Search

Background: Interim results from the children with HIV early antiretroviral (CHER) trial showed that early antiretroviral therapy (ART) was life-saving for infants infected with HIV. In view of the few treatment options and the potential toxicity associated with lifelong ART, in the CHER trial we compared early time-limited ART with deferred ART., Methods: CHER was an open-label randomised controlled trial of HIV-infected asymptomatic infants younger than 12 weeks in two South African trial sites with a percentage of CD4-positive T lymphocytes (CD4%) of 25% or higher. 377 infants were randomly allocated to one of three groups: deferred ART (ART-Def), immediate ART for 40 weeks (ART-40W), or immediate ART for 96 weeks (ART-96W), with subsequent treatment interruption. The randomisation schedule was stratified by clinical site with permuted blocks of random sizes to balance the numbers of infants allocated to each group. Criteria for ART initiation in the ART-Def group and re-initiation after interruption in the other groups were CD4% less than 25% in infancy; otherwise, the criteria were CD4% less than 20% or Centers for Disease Control and Prevention severe stage B or stage C disease. Combination therapy of lopinavir-ritonavir, zidovudine, and lamivudine was the first-line treatment regimen at ART initiation and re-initiation. The primary endpoint was time to failure of first-line ART (immunological, clinical, or virological) or death. Comparisons were done by intention-to-treat analysis, with use of time-to-event methods. This trial is registered with ClinicalTrials.gov, number NCT00102960., Findings: 377 infants were enrolled, with a median age of 7·4 weeks, CD4% of 35%, and HIV RNA log 5·7 copies per mL. Median follow-up was 4·8 years; 34 infants (9%) were lost to follow-up. Median time to ART initiation in the ART-Def group was 20 weeks (IQR 16-25). Time to restarting of ART after interruption was 33 weeks (26-45) in ART-40W and 70 weeks (35-109) in ART-96W; at the end of the trial, 19% of patients in ART-40W and 32% of patients in ART-96W remained off ART. Proportions of follow-up time spent on ART were 81% in the ART-Def group, 70% in the ART-40W group, and 69% in the ART-96W group. 48 (38%) of 125 children in the ART-Def group, 32 (25%) of 126 in the ART-40W group, and 26 (21%) of 126 in the ART-96W group reached the primary endpoint. The hazard ratio, relative to ART-Def, was 0·59 (95% CI 0·38-0·93, p=0·02) for ART-40W and 0·47 (0·27-0·76, p=0·002) for ART-96W. Three children in ART-Def, three in ART-40W, and one in ART-96W switched to second-line ART., Interpretation: Early time-limited ART had better clinical and immunological outcomes than deferred ART, with no evidence of excess disease progression during subsequent treatment interruption and less overall ART exposure than deferred ART. Longer time on primary ART permits longer subsequent interruption, with marginally better outcomes., Funding: US National Institutes of Health., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: Expanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor management of ART care for HIV-infected patients., Methods: This randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV-positive individuals with a CD4 cell count of less than 350 cells per microL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored ART care. Patients were randomly assigned by stratified permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primary objective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurse versus doctor group for cumulative treatment failure was prespecified as an upper 95% CI for the hazard ratio that was less than 1.40. This study is registered with ClinicalTrials.gov, number NCT00255840., Findings: 408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group. The hazard ratio for composite failure was 1.09 (95% CI 0.89-1.33), which was within the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60-144), deaths (ten vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctor groups, respectively., Interpretation: Nurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART., Funding: National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Objective: To describe the epidemiology of incomplete abortion (spontaneous miscarriage and illegally induced) in South Africa., Design: Multicentre, prospective, descriptive study., Setting: Fifty-six public hospitals in nine provinces (a stratified, random sample of all hospitals treating gynaecological emergencies)., Patients: All women of gestation under 22 weeks who presented with incomplete abortion during the 2-week study period., Main Outcome Measures: Incidence of, morbidity associated with and mortality from incomplete abortion., Main Results: An estimated 44686 (95% CI 35633-53709) women per year were admitted to South Africa's public hospitals with incomplete abortion. An estimated 425 (95% CI 78-735) women die in public hospitals from complications of abortion. Fifteen per cent (95% CI 13-18) of patients have severe morbidity while a further 19% (95% CI 16-22) have moderate morbidity, as assessed by categories designed for the study which largely reflect infection. There were marked inter-provincial differences and inter-age group differences in trimester of presentation and proportion of patients with appreciable morbidity., Conclusions: Incomplete abortions and, in particular, unsafe abortions are an important cause of mortality and morbidity in South Africa. The methods used in this study underestimate the true incidence for reasons that are discussed. A high priority should be given to the prevention of unsafe abortion.

Objective: The objective of this report was to review and describe the management of incomplete abortion by public sector hospitals., Design: A descriptive study in which data were collected prospectively from routine hospital records on all women admitted with incomplete abortion to a stratified random sample of hospitals between 14 and 28 September 1994., Setting: Public sector hospitals in South Africa., Patients: Women with incomplete abortions., Main Outcome Measures: Length of hospital stay, details of medical management, details of surgical management, determinants of the above., Main Results: Data were collected on 803 patients from the 56 participating hospitals. Of these, 767 (95.9%) were in hospital for 1 day or more, and 753 (95.3%) women underwent evacuation of the uterus. Sharp curettage was the method employed in 726 (96.9%) and general anaesthesia was used for 601 (68%) of the women requiring uterine evacuation. Antibiotics were prescribed for 396 (49.5%) and blood transfusions were administered to 125 (17%) women. Statistical analysis showed length of stay to be longer in small hospitals (under 500 beds) and when the medical condition was more severe. Antibiotic usage and blood transfusion were more common with increasing severity and a low haemoglobin level on admission. However, some inappropriate management was identified with regard to both., Main Conclusions: It is suggested that uncomplicated incomplete abortion can be more effectively and safely managed using the manual vacuum aspiration technique with sedation/analgesia as an outpatient procedure. Attention should be directed at the introduction of this management routine at all types of hospital and to the ensuring of appropriate management of women with complicated abortion.

Objective: To describe the patterns of use of injectable progestogen contraceptives (IPCs) among coloured and black women in the Western Cape. These data are part of an ongoing study in the Western Cape, the main aim of which is to explore the relationship between IPCs and breast cancer., Design: A population-based case-control study of breast cancer risk in relation to the use of IPCs among coloured and black women., Setting: The Western Cape, including the Cape metropole and surrounding rural areas., Study Subjects: All coloured and black women with newly diagnosed breast cancer, resident in the study area and below age 55 years, who present at either of the two tertiary care hospitals in the Western Cape are recruited. Controls are a sample of hospitalised patients representative of the populations from which the patients are drawn. Cases are frequency-matched to controls according to cross-tabulation of age, ethnic group and residential area in a ratio of approximately 1:3., Measurements: Questionnaires are administered by trained nurse interviewers, information is elicited on a wide range of variables, including sociodemographic variables, medical history, family history of breast disease, lifetime history of all methods of contraception and use of non-contraceptive female steroids, reproductive variables, cigarette smoking, alcohol consumption and other potentially confounding variables., Results: Between January and December 1994, 122 incident cases and 389 controls were enrolled. Ever-use of IPCs among the controls was 72% (N = 280) and use for 5 years or more was 30% (N = 117). Use of IPCs in the distant past was common, with 61% (N = 232) of all controls having initiated use 10 or more years previously. Current use was also high (19%). Other contraceptive methods were used far less commonly., Conclusion: Coloured and black women in South Africa have been using and continue to use IPCs for more commonly and for longer periods than women anywhere else in the world. It is therefore especially important to evaluate the risk of breast cancer and other health effects of IPCs. The rates of use identified in this study ensure that there will be adequate statistical power to evaluate long-term use, use in the distant past and current use of IPCs.

Helicobacter pylori is an important cause of gastritis and a number of therapeutic trials suggest that it may be important in the genesis of duodenal ulcer recurrence. The reported prevalence of gastric colonisation by the organism varies considerably. The aim of this cross-sectional survey was to determine its prevalence in non-ulcer dyspeptics and to determine whether this is influenced by age, race, sex, socio-economic status, educational level and the number of persons sharing accommodation. One hundred and sixty-nine patients underwent endoscopy; biopsy specimens were taken from the antrum and H. pylori status was determined histologically. Gastric colonisation was found in 106 patients (63%). The prevalence showed a marked ethnic difference: 40% in whites and 71% in coloureds (P < 0.001). The ethnic groups were characterised by significant differences in socio-economic status (P < 10(-6)), educational level (P < 10(-6)), number of persons sharing accommodation (P < 10(-6)) and age (P < 0.001). These same differences were found when comparing the H. pylori-positive and negative groups, but were less marked and could be attributed to the marked differences between ethnic groups. We conclude that H. pylori prevalence differs between the ethnic groups studied. This may be because of varying degrees of exposure risk.

The value of early intrapartum umbilical artery Doppler velocimetry in the prediction of fetal compromise was studied. One hundred patients were recruited into the study and fetal compromise was diagnosed by abnormal first- or second-stage fetal heart rate traces, a 5-minute Apgar score less than 7, or the development of hypoxic ischaemic encephalopathy. Fetal compromise developed in 30 patients. An umbilical artery resistance index (RI) of 0.66 or less did not predict fetal compromise (sensitivity 13%, specificity 89%, positive predictive value 25%, negative predictive value 70%). Since the mean umbilical artery RI was identical in the compromised and the non-compromised groups, we conclude that early intrapartum Doppler velocimetry is of very little clinical value in predicting fetal compromise at term.

A cross-sectional study of risk factors for ischaemic heart disease (IHD) in a random sample of 986 black people aged 15-64 years living in the Cape Peninsula revealed a population at lower risk for IHD than other South Africans. Blood pressures of 140/95 mmHg or above were found in 14.4% of males and 13.7% of females. Fifty-two per cent of males and 8.4% of females smoked, while 16.5% of males and 25.8% of females had a total cholesterol (TC) level imparting risk for developing IHD. In this population the TC level is not a good surrogate measure for low-density lipoprotein cholesterol because of the high level of high-density lipoprotein cholesterol (HDLC) found in this population. A protective HDLC/TC ratio of 20% was found in 96% of males and 96.1% of females. When considering the three major reversible IHD risk factors at a high level of risk, 30.8% of males and 12.5% of females had at least one such a risk factor. The population was frequently exposed to the media, with 80% listening to the radio every day and 55% watching television at least once a week. This suggests that a healthy lifestyle could be promoted successfully by means of these media. In addition, schools should promote a healthy lifestyle and the prevention of chronic degenerative diseases should be incorporated into the evolving primary health care services in South Africa.