A high incidence of nucleoside reverse transcriptase inhibitor (NRTI)-induced lactic acidosis in HIV-infected patients in a South African context

Objective. To determine the incidence of and predisposing risk factors for lactic acidosis in HIV-infected patients on antiretroviral drugs in South Africa. Design. Observational case series. Setting. Sinikithemba HIV Clinic, McCord Hospital, Durban. Subjects. Eight hundred and ninety-one HIV-positive patients on highly active antiretroviral therapy (HAART) during an 18-month period commencing in January 2004. Measurements and results. Fourteen cases of lactic acidosis (incidence rate of 19 (95% confidence interval (CI): 9 - 29) cases per 1 000 person-years of treatment) were reported. All cases were female, with a median age of 36 years and a median weight of 81 kg. The median time on HAART before developing lactic acidosis was 7.5 months and the median peak lactate level was 9.3 mmol/l. All cases were on stavudine (d4T), lamivudine (3TC) and 1 non-NRTI. The case mortality rate was 29% (4 patients). Conclusions. The incidence rate is higher than reported in studies in developed countries. This may be due to d4T, which is recommended as a first-line antiretroviral drug in South Africa. This implication raises the question whether it is an appropriate drug in first-line treatment of patients with predisposing risk factors such as female gender and being overweight. South African Medical Journal Vol. 96(8) 2006: 722-72

Towards universal ARV access: Achievements and challenges in Free State Province, South Africa

Objective. To study the progress and challenges with regard to universal antiretroviral (ARV) access in Free State Province, South Africa. Methods. Data from the first 4 years of the public sector ARV roll-out and selected health system indicators were used. Data were collected from the public sector ARV database in Free State Province for new patients on ARVs, average waiting times and median CD4 counts at the start of treatment. Information on staff training, vacancy rates and funding allocations for the ARV roll-out was obtained from official government reports. Projections were made of expected new ARV enrolments for 2008 and 2009 and compared with goals set by the National Strategic Plan (NSP) to achieve universal access to ARVs by 2011. Results. New ARV enrolments increased annually to 25% of the estimated need by the end of 2007. Average waiting times to enrolment decreased from 5.82 months to 3.24 months. Median CD4 counts at enrolment increased from 89 to 124 cells/mm3. There is a staff vacancy rate of 38% in the ARV programme and an inadequate increase in budget allocations. Conclusion. The current vertical model of ARV therapy delivery is unlikely to raise the number of new enrolments sufficiently to achieve the goals of universal access by 2011 as envisaged by the NSP. The Free State is implementing a project (STRETCH trial) to broaden the ARV roll-out in an attempt to increase access to ARVs

Expanding access to ART in South Africa: The role of nurse-initiated treatment

The South African government’s recent policy decision to expand access to HIV care rapidly and ‘ensure that all the health institutions in the country are ready to receive and assist patients and not just a few accredited ARV centres’ represents a dramatic and welcome about turn on years of hesitation and confusion in the country’s response to the HIV epidemic. In the first 6 years of the antiretroviral therapy (ART) programme, approximately 900 000 people have been started on treatment. In the next 2 - 3 years, the government proposes to initiate treatment in another 1.2 million people. The medical and moral imperative for providing this life-saving treatment to all who need it does not need to be defended, but the limited capacity of the public health sector to achieve this scale of increase raises serious questions about the practicality of this objective. Along with raising the CD4 thresholds for access to treatment and scrapping the antiretroviral site accreditation process, nurse initiation and management of patients on ART (NIM-ART) is under discussion at the national level as a key strategy for expanding access. There are simply not enough doctors in the public sector to introduce and follow up this number of patients. The major load from this increase will therefore have to be shifted to nurses, themselves under severe pressure and in short supply

Considerations for preparing a randomized population health intervention trial: lessons from a South African–Canadian partnership to improve the health of health workers

Background: Community-based cluster-randomized controlled trials (RCTs) are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster) RCTs of population health interventions in low- and middle-income countries. Objective: We aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships. Design: We reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB) and Human Immunodeficiency Virus (HIV) prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies. Results: The checklist of critical factors was grouped into eight categories: 1) Building trust and shared ownership; 2) Conducting feasibility studies throughout the process; 3) Building capacity; 4) Creating an appropriate information system; 5) Conducting pilot studies; 6) Securing stakeholder support, with a view to scale-up; 7) Continuously refining methodological rigor; and 8) Explicitly addressing all ethical issues both at the start and continuously as they arise. Conclusion: Researchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North–South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge

Task shifting and integration of HIV care into primary care in South Africa: The development and content of the streamlining tasks and roles to expand treatment and care for HIV (STRETCH) intervention

Background: Task shifting and the integration of human immunodeficiency virus (HIV) care into primary care services have been identified as possible strategies for improving access to antiretroviral treatment (ART). This paper describes the development and content of an intervention involving these two strategies, as part of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) pragmatic randomised controlled trial. Methods: Developing the intervention: The intervention was developed following discussions with senior management, clinicians, and clinic staff. These discussions revealed that the establishment of separate antiretroviral treatment services for HIV had resulted in problems in accessing care due to the large number of patients at ART clinics. The intervention developed therefore combined the shifting from doctors to nurses of prescriptions of antiretrovirals (ARVs) for uncomplicated patients and the stepwise integration of HIV care into primary care services. Results: Components of the intervention: The intervention consisted of regulatory changes, training, and guidelines to support nurse ART prescription, local management teams, an implementation toolkit, and a flexible, phased introduction. Nurse supervisors were equipped to train intervention clinic nurses in ART prescription using outreach education and an integrated primary care guideline. Management teams were set up and a STRETCH coordinator was appointed to oversee the implementation process. Discussion: Three important processes were used in developing and implementing this intervention: active participation of clinic staff and local and provincial management, educational outreach to train nurses in intervention sites, and an external facilitator to support all stages of the intervention rollout

Differences in access and patient outcomes across antiretroviral treatment clinics in the Free State province: A prospective cohort study

Objective. To assess differences in access to antiretroviral treatment (ART) and patient outcomes across public sector treatment facilities in the Free State province, South Africa. Design. Prospective cohort study with retrospective database linkage. We analysed data on patients enrolled in the treatment programme across 36 facilities between May 2004 and December 2007, and assessed percentage initiating ART and percentage dead at 1 year after enrolment. Multivariable logistic regression was used to estimate associations of facility-level and patient-level characteristics with both mortality and treatment status. Results. Of 44 866 patients enrolled, 15 219 initiated treatment within 1 year; 8 778 died within 1 year, 7 286 before accessing ART. Outcomes at 1 year varied greatly across facilities and more variability was explained by facility-level factors than by patient-level factors. The odds of starting treatment within 1 year improved over calendar time. Patients enrolled in facilities with treatment initiation available on site had higher odds of starting treatment and lower odds of death at 1 year compared with those enrolled in facilities that did not offer treatment initiation. Patients were less likely to start treatment if they were male, severely immunosuppressed (CD4 count ≤50 cells/µl), or underweight

Interventionalists’ perceptions on a culture of radiation protection

Background: Occupational exposure to ionising radiation poses potential health risks to radiation workers unless adequate protection is in place. The catheterisation laboratory is a highly contextualised workplace with a distinctive organisational and workplace culture.   Objective: This study was conducted to understand the culture of radiation protection (CRP).   Methods: This study was a qualitative study and data were collected through 30 in-depth and 6 group interviews with 54 purposively selected South African interventionalists (interventional radiologists and cardiologists). The participants included a diversity of interventionalists who varied in sex, geographic location and years of experience with fluoroscopy. The transcribed data were analysed thematically using a deductive and inductive approach.   Results: ‘Culture of radiation protection’ emerged as a complex theme that intersected with other themes: ‘knowledge and awareness of radiation’, ‘radiation safety practice’, ‘personal protective equipment (PPE) utilisation’ and ‘education and training’.   Conclusion: Establishing and sustaining a CRP provides an opportunity to mitigate the potentially detrimental health effects of occupational radiation exposure. Education and training are pivotal to establishing a CRP. The time to establish a culture of radiation in the catheterisation laboratory is now

Differences in access and patient outcomes across antiretroviral treatment clinics in the Free State Province : prospective cohort study

Objective: To assess differences in access to antiretroviral treatment (ART) and patient outcomes across public-sector treatment facilities in the Free State Province, South Africa. Design: Prospective cohort study with retrospective database linkage. We analysed data on patients enrolled in the treatment programme across 36 facilities between May 2004 and December 2007. We assessed percentage initiating ART and percentage dead, at one year after enrolment. Multivariable logistic regression was used to estimate associations of clinic-level and patient-level characteristics with both mortality and treatment status. Results: Of 44,866 patients enrolled, 15,219 initiated treatment within one year. 8,778 died within one year, of whom 7,286 died before accessing ART. Outcomes at one year varied greatly across facilities and more variability was explained by clinic-level factors than by patient-level factors. The odds of starting treatment within one year improved over calendar time. Patients enrolled in facilities with treatment initiation available on site had higher odds of starting treatment and lower odds of death at one year compared to those enrolled in facilities that do not offer treatment initiation. Patients were less likely to start treatment if they were male, severely immunosuppressed (CD4 count <50 cells/ mm3), or underweight (< 50kg). Men were also more likely to die in the first year after enrolment. Conclusions: Although increasing numbers of patients started ART between 2004 and 2007, many patients died before accessing ART. Patient outcomes could be improved by decentralisation of treatment services, fast-tracking the most immunodeficient patients and improving access especially for men

Streamlining tasks and roles to expand treatment and care for HIV : randomised controlled trial protocol

Background: A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design: This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART) for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a) 7400 registering with the programme with CD4 counts of ? 350 cells/mL (mainly to evaluate treatment initiation) and b) 4900 already receiving ART (to evaluate ongoing treatment and monitoring). The primary outcomes will be time to death (in the first group) and viral suppression (in the second group). Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register