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Bmjopen-2011-000195 1.7

Introduction and evaluation of a ‘pre-ART care' service in Swaziland:an operational research study David Burtle,1 William Welfare,2 Susan Elden,2 Canaan Mamvura,2Joris Vandelanotte,3 Emily Petherick,4 John Walley,1 John Wright4 To cite: Burtle D, Welfare W, Elden S, et al. Introduction Objective: To implement and evaluate a formal and evaluation of a ‘pre-ART pre-antiretroviral therapy (ART) care service at care' service in Swaziland: an a district hospital in Swaziland.
- Impact of pre-ART care on the quality of care in operational research study.
Design: Operational research.
BMJ Open 2012;2:e000195.
a district hospital in Southern Africa.
Setting: District hospital in Southern Africa.
Participants: 1171 patients with a previous diagnosis - After introduction of a pre-ART care service, of HIV. A baseline patient group consisted of the first < Prepublication history for a higher proportion of patients were assessed for 200 patients using the service. Two follow-up groups this paper is available online.
ART, a higher proportion of those eligible started were defined: group 1 was all patients recruited from To view these files please on ART and a higher proportion received key April to June 2009 and group 2 was 200 patients visit the journal online (http:// recruited in February 2010.
Intervention: Introduction of pre-ART careda package Strengths and limitations of this study of interventions, including counselling; regular review; - This was a pragmatic evaluation in a routine DB and WSW contributed clinical staging; timely initiation of ART; social and service setting.
equally to this work.
psychological support; and prevention and management - The intervention was implemented as part of of opportunistic infections, such as tuberculosis.
routine health service delivery by existing clinical Received 26 May 2011 Primary and secondary outcome Accepted 1 February 2012 measures: Proportion of patients assessed for ART - Routine data collection systems do not link This final article is available eligibility, proportion of eligible patients who were testing and HIV care data, preventing an for use under the terms of started on ART and proportion receiving defined evaluation from testing to initiation.
the Creative Commons evidence-based interventions (including prophylactic - The evaluation focuses on those with a known co-trimoxazole and tuberculosis screening).
status, rather than new testers, those with Results: Following the implementation of the pre-ART tuberculosis or those who are pregnant.
service, the proportion of patients receiving defined - The evaluation relies on intermediate outcomes, interventions increased; the proportion of patient being that is, initiation on ART, rather than long-term assessed for ART eligibility significantly increased outcomes, such as mortality.
(baseline: 59%, group 1: 64%, group 2: 76%; - There is a lack of information on those requiring p¼0.001); the proportion of ART-eligible patients long-term follow-up but not ART.
starting treatment increased (baseline: 53%, group 1:81%, group: 2, 81%; p<0.001) and the median time between patients being declared eligible for ART and Mortality rates of between 8% and 26% have Nuffield Centre for initiation of treatment significantly decreased (baseline: International Health and 61 days, group 1: 39 days, group 2: 14 days; p<0.001).
been reported,1 with advanced immunodefi- Development, Leeds Institute Conclusions: This intervention was part of a shift in ciency as a key risk factor.2 High rates of loss of Health Sciences, the model of care from a fragmented acute care model to follow-up after HIV testing result in late University of Leeds, Leeds, to a more comprehensive service. The introduction of presentation for ART initiation and are structured pre-ART was associated with significant associated with poor treatment outcomes.3 4 Good Shepherd Hospital, improvements in the assessment, management and In light of the negative outcomes associated Siteki, Swaziland3 timeliness of initiation of treatment for patients with ICAP Swaziland, Mbabane, with late presentation, there has been a renewed focus on the period after HIV 4Bradford Institute for Health diagnosis but before commencement of Research, Bradford Teaching treatment.5 Numerous studies have investi- Hospitals NHS Foundation gated retention of patients following HIV Trust, Bradford, UK diagnosis.3 4 6e23 Rates of enrolment of Correspondence to In sub-Saharan Africa, HIV-positive adults eligible patients on ART vary widely (14%e William Swithun Welfare; have a high mortality rate during the first 84%), and retention of patients not yet Burtle D, Welfare W, Elden S, et al. BMJ Open 2012;2:e000195. doi:10.1136/bmjopen-2011-000195 Pre-ART service evaluation eligible for ART treatment remains very challenging in estimated at 26%.27 The Swazi National Strategic many of these settings (45%e70%, though the majority Framework for HIV and AIDS 2009e2014 recommends of these studies did not provide data for those with HIV structured pre-ART care as part of a three pronged but not on ART). Asymptomatic patients, not yet eligible treatment strategy along with increasing HIV testing and for ART, may not appreciate the need for medical care at the expansion of ART provision.28 The framework this stage and may be put off by the disruption, expense recognised that pre-ART care was in ‘its infancy', with and stigma of repeated clinic visits for, what they a limited number of sites providing this package at the perceive as, little treatment.5 Patients with low CD4 cell counts at presentation may die before presentation and Good Shepherd Hospital (GSH) is the district referral so not complete ART enrolment.
There is emerging evidence of the relative success of a predominantly rural area of approximately 250 000 different approaches to improve retention during this period. These include rapid clinical staging through the Prior to the introduction of the pre-ART care service in use of point of care CD4 tests24 and the implementation February 2009, HIV care prior to commencing ART at of more coherent care pathways.5 There remains a need our institution was episodic. There was no continuum of for a clearer understanding of how to improve patient care, and patients were only followed up consistently retention at this point in resource-poor settings.
once they were started on ART. Patients with unknownstatus were tested in the HIV testing and counselling centre. If found to be HIV positive, a sample was taken Pre-ART care spans the period between a person testing for CD4 testing and they were instructed to return to the positive for HIV and needing ART. For some people, this separate ART centre in 3 days to collect the result. If they is very short, just the time for assessment, while for returned, they received counselling, TB screening, others, this could be a period of years. A short period of co-trimoxazole and further appointments as necessary.
pre-ART may result from delayed presentation for An internal audit of services in October 2008 revealed testing or a delay between receiving the initial test result and receiving (or seeking) HIV care. During the pre- < Over 1/3 (153/407) of pre-ART hospital patients did ART period, a number of interventions can improve the not return to collect CD4 counts and therefore health of people living with HIV and provide an effective received no follow-up.
pathway to ART for those who require it.25 26 < Patients started ART late, the median CD4 at first test was 116 cells/mm3.
The components of a pre-ART care service < Although co-trimoxazole was prescribed for pre-ART < Assessment for ART.
patients, there was no system of receiving a regular – Regular follow-up and review.
supply of this.
– Assessment for ART, including clinical staging, CD4, < HIV counsellors stated that they performed TB biochemistry and haematology.
screening, but it was not offered systematically nor – Initiation for ART when agreed criteria are met.
recorded or nor was there a system to follow-up Creation of the pre-ART care service linked hospital Opportunistic Infections (including co-trimoxazole HIV testing and ART services and aimed to improve and isoniazid prophylaxis, and tuberculosis (TB) patient follow-up by formalising previously fragmented – Counselling including advice to prevent onward transmission of HIV (including promotion of condoms) and promote testing of those at risk25 26 The service design drew on the following concepts: < Comprehensive care: using a patient care pathway.
< Active follow-up: structured follow-up by cell phone The aim of this study was to implement and evaluate and adherence officers.
a formal pre-ART care service at a district hospital in < Task shifting: to nurses and lay HIV counsellors.
Swaziland. The pre-ART service aimed to increase thekey outcomes of: Comprehensive care < assessment of patients for ART eligibility; Staff plotted the patient pathway from HIV testing to < initiation of those eligible on drug treatment; ART treatment. Service gaps along this pathway were < provision of evidence based interventions to improve identified and quantified. Monthly meetings were held with staff to review performance and develop the service.
Three records were introduced: (1) inpatient pre-ART file, (2) patient handheld file and (3) pre-ART registra- The Kingdom of Swaziland is suffering a ‘hyper- tion book. The inpatient file was a way of documenting epidemic' of HIV infection with adult prevalence a comprehensive and systematic care plan for each Burtle D, Welfare W, Elden S, et al. BMJ Open 2012;2:e000195. doi:10.1136/bmjopen-2011-000195


Pre-ART service evaluation patient. The patient handheld file enabled patients totake greater responsibility for their care and to improvethe continuity of care if patients presented at otherfacilities. The pre-ART registration book enabled follow-up when patients did not return for their appointmentsand monitoring of system performance.
Active follow-upPatients who did not return for appointment werecontacted by phone. Reasons for not returning wereidentified. Those who could not be reached by phonewere followed up by the motorcycle adherence officers attheir homes as part of a pre-existing service supportingHIV, TB and epilepsy services.
Task shifting to nurses and HIV counsellorsIn common with many rural HIV health services inSouthern Africa, the service demands outstripped thehuman resource capacity. When the pre-ART servicestarted in February 2009, the staff for the HIV serviceconsisted of two doctors, two nurses, three HIV coun-sellors and one pharmacist to attend to an average of2000 patients each month. Previously assessment forART initiation was doctor-led. The new pre-ART servicewas nurse-led. Nurses provided the triage for patientsentering the pre-ART system and most of the clinicalassessment for ART initiation. At the time of the analysis,only physicians were allowed to initiate ART drugs, Flow diagram outlining the current (new) HIV creating a bottleneck. Task shifting, including nurses pathway at Good Shepherd Hospital. ART, antiretroviral seeing majority of review patients and undertaking therapy; ART eligible?, definition based on the standardised pre-ART, freed up time for doctors to initiate ART.
WHO criteria; OPD, outpatients department; OPD (knownstatus), patients known to be HIV positive presenting to the HIV counsellors took on additional roles of TB outpatient department; pre-ART HTC, HIV testing and screening and phlebotomy from the nurses. Task shifting counselling as part of pre-ART care; VCT, Hospital Voluntary to nurses and HIV counsellors reduced the number of Counselling and Testing Service; ward, general hospital wards.
steps in the patient pathway, improved the efficiency andmade the most effective use of limited resources.
formed the population for this study. This register didnot include data from new testers, those who were pregnant or were known to be co-infected with TB.
A structured pre-ART care service was established at GSH These groups were entered in other registers. Data were in January 2009. The patient flow created is shown in entered in a Microsoft Excel 2007 spreadsheet. Three groups were defined: The interventions were based on the WHO guidance.
Baseline: 200 patients, February to March 2009, the first When the service was started, there were no national patients enrolled by the service pre-ART guidelines, although recently a Swaziland Group 1: 771 patients, April and June 2009, to assess the comprehensive package of care has been published.
impact of the initial service implementation.
Interventions provided as part of pre-ART care at this Group 2: 200 patients, February 2010, to assess the hospital included: baseline laboratory testing, CD4 cell impact of the service after 1 year.
count, initial clinical review and staging, regular reviewevery 3 or 6 months, TB symptom screening, manage- Data were collected from the pre-ART register in June prophylaxis and referral to the ART service when indi- 2010. All patients had at least 3 month follow-up.
cated. During the study, isoniazid chemoprophylaxis wasnot in routine use in Swaziland.
AnalysisDifferences in baseline values between the three groups EVALUATION METHOD were examined using analysis of variance for continuous variables and c2 tests for differences in proportions.
Patients with a known diagnosis were registered for the Comparisons between outcomes in groups were pre-ART service in the ART department and these examined between the groups using c2 tests and Burtle D, Welfare W, Elden S, et al. BMJ Open 2012;2:e000195. doi:10.1136/bmjopen-2011-000195 Pre-ART service evaluation a comparison of performance indicators using c2 tests management and care significantly improved over the for differences in proportions and KruskaleWallis test to study period. The proportions of patients being assessed look at differences in time between ART initiation in for ART eligibility and ART-eligible patients starting eligible patients between groups, using STATA IC 11.2.
treatment significantly increased; the time between The level of statistical significance was set at 5%.
PLHIV being declared eligible for ART and them The key outcomes analysed were as follows: starting ART significantly decreased. The proportion The proportion of patients with a documented assess- being assessed for ART remains lower than ideal. A ment of eligibility for ART initiation (including clinical significant proportion of patients are testing positive, stage, CD4 count and baseline biochemical and haema- being registered for pre-ART, but then not returning for tological testing) among patients recruited to the CD4 count results. Eligible patients commencing ART pre-ART service.
more rapidly is important given the very high mortality The proportion of patients started on ART among those risk immediately prior to starting ART.1 2 eligible for ART initiation.
The trend in proportion of patients on co-trimoxazole The proportion of patients who received specified is less clear. The supply of co-trimoxazole was dependent interventions (TB screening, initial CD4 count, clinical on the national system and out of the control of the staging, assessment of eligibility for ART and co-trimox- service. Problems with consistent supplies of co-trimox- azole prophylaxis), as part of pre-ART care.
azole and non-implementation of isoniazid prophylaxisare commonly recognised issues in resource-limitedsettings.29 RESULTSThe demographics of the three groups reflect largely Strengths and limitations of the study similar populations (table 1), although the proportion This study provides timely evidence about the impact of with CD4 counts under 200 and under 350 cells/mm3 a clinical intervention for a public health priority. The increased in each of the three groups, and the median findings are likely to be generalisable to other low- CD4 count was found to decrease in each of the groups.
resource settings where the prevalence of HIV/AIDS is The service's performance in assessing patients for high. The intervention was implemented as part of ART eligibility and then initiating those eligible is shown routine health service delivery by existing clinical staff, in table 2. The proportions of People living with HIV promoting sustainability. A randomised controlled trial (PLHIV) being assessed for ART eligibility and propor- would provide more robust evidence about effectiveness, tion of eligible patients being initiated on ART signifi- but this pragmatic evaluation provides useful evidence cantly increased in each group (c2 for variance, ps on how to improve care in a setting where HIV/AIDS is 0.01). The median time between eligibility and initia- a national emergency. While this study cannot prove tion significantly decreased (p<0.01).
causation, it demonstrates an association between the Rates of CD4 cell counting, clinical staging, TB introduction of the service and improved performance.
screening and ART assessment increased gradually The implementation of pre-ART care involved a number between groups (figure 2). The proportion receiving of changes to HIV services at GSH. It is not possible to co-trimoxazole prophylaxis fell between baseline and determine the weight of each changes' contribution.
group 1, reflecting problems with drug supply, but did The rapid change in performance of the service seen rise over the 1-year period.
between baseline and group 1 (table 2) suggests thatthe implementation of structured pre-ART care was associated with improving performance.
Following the introduction of structured pre-ART, the The reliance on routine data limits the quality of proportion of patients with HIV receiving appropriate analysis possible in this study. We were unable to link Summary of demographic and clinical characteristics of the three groups p Value comparison Mean age (SD) (years) Gender (% female) Number and proportion of adult patients with a recorded CD4 count, N (%)Median CD4, range (cells/mm3) Number and proportion of adult patients with a CD4 count <350, N (%)Number and proportion of adult patients with a CD4 count <200, N (%) Burtle D, Welfare W, Elden S, et al. BMJ Open 2012;2:e000195. doi:10.1136/bmjopen-2011-000195


Pre-ART service evaluation Comparison table of assessment for ART eligibility and initiation between the three groups Number assessed for ART/all patients attended clinic, N (%)Number assessed eligible for ART/ number assessed for ART, N (%)Number of eligible patients initiated on ART/number assessed as eligiblefor ART, N (%)Median time between eligibility and ART initiation (range) (days) ART, antiretroviral therapy.
testing data (some of which is anonymous) to pre-ART Over the study period, the proportion of patients information. Ideally, we would have followed cohorts of assessed as eligible has increased. This reflects differ- patients from testing to initiation, but this was not ences in health of the groups, as well as changes in possible. Data were collected from the register in the international and national guidelines on CD4 threshold ART department, which is of patients with a known for initiation. The reasons for increasing numbers of diagnosis and not those with a new diagnosis. The patients with advanced immunodeficiency in groups 1 people in this study are therefore likely to have more and 2 are unclear. This should not have affected the key advanced immunodeficiency and may not be typical of outcomes of this study: the proportion of patients all patients with HIV/AIDS. The data used excludes assessed for ART and the proportion of those eligible those who were pregnant or those on TB treatment as who were initiated.
those services also run parallel pre-ART services. Strati-fying the patient by source of referral and/or testing Lessons from implementing pre-ART care (eg, Voluntary counselling and Testing (VCT) or ward or Implementing a coherent HIV pathway across multiple outpatients) would be useful, but that information was programmes within the hospital was a complicated not routinely recorded.
process. The overall service includes HIV-positive The differing group sizes resulted from data that had patients in hospital TB and Prevention of Mother to been previously entered as part of a pilot evaluation. The Child Transmission (PMTCT) programmes in addition researchers opted to use all the available data, rather to the pathway described above. Integration of separate than ignoring any of it. The impact of a larger group 2 is vertical national programmes (eg, PMTCT, TB, ART) at unclear. A larger group 2 (ie, spanning a longer time a district level to provide a coherent service and clear period) may have increased the difference between pathway is challenging. The recent introduction of groups 1 and 2 but lessened the difference between a national integrated package of care for PLHIV may aid groups 2 and 3.
Comparison of priority interventions received by the threegroups. Initial CD4 cell count,p¼0.002; HIV clinical staging,p¼0.001; tuberculosis (TB)screening, p<0.001;co-trimoxazole, p<0.001,assessment of eligibility forantiretroviral therapy (ART),p¼0.001.
Burtle D, Welfare W, Elden S, et al. BMJ Open 2012;2:e000195. doi:10.1136/bmjopen-2011-000195


Pre-ART service evaluation Flow diagram showing (A) the actual impact of pre-antiretroviral therapy (ART)implementation care pathway and(B) the intended impact. HTC, HIVtesting and counselling.
Problems with monitoring, evaluating and reporting using paper-based records are well recognised as The introduction of structured pre-ART was associated constraining HIV services in other settings.25 30 Separate ‘silos' of information within the HIV programme (such management and timeliness of initiation of treatment as separate pre-ART registers) result in independent for patients with HIV pre-ART care provided the first step summaries of data about activities that are interrelated in linking HIV testing and ART services in this rural and restrict patient monitoring.
African setting. This study suggests that the introduction The advent and roll-out of ART in low-resource of a pre-ART service and consequent improved pathway settings has resulted in a focus on drug treatment to has been beneficial for patients.
reduce mortality.31 In addition, an emphasis on Acknowledgements The authors gratefully acknowledge the staff of GSH increasing knowledge of serostatus has aimed to detect who both implemented this intervention and supported the evaluation, in disease earlier and enable people to access ART.32 In particular Dr Petros (Senior Medical Officer), Mrs Dumsile Simelane, Sister some areas, this has resulted in a gap in the service Futhi Ndinisa. The authors also thank the Swaziland National AIDSProgramme, ICAP and the Lubombo Regional Health Management Team for implementation of HIV care pathwaysdthe link between their support.
the two.5 17 21 As testing and ART provision increase, Contributors SE, CM, JV, JWr and JWa devised and implemented the there will be an increasing group of those with known intervention. SE and CM undertook data collection and initial evaluation. DB, infection who need management but not yet ART. Pre- WSW, JWa, JWr devised the evaluation. DB and WSW undertook the ART services are key to managing this growing group, evaluation and initial analysis. EP undertook the statistical analysis. DB, WSW rather than just being a pathway to ART.
and EP prepared the manuscript. All contributed to revising the manuscript.
Though pre-ART has ‘filled the gap' between, previ- Funding This document is an output from a project funded by UK Aid from the ously distinct, HIV testing and ART services, its imple- UK Department for International Development (DFID) for the benefit of mentation has produced a system that consists of developing countries. However, the views expressed and informationcontained in it are not necessarily those of or endorsed by DFID, which can individual service component services linked together accept no responsibility for such views or information or for any reliance (figure 3A), rather than a fully coherent continuum of placed on them.
care advocated in the literature and standardised Competing interests None.
protocols (figure 3B).24e26 Decentralisation of HIV services is being implemented Ethics approval Ethics approval was provided by Swaziland Ministry of HealthScientific and Ethical Committee and University of Leeds.
throughout the Lubombo region.28 This may change therole of the hospital pre-ART service, as chronic HIV Provenance and peer review Not commissioned; externally peer reviewed.
management is moved to primary care.28 This provides Data sharing statement Anonymised data on request after review of request the obvious next step for the service. Operational by corresponding author (wwelfare@nhs.net).
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Burtle D, Welfare W, Elden S, et al. BMJ Open 2012;2:e000195. doi:10.1136/bmjopen-2011-000195 Introduction and evaluation of a 'pre-ART
care' service in Swaziland: an operational
research study

David Burtle, William Welfare, Susan Elden, et al.
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Edu-1077 topical antibiotics

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