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HIV care integrated into primary health care (PHC) encourages reorganized service delivery but could increase workload. In 2012-2013, we surveyed 910 patients and caregivers at two time points after integration in four clinics in Free State, South Africa. Likert surveys measured quality of care (QoC) and satisfaction with staff (SwS). QoC scores were lower for females, those older than 56 years, those visiting clinics every 3 months, and child health participants. Regression estimates showed QoC scores higher for ages 36-45 versus 18-25 years, and lower for those attending clinics for more than 10 years versus 6-12 months. Overall, SwS scores were lower for child health attendees and higher for tuberculosis attendees compared to chronic disease care attendees. Research is needed to understand determinants of disparities in QoC and SwS, especially for child health, diabetes, and hypertension attendees, to ensure high-quality care experiences for all patients attending PHC clinics with integrated HIV care., (Copyright © 2018 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.)

Background: Occupational exposure to tuberculosis (TB) constitutes a major health risk for healthcare workers (HCWs). The HIV epidemic equally affects the workforce because of the mutually reinforcing epidemiology of HIV and TB. Stigmas associated with HIV and TB have become so intricately entangled that they stop some HCWs from seeking care in a context where serious shortages in human resources for health besiege public health facilities. It is thus imperative to research, as well as attempt to tackle, HIV and TB stigma among HCWs. But little has been done internationally-and nationally, only our own exploratory studies. Our project aims to address this by (1) scientifically assessing the extent and sources of HIV and TB-related stigma among HCWs and (2) developing and testing evidence-based, stigma-reduction interventions in public hospitals in the Free State Province of South Africa., Methods/design: The research follows a stratified cluster randomised controlled trial (RCT) design. Pre intervention, a self-administered questionnaire with the pilot study's validated stigma scales is used to measure stigma and other key variables among randomly selected HCWs in eight hospitals-stratified by size and district and then randomly allocated to four intervention and four control sites. Interventions comprise HIV- and TB-stigma reduction activities-mainly Social and Behavioural Change Communication (SBCC) interventions-at three social-ecology levels (individual, community, and socio-structural). An outside assessor will appraise the trial mid-way through implementation. Post intervention, all baseline respondents will be followed up to complete the baseline questionnaire with additional items on interventions. Qualitative data will be collected to better understand HIV and TB stigma and explore if, and how, interventions impact stigma levels in the workplace., Discussion: The study regards as HCWs all staff, working in all different types of jobs, at all levels in the hospitals. Thus, the research addresses HIV and TB stigma across the whole workforce and the entire workplace. In doing so it will (1) generate essential information on stigma among HCWs and (2) implement stigma-reduction interventions that are innovative yet replicable, and potentially beneficial in addressing a pernicious human-rights-based issue., Trial Registration: South African National Clinical Trials Register, registration ID: DOH-27-1115-5204 . Prospectively registered on 26 August 2015.

Background: Noncommunicable diseases (NCDs), specifically diabetes and hypertension, are rising in high HIV-burdened countries such as South Africa. How integrated HIV care into primary health care (PHC) influences NCD care is unknown. We aimed to understand whether differences existed in NCD care (pre- versus post-integration) and how changes may relate to HIV patient numbers., Setting: Public sector PHC clinics in Free State, South Africa., Methods: Using a quasiexperimental design, we analyzed monthly administrative data on 4 indicators for diabetes and hypertension (clinic and population levels) during 4 years as HIV integration was implemented in PHC. Data represented 131 PHC clinics with a catchment population of 1.5 million. We used interrupted time series analysis at ±18 and ±30 months from HIV integration in each clinic to identify changes in trends postintegration compared with those in preintegration. We used linear mixed-effect models to study relationships between HIV and NCD indicators., Results: Patients receiving antiretroviral therapy in the 131 PHC clinics studied increased from 1614 (April 2009) to 57, 958 (April 2013). Trends in new diabetes patients on treatment remained unchanged. However, population-level new hypertensives on treatment decreased at ±30 months from integration by 6/100, 000 (SE = 3, P < 0.02) and was associated with the number of new patients with HIV on treatment at the clinics., Conclusions: Our findings suggest that during the implementation of integrated HIV care into PHC clinics, care for hypertensive patients could be compromised. Further research is needed to understand determinants of NCD care in South Africa and other high HIV-burdened settings to ensure patient-centered PHC.

Background: The dual burden of tuberculosis and human immunodeficiency virus (HIV) is severely impacting the South African healthcare workforce. However, the use of on-site occupational health services is hampered by stigma among the healthcare workforce. The success of stigma-reduction interventions is difficult to evaluate because of a dearth of appropriate scientific tools to measure stigma in this specific professional setting., Methods: The current pilot study aimed to develop and test a range of scales measuring different aspects of stigma-internal and external stigma toward tuberculosis as well as HIV-in a South African healthcare setting. The study employed data of a sample of 200 staff members of a large hospital in Bloemfontein, South Africa., Results: Confirmatory factor analysis produced 7 scales, displaying internal construct validity: (1) colleagues' external HIV stigma, (2) colleagues' actions against external HIV stigma, (3) respondent's external HIV stigma, (4) respondent's internal HIV stigma, (5) colleagues' external tuberculosis stigma, (6) respondent's external tuberculosis stigma, and (7) respondent's internal tuberculosis stigma. Subsequent analyses (reliability analysis, structural equation modeling) demonstrated that the scales displayed good psychometric properties in terms of reliability and external construct validity., Conclusions: The study outcomes support the use of the developed scales as a valid and reliable means to measure levels of tuberculosis- and HIV-related stigma among the healthcare workforce in a resource-limited context. Future studies should build on these findings to fine-tune the instruments and apply them to larger study populations across a range of different resource-limited healthcare settings with high HIV and tuberculosis prevalence., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.)

Fear of stigma and discrimination among health care workers (HCWs) in South African hospitals is thought to be a major factor in the high rates of HIV and tuberculosis infection experienced in the health care workforce. The aim of the current study is to inform the development of a stigma reduction intervention in the context of a large multicomponent trial. We analysed relevant results of four feasibility studies conducted in the lead up to the trial. Our findings suggest that a stigma reduction campaign must address community and structural level drivers of stigma, in addition to individual level concerns, through a participatory and iterative approach. Importantly, stigma reduction must not only be embedded in the institutional management of HCWs but also be attentive to the localised needs of HCWs themselves.

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.

Background: 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., Methods: 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., Results: 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., Conclusion: 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.

Background: Integration of human immunodeficiency virus (HIV) care into primary care services is one strategy proposed to achieve universal access to antiretroviral treatment (ART) for HIV-positive patients in high burden countries. There is a need for controlled studies of programmes to integrate HIV care with details of the services being integrated., Methods: A semi-quantitative questionnaire was developed in consultation with clinic staff, tested for internal consistency using Cronbach's alpha coefficients and checked for inter-observer reliability. It was used to conduct four assessments of the integration of HIV care into referring primary care clinics (mainstreaming HIV) and into the work of all nurses within ART clinics (internal integration) and the integration of pre-ART and ART care during the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) trial in South Africa. Mean total integration and four component integration scores at intervention and control clinics were compared using one way analysis of variance (ANOVA). Repeated measures ANOVA was used to analyse changes in scores during the trial., Results: Cronbach's alpha coefficients for total integration, pre-ART and ART integration and mainstreaming HIV and internal integration scores showed good internal consistency. Mean total integration, mainstreaming HIV and ART integration scores increased significantly at intervention clinics by the third assessment. Mean pre-ART integration scores were almost maximal at the first assessment and showed no further change. There was no change in mean internal integration score., Conclusion: The questionnaire developed in this study is a valid tool with potential for monitoring integration of HIV care in other settings. The STRETCH trial interventions resulted in increased integration of HIV care, particularly ART care, by providing HIV care at referring primary care clinics, but had no effect on integrating HIV care into the work of all nurses with the ART clinic.

Background: 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., Methods: 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., Findings: 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)., Interpretation: 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., Funding: UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme., Methods: This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis., Results: NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges., Conclusions: Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice.

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.

Objective: In South Africa, many HIV-infected patients experience delays in accessing antiretroviral therapy (ART). We examined pretreatment mortality and access to treatment in patients waiting for ART., Design: Cohort of HIV-infected patients assessed for ART eligibility at 36 facilities participating in the Comprehensive HIV and AIDS Management (CHAM) program in the Free State Province., Methods: Proportion of patients initiating ART, pre-ART mortality and risk factors associated with these outcomes were estimated using competing risks survival analysis., Results: Forty-four thousand, eight hundred and forty-four patients enrolled in CHAM between May 2004 and December 2007, of whom 22 083 (49.2%) were eligible for ART; pre-ART mortality was 53.2 per 100 person-years [95% confidence interval (CI) 51.8-54.7]. Median CD4 cell count at eligibility increased from 87 cells/μl in 2004 to 101 cells/μl in 2007. Two years after eligibility an estimated 67.7% (67.1-68.4%) of patients had started ART, and 26.2% (25.6-26.9%) died before starting ART. Among patients with CD4 cell counts below 25 cells/μl at eligibility, 48% died before ART and 51% initiated ART. Men were less likely to start treatment and more likely to die than women. Patients in rural clinics or clinics with low staffing levels had lower rates of starting treatment and higher mortality compared with patients in urban/peri-urban clinics, or better staffed clinics., Conclusions: Mortality is high in eligible patients waiting for ART in the Free State Province. The most immunocompromised patients had the lowest probability of starting ART and the highest risk of pre-ART death. Prioritization of these patients should reduce waiting times and pre-ART mortality.

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

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

Background: A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design: This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART) for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a) 7400 registering with the programme with CD4 counts of ? 350 cells/mL (mainly to evaluate treatment initiation) and b) 4900 already receiving ART (to evaluate ongoing treatment and monitoring). The primary outcomes will be time to death (in the first group) and viral suppression (in the second group). Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register. Trial registration: Controlled Clinical Trials ISRCTN46836853 [ABSTRACT FROM AUTHOR]