Verification of chemistry reference ranges using a simple method in sub-Saharan Africa

Background: Chemistry safety assessments are interpreted by using chemistry reference ranges (CRRs). Verification of CRRs is time consuming and often requires a statistical background. Objectives: We report on an easy and cost-saving method to verify CRRs. Methods: Using a former method introduced by Sigma Diagnostics, three study sites in sub- Saharan Africa, Bondo, Kenya, and Pretoria and Bloemfontein, South Africa, verified the CRRs for hepatic and renal biochemistry assays performed during a clinical trial of HIV antiretroviral pre-exposure prophylaxis. The aspartate aminotransferase/alanine aminotransferase, creatinine and phosphorus results from 10 clinically-healthy participants at the screening visit were used. In the event the CRRs did not pass the verification, new CRRs had to be calculated based on 40 clinically-healthy participants. Results: Within a few weeks, the study sites accomplished verification of the CRRs without additional costs. The aspartate aminotransferase reference ranges for the Bondo, Kenya site and the alanine aminotransferase reference ranges for the Pretoria, South Africa site required adjustment. The phosphorus CRR passed verification and the creatinine CRR required adjustment at every site. The newly-established CRR intervals were narrower than the CRRs used previously at these study sites due to decreases in the upper limits of the reference ranges. As a result, more toxicities were detected. Conclusion: To ensure the safety of clinical trial participants, verification of CRRs should be standard practice in clinical trials conducted in settings where the CRR has not been validated for the local population. This verification method is simple, inexpensive, and can be performed by any medical laboratory

Strengthening HIV surveillance in the antiretroviral therapy era: rationale and design of a longitudinal study to monitor HIV prevalence and incidence in the uMgungundlovu District, KwaZulu-Natal, South Africa.

CAPRISA, 2015.Abstract available in pdf

Prevalence of Vitamin D deficiency in a multiracial female population in KwaZulu-Natal province, South Africa

Objective: Vitamin D deficiency is a global health issue affecting many countries, especially those in temperate climates. The aim of this study was to determine the prevalence of Vitamin D deficiency and level of 25-hydroxyvitamin D [25(OH)D] in females categorised by age and race.Methods: The study was performed between January 2015 and January 2016. This study consisted of 1 976 females stratified by age into 18, reproductive age (18–45) and 45 years. Demographic variables were recorded and serum 25(OH)D levels measured by chemiluminescent emission.Results: The predictors of lower 25(OH)D levels included age and race, (p 0.0001 for each predictor). Approximately 46% of females had 20 ng/ml 25(OH)D level, the majority of whom were Indian (35%). The 25(OH)D level varied by race (White 27.33 ng/ml; Black 23.43 ng/ml and Indian 15.05 ng/ml; p 0.0001). In the 18-year age category, White and Black women had significantly higher 25(OH)D levels when compared with Indian women (38.25 ng/ml vs. 37.51 ng/ml vs. 13.68 ng/ml respectively; p 0.0001). Similarly, in the reproductive age category (18–45 years); White (27.63 ng/ml) and Black (20.93 ng/ml) women had a significantly higher 25(OH)D level compared with Indian (13.15 ng/ml) women (p 0.0001). Moreover, similar data were observed within the 45-year age category, where the White and Black women had higher 25(OH)D levels compared with Indian women (25.46 ng/ml vs. 22.73 ng/ml vs. 17.04 ng/ml; p 0.0001) respectively. Irrespective of age category, severe vitamin D deficiency was highest amongst Indian females.Conclusion: This study demonstrates a significant difference in 25(OH)D concentration in healthy females living in Durban, with Indians presenting with the highest vitamin D deficiency. These findings clearly highlight the need for a policy on vitamin D supplementation and/or fortification of food. Further studies are under way to assess the genetic predisposition of women to vitamin D deficiency

Health expenditure and catastrophic spending among older adults living with HIV

Introduction: The burden of HIV is increasing among adults aged over 50, who generally experience increased risk of cormorbid illnesses and poorer financial protection. We compared patterns of health utilisation and expenditure among HIV-positive and HIV-negative adults over 50. Methods: Data were drawn from the Study on global AGEing and adult health in South Africa with analysis focusing on individual and household-level data of 147 HIV-positive and 2725 HIV-negative respondents. Results: HIV-positive respondents reported lower utilisation of private health-care facilities (11.8%) than HIV-negative respondents (25.0%) (p = .03) and generally had more negative attitudes towards health system responsiveness than HIV-negative counterparts. Less than 10% of HIV-positive and HIV-negative respondents experienced catastrophic health expenditure (CHE). Women (OR 1.8; p < .001) and respondents from rural settings (OR 2.9; p < .01) had higher odds of CHE than men or respondents in urban settings. Over half the respondents in both groups indicated that they had received free health care. Conclusions: These findings suggest that although HIV-positive and HIV-negative older adults in South Africa are protected to some extent from CHE, inequalities still exist in access to and quality of care available at health-care services – which can inform South Africa’s development of a national health insurance scheme

Prevalence of HIV and chronic comorbidities among older adults

Objectives: Limited evidence is available on HIV, aging and comorbidities in sub-Saharan Africa. This article describes the prevalence of HIV and chronic comorbidities among those aged 50 years and older in South Africa using nationally representative data. Design: The WHO's Study of global AGEing and adult health (SAGE) was conducted in South Africa in 2007–2008. SAGE includes nationally representative cohorts of persons aged 50 years and older, with comparison samples of those aged 18–49 years, which aims to study health and its determinants. Methods: Logistic and linear regression models were applied to data from respondents aged 50 years and older to determine associations between age, sex and HIV status and various outcome variables including prevalence of seven chronic conditions. Results: HIV prevalence among adults aged 50 and older in South Africa was 6.4% and was particularly elevated among Africans, women aged 50–59 and those living in rural areas. Rates of chronic disease were higher among all older adults compared with those aged 18–49. Of those aged 50 years and older, 29.6% had two or more of the seven chronic conditions compared with 8.8% of those aged 18–49 years (P < 0.0001). When controlling for age and sex among those aged 50 and older, BMI was lower among HIV-infected older adults aged 50 and older (27.5 kg/m²) than in HIV-uninfected individuals of the same age (30.6) (P < 0.0001). Grip strength among HIV-infected older adults was significantly (P=0.004) weaker than among similarly-aged HIV-uninfected individuals. Conclusion: HIV-infected older adults in South Africa have high rates of chronic disease and weakness. Studies are required to examine HIV diagnostics and treatment instigation rates among older adults to ensure equity of access to quality care, as the number and percentage of older adults living with HIV is likely to increase

Leveraging ongoing research to evaluate the health impacts of South Africa\u27s salt reduction strategy: a prospective nested cohort within the WHO-SAGE multicountry, longitudinal study

Introduction: Attempting to curb the rising epidemic of hypertension, South Africa implemented legislation in June 2016 mandating maximum sodium levels in a range of manufactured foods that contribute significantly to population salt intake. This natural experiment, comparing two African countries with and without salt legislation, will provide timely information on the impact of legislative approaches addressing the food supply to improve blood pressure in African populations. This article outlines the design of this ongoing prospective nested cohort study. Methods and analysis: Baseline sodium intake was assessed in a nested cohort of the WHO Study on global AGEing and adult health (WHO-SAGE) wave 2 (2014-2015), a multinational longitudinal study on the health and well-being of adults and the ageing process. The South African cohort consisted of randomly selected households (n=4030) across the country. Spot and 24-hour urine samples are collected in a random subsample (n=1200) and sodium, potassium, creatinine and iodine analysed. Salt behaviour and sociodemographic data are captured using face-to-face interviews, alongside blood pressure and anthropometric measures. Ghana, the selected control country with no formal salt policy, provided a nested subsample (n=1200) contributing spot and 24-hour urine samples from the SAGE Ghana cohort (n=5000). Follow-up interviews and urine collection (wave 3) in both countries will take place in 2017 (postlegislation) to assess change in population-level sodium intake and blood pressure. Ethics and dissemination: SAGE was approved by the WHO Ethics Review Committee (reference number RPC149) with local approval from the North-West University Human Research Ethics Committee and University of the Witwatersrand Human Research Ethics Committee (South Africa), and University of Ghana Medical School Ethics and Protocol Review Committee (Ghana). The results of the study will be published in peer-reviewed international journals, presented at national and international conferences, and summarised as research and policy briefs

Carraguard Vaginal Gel Safety in HIV-Positive Women and Men in South Africa

OBJECTIVE: To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men. DESIGN: A randomized, placebo-controlled, triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women; and when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men. METHODS: In each cohort (n = 20 per cohort), participants were randomized to Carraguard, methylcellulose placebo, or no product (1:1:1). In addition to traditional microbicide trial safety endpoints, the effects of microbicide use on vaginal shedding of HIV-1 RNA and markers of genital inflammation, epithelial sloughing, and microhemorrhage were also explored. RESULTS: Gel compliance was high in both gel-use groups in the 3 cohorts. Carraguard use was not associated with abnormal genital findings, other abnormal clinical findings, markers of genital inflammation, epithelial sloughing or microhemorrhage, or self-reported symptoms in women and men, or with abnormal vaginal flora or genital shedding of HIV-1 RNA in women. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. CONCLUSIONS: Once-daily use of Carraguard for 7 to 14 days appeared to be safe in HIV-positive women and me