A model-based approach to estimating the prevalence of disease combinations in South Africa.

BACKGROUND: The development of strategies to better detect and manage patients with multiple long-term conditions requires estimates of the most prevalent condition combinations. However, standard meta-analysis tools are not well suited to synthesising heterogeneous multimorbidity data. METHODS: We developed a statistical model to synthesise data on associations between diseases and nationally representative prevalence estimates and applied the model to South Africa. Published and unpublished data were reviewed, and meta-regression analysis was conducted to assess pairwise associations between 10 conditions: arthritis, asthma, chronic obstructive pulmonary disease (COPD), depression, diabetes, HIV, hypertension, ischaemic heart disease (IHD), stroke and tuberculosis. The national prevalence of each condition in individuals aged 15 and older was then independently estimated, and these estimates were integrated with the ORs from the meta-regressions in a statistical model, to estimate the national prevalence of each condition combination. RESULTS: The strongest disease associations in South Africa are between COPD and asthma (OR 14.6, 95% CI 10.3 to 19.9), COPD and IHD (OR 9.2, 95% CI 8.3 to 10.2) and IHD and stroke (OR 7.2, 95% CI 5.9 to 8.4). The most prevalent condition combinations in individuals aged 15+ are hypertension and arthritis (7.6%, 95% CI 5.8% to 9.5%), hypertension and diabetes (7.5%, 95% CI 6.4% to 8.6%) and hypertension and HIV (4.8%, 95% CI 3.3% to 6.6%). The average numbers of comorbidities are greatest in the case of COPD (2.3, 95% CI 2.1 to 2.6), stroke (2.1, 95% CI 1.8 to 2.4) and IHD (1.9, 95% CI 1.6 to 2.2). CONCLUSION: South Africa has high levels of HIV, hypertension, diabetes and arthritis, by international standards, and these are reflected in the most prevalent condition combinations. However, less prevalent conditions such as COPD, stroke and IHD contribute disproportionately to the multimorbidity burden, with high rates of comorbidity. This modelling approach can be used in other settings to characterise the most important disease combinations and levels of comorbidity.

Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol.

INTRODUCTION: South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months' post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package. METHODS AND ANALYSES: Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24-36 weeks' gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6-8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6-8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention. ETHICS AND DISSEMINATION: Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers. PROTOCOL VERSION: 1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries. TRIAL REGISTRATION NUMBER: PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).

Evaluation of a collaborative care model for integrated primary care of common mental disorders comorbid with chronic conditions in South Africa.

BACKGROUND: The rise in multimorbid chronic conditions in South Africa, large treatment gap for common mental disorders (CMDs) and shortage of mental health specialists demands a task sharing approach to chronic disease management that includes treatment for co-existing CMDs to improve health outcomes. The aim of this study was thus to evaluate a task shared integrated collaborative care package of care for chronic patients with co-existing depressive and alcohol use disorder (AUD) symptoms. METHODS: The complex intervention strengthened capacity of primary care nurse practitioners to identify, diagnose and review symptoms of CMDs among chronic care patients; and implemented a stepped up referral system, that included clinic-based psychosocial lay counsellors, doctors and mental health specialists. Under real world conditions, in four PHC facilities, a repeat cross-sectional Facility Detection Survey (FDS) assessed changes in capacity of nurses to correctly detect CMDs in 1310 patients before implementation and 1246 patients following implementation of the intervention at 12 months; and a non-randomly assigned comparison group cohort study comprising 373 screen positive patients with depressive symptoms using the Patient Health Questionnaire-9 (PHQ9) at baseline, evaluated responses of patients correctly identified and referred for treatment (intervention arm) or not identified and referred (control arm) at three and 12 months. RESULTS: The FDS showed a significant increase in the identification of depression and AUD from pre-implementation to 12-month post-implementation. Depression: (5.8 to 16.4%) 95% CI [2.9, 19.1]); AUD: (0 to 13.8%) 95% CI [0.6-24.9]. In the comparison group cohort study, patients with depressive symptoms having more than a 50% reduction in PHQ-9 scores were greater in the treatment group (n = 69, 55.2%) compared to the comparison group (n = 49, 23.4%) at 3 months (RR = 2.10, p < 0.001); and 12 months follow-up (intervention: n = 57, 47.9%; comparison: n = 60, 30.8%; RR = 1.52, p = 0.006). Remission (PHQ-9 ≤ 5) was greater in the intervention group (n = 32, 26.9%) than comparison group (n = 33, 16.9%) at 12 months (RR = 1.72, p = 0.016). CONCLUSION: A task shared collaborative stepped care model can improve detection of CMDs and reduce depressive symptoms among patients with chronic conditions under real world conditions.

Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianópolis, Brazil.

INTRODUCTION: The Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it. METHODS: Twenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates. RESULTS: Asthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms. CONCLUSION: PACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates. TRIAL REGISTRATION: NCT02786030 (https://clinicaltrials.gov/).

Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials.

BACKGROUND: Multimorbidity is increasing common in Brazilian adults. Comorbid chronic lung disease, cardiovascular disease and diabetes are often inaccurately diagnosed or ineffectively treated. The Global Alliance against Chronic Respiratory Diseases (GARD) aims to strengthen health systems to prevent and control non-communicable diseases through primary health care. The Practical Approach to Care Kit (PACK Adult) is a clinical decision support tool that provides evidence-supported algorithmic guidelines for screening, diagnosis and treatment of chronic diseases, and is widely used in South Africa. It was adapted for Brazil by family physicians in the Florianopolis City Health Department, which trains clinic doctors and nurses to use it. METHODS: Effectiveness of PACK Adult training will be evaluated in two pragmatic cluster randomised trials, one enrolling adults with chronic lower respiratory diseases and the other enrolling adults with cardiovascular disease or diabetes. Forty-eight municipal clinics in Florianopolis were randomly allocated to intervention or control arms. In intervention arm clinics, doctors and nurses will receive educational outreach training and the PACK Adult clinical decision support tool. In control arm clinics, doctors and nurses will receive only the tool. Trial outcomes will be measured using patients' electronic medical records during 12 months after completion of basic training. Primary outcomes for the respiratory trial are appropriate prescribing, spirometry and diagnosis rates. Primary outcomes for the cardiovascular trial are testing for cardiovascular risk and diabetes, and systolic blood pressure. Educational outreach to primary care professionals could improve respiratory, cardiovascular and diabetes care in Brazil. TRIAL REGISTRATION: NCT02786030 and NCT02795910 (https://clinicaltrials.gov/).

Educational Outreach with an Integrated Clinical Tool for Nurse-Led Non-communicable Chronic Disease Management in Primary Care in South Africa: A Pragmatic Cluster Randomised Controlled Trial.

BACKGROUND: In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses' role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses' capacity to manage NCDs. METHODS AND FINDINGS: In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1.24; p = 0.252]; diabetes: 57% versus 50%, RR 1.10 [0.97 to 1.24; p = 0.126]; chronic respiratory disease: 14% versus 12%, RR 1.08 [0.75 to 1.55; p = 0.674]), nor was case detection of depression (18% versus 24%, RR 0.76 [0.53 to 1.10; p = 0.142]). No adverse effects of the nurses' expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up. CONCLUSIONS: Educational outreach to primary care nurses to train them in the use of a management tool involving an expanded role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa. TRIAL REGISTRATION: The trial is registered with Current Controlled Trials (ISRCTN20283604).

Socioeconomic predictors and consequences of depression among primary care attenders with non-communicable diseases in the Western Cape, South Africa: cohort study within a randomised trial.

BACKGROUND: Socioeconomic predictors and consequences of depression and its treatment were investigated in 4393 adults with specified non-communicable diseases attending 38 public sector primary care clinics in the Eden and Overberg districts of the Western Cape, South Africa. METHODS: Participants were interviewed at baseline in 2011 and 14 months later, as part of a randomised controlled trial of a guideline-based intervention to improve diagnosis and management of chronic diseases. The 10-item Center for Epidemiologic Studies Depression Scale (CESD-10) was used to assess depression symptoms, with higher scores representing more depressed mood. RESULTS: Higher CESD-10 scores at baseline were independently associated with being less educated (p = 0.004) and having lower income (p = 0.003). CESD-10 scores at follow-up were higher in participants with less education (p = 0.010) or receiving welfare grants (p = 0.007) independent of their baseline scores. Participants with CESD-10 scores of ten or more at baseline (56 % of all participants) had 25 % higher odds of being unemployed at follow-up (p = 0.016), independently of baseline CESD-10 score and treatment status. Among participants with baseline CESD-10 scores of ten or more, antidepressant medication at baseline was independently more likely in participants who had more education (p = 0.002), higher income (p < 0.001), or were unemployed (p = 0.001). Antidepressant medication at follow up was independently more likely in participants with higher income (p = 0.023), and in clinics with better access to pharmacists (p = 0.053) and off-site drug delivery (p = 0.013). CONCLUSIONS: Socioeconomic disadvantage appears to be both a cause and consequence of depression, and may also be a barrier to treatment. There are opportunities for improving the prevention, diagnosis and treatment of depression in primary care in inequitable middle income countries like South Africa. TRIAL REGISTRATION: The trial is registered with Current Controlled Trials ( ISRCTN20283604 ).

Effect of antiretroviral treatment on the risk of tuberculosis during South Africa's programme expansion.

OBJECTIVE: The objective of this study is to estimate the effectiveness of antiretroviral treatment (ART) in preventing tuberculosis (TB) in HIV-infected people during the first 6 years of ART programme expansion. DESIGN: A cohort study comparing TB risk without ART and after ART initiation. SETTING: Public sector HIV programme of the Free State province, South Africa. PARTICIPANTS: Seventy-four thousand and seventy-four HIV-infected people enrolled from 2004 until 2010, of whom 43 898 received ART and 30 176 did not. INTERVENTION: Combination ART. MAIN OUTCOME MEASURES: Time to first TB diagnosis, adjusted for CD4 cell count, weight, age, sex, previous TB, district and year, with ART, CD4 cell count and weight as time-varying covariates and with death as a competing risk. RESULTS: Three thousand eight hundred and fifty-eight first TB episodes occurred during 78 202 person-years at risk with ART and 5669 episodes occurred during 62 801 person-years without ART [incidence rates 4.9 and 9.0 per 100 person-years, crude incidence rate ratio 0.55 (95% confidence interval 0.52-0.57)]. The adjusted subhazard ratio (SHR) of time to first TB episode after starting ART, compared with follow-up without ART, was 0.67 (0.64-0.70). Within CD4 cell count subgroups (<50, 50-199, 100-199, 200-349 and >350 cells/µl), the respective SHRs were 0.64 (0.57-0.71), 0.63 (0.57-0.70), 0.66 (0.61-0.72), 0.67 (0.62-0.72), 0.72 (0.63-0.83) and 0.97 (0.60-1.59). Adjusted SHRs for ART decreased with each year of enrolment, from 0.90 (0.77-1.04) in 2004 to 0.54 (0.43-0.67) in 2010. CONCLUSION: ART was effective in preventing TB in HIV-infected patients with CD4 cell counts below 350 cells/µl, but less so than previously estimated. Effectiveness increased each year.

Multimorbidity, control and treatment of noncommunicable diseases among primary healthcare attenders in the Western Cape, South Africa.

BACKGROUND: South Africa (SA) is facing a heavy burden of non-communicable diseases (NCDs). Few studies address multimorbidity, control and treatment of NCDs in patients attending primary healthcare (PHC) clinics. OBJECTIVES: To describe multimorbidity, related risk factors, disease severity and treatment status of patients with four important NCDs attending public sector PHC clinics in two districts in SA. METHODS: A cross-sectional sample of patients completed baseline data collection for a randomised controlled trial of a health systems intervention. The study population comprised adults attending PHC clinics in the Eden and Overberg districts of the Western Cape in 2011. Four subgroups of patients were identified: hypertension, diabetes, chronic respiratory disease and depression. A total of 4 393 participants enrolled from 38 clinics completed a baseline structured questionnaire and had measurements taken. Prescription data were recorded. RESULTS: Of participants with hypertension, diabetes, respiratory disease and depression, 80%, 92%, 88% and 80%, respectively, had at least one of the other three conditions. There were low levels of control and treatment: 59% of participants with hypertension had a blood pressure ≥140/90 mmHg, the mean haemoglobin A1c (HbA1c) value in participants with diabetes was 9%, 12% of participants in the depression group were prescribed an antidepressant at a therapeutic dose, and 48% of respiratory participants were prescribed a b2-agonist and 34% an inhaled corticosteroid. CONCLUSION: Considerable multimorbidity and unmet treatment needs exist among patients with NCDs attending public sector PHC clinics. Improved strategies are required for diagnosing and managing NCDs in this sector.

Integration of HIV care into primary care in South Africa: effect on survival of patients needing antiretroviral treatment.

BACKGROUND: Integration of HIV care into primary care is a potential strategy to improve access to antiretroviral therapy (ART) in high-burden countries. This study was conducted to determine the effect of integration of HIV care on the survival of patients needing ART. METHODS: A questionnaire was used to measure the integration of HIV care into primary care during a randomized controlled trial of task shifting and decentralization of HIV care in South Africa. Cox proportional hazard ratios (HRs) were estimated for the effect of 5 different integration scores (total, pre-ART, ART, mainstreaming HIV, and internal integration) on the survival of patients with CD4 count ≤350 cells per microliter and not yet on ART. RESULTS: A total of 9252 patients were followed up for 12-18 months. Cox proportional HRs adjusted for patient and clinic characteristics showed decreased risk of mortality in clinics with high scores for total integration [HR, 0.97; 95% confidence interval (CI), 0.95 to 0.98; P < 0.001], ART integration (HR, 0.94; 95% CI, 0.90 to 0.99; P = 0.013), and internal integration (HR, 0.97; 95% CI, 0.95 to 1.00; P = 0.041). Analysis of the effect of component scores adjusted for patient characteristics only showed decreased risk of mortality in clinics with high scores for total integration (HR, 0.97; 95% CI, 0.94 to 1.00; P = 0.032), pre-ART integration (HR, 0.92; 95% CI, 0.85 to 0.99; P = 0.027), ART integration (HR, 0.95; 95% CI, 0.93 to 0.98; P = 0.001), and mainstreaming HIV (HR, 0.90; 95% CI, 0.83 to 0.97; P = 0.007). CONCLUSION: In a context of task shifting and decentralization of care, integration of HIV care into primary care is associated with improved survival of HIV-positive patients needing ART.

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.The STRETCH trial is registered with Current Control Trials ISRCTN46836853.

Outreach education for integration of HIV/AIDS care, antiretroviral treatment, and tuberculosis care in primary care clinics in South Africa: PALSA PLUS pragmatic cluster randomised trial.

OBJECTIVE: To investigate whether PALSA PLUS, an on-site educational outreach programme of non-didactic, case based, iterative clinical education of staff, led by a trainer, can increase access to and comprehensiveness of care for patients with HIV/AIDS. DESIGN: Cluster randomised trial. SETTING: Public primary care clinics offering HIV/AIDS care, antiretroviral treatment (ART), tuberculosis care, and ambulatory primary care in Free State province, South Africa. PARTICIPANTS: Fifteen clinics all implementing decentralisation and task shifting were randomised. The clinics cared for 400,000 general primary care patients and 10,136 patients in an HIV/AIDS/ART programme. There were 150 nurses. INTERVENTION: On-site outreach education in eight clinics; no such education in seven (control). MAIN OUTCOME MEASURES: Provision of co-trimoxazole prophylaxis among patients referred to the HIV/AIDS/ART programme, and detection of cases of tuberculosis among those in the programme. Proportion of patients in the programme enrolled through general primary care consultations. RESULTS: Patients referred to the HIV/AIDS programme through general primary care at intervention clinics were more likely than those at control clinics to receive co-trimoxazole prophylaxis (41%, (2253/5523) v 32% (1340/4210); odds ratio 1.95, 95% confidence interval 1.11 to 3.40), and tuberculosis was more likely to be diagnosed among patients with HIV/AIDS/ART (7% (417/5793) v 6% (245/4343); 1.25, 1.01 to 1.55). Enrolment in the HIV/AIDS and ART programme through HIV testing in general primary care was not significantly increased (53% v 50%; 1.19, 0.51 to 2.77). Secondary outcomes were similar, except for weight gain, which was higher in the intervention group (2.3 kg v 1.9 kg, P<0.001). CONCLUSION: Though outreach education is an effective and feasible strategy for improving comprehensiveness of care and wellbeing of patients with HIV/AIDS, there is no evidence that it increases access to the ART programme. It is now being widely implemented in South Africa. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 24820584.

Development of a South African integrated syndromic respiratory disease guideline for primary care.

AIMS: The Practical Approach to Lung Health in South Africa (PALSA) initiative aimed to develop an integrated symptom- and sign-based (syndromic) respiratory disease guideline for nurse care practitioners working in primary care in a developing country. METHODS: A multidisciplinary team developed the guideline after reviewing local barriers to respiratory health care provision, relevant health care policies, existing respiratory guidelines, and literature. Guideline drafts were evaluated by means of focus group discussions. Existing evidence-based guideline development methodologies were tailored for development of the guideline. RESULTS: A locally-applicable guideline based on syndromic diagnostic algorithms was developed for the management of patients 15 years and older who presented to primary care facilities with cough or difficulty breathing. CONCLUSIONS: PALSA has developed a guideline that integrates and presents diagnostic and management recommendations for priority respiratory diseases in adults using a symptom- and sign-based algorithmic guideline for nurses in developing countries.

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

Effectiveness of antiretroviral treatment in a South African program: a cohort study.

BACKGROUND: The effectiveness of the South African government's expanding antiretroviral treatment program is unknown. Observational studies of treatment effectiveness are prone to selection bias, rarely compare patients receiving antiretroviral treatment with similar patients not receiving antiretroviral treatment, and underestimate mortality rates unless patients are actively followed up. METHODS: We followed up 14 267 patients in the Public Sector Anti-Retroviral Treatment project in Free State, South Africa, for up to 20 months after enrollment. A total of 3619 patients received highly active triple antiretroviral treatment (HAART) for up to 19 months (median, 6 months; interquartile range, 3-9 months) after enrollment. Patients' clinical data were linked with the national mortality register. Marginal structural regression models adjusted for baseline and time-varying covariates. RESULTS: Of 4570 patients followed up for at least 1 year, 53.2% died. Eighty-seven percent of patients who died had not received HAART. HAART was associated with lower mortality (hazard ratio, 0.14; 95% confidence interval [CI], 0.11-0.18) and with the presence of tuberculosis (hazard ratio, 0.61; 95% CI, 0.46-0.81) after adjusting for age, sex, weight, clinic, district, CD4 cell count, cotrimoxazole therapy, tuberculosis at baseline, and previous antiretroviral therapy. Cotrimoxazole therapy was associated with lower mortality (hazard ratio, 0.37; 95% CI, 0.32-0.42). Each month of HAART was associated with an increase in CD4 cell count of 15.1 cells/microL (95% CI, 14.7-15.5 cells/microL) and with an increase in body weight of 602 g (95% CI, 548-658 g). CONCLUSIONS: HAART provided through these South African government health services seems as effective as that provided in high-income countries. Delays starting HAART contributed to high mortality rates. Faster expansion and timely commencement of HAART are needed.

Highly active antiretroviral treatment and health related quality of life in South African adults with human immunodeficiency virus infection: A cross-sectional analytical study.

BACKGROUND: 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.

Diagnostic accuracy of an integrated respiratory guideline in identifying patients with respiratory symptoms requiring screening for pulmonary tuberculosis: a cross-sectional study.

BACKGROUND: 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.

Effect of educational outreach to nurses on tuberculosis case detection and primary care of respiratory illness: pragmatic cluster randomised controlled trial.

OBJECTIVES: To develop and implement an educational outreach programme for the integrated case management of priority respiratory diseases (practical approach to lung health in South Africa; PALSA) and to evaluate its effects on respiratory care and detection of tuberculosis among adults attending primary care clinics. DESIGN: Pragmatic cluster randomised controlled trial, with clinics as the unit of randomisation. SETTING: 40 primary care clinics, staffed by nurse practitioners, in the Free State province, South Africa. PARTICIPANTS: 1999 patients aged 15 or over with cough or difficult breathing (1000 in intervention clinics, 999 in control clinics). INTERVENTION: Between two and six educational outreach sessions delivered to nurse practitioners by usual trainers from the health department. The emphasis was on key messages drawn from the customised clinical practice guideline for the outreach programme, with illustrative support materials. MAIN OUTCOME MEASURES: Sputum screening for tuberculosis, tuberculosis case detection, inhaled corticosteroid prescriptions for obstructive lung disease, and antibiotic prescriptions for respiratory tract infections. RESULTS: All clinics and almost all patients (92.8%, 1856/1999) completed the trial. Although sputum testing for tuberculosis was similar between the groups (22.6% in outreach group v 19.3% in control group; odds ratio 1.22, 95% confidence interval 0.83 to 1.80), the case detection of tuberculosis was higher in the outreach group (6.4% v 3.8%; 1.72, 1.04 to 2.85). Prescriptions for inhaled corticosteroids were also higher (13.7% v 7.7%; 1.90, 1.14 to 3.18) but the number of antibiotic prescriptions was similar (39.7% v 39.4%; 1.01, 0.74 to 1.38). CONCLUSIONS: Combining educational outreach with integrated case management provides a promising model for improving quality of care and control of priority respiratory diseases, without extra staff, in resource poor settings. TRIAL REGISTRATION: Current controlled trials ISRCTN13438073.