CobALT (Comorbid Affective disorders, AIDS/HIV, and Long Term health) is a pragmatic cluster randomised controlled trial in public sector primary care clinics in the North West province of South Africa. The trial evaluated the effectiveness of a facility-based intervention combining depression case detection by non-physician clinicians (in this setting, nurses) with individual and group psychosocial counselling for depression delivered by lay-health workers, on mental health and HIV outcomes in depressed adults receiving antiretroviral treatment (ART). Forty primary care clinics in two districts of the North West province were randomised either to receive the intervention or to continue with usual care. Data were collected at a patient level, with 2002 participants being interviewed at three time-points (baseline, 6 and 12 months) between April 2015 and December 2017.The co-primary outcomes are depression symptoms measured at 6 months and viral load blood tests measured at 12 months. Secondary outcome measures include adherence to ART medication, risk factors for cardiovascular disease (blood pressure, body mass index and smoking status) and cost effectiveness of the intervention. The trial is designed to provide vital evidence on how integrated multi-disease management can be achieved within resource constrained settings. This evidence will also have important implications internationally, especially for other low and middle-income countries as ART becomes more available. Data collection closed in December 2017 and data is currently being analysed.
CobALT is funded by the National Institute of Mental Health, National Institutes of Health (NIH). Ethical approval for the study has been obtained from the University of Cape Town Human Research Ethics Committee, the University of KwaZulu-Natal Biomedical Research Ethics Committee, and the King’s College London Research Ethics Committee. The principal investigators are Prof Graham Thornicroft, King’s College London; Dr Lara Fairall, University of Cape Town Lung Institute; and Prof Inge Petersen, University of KwaZulu-Natal.
Fairall L, Petersen I, Zani B, Folb N, Georgeu-Pepper D, Selohilwe O, Petrus R, Mntambo N, Bhana A, Lombard C, Bachmann M, Lund C, Hanass-Hancock J, Chisholm D, McCrone P, Carmona S, Gaziano T, Levitt N, Kathree T, Thornicroft G; CobALT research team. Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial. Trials. 2018 Mar 22;19(1):193. doi: 10.1186/s13063-018-2517-7.
The goal of the PRogramme for Improving Mental health carE (PRIME) is to generate research evidence on the implementation and scaling-up of treatment programmes for mental disorders in low resource settings. PRIME is a multi-country initiative supported by the Department for International Development (DFID), and is a six year programme which was launched in May 2011.
PRIME South Africa is being conducted in the North West Province. The initiative includes the stepped-care intervention described above, aimed at improving the diagnosis and management of depression in patients attending public sector primary care clinics. A pragmatic cluster randomsied controlled trial was conducted alongside the COBALT trial to evaluate the stepped-care intervention on mental health and hypertension outcomes in depressed adults receiving antihypertensive medication. Data collection for the PRIME trail closed in October 2016, with 1043 enrolled participants interviewed at baseline, six and twelve months. Data analysis for the PRIME trial is in progress.
Petersen I, Bhana A, Folb N, Thornicroft G, Zani B, Selohilwe O, Petrus R, Mntambo N, Georgeu-Pepper D, Kathree T, Lund C, Lombard C, Bachmann M, Gaziano T, Levitt N, Fairall L; PRIME-SA research team. Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial. Trials. 2018 Mar 22;19(1):192. doi: 10.1186/s13063-018-2518-6.
Testing of PACK by the University of Stellenbosch undergraduate medical students
The Knowledge Translation Unit undertook formative work to determine how best to integrate the Practical Approaches Care Kit with existing clinical mentorship (by Family Physicians) for students during their Primary Care rotations in their final year of study. This evaluation focused on how evidence summaries are used and the extent to which inter-professional collaboration is modelled, either positively or negatively, in primary care settings where task-sharing is increasingly used. Secondly, the KTU undertook a quasi-experimental evaluation of how the intervention impacted students’ performance in their exams and attitudes towards inter-professional collaboration. Student performance in examinations was significantly better in those exposed to the PACK. Students varied from using the PACK overtly or covertly during the consultation to checking up on decisions made after the consultation. Some felt that the PACK was more suitable for nurses or more junior students. Although tutors openly endorsed PACK, very few modelled the use of PACK in their clinical practice. The use of PACK in the final phase of undergraduate medical education improved their performance in primary care. Students might be more accepting and find the tool more useful in the earlier clinical rotations. Supervisors should be trained further in how to incorporate the use of the PACK in their practice and educational conversations.
Reference:Mash R, Pather M, Rhode H, Fairall L. Evaluating the effect of the Practical Approach to Care Kit on teaching medical students primary care: Quasi-experimental study. Afr J Prim Health Care Fam Med. 2017 Dec 8;9(1):e1-e8. doi: 10.4102/phcfm.v9i1.1602.
Piloting the feasibility and usability of the electronic version of PACK
The availability, ease of use and technical capabilities of mobile technology (smart phones and tablets) provide many opportunities to strengthen the provision of quality healthcare. The Knowledge Translation Unit developed an interactive electronic version of the PACK guideline, then called e-PC101, now renamed e-PACK, which is suitable for use on tablets. Electronic guidelines offer many potential advantages such as saving on printing and distribution costs, providing a platform to enrich user experience through feedback, and streamlining updating processes. While the field of e-Health is growing rapidly, and electronic applications are increasingly being developed for healthcare settings, few are adequately tested before implementation, and many fail to deliver on their promised efficiencies. The KTU piloted the use of e-PACK at four primary care facilities in the Western Cape Province during 2014. We evaluated the feasibility, usability and user interface design before further development and testing in pragmatic trials.
The pilot is described in a PACK Collection Paper Submitted to BMJ Global Health as part of the PACK Collection
Yau M et al. e-PC101 - An electronic clinical decision support tool for primary care in low and middle-income countries.
Evidence on the effectiveness of the Primary Care 101 guidelineThis pragmatic randomised controlled trial was conducted during 2011-2013 in 38 clinics in the Eden and Overberg districts of the Western Cape, South Africa. It aimed to test whether the Primary Care 101 programme improved quality of primary care for adult chronic diseases. The trial evaluated treatment outcomes for hypertension, diabetes, chronic respiratory disease and the detection of depression. 4393 patients were interviewed in 2011 at baseline and re-interviewed approximately 14 months later. A 90% follow up rate was achieved. Treatment intensification rates in intervention clinics were not superior to those in the control clinics 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 at follow-up. 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.
- Fairall LR, Folb N, Timmerman V, Lombard C, Steyn K, Bachmann MO, Bateman ED, Lund C, Cornick R, Faris G, Gaziano T, Georgeu-Pepper D, Zwarenstein M, Levitt NS. 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. PLoS Med. 2016 Nov 22;13(11):e1002178. doi: 10.1371/journal.pmed.1002178. eCollection 2016 Nov.
- Folb N, Bachmann MO, Bateman ED, Steyn K, Levitt NS, Timmerman V, Lombard C, Gaziano TA, Fairall LR. Socioeconomic and modifiable predictors of blood pressure control for hypertension in primary care attenders in the Western Cape, South Africa. S Afr Med J. 2016 Dec 1;106(12):1241-1246. doi: 10.7196/SAMJ.2016.v106.i12.12005.
- Elwell-Sutton T, Folb N, Clark A, Fairall LR, Lund C, Bachmann MO. Socioeconomic position and depression in South African adults with long-term health conditions: a longitudinal study of causal pathways. Epidemiol Psychiatr Sci. 2017 Aug 14:1-11. doi: 10.1017/S2045796017000427.
- Folb N, Timmerman V, Levitt NS, Steyn K, Bachmann MO, Lund C, et al. Multimorbidity, control and treatment of non-communicable diseases among primary healthcare attenders in the Western Cape, South Africa. SAMJ 2015;105:642-7
- Folb N, Lund C, Fairall LR, Timmerman V, Levitt NS, Steyn K, Bachmann MO. 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. BMC Public Health. 2015; 15:1194
Task shifting of antiretroviral treatment from doctors to primary-care nurses in South AfricaThe Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme provides educational outreach training of nurses to initiate and prescribe ART, and to decentralise care. We aimed to assess the effectiveness of the programme on mortality, viral suppression, and other health outcomes and quality indicators. The trial which randomized 31 primary-care ART clinics in the Free State Province in South Africa enrolled adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART in cohort 1, and those who had already received ART for at least 6 months and were being treated at enrolment in cohort 2. A total of 15483 participants were enrolled. While the risk of death did not differ between the intervention and control group in cohort 1, in a pre-planned subgroup analysis of patients with baseline CD4 counts of 201-350 cells per μL, mortality was slightly lower in the intervention group than in the control group. Viral load suppression at 12 months was equivalent between groups in cohort 2. Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality.
- Fairall LR, Bachmann MO, Zwarenstein MF, Lombard CJ, Uebel K, van Vuuren C, Steyn D, Boulle A, Bateman ED. Streamlining Tasks and Roles to Expand Treatment and Care for HIV: Randomised Controlled Trial Protocol. Trials 9 (2008): 21. doi:10.1186/1745-6215-9-21.
- Fairall L, Bachmann MO, Lombard C, Timmerman V, Uebel K, Zwarenstein M, Boulle A, Georgeu D, Colvin CJ, Lewin S, Faris G, Cornick R, Draper B, Tshabalala M, Kotze E, van Vuuren C, Steyn D, Chapman R, Bateman E. Task Shifting of Antiretroviral Treatment from Doctors to Primary-care Nurses in South Africa (STRETCH): a Pragmatic, Parallel, Cluster-randomised Trial. Lancet. 2012 Sep 8;380(9845):889-98.
- Georgeu D, Colvin CJ, Lewin S, Fairall L, Bachmann MO, Uebel K, Zwarenstein M, Draper B, Bateman ED. Implementing Nurse-initiated and Managed Antiretroviral Treatment (NIMART) in South Africa: a Qualitative Process Evaluation of the STRETCH Trial. Implementation Science 7, no. 1 (July 16, 2012): 66. doi:10.1186/1748-5908-7-66.
- Uebel KE, Fairall LR, van Rensburg DH, Mollentze WF, Bachmann MO, Lewin S, Zwarenstein M, Colvin CJ, Georgeu D, Mayers P, Faris GM, Lombard C, Bateman ED. 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. Implementation Science 6, no. 1 (August 2, 2011): 86. doi:10.1186/1748-5908-6-86.
- Uebel KE, Lombard C, Joubert G, Fairall LR, Bachmann MO, Mollentze WF, van Rensburg D, Wouters E. Integration of HIV Care into Primary Care in South Africa: Effect on Survival of Patients Needing Antiretroviral Treatment. Journal of Acquired Immune Deficiency Syndromes (1999) 63, no. 3 (July 1, 2013): e94–100. doi:10.1097/QAI.0b013e318291cd08.
Outreach education for integration of HIV/AIDS care, antiretroviral treatment and tuberculosisWe sought 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. Fifteen public primary care clinics implementing decentralisation and task shifting, that is offering HIV/AIDS care, antiretroviral treatment (ART), tuberculosis care and ambulatory primary care in Free State Province of South Africa were randomized. Patients referred to the HIV/AIDS programme through general primary care at intervention clinics were more likely to receive co-trimoxazole prophylaxis and tuberculosis was more likely to be diagnosed among patients with HIV/AIDS and/or on ART. There was no difference in HIV testing and ART initiation. Patients in intervention facilities were more likely to gain weight. Though outreach education didn’t prove to increase access to the ART programme, it is an effective and feasible strategy for improving comprehensiveness of care and wellbeing of patients with HIV/AIDS and is now being widely implemented in South Africa.
- Zwarenstein M, Fairall LR, Lombard C, Mayers P, Bheekie A, English RG, et al. 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. BMJ. 2011;342:d2022.
- Fairall L, Bachmann MO, Zwarenstein M, Bateman ED, Niessen LW, Lombard C, Majara B, English R, Bheekie A, van Rensburg D, Mayers P, Peters A, Chapman R. Cost-effectiveness of Educational Outreach to Primary Care Nurses to Increase Tuberculosis Case Detection and Improve Respiratory Care: Economic Evaluation Alongside a Randomised Trial. Tropical Medicine & International Health: TM & IH 15, no. 3 (March 2010): 277–286. doi:10.1111/j.1365-3156.2009.02455.x.
- Stein J, Lewin S, Fairall L, Mayers P, English R, Bheekie A, Bateman E, Zwarenstein M. Building Capacity for Antiretroviral Delivery in South Africa: A Qualitative Evaluation of the PALSA PLUS Nurse Training Programme. BMC Health Services Research 8, no. 1 (November 18, 2008): 240. doi:10.1186/1472-6963-8-240.
- Bachmann MO, Fairall LR, Lombard C, Timmerman V, van der Merwe S, Bateman ED, Zwarenstein M. Effect on Tuberculosis Outcomes of Educational Outreach to South African Clinics During Two Randomised Trials. The International Journal of Tuberculosis and Lung Disease: The Official Journal of the International Union Against Tuberculosis and Lung Disease 14, no. 3 (March 2010): 311–317.
Practical approach to lung health in South AfricaThe PALSA trial sought to develop and implement an educational outreach programme for the integrated case management of priority respiratory diseases and to evaluate its effects on respiratory care and detection of tuberculosis among adults attending primary care clinics. In this pragmatic cluster randomised controlled trial conducted in 40 primary care clinics in the Free State Province of South Africa, we enrolled 1999 patients aged 15 years and above with cough or difficult breathing. Although sputum testing for tuberculosis was similar between the groups, case detection of tuberculosis was higher in the outreach group. Prescriptions for inhaled corticosteroids were also higher while the number of antibiotic prescriptions was similar. 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.
- Bheekie A, Buskens I, Allen S, English R, Mayers P, Fairall L, Majara B, Bateman ED, Zwarenstein M, Bachmann M. The Practical Approach to Lung Health in South Africa (PALSA) Intervention: Respiratory Guideline Implementation for Nurse Trainers. International Nursing Review 53, no. 4 (December 2006): 261–268. doi:10.1111/j.1466-7657.2006.00520.x.
- English RG, Bateman ED, Zwarenstein MF, Fairall LR, Bheekie A, Bachmann MO, Majara B, Ottmani SE, Scherpbier RW. Development of a South African Integrated Syndromic Respiratory Disease Guideline for Primary Care. Primary Care Respiratory Journal: Journal of the General Practice Airways Group 17, no. 3 (September 2008): 156–163. doi:10.3132/pcrj.2008.00044.
- Fairall L, Zwarenstein M, Bateman ED, Bachmann OM, Lombard C, Majara B, Joubert G, English RG, Bheekie A, van Rensburg HCJ, Mayers P, Peters AC, Chapman RD. Effect of educational outreach to nurses on tuberculosis case detection and primary care of respiratory illness: pragmatic cluster randomised controlled trial. BMJ. 2005; 331:750-754