Browsing by Author "Fairall, Lara"
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- ItemOpen AccessAddressing the quality and scope of paediatric primary care in South Africa: evaluating contextual impacts of the introduction of the Practical Approach to Care Kit for children (PACK Child)(2020-05-29) Murdoch, Jamie; Curran, Robyn; Cornick, Ruth; Picken, Sandy; Bachmann, Max; Bateman, Eric; Simelane, Makhosazana L; Fairall, LaraBackground Despite significant reductions in mortality, preventable and treatable conditions remain leading causes of death and illness in children in South Africa. The PACK Child intervention, comprising clinical decision support tool (guide), training strategy and health systems strengthening components, was developed to expand on WHO’s Integrated Management of Childhood Illness programme, extending care of children under 5 years to those aged 0–13 years, those with chronic conditions needing regular follow-up, integration of curative and preventive measures and routine care of the well child. In 2017–2018, PACK Child was piloted in 10 primary healthcare facilities in the Western Cape Province. Here we report findings from an investigation into the contextual features of South African primary care that shaped how clinicians delivered the PACK Child intervention within clinical consultations. Methods Process evaluation using linguistic ethnographic methodology which provides analytical tools for investigating human behaviour, and the shifting meaning of talk and text within context. Methods included semi-structured interviews, focus groups, ethnographic observation, audio-recorded consultations and documentary analysis. Analysis focused on how mapped contextual features structured clinician-caregiver interactions. Results Primary healthcare facilities demonstrated an institutionalised orientation to minimising risk upheld by provincial documentation, providing curative episodic care to children presenting with acute symptoms, and preventive care including immunisations, feeding and growth monitoring, all in children 5 years or younger. Children with chronic illnesses such as asthma rarely receive routine care. These contextual features constrained the ability of clinicians to use the PACK Child guide to facilitate diagnosis of long-term conditions, elicit and manage psychosocial issues, and navigate use of the guide alongside provincial documentation. Conclusion Our findings provide evidence that PACK Child is catalysing a transition to an approach that strikes a balance between assessing and minimising risk on the day of acute presentation and a larger remit of care for children over time. However, optimising success of the intervention requires reviewing priorities for paediatric care which will facilitate enhanced skills, knowledge and deployment of clinical staff to better address acute illnesses and long-term health conditions of children of all ages, as well as complex psychosocial issues surrounding the child.
- ItemOpen AccessAddressing the quality of paediatric primary care: health worker and caregiver perspectives from a process evaluation of PACK child, a health systems intervention in South Africa(2021-01-28) Curran, Robyn; Murdoch, Jamie; Bachmann, Max; Bateman, Eric; Cornick, Ruth; Picken, Sandra; Simelane, Makhosazana L; Fairall, LaraBackground The WHO’s Integrated Management of Childhood Illness (IMCI) has resulted in progress in addressing infant and child mortality. However, unmet needs of children continue to present a burden upon primary healthcare services. The capacity of services and quality of care offered require greater support to address these needs by extending and integrating curative and preventive care for the child with a long-term health condition and the child older than 5, not prioritised in IMCI. In response to these needs, the PACK Child intervention was developed and piloted in October 2017–February 2019 in the Western Cape Province of South Africa. We report health worker and caregiver perspectives of the existing paediatric primary care context as well as the extent to which PACK Child functions to address perceived problems within the current local healthcare system. Methods This process evaluation involved 52 individual interviews with caregivers, 10 focus group discussions with health workers, 3 individual interviews with trainers, and 31 training observations. Interviews and focus groups explored participants’ experiences of paediatric primary care, perspectives of the PACK Child intervention, and tensions with implementation in each context. Inductive thematic analysis was used to analyse verbatim interview and discussion transcripts. Results Perspectives of caregivers and health workers suggest an institutionalised focus of paediatric primary care to treating children’s symptoms as acute episodic conditions. Health workers’ reports imply that this focus is perpetuated by interactions between contextual features such as, IMCI policy, documentation-driven consultations, overcrowded clinics and verticalised care. Whilst these contextual conditions constrained health workers’ ability to translate skills developed within PACK Child training into practice, the intervention initiated expanded care of children 0–13 years and those with long-term health conditions, enhanced professional competence, improved teamwork and referrals, streamlined triaging, and facilitated probing for psychosocial risk. Conclusion PACK Child appears to be catalysing paediatric primary care to address the broader needs of children, including long-term health conditions and the identification of psychosocial problems. However, to maximise this requires primary care to re-orientate from risk minimisation on the day of attendance towards a view of the child beyond the day of presentation at clinics.
- ItemOpen AccessCollaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial(BioMed Central, 2018-03-22) Fairall, Lara; Petersen, Inge; Zani, Babalwa; Folb, Naomi; Georgeu-Pepper, Daniella; Selohilwe, One; Petrus, Ruwayda; Mntambo, Ntokozo; Bhana, Arvin; Lombard, Carl; Bachmann, Max; Lund, Crick; Hanass-Hancock, Jill; Chisholm, Daniel; McCrone, Paul; Carmona, Sergio; Gaziano, Thomas; Levitt, Naomi; Kathree, Tasneem; Thornicroft, GrahamBackground The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.
- ItemOpen AccessCollaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial(BioMed Central, 2018-03-22) Petersen, Inge; Bhana, Arvin; Folb, Naomi; Thornicroft, Graham; Zani, Babalwa; Selohilwe, One; Petrus, Ruwayda; Mntambo, Ntokozo; Georgeu-Pepper, Daniella; Kathree, Tasneem; Lund, Crick; Lombard, Carl; Bachmann, Max; Gaziano, Thomas; Levitt, Naomi; Fairall, LaraBackground The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA). Methods/design The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months. Discussion This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa. Trial registration South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015.
- ItemOpen AccessComorbidities between tuberculosis and common mental disorders: a scoping review of epidemiological patterns and person-centred care interventions from low-to-middle income and BRICS countries(2020-01-15) Janse Van Rensburg, André; Dube, Audry; Curran, Robyn; Ambaw, Fentie; Murdoch, Jamie; Bachmann, Max; Petersen, Inge; Fairall, LaraAbstract Background There is increasing evidence that the substantial global burden of disease for tuberculosis unfolds in concert with dimensions of common mental disorders. Person-centred care holds much promise to ameliorate these comorbidities in low-to-middle income countries (LMICs) and emerging economies. Towards this end, this paper aims to review 1) the nature and extent of tuberculosis and common mental disorder comorbidity and 2) person-centred tuberculosis care in low-to-middle income countries and emerging economies. Main text A scoping review of 100 articles was conducted of English-language studies published from 2000 to 2019 in peer-reviewed and grey literature, using established guidelines, for each of the study objectives. Four broad tuberculosis/mental disorder comorbidities were described in the literature, namely alcohol use and tuberculosis, depression and tuberculosis, anxiety and tuberculosis, and general mental health and tuberculosis. Rates of comorbidity varied widely across countries for depression, anxiety, alcohol use and general mental health. Alcohol use and tuberculosis were significantly related, especially in the context of poverty. The initial tuberculosis diagnostic episode had substantial socio-psychological effects on service users. While men tended to report higher rates of alcohol use and treatment default, women in general had worse mental health outcomes. Older age and a history of mental illness were also associated with pronounced tuberculosis and mental disorder comorbidity. Person-centred tuberculosis care interventions were almost absent, with only one study from Nepal identified. Conclusions There is an emerging body of evidence describing the nature and extent of tuberculosis and mental disorders comorbidity in low-to-middle income countries. Despite the potential of person-centred interventions, evidence is limited. This review highlights a pronounced need to address psychosocial comorbidities with tuberculosis in LMICs, where models of person-centred tuberculosis care in routine care platforms may yield promising outcomes.
- ItemOpen AccessDiagnostic accuracy of an integrated respiratory guideline in identifying patients with respiratory symptoms requiring screening for pulmonary tuberculosis: a cross-sectional study(BioMed Central Ltd, 2006) English, Rene; Bachmann, Max; Bateman, Eric; Zwarenstein, Merrick; Fairall, Lara; Bheekie, Angeni; Majara, Bosielo; Lombard, Carl; Scherpbier, Robert; Ottomani, SalahBACKGROUND:To evaluate the diagnostic accuracy of the integrated Practical Approach to Lung Health in South Africa (PALSA) guideline in identifying patients requiring bacteriological screening for tuberculosis (TB), and to determine which clinical features best predict suspected and bacteriologically-confirmed tuberculosis among patients with respiratory symptoms. METHODS: A prospective, cross-sectional study in which 1392 adult patients with cough and/or difficult breathing, attending a primary care facility in Cape Town, South Africa, were evaluated by a nurse using the guideline. The accuracy of a nurse using the guideline to identify TB suspects was compared to that of primary care physicians' diagnoses of (1) suspected TB, and (2) proven TB supported by clinical information and chest radiographs. RESULTS: The nurse using the guideline identified 516 patients as TB suspects compared with 365 by the primary care physicians, representing a sensitivity of 76% (95% confidence interval (CI) 71%-79%), specificity of 77% (95% CI 74%-79%), positive predictive value of 53% (95% CI 49%-58%), negative predictive value of 90% (95% CI 88%-92%), and area under the receiver operating characteristic curve (ARUC) of 0.76 (95% CI 0.74-0.79). Sputum results were obtained in 320 of the 365 primary care physicians TB suspects (88%); 40 (13%) of these were positive for TB. Only 4 cases were not identified by the nurse using the guideline. The primary care physicians diagnostic accuracy in diagnosing bacteriologically-confirmed TB (n = 320) was as follows: sensitivity 90% (95% CI 76%-97%), specificity 65% (95% CI 63%-68%), negative predictive value 7% (95% CI 5%-10%), positive predictive value 99.5% (95% CI 98.8%-99.8%), and ARUC 0.78 (95% CI 0.73-0.82). Weight loss, pleuritic pain, and night sweats were independently associated with the diagnosis of bacteriologically-confirmed tuberculosis (positive likelihood ratio if all three present = 16.7, 95% CI 5.9-29.4). CONCLUSION: The PALSA guideline is an effective screening tool for identifying patients requiring bacteriological screening for pulmonary tuberculosis in this primary care setting. This supports the randomized trial finding that use of the guideline increased TB case detection.
- ItemOpen AccessDifferences in access and patient outcomes across antiretroviral treatment clinics in the Free State province: A prospective cohorot study(2010) Ingle, Suzanne M; May, Margaret; Uebel, Kerry; Timmerman, Venessa; Kotze, Eduan; Bachmann, Max; Sterne, Jonathan A C; Egger, Matthias; Fairall, LaraObjective. 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 (<50 kg). 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.
- ItemOpen AccessThe effect of antiretroviral treatment on HIV associated tuberculosis incidence and outcomes in the Free State Province, South Africa.(2013) Timmerman, Venessa; Fairall, Lara; Bachmann, M OOf people co-infected with HIV and tuberculosis (TB) globally, 79% are in Sub-Saharan Africa. While scale-up of antiretroviral treatment (ART) is reducing mortality in the region, there is little direct evidence of the magnitude of its effect on mortality in people coinfected with TB, or on TB treatment outcomes. There is little evidence on the effect of ART on TB incidence in HIV positive people in South Africa, which has most HIV-TB cases in the region.
- ItemOpen AccessEvaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study(BioMed Central Ltd, 2011) Sodhi, Sumeet; Banda, Hastings; Kathyola, Damson; Burciul, Barry; Thompson, Sandy; Joshua, Martias; Bateman, Eric; Fairall, Lara; Martiniuk, Alexandra; Cornick, Ruth; Faris, Gill; Draper, Beverley; Mondiwa, Martha; Katengeza, Egnat; Sanudi, Lifah; ZwBACKGROUND: Nearly 3 million people in resource-poor countries receive antiretrovirals for the treatment of HIV/AIDS, yet millions more require treatment. Key barriers to treatment scale up are shortages of trained health care workers, and challenges integrating HIV/AIDS care with primary care.THE RESEARCH:PALM PLUS (Practical Approach to Lung Health and HIV/AIDS in Malawi) is an intervention designed to simplify and integrate existing Malawian national guidelines into a single, simple, user-friendly guideline for mid-level health care workers. Training utilizes a peer-to-peer educational outreach approach. Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi. The research consists of a cluster randomized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention, quality of patient care, and costs through quantitative, qualitative and health economics methods.RESULTS AND OUTCOMES:In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites. Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients. Interim staff retention data shows that there were, on average, 3 to 4 staff departing from the control and intervention sites per month. Additional qualitative, quantitative and economic analyses are planned.THE PARTNERSHIP:Dignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention, using experience gained through the implementation of the South African precursor, PALSA PLUS. The Malawian partners, REACH Trust and the Research Unit at the Ministry of Health, have led the qualitative and economic evaluations. Dignitas and Ministry of Health have facilitated interaction with implementers and policy-makers.CHALLENGES AND SUCCESSES:This initiative is an example of South-South knowledge translation between South Africa and Malawi, mediated by a Canadian academic-NGO hybrid. Our success in developing and rolling out PALM PLUS in Malawi suggests that it is possible to adapt and implement this intervention for use in other resource-limited settings.
- ItemOpen AccessFrom PALSA PLUS to PALM PLUS: adapting and developing a South African guideline and training intervention to better integrate HIV/AIDS care with primary care in rural health centers in Malawi(BioMed Central Ltd, 2011) Schull, Michael; Cornick, Ruth; Thompson, Sandy; Faris, Gill; Fairall, Lara; Burciul, Barry; Sodhi, Sumeet; Draper, Beverley; Joshua, Martias; Mondiwa, Martha; Banda, Hastings; Kathyola, Damson; Bateman, Eric; Zwarenstein, MerrickBACKGROUND: Only about one-third of eligible HIV/AIDS patients receive anti-retroviral treatment (ART). Decentralizing treatment is crucial to wider and more equitable access, but key obstacles are a shortage of trained healthcare workers (HCW) and challenges integrating HIV/AIDS care with other primary care. This report describes the development of a guideline and training program (PALM PLUS) designed to integrate HIV/AIDS care with other primary care in Malawi. PALM PLUS was adapted from PALSA PLUS, developed in South Africa, and targets middle-cadre HCWs (clinical officers, nurses, and medical assistants). We adapted it to align with Malawi's national treatment protocols, more varied healthcare workforce, and weaker health system infrastructure.METHODS/DESIGN:The international research team included the developers of the PALSA PLUS program, key Malawi-based team members and personnel from national and district level Ministry of Health (MoH), professional associations, and an international non-governmental organization. The PALSA PLUS guideline was extensively revised based on Malawi national disease-specific guidelines. Advice and input was sought from local clinical experts, including middle-cadre personnel, as well as Malawi MoH personnel and representatives of Malawian professional associations. RESULTS: An integrated guideline adapted to Malawian protocols for adults with respiratory conditions, HIV/AIDS, tuberculosis, and other primary care conditions was developed. The training program was adapted to Malawi's health system and district-level supervision structure. PALM PLUS is currently being piloted in a cluster-randomized trial in health centers in Malawi (ISRCTN47805230).DISCUSSION:The PALM PLUS guideline and training intervention targets primary care middle-cadre HCWs with the objective of improving HCW satisfaction and retention, and the quality of patient care. Successful adaptations are feasible, even across health systems as different as those of South Africa and Malawi.
- ItemOpen AccessHighly active antiretroviral treatment and health related quality of life in South African adults with human immunodeficiency virus infection: A cross-sectional analytical study(BioMed Central Ltd, 2007) Louwagie, Goedele; Bachmann, Max; Meyer, Kobus; Booysen, Frikkie; Fairall, Lara; Heunis, ChristoBACKGROUND:Health Related Quality of Life (HRQoL) is an important outcome in times of Highly Active Antiretroviral Treatment (HAART). We compared the HRQoL of HIV positive patients receiving HAART with those awaiting treatment in public sector facilities in the Free State province in South Africa. METHODS: A stratified random sample of 371 patients receiving or awaiting HAART were interviewed and the EuroQol-profile, EuroQol-index and Visual Analogue Scale (VAS) were compared. Independent associations between these outcomes and HAART, socio-demographic, clinical and health service variables were estimated using linear and ordinal logistic regression, adjusted for intra-clinic clustering of outcomes. RESULTS: Patients receiving HAART reported better HRQoL for 3 of the 5 EuroQol-dimensions, for the VAS score and for the EuroQol index in bivariable analysis. They had a higher mean EuroQol index (0.11 difference, 95% confidence interval [CI] 0.04; 0.23), and were more likely to have a higher index (odds ratio 1.9, 95% CI 1.1; 1.3), compared to those awaiting HAART, in multivariate analysis. Higher mean VAS scores were reported for patients who were receiving HAART (6.5 difference, 95% CI 1.3; 11.7), were employed (9.1, 95% CI 4.3; 13.7) or were female (4.7, 95% CI 0.79; 8.5). CONCLUSION: HAART was associated with improved HRQoL in patients enrolled in a public sector treatment program in South Africa. Our finding that the EuroQol instrument was sensitive to HAART supports its use in future evaluation of HIV/AIDS care in South Africa. Longitudinal studies are needed to evaluate changes in individuals' HRQoL.
- ItemOpen AccessImplementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial(BioMed Central Ltd, 2012) Georgeu, Daniella; Colvin, Christopher; Lewin, Simon; Fairall, Lara; Bachmann, Max; Uebel, Kerry; Zwarenstein, Merrick; Draper, Beverly; Bateman, EricBACKGROUND:Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. METHODS: This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. RESULTS: NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges. CONCLUSIONS: Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice.TRIAL REGISTRATION:ISRCTN46836853
- ItemOpen AccessMethods for analyzing cost effectiveness data from cluster randomized trials(BioMed Central Ltd, 2007) Bachmann, Max; Fairall, Lara; Clark, Allan; Mugford, MirandaBACKGROUND:Measurement of individuals' costs and outcomes in randomized trials allows uncertainty about cost effectiveness to be quantified. Uncertainty is expressed as probabilities that an intervention is cost effective, and confidence intervals of incremental cost effectiveness ratios. Randomizing clusters instead of individuals tends to increase uncertainty but such data are often analysed incorrectly in published studies. METHODS: We used data from a cluster randomized trial to demonstrate five appropriate analytic methods: 1) joint modeling of costs and effects with two-stage non-parametric bootstrap sampling of clusters then individuals, 2) joint modeling of costs and effects with Bayesian hierarchical models and 3) linear regression of net benefits at different willingness to pay levels using a) least squares regression with Huber-White robust adjustment of errors, b) a least squares hierarchical model and c) a Bayesian hierarchical model. RESULTS: All five methods produced similar results, with greater uncertainty than if cluster randomization was not accounted for. CONCLUSION: Cost effectiveness analyses alongside cluster randomized trials need to account for study design. Several theoretically coherent methods can be implemented with common statistical software.
- ItemOpen AccessMonitoring the South African National Antireteoviral Treatment Programme, 2003-2007: The IeDEA Southern Africa Collaboration(2009) Cornell, Morna; Technau, Karl; Fairall, Lara; Wood, Robin; Moultrie, Harry; Van Cutsem, Gilles; Giddy, Janet; Mohapi, Lerato; Eley, Brian; MacPhail, Patrick; Prozesky, Hans; Rabie, Helena; Davies, Mary-Ann; Maxwell, Nicola; Boulle, AndrewObjectives: To introduce the combined South African cohorts of the International Epidemiologic Databases to Evaluate AIDS-Southern Africa (IeDEA-SA) collaboration as reflecting the South African national antiretroviral treatment (ART) programme; to characterize patients accessing these services; and to describe changes in services and patients 2003-2007. Design & setting Multi-cohort study of 11 ART programmes in Gauteng, Western Cape, Free State and KwaZulu-Natal. Subjects ART-naïve adults and children (<16 years old) who initiated ART with ≥3 antiretroviral drugs before 2008. Results: Most sites were offering free treatment to adults and children in the public sector, ranging from 264 to 17,835 patients per site. Among 45,383 adults and 6,198 children combined, median (IQR) range was 35.0 years (29.8-41.4) and 42.5 months (14.7-82.5) respectively. Of adults, 68% were female. Median CD4 cell count was 102 cells/µL (44-164) and was lower among males than females (86, 34-150 vs 110, 50-169, p<0.001). Median CD4% among children was 12% (7-17.7). Between 2003 and 2007, enrolment increased 11-fold in adults and 3-fold in children. Median CD4 count at enrolment increased for all adults (67-111 cells/µL, p<0.001) and for those in Stage IV (39-89 cells/µL, p<0.001). Among children <5 years, baseline CD4% increased over time (11.5%-16.0%, p<0.001). Conclusions: IeDEA-SA provides a unique opportunity to report on the national ART programme. The study describes dramatically increasing enrolment. Late presentation, especially of men and children, remains a concern. Investment in sentinel sites ensures good individual-level data while freeing most sites to continue with simplified reporting.
- ItemOpen AccessNon-communicable diseases in public sector primary care clinics in South Africa: multimorbidity, control, treatment, socioeconomic associations, and evaluation of educational outreach with a clinical management tool(2017) Folb, Naomi; Fairall, Lara; Bachmann, Max OThis thesis uses experience gained from a large implementation trial in two rural districts of the Western Cape, South Africa, to address the needs of patients with non-communicable diseases (NCDs) and depression, and to identify solutions to those needs. The Primary Care 101 intervention supports and expands nurses' role in integrated care, in particular for NCDs. It comprises a comprehensive clinical management tool implemented in primary care services using educational outreach training. It was evaluated using a pragmatic cluster randomised controlled trial: 38 clinics in the Eden and Overberg districts of the Western Cape were randomised to receive the intervention or to continue with usual care. 4393 Patients were enrolled and four cohorts identified: hypertension, diabetes, chronic respiratory disease and depression. Patients were re-interviewed once, 14 months later. Primary outcomes for the trial were treatment intensification for the hypertension, diabetes and chronic respiratory disease cohorts, and case detection for the depression cohort. Multimorbidity, NCD care and their socioeconomic associations were assessed on the whole trial cohort (combining intervention and control arms) at baseline and follow-up. The results are presented in published papers. Baseline data revealed considerable multimorbidity and unmet treatment needs (Paper 1). Socioeconomic indicators such as education, and modifiable clinic-level factors such as adequate staffing and communitybased chronic medication collection services were associated with blood pressure control (Paper 2) and depression management (Paper 3). The intervention was shown to be feasible and safe but none of the four primary outcomes showed significant improvement (Paper 4). The thesis addresses the public health challenge of providing integrated chronic disease primary care in South Africa by: • Providing original evidence for high levels of NCD multimorbidity and unmet treatment needs. • Identifying modifiable factors that could improve care for these diseases. • Providing new evidence from South Africa to support the bidirectional relationship between poverty and depression. • Reporting evidence of the effectiveness of a novel intervention aimed at improving NCD care. The findings point to the need for improved strategies for NCD care, including equipping primary health care providers to manage the complexities of multimorbidity.
- ItemOpen AccessStreamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol(BioMed Central Ltd, 2008) Fairall, Lara; Bachmann, Max; Zwarenstein, Merrick; Lombard, Carl; Uebel, Kerry; van Vuuren, Cloete; Steyn, Dewald; Boulle, Andrew; Bateman, EricBACKGROUND: 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 [less than or equal to] 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.TRIAL REGISTRATION:Controlled Clinical Trials ISRCTN46836853
- ItemOpen AccessStrengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial(BioMed Central Ltd, 2010) Schull, Michael; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, EricBACKGROUND:In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care.METHODS/DESIGN:A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation.DISCUSSION:The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice.TRIAL REGISTRATION:Current controlled Trials: ISRCTN47805230
- ItemOpen AccessSupporting middle-cadre health care workers in Malawi: lessons learned during implementation of the PALM PLUS package(BioMed Central, 2014-05-12) Sodhi, Sumeet; Banda, Hastings; Kathyola, Damson; Joshua, Martias; Richardson, Faye; Mah, Emmay; MacGregor, Hayley; Kanike, Emmanuel; Thompson, Sandy; Fairall, Lara; Bateman, Eric; Zwarenstein, Merrick; Schull, Michael JBackground: The government of Malawi is committed to the broad rollout of antiretroviral treatment in Malawi in the public health sector; however one of the primary challenges has been the shortage of trained health care workers. The Practical Approach to Lung Health Plus HIV/AIDS in Malawi (PALM PLUS) package is an innovative guideline and training intervention that supports primary care middle-cadre health care workers to provide front-line integrated primary care. The purpose of this paper is to describe the lessons learned in implementing the PALM PLUS package. Methods: A clinical tool, based on algorithm- and symptom-based guidelines was adapted to the Malawian context. An accompanying training program based on educational outreach principles was developed and a cascade training approach was used for implementation of the PALM PLUS package in 30 health centres, targeting clinical officers, medical assistants, and nurses. Lessons learned were identified during program implementation through engagement with collaborating partners and program participants and review of program evaluation findings. Results: Key lessons learned for successful program implementation of the PALM PLUS package include the importance of building networks for peer-based support, ensuring adequate training capacity, making linkages with continuing professional development accreditation and providing modest in-service training budgets. The main limiting factors to implementation were turnover of staff and desire for financial training allowances. Conclusions: The PALM PLUS approach is a potential model for supporting mid-level health care workers to provide front-line integrated primary care in low and middle income countries, and may be useful for future task-shifting initiatives.
- ItemOpen AccessTask 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(BioMed Central Ltd, 2011) Uebel, Kerry; Fairall, Lara; van Rensburg, Dingie; Mollentze, Willie; Bachmann, Max; Lewin, Simon; Zwarenstein, Merrick; Colvin, Christopher; Georgeu, Daniella; Mayers, Pat; Faris, Gill; Lombard, Carl; Bateman, EricBACKGROUND: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.The STRETCH trial is registered with Current Control Trials ISRCTN46836853.