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1.  A comparison of linkage to HIV care after provider-initiated HIV testing and counselling (PITC) versus voluntary HIV counselling and testing (VCT) for patients with sexually transmitted infections in Cape Town, South Africa 
We examined linkage to care for patients with sexually transmitted infection who were diagnosed HIV-positive via the provider-initiated HIV testing and counselling (PITC) approach, as compared to the voluntary counselling and testing (VCT) approach, as little is known about the impact of expanded testing strategies on linkage to care.
In a controlled trial on PITC (Cape Town, 2007), we compared HIV follow-up care for a nested cohort of 930 HIV-positive patients. We cross-referenced HIV testing and laboratory records to determine access to CD4 and viral load testing as primary outcomes. Secondary outcomes were HIV immune status and time taken to be linked to HIV care. Logistic regression was performed to analyse the difference between arms.
There was no difference in the main outcomes of patients with a record of CD4 testing (69.9% in the intervention, 65.2% in control sites, OR 0.82 (CI: 0.44-1.51; p = 0.526) and viral load testing (14.9% intervention versus 10.9% control arm; OR 0.69 (CI: 0.42-1.12; p = 0.131). In the intervention arm, ART-eligible patients (based on low CD4 test result), accessed viral load testing approximately 2.5 months sooner than those in the control arm (214 days vs. 288 days, HR: 0.417, 95% CI: 0.221-0.784; p = 0.007).
The PITC intervention did not improve linkage to CD4 testing, but shortened the time to viral load testing for ART-eligible patients. Major gaps found in follow-up care across both arms, indicate the need for more effective linkage-to-HIV care strategies.
Trial registration
Current Controlled Trials ISRCTN93692532
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6963-14-350) contains supplementary material, which is available to authorized users.
PMCID: PMC4147183  PMID: 25134822
Routine HIV screening; Linkage to HIV care; Sexually transmitted infections; Controlled trial; South Africa
2.  Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial 
Trials  2014;15:236.
Poverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients’ adherence to treatment, and their treatment outcomes. Although the trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. A qualitative process evaluation, conducted in the final few months of the trial, explained some of the factors that contributed to this low fidelity.
In-depth interviews were conducted with patients who received vouchers, nurses in intervention clinics, personnel in shops who administered the vouchers, and managers of the TB Control Programme. These interviews were analyzed thematically.
The low fidelity to the trial intervention can be explained by two main factors. The first was nurses’ tendency to ‘ration’ the vouchers, only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable. The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates, necessitating further visits to the clinics which they were not always able to make.
This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial. It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ‘street level bureaucrats’ who may profoundly affect the way an intervention is administered.
Trial registration
Current Controlled Trials ISRCTN50689131, registered 21 April 2009.
The trial protocol is available at the following web address:
PMCID: PMC4086265  PMID: 24947537
Economic; Support; Incentives; Enablers; Tuberculosis; Qualitative process evaluation; RCT
3.  The provision of TB and HIV/AIDS treatment support by lay health workers in South Africa: a time-and-motion study 
Lay or community health workers (LHWs) are an important human resource in primary health care, and contribute to improving access to care. However, optimal use of LHWs within the health system is often hampered by a poor understanding of how this cadre organizes its work. This study aimed to better understand how LHWs organize and structure their time in providing treatment and adherence support to people on TB treatment and/or antiretroviral therapy (ART) in South Africa.
Fourteen LHWs participated across three low-income peri-urban communities in Cape Town. Each LHW was observed by a researcher for one day, and data collected on each activity and the time spent on it. Data were summarized in the following categories: travel to the patient’s home, waiting time and patient contact time.
Ninety-seven attempted visits to patients were observed, and patients were located in 69 of these. On average, LHWs conducted six visits per day, each lasting an average of nine minutes. Forty-six percent of the observed time was spent with patients, with the balance spent on ‘non-contact’ activities, including walking to and waiting for patients. The average walking time between patients was 8 minutes (range: 3 to 15 minutes). Activities during visits comprised medical care (that is ensuring that medication was being taken correctly and that patients were not experiencing side-effects) and social support. Other tasks included conducting home assessments to determine risks to treatment adherence, and tracing patients who had defaulted from treatment.
Because of their tasks and working environment, LHWs providing support to people on TB treatment and ART in South Africa spend a substantial proportion of their time on ‘non-contact’ activities. Programme managers need to take this into account when developing job descriptions and determining patient case-loads for this cadre. More research is also needed to explore whether these findings apply to other tasks and settings. Strategies should be explored to mitigate the challenges that LHWs experience in locating and supporting patients, including the use of new technologies, such as mobile phones.
PMCID: PMC3978134  PMID: 24708871
Antiretroviral therapy; Community health workers; HIV/AIDS; Lay health workers; Low-income; Primary health care; TB; Time-and-motion study; Treatment support
4.  Stakeholder views on the incorporation of traditional birth attendants into the formal health systems of low-and middle-income countries: a qualitative analysis of the HIFA2015 and CHILD2015 email discussion forums 
Health workforce shortages are key obstacles to the achievement of the health-related Millennium Development Goals. Task shifting is seen as a way to improve access to pregnancy and childbirth care. However, the role of traditional birth attendants (TBAs) within task shifting initiatives remains contested. The objective of this study was to explore stakeholder views and justifications regarding the incorporation of TBAs into formal health systems.
Data were drawn from messages submitted to the HIFA2015 and CHILD2015 email discussion forums. The forums focus on the healthcare information needs of frontline health workers and citizens in low - and middle-income countries, and how these needs can be met, and also include discussion of diverse aspects of health systems. Messages about TBAs submitted between 2007-2011 were analysed thematically.
We identified 658 messages about TBAs from a total of 193 participants. Most participants supported the incorporation of trained TBAs into primary care systems to some degree, although their justifications for doing so varied. Participant viewpoints were influenced by the degree to which TBA involvement was seen as a long-term or short-term solution and by the tasks undertaken by TBAs.
Many forum members indicated that they were supportive of trained TBAs being involved in the provision of pregnancy care. Members noted that TBAs were already frequently used by women and that alternative options were lacking. However, a substantial minority regarded doing so as a threat to the quality and equity of healthcare. The extent of TBA involvement needs to be context-specific and should be based on evidence on effectiveness as well as evidence on need, acceptability and feasibility.
PMCID: PMC3986654  PMID: 24674648
Traditional birth attendant; TBA; Qualitative; Community health worker; Health manpower; Social media
5.  Non-specialist health worker interventions for mental health care in low- and middle- income countries 
This is the protocol for a review and there is no abstract. The objectives are as follows:
Overall objective
In order to assess the impact of delivery by non-specialist health workers (NSHWs) and other professionals with health roles (OPHRs) on the effectiveness of mental healthcare interventions in low- and middle- income countries (LMICs), we will specifically analyse the effectiveness of NSHWs and OPHRS in delivering acute mental health interventions; as well as the effectiveness of NSHWs and OPHRs in delivering long term follow-up and rehabilitation for people with mental disorders; and the effect of the detection of mental disorders by NSHWs and OPHRs on patient and health delivery outcomes. For each of these objectives we will examine the current evidence for the impact of delivery by NSHWs and OPHRs on the resource use and costs associated with mental healthcare provision in LMICs.
PMCID: PMC3797510  PMID: 24143128
7.  Implementing a provider-initiated testing and counselling (PITC) intervention in Cape town, South Africa: a process evaluation using the normalisation process model 
Provider-initiated HIV testing and counselling (PITC) increases HIV testing rates in most settings, but its effect on testing rates varies considerably. This paper reports the findings of a process evaluation of a controlled trial of PITC for people with sexually transmitted infections (STI) attending publicly funded clinics in a low-resource setting in South Africa, where the trial results were lower than anticipated compared to the standard Voluntary Counselling and Testing (VCT) approach.
This longitudinal study used a variety of qualitative methods, including participant observation of project implementation processes, staff focus groups, patient interviews, and observation of clinical practice. Data were content analysed by identifying the main influences shaping the implementation process. The Normalisation Process Model (NPM) was used as a theoretical framework to analyse implementation processes and explain the trial outcomes.
The new PITC intervention became embedded in practice (normalised) during a two-year period (2006 to 2007). Factors that promoted the normalising include strong senior leadership, implementation support, appropriate accountability mechanisms, an intervention design that was responsive to service needs and congruent with professional practice, positive staff and patient perceptions, and a responsive organisational context. Nevertheless, nurses struggled to deploy the intervention efficiently, mainly because of poor sequencing and integration of HIV and STI tasks, a focus on HIV education, tension with a patient-centred communication style, and inadequate training on dealing with the operational challenges. This resulted in longer consultation times, which may account for the low test coverage outcome.
Leadership and implementation support, congruent intervention design, and a responsive organisational context strengthened implementation. Poor compatibility with nurse skills on the level of the clinical consultation may have contributed to limiting the size of the trial outcomes. A close fit between the PITC intervention design and clinical practices, as well as appropriate training, are needed to ensure sustainability of the programme. The use of a theory-driven analysis promotes transferability of the results, and the findings are therefore relevant to the implementation of HIV testing and to the design and evaluation of complex interventions in other settings.
Trial registration
Current controlled trials ISRCTN93692532
PMCID: PMC3765808  PMID: 23972055
Routine ‘opt-out’ HIV testing; Process evaluation; Normalisation process model; Sexually transmitted infection; Qualitative method
8.  Completeness of reporting of setting and health worker cadre among trials on antenatal iron and folic acid supplementation in pregnancy: an assessment based on two Cochrane reviews 
Systematic Reviews  2013;2:42.
Poor reporting of medical trials has triggered the development of trial reporting standards within the scientific community. In addition to a description of the proposed intervention, adequate information about the trial setting and the group of health workers (cadre) delivering the intervention would allow a better understanding of the generalizability of the trial findings, facilitate replication of trial interventions and assist with assessment of trials for inclusion in systematic reviews. This study aims to determine the completeness of reporting for trial setting and cadre among trials included in two Cochrane reviews on iron and folic acid supplementation for women during pregnancy.
From the 81 trials included in the two Cochrane reviews, we extracted data on the trial setting, including the facility type and geographic location, facility descriptors (i.e. level of care) and population descriptors (i.e. socioeconomic status); and the cadre, including professional qualifications, training and supervision.
Almost all studies reported the facility type and location (96%). However, only 68% included this information in the “methods” section of the report. Facility descriptors and population descriptors were less commonly reported (26% and 54% respectively). For 34% of the trials, we found some account of the type of health worker that delivered the intervention. Only 4% of the trials reported any training procedures.
Currently, complete reporting of setting and health worker cadre in iron and folic acid supplementation in pregnancy trials remains far from ideal, limiting assessments of the applicability of the trial findings. Trialists and journals need to ensure that this information is included in trial reports by adhering to and improving current reporting standards and by not making assumptions regarding readers’ knowledge of the context and of the intervention delivery mechanism.
PMCID: PMC3689645  PMID: 23773404
9.  Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial 
Trials  2013;14:154.
Poverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa.
This was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n = 2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n = 1,984) received usual tuberculosis care.
Intention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P = 0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose–response relationship between frequency of receipt of the voucher and treatment success (P <0.001).
Our pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it.
Trial registration
Current Controlled Trials ISRCTN50689131
PMCID: PMC3680200  PMID: 23714270
Conditional cash transfers; Economic support; Incentives; Poverty; TB
10.  Policymakers’ and other stakeholders’ perceptions of key considerations for health system decisions and the presentation of evidence to inform those considerations: an international survey 
The DECIDE framework was developed to support evidence-informed health system decisions through evidence summaries tailored to health policymakers. The objective of this study was to determine policymakers’ perceptions regarding the criteria in the DECIDE framework and how best to summarise and present evidence to support health system decisions.
We conducted an online survey of a diverse group of stakeholders with health system decision experience from 15 countries and the World Health Organization. We asked about perceptions of criteria relevant to making health system decisions, use of evidence, grading systems, and evidence summaries.
We received 112 responses (70% response rate). Most respondents had healthcare (85%) and research (79%) experience. They (99%) indicated that systematic consideration of the available evidence would help to improve health system decision-making processes and supported the use of evidence from other countries (94%) and grading systems (81%). All ten criteria in the DECIDE framework were rated as important in the decision-making process. Respondents had divergent views regarding whether the same (38%) or different (45%) grading systems should be used across different types of health decisions. All components of our evidence summary were rated as important by over 90% of respondents.
Survey respondents were supportive of the DECIDE framework for health system decisions and the use of succinct summaries of the estimated size of effects and the quality of evidence. It is uncertain whether the findings of this survey represent the views of policymakers with little or no healthcare and research experience.
PMCID: PMC3672010  PMID: 23705832
Decide; Evidence summaries; Health system decisions
11.  “Communicate to vaccinate”: the development of a taxonomy of communication interventions to improve routine childhood vaccination 
Vaccination is a cost-effective public health measure and is central to the Millennium Development Goal of reducing child mortality. However, childhood vaccination coverage remains sub-optimal in many settings. While communication is a key feature of vaccination programmes, we are not aware of any comprehensive approach to organising the broad range of communication interventions that can be delivered to parents and communities to improve vaccination coverage. Developing a classification system (taxonomy) organised into conceptually similar categories will aid in: understanding the relationships between different types of communication interventions; facilitating conceptual mapping of these interventions; clarifying the key purposes and features of interventions to aid implementation and evaluation; and identifying areas where evidence is strong and where there are gaps. This paper reports on the development of the ‘Communicate to vaccinate’ taxonomy.
The taxonomy was developed in two stages. Stage 1 included: 1) forming an advisory group; 2) searching for descriptions of interventions in trials (CENTRAL database) and general health literature (Medline); 3) developing a sampling strategy; 4) screening the search results; 5) developing a data extraction form; and 6) extracting intervention data. Stage 2 included: 1) grouping the interventions according to purpose; 2) holding deliberative forums in English and French with key vaccination stakeholders to gather feedback; 3) conducting a targeted search of grey literature to supplement the taxonomy; 4) finalising the taxonomy based on the input provided.
The taxonomy includes seven main categories of communication interventions: inform or educate, remind or recall, teach skills, provide support, facilitate decision making, enable communication and enhance community ownership. These categories are broken down into 43 intervention types across three target groups: parents or soon-to-be-parents; communities, community members or volunteers; and health care providers.
Our taxonomy illuminates and organises this field and identifies the range of available communication interventions to increase routine childhood vaccination uptake. We have utilised a variety of data sources, capturing information from rigorous evaluations such as randomised trials as well as experiences and knowledge of practitioners and vaccination stakeholders. The taxonomy reflects current public health practice and can guide the future development of vaccination programmes.
PMCID: PMC3655915  PMID: 23663327
Childhood; Vaccination; Immunisation; Communication; Low- and middle-income country; Intervention; Consumer; Taxonomy; Parents
12.  Integrating HIV care into nurse-led primary health care services in South Africa: a synthesis of three linked qualitative studies 
The integration of HIV care into primary care services is one of the strategies proposed to increase access to treatment for people living with HIV/AIDS in high HIV burden countries. However, how best to do this is poorly understood. This study documents different factors influencing models of integration within clinics.
Using methods based on the meta-ethnographic approach, we synthesised the findings from three qualitative studies of the factors that influenced integration of HIV care into all consultations in primary care. The studies were conducted amongst staff and patients in South Africa during a randomised trial of nurse initiation of antiretroviral therapy (ART) and integration of HIV care into primary care services – the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) trial. Themes from each study were identified and translated into each other to develop categories and sub-categories and then to inform higher level interpretations of the synthesised data.
Clinics varied as to how HIV care was integrated. Existing administration systems, workload and support staff shortages tended to hinder integration. Nurses’ wanted to be involved in providing HIV care and yet also expressed preferences for developing expertise in certain areas and for establishing good nurse patient relationships by specialising in certain services. Patients, in turn, were concerned about the stigma of separate HIV services and yet preferred to be seen by nurses with expertise in HIV care. These factors had conflicting effects on efforts to integrate HIV care.
Local clinic factors and nurse and patient preferences in relation to care delivery should be taken into account in programmes to integrate HIV care into primary care services. The integration of medical records, monitoring and reporting systems would support clinic based efforts to integrate HIV care into primary care services.
PMCID: PMC3652780  PMID: 23647922
Integration; HIV care; Primary health care; Nurse specialisation; Stigma
13.  Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial 
Lancet  2012;380(9845):889-898.
Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.
We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853.
5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned 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 (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6).
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.
UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.
PMCID: PMC3442223  PMID: 22901955
14.  Towards an empowerment approach in tuberculosis treatment in Cape Town, South Africa: a qualitative analysis of programmatic change 
Global Health Action  2012;5:10.3402/gha.v5i0.14385.
Tuberculosis rates in the world remain high, especially in low- and middle-income countries. International tuberculosis (TB) policy generally recommends the use of directly observed therapy (DOT) to ensure treatment adherence.
This article examines a change in TB treatment support that occurred in 2005 in South Africa, from DOT to the enhanced TB adherence programme (ETA).
Seven key individuals representing academics, policy makers and service providers involved in the development of the ETA programme or knowledgeable about the issue were purposively sampled and interviewed, and participant observation was conducted at ETA programme steering group meetings. Qualitative content analysis was used to analyse the data, drawing on the Kingdon model of agenda setting. This model suggests that three independent streams – problem, policy and politics – come together at a certain point, often facilitated by policy entrepreneurs, to provide an opportunity for an issue to enter the policy agenda.
The results suggest the empowerment-oriented programme emerged through the presence of policy entrepreneurs with access to resources. Policy entrepreneurs were influenced by a number of simultaneously occurring challenges including problems within the existing programme; a perceived mismatch between patient needs and the existing TB treatment model; and the TB-HIV co-epidemic. Policy entrepreneurs saw the ART approach as a possible solution to these challenges.
The Kingdon model contributed to describing the process of policy change. Research evidence seemed to influence this change diffusely, through the interaction of policy entrepreneurs and academics.
PMCID: PMC3422464  PMID: 22902052
tuberculosis; South Africa; policy; treatment; DOT; qualitative
15.  Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial 
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.
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.
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.
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
PMCID: PMC3464669  PMID: 22800379
Antiretroviral treatment; NIMART; South Africa; Primary healthcare; Nurse training; Process evaluation; PALSA PLUS
16.  Guidance for Evidence-Informed Policies about Health Systems: Assessing How Much Confidence to Place in the Research Evidence 
PLoS Medicine  2012;9(3):e1001187.
In the third paper in a three-part series on health systems guidance, Simon Lewin and colleagues explore the challenge of assessing how much confidence to place in evidence on health systems interventions.
PMCID: PMC3308931  PMID: 22448147
17.  Guidance for Evidence-Informed Policies about Health Systems: Linking Guidance Development to Policy Development 
PLoS Medicine  2012;9(3):e1001186.
In the second paper in a three-part series on health systems guidance, John Lavis and colleagues explore the challenge of linking guidance development and policy development at global and national levels.
PMCID: PMC3302830  PMID: 22427746
18.  Guidance for Evidence-Informed Policies about Health Systems: Rationale for and Challenges of Guidance Development 
PLoS Medicine  2012;9(3):e1001185.
In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.
PMCID: PMC3295823  PMID: 22412356
19.  'Communicate to vaccinate' (COMMVAC). building evidence for improving communication about childhood vaccinations in low- and middle-income countries: protocol for a programme of research 
Effective provider-parent communication can improve childhood vaccination uptake and strengthen immunisation services in low- and middle-income countries (LMICs). Building capacity to improve communication strategies has been neglected. Rigorous research exists but is not readily found or applicable to LMICs, making it difficult for policy makers to use it to inform vaccination policies and practice.
The aim of this project is to build research knowledge and capacity to use evidence-based strategies for improving communication about childhood vaccinations with parents and communities in LMICs.
Methods and design
This project is a mixed methods study with six sub-studies. In sub-study one, we will develop a systematic map of provider-parent communication interventions for childhood vaccinations by screening and extracting data from relevant literature. This map will inform sub-study two, in which we will develop a taxonomy of interventions to improve provider-parent communication around childhood vaccination. In sub-study three, the taxonomy will be populated with trial citations to create an evidence map, which will also identify how evidence is linked to communication barriers regarding vaccination.
In the project's fourth sub-study, we will present the interventions map, taxonomy, and evidence map to international stakeholders to identify high-priority topics for systematic reviews of interventions to improve parent-provider communication for childhood vaccination. We will produce systematic reviews of the effects of high-priority interventions in the fifth sub-study. In the sixth and final sub-study of the project, evidence from the systematic reviews will be translated into accessible formats and messages for dissemination to LMICs.
This project combines evidence mapping, conceptual and taxonomy development, priority setting, systematic reviews, and knowledge transfer. It will build and share concepts, terms, evidence, and resources to aid the development of communication strategies for effective vaccination programmes in LMICs.
PMCID: PMC3259054  PMID: 22132930
20.  Thirty years after Alma-Ata: a systematic review of the impact of community health workers delivering curative interventions against malaria, pneumonia and diarrhoea on child mortality and morbidity in sub-Saharan Africa 
Over thirty years have passed since the Alma-Ata Declaration on primary health care in 1978. Many governments in the first decade following the declaration responded by developing national programmes of community health workers (CHWs), but evaluations of these often demonstrated poor outcomes. As many CHW programmes have responded to the HIV/AIDS pandemic, international interest in them has returned and their role in the response to other diseases should be examined carefully so that lessons can be applied to their new roles. Over half of the deaths in African children under five years of age are due to malaria, diarrhoea and pneumonia - a situation which could be addressed through the use of cheap and effective interventions delivered by CHWs. However, to date there is very little evidence from randomised controlled trials of the impacts of CHW programmes on child mortality in Africa. Evidence from non-randomised controlled studies has not previously been reviewed systematically.
We searched databases of published and unpublished studies for RCTs and non-randomised studies evaluating CHW programmes delivering curative treatments, with or without preventive components, for malaria, diarrhoea or pneumonia, in children in sub-Saharan Africa from 1987 to 2007. The impact of these programmes on morbidity or mortality in children under six years of age was reviewed. A descriptive analysis of interventional and contextual factors associated with these impacts was attempted.
The review identified seven studies evaluating CHWs, delivering a range of interventions. Limited descriptive data on programmes, contexts or process outcomes for these CHW programmes were available. CHWs in national programmes achieved large mortality reductions of 63% and 36% respectively, when insecticide-treated nets and anti-malarial chemoprophylaxis were delivered, in addition to curative interventions.
CHW programmes could potentially achieve large gains in child survival in sub-Saharan Africa if these programmes were implemented at scale. Large-scale rigorous studies, including RCTs, are urgently needed to provide policymakers with more evidence on the effects of CHWs delivering these interventions.
PMCID: PMC3214180  PMID: 22024435
21.  Provider experiences of the implementation of a new tuberculosis treatment programme: A qualitative study using the normalisation process model 
Tuberculosis (TB) is a major contributor to the global burden of disease. In many settings, including South Africa, treatment outcomes remain poor. In contrast, many antiretroviral treatment (ART) programmes are achieving high levels of adherence and good outcomes. The ART programme model for maintaining treatment adherence may therefore hold promise for TB treatment. Changing treatment models, however, requires an assessment of how staff receive the new model, as they are responsible for programme implementation. Using the normalization process model as an analytic framework, this paper aims to explore staff perceptions of a new TB treatment programme modelled on the ART treatment programme.
A qualitative approach was used. Interviews and focus group discussions were conducted with clinic staff from five intervention clinics. Data were analysed initially using qualitative content analysis. The resulting categories were then organised under the constructs of the normalization process model.
Staff recounted a number of challenges with implementing the programme. Interviews and focus group discussions identified factors relating to the main categories of the normalization process model. The key issues hindering the normalisation of the programme within clinics related to the interactional workability, relational integration and skill-set workability constructs of the model. These included hierarchical relationships, teamwork, training needs and insufficient internalisation by staff of the empowerment approach included in the programme. Logistical and management issues also impacted negatively on the normalization of the programme at the clinics.
The normalization process model assisted in categorising the challenges experienced during implementation of the intervention. The results suggest that issues remain that need to be resolved before the programme is implemented more widely. Considerable work is needed in order to embed the intervention in routine clinic practice.
PMCID: PMC3215962  PMID: 22004533
22.  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 
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.
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.
PMCID: PMC3163620  PMID: 21810242
23.  Still too little qualitative research to shed light on results from reviews of effectiveness trials: A case study of a Cochrane review on the use of lay health workers 
Qualitative research is used increasingly alongside trials of complex interventions to explore processes, contextual factors, or intervention characteristics that may have influenced trial outcomes. Qualitative research conducted alongside trials can also be used to shed light on the results of systematic reviews of effectiveness by looking for factors that can help explain heterogeneous results across trials. In a Cochrane review on the effects of using lay health workers on maternal and child health and infectious disease control, we identified 82 trials. These trials showed promising benefits but results were heterogeneous.
To use qualitative studies conducted alongside these trials to explore factors and processes that might have influenced intervention outcomes.
We attempted to identify qualitative research carried out alongside the trials by contacting trial authors, checking papers for references to qualitative research, searching Pubmed for related studies, and carrying out citation searches. For those qualitative studies that we included, we extracted information regarding study objective, data collection and analysis methods, and key themes and categories.
For 52 (63%) of the trials, we found no qualitative research that had been conducted alongside the trials. For 16 (20%) trials, some form of qualitative data collection had been done but was unavailable or had been done before the trial. For 14 (17%) trials, qualitative research had been done during or shortly after the trial, although descriptions of qualitative methods and results were often sparse. Most of these 14 studies aimed to elicit trial participants' perspectives and experiences of the intervention. A common theme was participants' appreciation of the lay health workers' shared circumstances, for instance with regard to social background or experience of the health condition. In six studies, researchers explored the experiences of the lay health workers themselves. Issues included the importance of regular supervision and health professionals' support or lack of support.
Qualitative studies carried out alongside trials of complex interventions could offer opportunities to authors of systematic reviews of effectiveness wishing to understand the heterogeneity of trial results. For interventions of lay health worker programmes at least, too few such studies exist at present for these opportunities to be realised.
PMCID: PMC3117743  PMID: 21619645
24.  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.
PMCID: PMC3080737  PMID: 21511783
25.  The growth of a culture of evidence-based obstetrics in South Africa: a qualitative case study 
While the past two decades have seen a shift towards evidence-based obstetrics and midwifery, the process through which a culture of evidence-based practice develops and is sustained within particular fields of clinical practice has not been well documented, particularly in LMICs (low- and middle-income countries). Forming part of a broader qualitative study of evidence-based policy making, this paper describes the development of a culture of evidence-based practice amongst maternal health policy makers and senior academic obstetricians in South Africa
A qualitative case-study approach was used. This included a literature review, a policy document review, a timeline of key events and the collection and analysis of 15 interviews with policy makers and academic clinicians involved in these policy processes and sampled using a purposive approach. The data was analysed thematically.
The concept of evidence-based medicine became embedded in South African academic obstetrics at a very early stage in relation to the development of the concept internationally. The diffusion of this concept into local academic obstetrics was facilitated by contact and exchange between local academic obstetricians, opinion leaders in international research and structures promoting evidence-based practice. Furthermore the growing acceptance of the concept was stimulated locally through the use of existing professional networks and meetings to share ideas and the contribution of local researchers to building the evidence base for obstetrics both locally and internationally. As a testimony to the extent of the diffusion of evidence-based medicine, South Africa has strongly evidence-based policies for maternal health.
This case study shows that the combined efforts of local and international researchers can create a culture of evidence-based medicine within one country. It also shows that doing so required time and perseverance from international researchers combined with a readiness by local researchers to receive and actively promote the practice.
PMCID: PMC3072938  PMID: 21443794

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