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BACKGROUND: Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. METHODS: The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. RESULTS: Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. CONCLUSION: Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

The growing movement to make antiretroviral therapy (ART) widely available in South Africa has spurred discussion on different aspects of delivering HIV treatment services,1 2 deliberations that have taken on new importance in light of the national government's recent announcement of a plan to make ART widely available in the public sector. Yet one critical aspect of delivering ART effectively within HIV care services has received surprisingly little attention, namely the challenge of retaining patients in long-term programmes of primary care. Here we discuss the importance of distinguishing adherence to medications from retention in care, as well as the possible interventions that may be employed to improve long-term patient retention.

BackgroundThe impact of highly active antiretroviral therapy (HAART) on health‐related quality of life has been widely researched in the developed world, but there are few data from sub‐Saharan Africa, where the vast majority of HIV‐infected individuals live. This study examined health‐related quality of life among HIV‐positive individuals initiating HAART in Cape Town, South Africa, and explored the impact of HAART‐related drug toxicities on quality of life.MethodsHealth‐related quality of life was assessed using a standardised questionnaire, the Medical Outcomes Survey Short Form 36. Physical health summary scores and mental health summary scores were compared pre‐HAART and at regular intervals during the first 48 weeks of HAART. The relationships between socio‐demographic, baseline and on‐treatment variables and decline in health‐related quality of life, as well as the impact of drug toxicities on quality of life, were assessed in unadjusted bivariate and adjusted multivariate analyses.ResultsTwo hundred and ninety‐five patients were enrolled into the study. There was a significant increase in health‐related quality of life during the first 48 weeks on HAART. The median physical health summary score increased from 45 to 53 units (p < 0.001) and median mental health summary score increased from 45 to 50 units (p < 0.001).The bulk of this increase occurred during the first 16 weeks. Overall, 23% of participants experienced a decline in their physical health summary score, while 34% showed a decline in the mental health summary score. Average drops in median physical and mental health summary scores were 8.4 units (SD 9.31) and 9.9 (SD 11.4) units respectively. Participants with drug toxicity had lower physical health summary scores than participants without drug toxicity at all time points. However, only three participants with toxicity (27%) reported an actual decline in health‐related quality of life by week 48. Drug toxicities had little impact on mental health summary scores.ConclusionThese results confirm the health‐related quality of life benefits of HAART. While the majority of patients experienced a significant improvement in health‐related quality of life on HAART, up to a third of patients reported declines in this quality of life. This was largely related to better baseline clinical state. HAART‐related drug toxicities did not have a significant impact on health‐related quality of life during the first year of HAART, which supports the ongoing use of the current national first‐line regimen.

BACKGROUND:In order to ensure that legalized abortion in South Africa improves reproductive health, women must know that abortion is a legal option in the case of unwanted pregnancy. This study investigated knowledge of abortion legislation eight years after the introduction of legal abortion services in one province of South Africa. METHODS: In 2004/2005, we conducted a cross-sectional study among 831 sexually-active women attending 26 public health clinics in one urban and one rural health region of the Western Cape Province. RESULTS: Thirty-two percent of women did not know that abortion is currently legal. Among those who knew of legal abortion, few had knowledge of the time restrictions involved. CONCLUSION: In South Africa there is an unmet need among women for information on abortion. Strategies should be developed to address this gap so that women are fully informed of their rights to a safe and legal termination of pregnancy.

The growing movement to make antiretroviral therapy (ART) widely available in South Africa has spurred discussion on different aspects of delivering HIV treatment services, deliberations that have taken on new importance in light of the national government's recent announcement of a plan to make ART widely available in the public sector. Yet one critical aspect of delivering ART effectively within HIV care services has received surprisingly little attention, namely the challenge of retaining patients in long-term programmes of primary care. Here we discuss the importance of distinguishing adherence to medications from retention in care, as well as the possible interventions that may be employed to improve long-term patient retention.

Despite improvements in PMTCT services in low‐ and middle‐income countries, there are still almost 200,000 new paediatric HIV infections annually in sub‐Saharan Africa. This has led to early infant HIV diagnosis (EID) programmes becoming a public health priority, but until recently, EID has required specialist laboratory equipment and trained personnel which is only feasible in urban, centralized facilities. It is thought that the successful implementation of a point‐of‐care (POC) test for EID has the potential to increase access to virological tests and address some of the barriers regarding retention of infants in care. However, POC evaluation has not integrated focus on performance characteristics with the health systems issues surrounding the adoption of and optimum use of these new technologies. We propose that moderate improvements in linkage to care can more than offset suboptimal sensitivity of a POC EID test which could be critical in adjusting the focus for EID programme management away from test performance and towards their ability to facilitate successful linkage to antiretroviral therapy (ART) services. These findings also highlight the urgent need to explore the implementation and operational aspects of emerging POC tests in order to fully realize the potential benefits of new technologies in practice.

IntroductionEarly initiation of antiretroviral therapy (ART) in eligible pregnant women is a key intervention for prevention of mother‐to‐child transmission (PMTCT) of HIV. However, in many settings in sub‐Saharan Africa where ART‐eligibility is determined by CD4 cell counts, limited access to laboratories presents a significant barrier to rapid ART initiation. Point‐of‐care (POC) CD4 cell count testing has been suggested as one approach to overcome this challenge, but there are few data on the agreement between POC CD4 cell enumeration and standard laboratory‐based testing.MethodsWorking in a large antenatal clinic in Cape Town, South Africa, we compared POC CD4 cell enumeration (using the Alere PimaTM Analyzer) to laboratory‐based flow cytometry in consecutive HIV‐positive pregnant women. Bland–Altman methods were used to compare the two methods, including analyses by subgroups of participant gestational age.ResultsAmong the 521 women participating, the median gestational age was 23 weeks, and the median CD4 cell count according to POC and laboratory‐based methods was 388 and 402 cells/µL, respectively. On average, the Pima POC test underestimated CD4 cell count relative to flow cytometry: the mean difference (laboratory test minus Pima POC) was 22.7 cells/µL (95% CI, 16.1 to 29.2), and the limits of agreement were −129.2 to 174.6 cells/µL. When analysed by gestational age categories, there was a trend towards increasing differences between laboratory and POC testing with increasing gestational age; in women more than 36 weeks' gestation, the mean difference was 45.0 cells/µL (p=0.04).DiscussionThese data suggest reasonable overall agreement between Pima POC CD4 testing and laboratory‐based flow cytometry among HIV‐positive pregnant women. The finding for decreasing agreement with increasing gestational age requires further investigation, as does the operational role of POC CD4 testing to increase access to ART within PMTCT programmes.

The South African population is exposed to multiple forms of violence. Using nationally representative data from 4,351 South African adults, this study examined the relative risk for posttraumatic stress disorder (PTSD) associated with political, domestic, criminal, sexual and other (miscellaneous) forms of assault in the South African population. Violence exposure was assessed using the 'worst event' list from the WHO's Composite International Diagnostic Interview (CIDI) and a separate questionnaire assessing experiences of human rights abuses, and lifetime PTSD was assessed according to the APA's Diagnostic and Statistical Manual of Mental Disorders criteria using the CIDI. Findings indicated that over a third of the South African population has been exposed to some form of violence. The most common forms of violence experienced by men were criminal and miscellaneous assaults, while physical abuse by an intimate partner, childhood physical abuse and criminal assaults were most common for women. Among men, political detention and torture were the forms of violence most strongly associated with a lifetime diagnosis of PTSD, while rape had the strongest association with PTSD among women. At a population level, criminal assault and childhood abuse were associated with the greatest number of PTSD cases among men, while intimate partner violence was associated with the greatest number of PTSD cases among women. Recommendations for mental health service provision in South Africa and for future research on the relative risk for PTSD are offered.

IntroductionCommunity‐based models of antiretroviral therapy (ART) delivery have been recommended to support ART expansion and retention in resource‐limited settings. However, the evidence base for community‐based models of care is limited. We describe the implementation of community‐based adherence clubs (CACs) at a large, public‐sector facility in peri‐urban Cape Town, South Africa.MethodsStarting in May 2012, stable ART patients were down‐referred from the primary care community health centre (CHC) to CACs. Eligibility was based on self‐reported adherence, >12 months on ART and viral suppression. CACs were facilitated by four community health workers and met every eight weeks for group counselling, a brief symptom screen and distribution of pre‐packed ART. The CACs met in community venues for all visits including annual blood collection and clinical consultations. CAC patients could send a patient‐nominated treatment supporter ("buddy") to collect their ART at alternate CAC visits. Patient outcomes [mortality, loss to follow‐up and viral rebound (>1000 copies/ml)] during the first 18 months of the programme are described using Kaplan–Meier methods.Results and DiscussionFrom June 2012 to December 2013, 74 CACs were established, each with 25–30 patients, providing ART to 2133 patients. CAC patients were predominantly female (71%) and lived within 3 km of the facility (70%). During the analysis period, 9 patients in a CAC died (<0.1%), 53 were up‐referred for clinical complications (0.3%) and 573 CAC patients sent a buddy to at least one CAC visit (27%). After 12 months in a CAC, 6% of patients were lost to follow‐up and fewer than 2% of patients retained experienced viral rebound.ConclusionsOver a period of 18 months, a community‐based model of care was rapidly implemented decentralizing more than 2000 patients in a high‐prevalence, resource‐limited setting. The fundamental challenge for this out of facility model was ensuring that patients receiving ART within a CAC were viewed as an extension of the facility and part of the responsibility of CHC staff. Further research is needed to support down‐referral sooner after ART initiation and to describe patient experiences of community‐based ART delivery.

AbstractIntroduction: Rapid diagnostic tests (RDTs) are the primary diagnostic tools for HIV used in resource‐constrained settings. Without a proper confirmation algorithm, there is concern that false‐positive (FP) RDTs could result in misdiagnosis of HIV infection and inappropriate antiretroviral treatment (ART) initiation, but programmatic data on FP are few.Methods: We examined the accuracy of RDT diagnosis among HIV‐infected pregnant women attending public sector antenatal services in Cape Town, South Africa. We describe the proportion of women found to have started on ART erroneously due to FP RDT results based on pre‐ART viral load (VL) testing and enzyme‐linked immunosorbent assay (ELISA).Results: We analysed 952 consecutively enrolled pregnant women diagnosed as HIV infected based on two RDTs per local guideline and found 4.5% (43/952) of pre‐ART VL results to be <50 copies/ml. After excluding 6 women who had detectable virus on subsequent VL measurements, ELISA was performed on the 37 remaining women. Of these, 3/952 (0.3%) HIV RDT diagnoses were found to be FP. We estimate that using ELISA to confirm all positive RDTs would cost $1110 (uncertainty interval $381–$5382) to identify one patient erroneously initiated on ART, while it costs $3912 for a lifetime of antiretrovirals with VL monitoring for one person.Conclusions: Compared to the cost of confirming the RDT‐based diagnoses, the cost of HIV misdiagnosis is high. While testing programmes based on RDT should strive for constant quality improvement, where resources permit, laboratory confirmation algorithms can play an important role in strengthening the quality of HIV diagnosis in the era of universal ART.