjusted for assay–specific parameters to estimate annual incidence. Survey multinomial logistic regression was used to examine factors associated with being recently infected using HIV negative women as a reference group. Age–disparate relationship was defined as having a partner 5 or more years older. Results: Of 10,049 HIV positive participants with LAg and viral load data, 1.4% (136) were identified as recently infected. The annual HIV incidence was 1.5% (95% confidence interval (CI): 1.2–1.7). In multivariable analyses, being single (adjusted odds ratio, aOR: 3.4, 95% CI: 1.8–6.2) or cohabiting (aOR: 3.8, 95% CI: 1.8–7.7), compared to being married as well as being in an age–disparate relationship among young women (aOR: 3.1, 95% CI: 2.0–4.7; reference group: young women (15–24years) whose partners were not 5 years or more older) were associated with higher odds of recent infection. Conclusions: Compared to previous studies among pregnant women, the incidence estimated in this study was substantially lower. However, the UNAIDS target to reduce incidence by 75% by 2020 (which is equivalent to reducing incidence to <1%) has not been met. The implementation of HIV prevention and treatment interventions should be intensified, targeting young women engaged in age–disparate relationship and unmarried women to fast track progress towards the UNAIDS target. [ABSTRACT FROM AUTHOR]

Background: In most countries, reliable national statistics on femicide, intimate partner femicide (IPF), and non-intimate partner femicide (NIPF) are not available. Surveys are required to collect robust data on this most extreme consequence of intimate partner violence (IPV). We analysed 3 national surveys to compare femicide, IPF, and NIPF from 1999 to 2017 using age-standardised rates (ASRs) and incidence rate ratios (IRRs). Methods and findings: We conducted 3 national mortuary-based retrospective surveys using weighted cluster designs from proportionate random samples of medicolegal laboratories. We included females 14 years and older who were identified as having been murdered in South Africa in 1999 (n = 3,793), 2009 (n = 2,363), and 2017 (n = 2,407). Further information on the murdered cases were collected from crime dockets during interviews with police investigating officers. Our findings show that South Africa had an IPF rate of 4.9/100,000 female population in 2017. All forms of femicide among women 14 years and older declined from 1999 to 2017. For IPF, the ASR was 9.5/100,000 in 1999. Between 1999 and 2009, the decline for NIPF was greater than for IPF (IRR for NIPF 0.47 (95% confidence interval (CI) 0.42 to 0.53) compared to IRR for IPF 0.69 (95% CI 0.63 to 0.77). Rates declined from 2009 to 2017 and did not differ by femicide type. The decline in IPF was initially larger for women aged 14 to 29, and after 2009, it was more pronounced for those aged 30 to 44 years. Study limitations include missing data from the police and having to use imputation to account for missing perpetrator data. Conclusions: In this study, we observed a reduction in femicide overall and different patterns of change in IPF compared to NIPF. The explanation for the reductions may be due to social and policy interventions aimed at reducing IPV overall, coupled with increased social and economic stability. Our study shows that gender-based violence is preventable even in high-prevalence settings, and evidence-based prevention efforts must be intensified globally. We also show the value of dedicated surveys in the absence of functional information systems. Using data from three national surveys, Naeemah Abrahams and colleagues compare rates of femicide, intimate partner femicide and non-intimate partner femicide in South Africa between 1999 and 2017. Author summary: Why was the study done?: Femicide, the most severe form of gender-based violence, is not well described in middle- and low-income countries. Reliable routine data from police, justice and statistical departments are not available, and dedicated studies are needed to understand the scope of femicide in the country. What did the researchers do and find?: South Africa has a methodogy to collect national data from forensic and police services to estimate femicide and repeated surveys on 3 occasions (1999, 2009, and 2017) allowed for the assessement of change over 18 years. We found that an estimated 3,793 women 14 years and older were victims of femicide in 1999, and this decreased to an estimated 2,407 femicide victims in 2017. We further found a decrease in intimate partner femicide with the age-standardised rates decreasing from 9.5/100,000 population in 1999 to 4.9/100,000 population in 2017. What do the findings mean?: The 3 surveys over 18 years shows that femicide is preventable but that South Africa remains a country with the highest globally recorded rate of femicide. The reduction in femicide rates may be partially due to the contribution of activism of women and community-based organisations in bringing about change in Government's gender-based violence policy and programme. A concern is the increase in missing data from police sources over the years, which points to the urgent need to improve information systems and integration of data across departments. [ABSTRACT FROM AUTHOR]

Higher exercise heart rate (HR) and prolonged return-to-sport in athletes with SARS-CoV-2 infection are described, but the cardiovascular response to exercise during recovery is not understood. This prospective, cohort, experimental study with repeated measures evaluated the cardiovascular response to exercise over 16 weeks in athletes recovering from SARS-CoV-2 infection. Athletes (n = 82) completed 2–5 repeat assessments at regulated intervals over 16 weeks post-SARS-CoV-2 infection. Data from 287 assessments (submaximal exercise tests; Modified Bruce protocol) are included. HR (bpm), systolic blood pressure (SBP) (mmHg) and rating of perceived exertion (RPE) (Borg scale 6–20) were measured. Rates of change in HR, SBP and RPE over time are reported. Submaximal exercise HR, SBP and RPE decreased significantly over 16 weeks (p < 0.01). There was a steeper rate of decline for HR and RPE ≤30 days compared to >30 days after SARS-CoV-2 infection: HR at Stage 3: ≤30 days −0.53 (0.01); >30 days −0.06 (0.02) and Stage 5: ≤30 days −0.77 (0.12); >30 days −0.12 (0.02); RPE at Stage 3: ≤30 days −0.09 (0.02); >30 days −0.01 (0.0002) and Stage 5: ≤30 days −0.13 (0.02); >30 days −0.02 (0.004). The findings provide clinical recommendation for exercise prescription and monitoring RPE in response to exercise post-SARS-CoV-2 infection and contribute to the clinical understanding of recovery which can help manage athlete expectations. [ABSTRACT FROM AUTHOR]

This study investigates the prevalence of vitamin and iron deficiencies at cancer diagnosis. Newly diagnosed children between October 2018 and December 2020 at two South African pediatric oncology units (POUs) were assessed for nutritional and micronutrient status (Vit A, Vit B12, Vit D, folate, and iron). A structured interview with caregivers provided information regarding hunger and poverty risks. There were 261 patients enrolled with a median age of 5.5 years and a male-to-female ratio of 1:0.8. Nearly half had iron deficiency (47.6%), while a third had either Vit A (30.6%), Vit D (32.6%), or folate (29.7%) deficiencies. Significant associations existed between moderate acute malnutrition (MAM) and low levels of Vit A (48.4%; p =.005), Vit B12 (29.6%; p <.001), and folate (47.3%; p =.003), while Vit D deficiency was associated with wasting (63.6%) (p <.001). Males had significantly lower Vit D levels (respectively, 40.9%; p =.004). Folate deficiency was significantly associated with patients born at full term (33.5%; p =.017), age older than five years (39.8%; p =.002), residing in provinces Mpumalanga (40.9%) and Gauteng (31.5%) (P =.032); as well as having food insecurity (46.3%; p <.001), or hematological malignancies (41.3%; p =.004). This study documents the high prevalence of Vit A, Vit D, Vit B12, folate, and iron deficiency in South African pediatric cancer patients, demonstrating the need to include micronutrient assessment at diagnosis to ensure optimal nutritional support for macro-and micronutrients. [ABSTRACT FROM AUTHOR]

Background There is limited knowledge of chest radiographic abnormalities over time in HIV-infected children in resource-limited settings. Objective To investigate the natural history of chest radiographic abnormalities in HIV-infected African children, and the impact of antiretroviral therapy (ART). Methods Prospective longitudinal study of the association of chest radiographic findings with clinical and immunological parameters. Chest radiographs were performed at enrolment, 6-monthly, when initiating ART and if indicated clinically. Radiographic abnormalities were classified as normal, mild or moderate severity and considered persistent if present for 6 consecutive months or longer. An ordinal multiple logistic regression model assessed the association of enrolment and timedependent variables with temporal radiographic findings. Results 258 children (median (IQR) age: 28 (13-51) months; median CD4+%: 21 (15-24)) were followed for a median of 24 (18-42) months. 70 (27%) were on ART at enrolment; 130 (50%) (median age: 33 (18-56) months) commenced ART during the study. 154 (60%) had persistent severe radiographic abnormalities, with median duration 18 (6-24) months. Among children on ART, 69% of radiographic changes across all 6-month transition periods were improvements, compared with 45% in those not on ART. Radiographic severity was associated with previous radiographic severity (OR=120.80; 95% CI 68.71 to 212.38), lack of ART (OR=1.72; 95% CI 1.29 to 2.27), enrolment age <18 months (OR=1.39; 95% CI 1.06 to 1.83), diffuse, severe radiographic abnormality at enrolment (OR=2.18; 95% CI 1.33 to 3.56), hospitalisation for lower respiratory tract infection during the previous 6 months (OR=1.88; 95% CI 1.06 to 3.30) and length of followup: at 18-24 months (OR=0.66; 95% CI 0.49 to 0.90), and at 30-54 months (OR=0.42; 95% CI 0.32 to 0.56). Conclusions Most children had severe radiographic abnormalities persisting for at least 18 months. ART was beneficial, reducing the risk of radiographic deterioration or increasing the likelihood of radiological improvement. [ABSTRACT FROM AUTHOR]

Introduction: A computed tomography (CT) brain scan is an often-utilised emergency department imaging modality to detect emergent intra-cranial pathology in a child with a first seizure. Identifying children at low risk of having a clinically significant intra-cranial abnormality could prevent unnecessary radiation exposure and contrast/sedation-related risks.Objectives: To identify clinical variables which could predict clinically significant CT brain abnormalities and use recursive partitioning analysis to define a low-risk group of children in whom emergent CT brain can be deferred.Methods: Retrospective cross-sectional review of 468 children who underwent emergent CT brain after presenting to a low- and middle-income paediatric emergency department following first seizure.Results: In total 133/468 (28.4%) of CT brain scans had clinically significant abnormalities. Failure to return to neurological baseline and focal neurological deficit persisting >36 h had statistical significance in a multiple regression analysis. Recursive partitioning analysis, applied to a subgroup without suspected tuberculous meningitis (n = 414), classified 153 children aged between 6 months and 5 years, who had a normal neurological baseline, had returned to baseline post-seizure, and were not in status epilepticus, as non-clinically significant scans and 98% were correctly classified.Conclusion: Our study re-inforces the American Academy of Neurology recommendation that children with persistent post-ictal abnormal neurological status and/or post-ictal focal deficit be prioritised for emergent CT brain. Having excluded children with suspected tuberculous meningitis, the remaining subgroup aged 6 months to 5 years presenting with a non-status first seizure, normal neurological baseline and return to baseline post-seizure, are at very low risk of having a clinically significant CT brain abnormality. [ABSTRACT FROM AUTHOR]

Many South African children live in poverty and food insecurity; therefore, malnutrition within the context of childhood cancer should be examined. Parents/caregivers completed the Poverty-Assessment Tool (divided into poverty risk groups) and the Household Hunger Scale questionnaire in five pediatric oncology units. Height, weight, and mid-upper arm circumference assessments classified malnutrition. Regression analysis evaluated the association of poverty and food insecurity with nutritional status, abandonment of treatment, and one-year overall survival (OS). Nearly a third (27.8%) of 320 patients had a high poverty risk, associated significantly with stunting (p = 0.009), food insecurity (p < 0.001) and residential province (p < 0.001) (multinomial regression). Stunting was independently and significantly associated with one-year OS on univariate analysis. The hunger scale was significant predictor of OS, as patients living with hunger at home had an increased odds ratio for treatment abandonment (OR 4.5; 95% CI 1.0; 19.4; p = 0.045) and hazard for death (HR 3.2; 95% CI 1.02, 9.9; p = 0.046) compared to those with food security. Evaluating sociodemographic factors such as poverty and food insecurity at diagnosis is essential among South African children to identify at-risk children and implement adequate nutritional support during cancer treatment. [ABSTRACT FROM AUTHOR]

Many drinkers globally are at risk of developing an alcohol use disorder (AUD). The study aimed to identify the extent of AUDs and associated individual and societal-level risk factors or vulnerabilities among adult drinkers in a country with high levels of heavy episodic drinking. A household survey was conducted in the Tshwane Metro, South Africa, using multistage stratified cluster random sampling. Complete data were available on 949 adult drinkers. Half (49%) reported symptoms of alcohol problems, as a proxy for AUDs, as measured using the RAPS4. Gender and age were not associated with symptoms of alcohol problems. White persons had 74% lower odds of symptoms of alcohol problems compared to Black Africans, and persons who reported stressful life events in the past 6 months were four times more likely to report symptoms of alcohol problems. Persons whose primary drinking location was a pub/bar/tavern and "other club" were more than twice as likely to have symptoms of alcohol problems than persons who drank at home, and persons whose primary beverage was wine were 74% less likely to have symptoms of alcohol problems compared to beer drinkers. The findings raise important implications regarding particular vulnerabilities experienced by Black Africans; the sale of alcoholic beverages, and especially beer, in locations such as pubs/bars/taverns; and the need for more comprehensive epidemiological research to assess the nature and extent of AUDs in South Africa together with focused contextual research on particular groups at risk. [ABSTRACT FROM AUTHOR]

A reply from the authors of the article "Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled," is presented.

Background: The association of traumatic experiences with problematic alcohol use has been described, but data on possible mediation effects of mental distress are sparse. We examined whether mental ill-health mediated the association between trauma exposure across the lifespan and alcohol use. Method: We analysed cross-sectional data from a sample of rape-exposed and non-rape-exposed women, living in KwaZulu-Natal, with self-reported data on alcohol misuse (AUDIT-C cut-off ≥ 3) and exposure to childhood maltreatment (CM), intimate partner violence (IPV), non-partner sexual violence (NPSV), other traumatic events, and mental ill-health. Logistic regression and multiple mediation models were used to test the mediation effects of symptoms of depression and PTSS on the association between abuse/trauma and alcohol misuse. Results: Of 1615 women, 31% (n = 498) reported alcohol misuse. Exposure to any CM (adjusted odds ratio (aOR): 1.59, 95% confidence interval (CI): 1.27–1.99), as well as to sexual, physical and emotional CM, were independently associated with alcohol misuse. Lifetime exposure to any IPV (aOR:2.01, 95%CI:1.59–2.54), as well as to physical, emotional and economic IPV, NPSV (aOR: 1.75, 95%CI: 1.32–2.33), and other trauma (aOR:2.08, 95%CI:1.62–2.66), was associated with alcohol misuse. Exposure to an increasing number of abuse types, and other traumatic events, was independently associated with alcohol misuse. PTSS partially mediated the associations of CM, IPV, NPSV and other trauma exposures with alcohol misuse (ps ≤ 0.04 for indirect effects), but depression symptoms did not. Conclusions: These findings highlight the need for trauma-informed interventions to address alcohol misuse that are tailored to the needs of women who have experienced violence. [ABSTRACT FROM AUTHOR]

Sexual homicides of women and children are extreme forms of violence against women and children and are located within the broader context of gender inequality and social norms that condone sexual violence and gender based violence against women and children. The aim of this study is to describe the prevalence and characteristics of sexual homicide of women and children nationally in South Africa. Methods: We conducted a retrospective national mortuary based study to identify all adult female homicides (18 years and older) and all child homicides (boys and girls < 18 years) in 2009 in a randomly selected, proportionate sample of mortuaries. Victim, perpetrator and crime data were collected in three processes: from the mortuary register, the autopsy report and from police with the identification of sexual homicides validated across the data collection processes. Findings: Among the 2670 (95% CI: 2311–2979) adult women killed in 2009, 494 (95% CI: 406–574) were identified as sexual homicides which was 19.8% (95% CI: 17.6–22.0) of all adult female homicides and among 1277 (95% CI: 1091–1462) children killed in SA, sexual homicides were found in 104 (95% CI: 77–132) of the child homicides which was 8.7% (95% CI: 10.9–11.2%) of these murders. Strangulation was the most common cause of death for both children and adult females. A distinct age and sex pattern was found among children with only 1% boy child death identified as a sexual homicide and 92% of all the child sexual homicides were among girls. Strangulation was the most common manner of death among children (35.5%) and perpetrators were seldom strangers. However, no difference in the proportion of convictions between the sexual homicides and non-sexual homicides were found for both adult females and children. Conclusion: Rape homicide is not a rare event in South Africa, with one in five female homicides and nearly one in ten child homicides identified with an associated sexual crime. These high prevalences are amongst the highest levels reported in the literature with our study among the few reporting on the epidemiology of child sexual homicide. Reducing mortality is an important policy goal for South Africa and for the rest of the world and the prevention of female and child homicide is an important part of attaining this goal. [ABSTRACT FROM AUTHOR]

We describe coverage of maternal syphilis screening, syphilis positivity, coverage of treatment and their association with maternal HIV infection and antiretroviral treatment (ART) status among pregnant women attending South African antenatal clinics. The 2019 antenatal care sentinel survey was a cross-sectional survey conducted from 1 October to 15 November 2019 at 1589 sentinel sites in all nine provinces of the country and aimed to enrol 36,000 pregnant women ages 15–49 years regardless of HIV, ART or syphilis status. Data collection procedures included obtaining written informed consent, a brief interview, medical record review and blood specimen collection. Completed data collection forms and specimens were sent to designated regional laboratories for data capture and HIV serology testing. Data analysis determined four outcomes i) syphilis screening coverage ii) syphilis positivity iii) coverage of any treatment and iv) with Benzathine penicillin G (BPG). Multivariable logistic regression models with or without interaction between HIV infection and ART status with province were used to determine factors associated with syphilis positivity. Of the 41 598 women enrolled, 35 900 were included in the analysis for syphilis screening coverage. The weighted syphilis screening coverage was 96.4% [95% Confidence Interval (CI) 95.9–96.7%] nationally and was lowest among HIV positive women not on ART at 93.5% (95% CI 92.2–94.5%). Syphilis positivity was 2.6% (95% CI 2.4–2.9%) nationally. Among those who were syphilis positive, 91.9% (95% CI 89.8–93.7%) had documentation of syphilis treatment status, of whom 92.0% (95% CI 89.8–93.9%) were treated, with the majority treated with one or more doses of BPG [92.2% (95% CI 89.8–94.3%)]. HIV-positive women, not on ART [adjusted odd ratio (aOR) 2.24 (95% 1.71–2.93)] and those on ART [aOR 2.25 (95% CI 1.91–2.64)] were more likely to be syphilis positive compared to those who were HIV negative. The national syphilis screening coverage met the global screening target of 95%. Syphilis positivity was higher among HIV positive women compared to negative women. Introduction of rapid syphilis testing and ensuring a universal supply of appropriate treatment for syphilis will reduce the likelihood of mother-to-child transmission of syphilis. [ABSTRACT FROM AUTHOR]

Aim: Hospital acquired bloodstream infection (HA-BSI) is a major contributor to morbidity and mortality in preterm, very low birthweight infants, especially in low-to-middle-income countries. Materials and Methods: We conducted a double-blind, placebo-controlled, randomized clinical trial to investigate the effect of a multi-strain probiotic formulation (LabinicTM) on the incidence and severity of HA-BSI in preterm neonates. Results: Two hundred neonates (100 per arm) were included in this trial. Fifteen neonates developed HA-BSI events (2 in the probiotic arm and 13 in the placebo arm). The median day of life at HA-BSI onset for the probiotic group was 10.5±3.5, and for the placebo group, it was 11.2±6.4. The incidence of HA-BSI in neonates receiving the probiotic was significantly lower compared to those receiving the placebo [0.93 versus 5.99 HA-BSI events/1,000 neonate-days; incidence rate ratio (IRR) of 0.156 [95% confidence interval (CI): 0.017 to 0.691], p=0.0046]. Calculating the incidence rate of the combined outcome (sepsis/death) was also lower in the probiotic group versus the placebo group [2.34 versus 6.45 events/1,000 neonate days; IRR 0.33 (95% CI: 0.11 to 0.97), p=0.043]. Conclusion: The use of a multi-strain probiotic significantly reduced HA-BSI incidence in this cohort of preterm neonates. [ABSTRACT FROM AUTHOR]

Background: Rape is a common traumatic event which may result in the development of posttraumatic stress disorder (PTSD), yet few studies have investigated risk biomarkers in sexually traumatised individuals. Adiponectin is a novel cytokine within inflammatory and cardiometabolic pathways with evidence of involvement in PTSD. Objective: This prospective exploratory study in a sample of female rape survivors investigated the association of single nucleotide polymorphisms (SNPs) in the adiponectin gene (ADIPOQ) and posttraumatic stress symptom (PTSS) severity, and the interaction of these SNPs of interest with childhood trauma in modifying the association with PTSS severity. Method: The study involved 455 rape-exposed black South African women (mean age (SD), 25.3 years (±5.5)) recruited within 20 days of being raped. PTSS was assessed using the Davidson Trauma Scale (DTS) and childhood trauma was assessed using a modified version of the Childhood Trauma Scale-Short Form Questionnaire. Eight ADIPOQ SNPs (rs17300539, rs16861194, rs16861205, rs2241766, rs6444174, rs822395, rs1501299, rs1403697) were genotyped using KASP. Mixed linear regression models were used to test additive associations of ADIPOQ SNPs and PTSS severity at baseline, 3 and 6 months following rape. Results: The mean DTS score post-sexual assault was high (71.3 ± 31.5), with a decrease in PTSS severity shown over time for all genotypes. rs6444174TT genotype was inversely associated with baseline PTSS in the unadjusted model (β = −13.6, 95% CI [−25.1; −2.1], p =.021). However, no genotype was shown to be significantly associated with change in PTSS severity over time and therefore ADIPOQ SNP x childhood trauma interaction was not further investigated. Conclusion: None of the ADIPOQ SNPs selected for investigation in this population were shown to be associated with change in PTSS severity over a 6-month period and therefore their clinical utility as risk biomarkers for rape-related PTSD appears limited. These SNPs should be further investigated in possible gene-gene and gene-environment interactions. Women who are sexually assaulted are at increased risk of PTSD. The adiponectin gene (ADIPOQ) has been linked to cardiometabolic disease which frequently co-occurs with PTSD. ADIPOQ variants were not shown to predict PTSD symptom severity post-rape in this population. [ABSTRACT FROM AUTHOR]