Summary of findings
Description of the condition
The spread and volume of HIV care and treatment services has increased markedly in lower- and middle-income countries (LMIC). As of mid-2011, around 8 million people were receiving antiretroviral therapy (ART) in LMIC. In spite of considerable progress in improving access to ART to date, global coverage for ART is still around 50% (UNAIDS 2011). There is high-level political commitment to provide ART to 15 million people by 2015, but the current rate of enrolment of patients on ART may be insufficient to reach the global goal, therefore, adaptations to service delivery models are needed.
An effective service needs HIV testing and counselling services to be linked to HIV care and treatment; requires ART initiation as early as clinically indicated; and a service that retains patients. This will help decrease AIDS-related morbidity and mortality, reduce costs and maximise efficiency gains, and avert new infections (Ford 2011). Yet there are a number of constraints at all of these steps. Recent systematic reviews have indicated that, for those who do initiate ART, retention in care is a major challenge, with around 25% of patients estimated to be lost to follow-up within 24 months of initiating ART (Fox 2010). Barriers to access to care appear to be important drivers of poor retention, with transport costs, time spent travelling to health facilities, and time waiting for services at health facilities all cited as reasons for defaulting (Kagee 2011; Miller 2010; Ware 2009).
Description of the intervention
In order to increase access to care - both to allow more people to be treated, and to improve retention among those in care - a number of countries have introduced two important, linked adaptations to the traditional, "Western-based" (i.e. hospital-based and doctor-led) model of care provision:
- decentralisation of ART care delivery from hospitals to more peripheral health facilities (this review).
- task shifting of treatment provision from highly trained specialists and medical practitioners to nurses and other non-physician providers (Kredo 2012).
Decentralisation of care broadly means relocating services from centralised sites (i.e. hospitals) to peripheral health centres or lower levels of healthcare, generally geographically closer to the homes of patients. However, definitions of decentralised services vary considerably, and "community," "health post," "health centre" and "hospital services" all may vary in meaning between countries.
In this review, we define each "tier" in the health system according to their staffing configuration ( Table 1). Thus, for community, care is provided by someone with only a few months training; for a health centre, this is led by a paramedic or nurse; for a hospital, it is led by a doctor or equivalent; and for an advanced hospital, there are specialist doctors present. In the table we also define community in three categories: family member, village volunteer, or a primary health care clinic with a nurse aide or community health worker. At community care level, systems may thus be established to deliver treatment at household level. This framework is to help describe different programmes. For HIV care, the emerging models are giving rise to a variety of terms, such as "full decentralisation", "partial decentralisation" (also sometimes referred to as down referral) and "full decentralisation with regular hospital support". To help classify models and allow cross study comparisons, we have developed a nomenclature ( Table 2). This is not meant to be definitive and may need to be modified as the models of care develop, but provides a working framework for this review.
Task shifting is related to decentralisation, and is the process whereby specific tasks are transferred to different cadres of health workers who have had less training and have fewer qualifications (WHO 2008).Task shifting is being addressed by a separate Cochrane Review (Kredo 2012).
How the intervention might work
Decentralisation aims to increase access to care and improve health outcomes, in particular retention in care. These benefits may result from a number of factors, including the improved patient care by nurses and counsellors due to lower workload (i.e. lower staff to patient ratios) compared to centralised sites; and reduced time and financial cost to patient due to greater proximity of services (Fatti 2010). On the other hand, there may be concern that providing care at less sophisticated levels of the health system may decrease quality of care and result in worse health outcomes (Decroo 2009). As a result of these uncertainties, countries and regions vary in the extent to which HIV/AIDS treatment is decentralised beyond hospitals, and there is a need for clarity around the risks and benefits of decentralising ART services in order to inform future operational guidance.
To assess the effects of decentralised HIV care in relation to initiation and maintenance of antiretroviral therapy.
Criteria for considering studies for this review
Types of studies
Randomised, non-randomised and controlled before-and-after studies.
Prospective and retrospective cohort studies with a comparison between standard and decentralised delivery. For cohort studies, comparators needed to be contemporaneous (delivered at the same time), in the same country, and geographically adjacent (i.e. within the same district, or in adjacent districts within a province).
Types of participants
HIV-infected patients at the point of initiating treatment, and patients already on treatment requiring maintenance and follow-up.
Types of interventions
Any form of decentralised care delivery model for the initiation of treatment, continuation of treatment, or both. Decentralisation is defined as the provision of treatment at a more basic level in the health system than the centralised site ( Table 1), according to the definitions described above ( Table 2).
Care delivered at the centralised site (usually a hospital, or in the case of community interventions, any facility)
Types of outcome measures
- Attrition, defined as a composite of loss to follow-up or death.
- Loss to follow-up at set time points after the intervention has been introduced, as defined by the study authors.
- Death, after being considered eligible for treatment, or during treatment.
- Time to starting antiretroviral treatment.
- Patients diagnosed with tuberculosis after entry into HIV care.
- Virologic response to ART (the proportion of participants that reach or maintain a pre-defined level of viral load suppression, as defined by the study authors).
- Immunologic response to ART (mean change in the concentration of CD4+ lymphocytes from baseline, as expressed in cells/mm
- Occurrence of a new AIDS-defining illness.
- Patient satisfaction with care, as defined by the study authors. We will include qualitative data if available from the included studies.
- Cost to the provider.
- Cost to the patient and family.
- Any negative impact on other programme and health care delivery reported by the authors.
Search methods for identification of studies
See the Cochrane HIV/AIDS Group search strategy.
In collaboration with the trial search coordinator of the Cochrane HIV/AIDS Review Group, we developed a comprehensive search strategy to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress). We searched from 1 January 1996 (the advent of triple-drug ART) to 11 March 2013. We searched the following electronic databases:
- Cochrane Central Register of Controlled Trials (CENTRAL) (Appendix 1)
- MEDLINE (Appendix 2)
- EMBASE (Appendix 3)
- Web of Science
- WHO Index Medicus
Key words included MeSH terms and free-text terms relevant to decentralisation, down referral, delivery of health care, health services accessibility, and other relevant terms.
Searching other resources
Researchers and relevant organisations. We contacted individual researchers working in the field and staff of international organisations including the Joint United Nations Programme on HIV/AIDS (UNAIDS), and the World Health Organization (WHO), and Médecins Sans Frontières (MSF) to identify studies either completed or ongoing.
Reference lists. We checked the reference lists of all studies identified by the above methods and examined the bibliographies of any systematic reviews, meta-analyses, or current guidelines identified during the search process.
Ongoing studies. We searched the WHO International Clinical Trials Registry Platform and clinicaltrials.gov search portals for information on unpublished and ongoing trials.
Data collection and analysis
The methodology for data collection and analysis was based on the guidance of Cochrane Handbook of Systematic Reviews of Interventions (Higgins 2008). Abstracts of all trials identified by electronic or bibliographic scanning was examined by two authors working independently. Where necessary, the full text was obtained to determine the eligibility of studies for inclusion.
Selection of studies
We removed duplicate references using a reference management software. Following this, a Cochrane research specialist did a broad review of results, excluding those that were clearly irrelevant. TK and FBA independently selected potentially relevant studies by scanning the titles, abstracts, and descriptor terms of the remaining references and applied the inclusion criteria. We discarded irrelevant reports and obtained the full article or abstract for all potentially relevant or uncertain reports. TK and FBA independently applied the inclusion criteria using a standardised eligibility form. Studies were reviewed for relevance, based on study design, types of participants, exposures and outcomes measures. All authors contributed to a consensus decision for any uncertainties or disagreements about inclusion.
Data extraction and management
After initial search and article screening, two authors independently double-coded and entered information from each selected study onto standardised data extraction forms. Extracted information included:
- Study details: citation, start and end dates, location, study design and details.
- Participant details: study population eligibility (inclusion and exclusion) criteria, ages, population size, attrition rate, details of HIV care and disease progression and any clinical, immunologic or virologic staging, tuberculosis or laboratory information.
- Intervention details: level of health service, cadre of health worker and other forms of patient support, including diagnosis of tuberculosis.
- Outcome details: retention in care, mortality, tuberculosis case finding, AIDS-related progression of disease, virological and immunological outcomes, patient satisfaction, cost of care.
The interventions were carefully and systematically described to ensure that all of the interventions and co-interventions that were reported were captured.
Assessment of risk of bias in included studies
Two authors independently assessed the risk of bias within the included studies against criteria described below in accordance with methods recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) Group and the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008). The following judgments were used: low risk of bias, high risk of bias or unclear risk of bias (either due to lack of information or uncertainty over the potential for bias). We resolved disagreements by consensus.
Randomised controlled trials and cohort studies:
Standard criteria are suggested for all randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs) and controlled before-after studies (CBA studies) from the EPOC group. Further information can be obtained from the Cochrane Handbook section on risk of bias (Higgins 2008a). We adapted these criteria, referring to the Newcastle-Ottawa (Newcastle-Ottawa Scale) and EPOC recommendations to best address the included studies and potential risk of bias presented by them as follows:
- Adequate generation of the allocation sequence [trials]
- Adequate allocation concealment [trials]
- Baseline CD4 count measurements were similar [all studies]
- Other baseline characteristics were similar [all studies]
- The study was adequately protected against contamination [trials]
- Data collection methods (i.e. retrospective of prospective) [cohorts]
- The study was free from other risks of bias [ we have specified co-interventions as possibly introducing bias] [all studies]
- Patient selection bias [cohorts]
Assessment of overall quality of evidence We assessed the quality of evidence across particular models of care with Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology (Guyatt 2011), defining the quality of evidence for each outcome as “the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest” (Higgins 2008). The quality rating across studies has four levels: high, moderate, low or very low. Randomised controlled trials are initially categorised as providing high quality evidence, but the quality can be downgraded; similarly, other types of controlled trials and observational studies are categorised as providing low quality evidence but the quality can be upgraded if justified. Factors that decrease the quality of evidence include limitations in design, indirectness of evidence, unexplained heterogeneity or inconsistency of results, imprecision of results or high probability of publication bias. Factors that can increase the quality level of a body of evidence include studies with a large magnitude of effect, and studies in which all plausible confounding would lead to an underestimation of effect.
Measures of treatment effect
We used Review Manager software (Review Manager 2011) provided by the Cochrane Collaboration for statistical analysis and GRADEpro software (GRADEpro 2008) provided by the GRADE Working Group to produce GRADE Summary of Findings tables and GRADE Evidence Profiles. We summarised dichotomous outcomes for effect in terms of risk ratios (RRs) with their 95% confidence intervals. We calculated summary statistics using meta-analytic methods, presented as forest plots, and presented findings in GRADE Summary of Findings tables and GRADE Evidence Profiles for all critical outcomes of interest.
Dealing with missing data
Assessment of heterogeneity
For the main outcomes death and loss to follow-up, we conducted meta-analyses. We examined heterogeneity by using the χ
We grouped data by the tiers of service and care configurations outlined in Table 1 and Table 2. The main comparisons for decentralisation included partial decentralisation, full decentralisation and referral to community maintenance care. When interventions and study populations were sufficiently similar across the different studies, we pooled the data across studies and estimated summary effect sizes using random-effects models. We used the inverse variance method for analysis of cluster randomised designs.The inverse variance method assumes that the variance for each study is inversely proportional to its importance, therefore more weight is given to studies with less variance than studies with greater variance. We did not meta-analyse data where different study designs were included, as the data were considered too heterogeneous for pooling.
We summarised the quality of evidence for the studies separately for each outcome, and for the different study designs, in the GRADE Summary of Findings tables and GRADE Evidence Profiles (Guyatt 2011).
Subgroup analysis and investigation of heterogeneity
We examined outcomes under the three models of care: partial decentralisation (initiated at hospital, continued at health centre), full decentralisation (initiated and treated at health centre) and community care for maintenance of ART ( Table 2). We defined hospital and health centre strictly as established in the protocol ( Table 1). Sub-groups were formed by duration of follow-up (i.e. 6 months, 12 months or 24 months).
A sensitivity analysis was conducted in which 40% of all patients lost to follow-up were reclassified as being dead. This figure was chosen because, according to a systematic review of HIV infected patients in treatment programmes in low resource setting, 40% of patients lost to follow-up were found upon tracing to have died (Brinkhof 2009).
Description of studies
Results of the search
Searches were conducted in May 2012 and March 2013 and identified 3437 titles (see prisma flow diagram Figure 1). Twenty-nine full-text articles were closely examined by two authors (TK and FBA), including a trial, identified by checking references; an unpublished study provided by the co-author, on hearing of this review in progress, however this is awaiting further data before inclusion; and a further study was suggested through contact with the technical team at the WHO.
|Figure 1. Study flow diagram.|
We finally identified two cluster randomised controlled trials and 14 cohort studies that met our inclusion criteria for data extraction, coding and potential meta-analysis. TK, FBA and NF independently extracted data for the included studies.
Sixteen studies met the inclusion criteria, two cluster randomised controlled trials (Jaffar 2009; Selke 2010), two prospective cohorts (Humphreys 2010; Kipp 2010) and 12 retrospective cohort studies (Assefa 2012; Balcha 2010; Bedelu 2007; Bock 2008; Brennan 2011; Chan 2010; Fatti 2010; Fayorsey 2013; Hansudewechakul 2012; McGuire 2012; Massaquoi 2009; Odafe 2012).
Three studies took place in rural Malawi (Chan 2010; Massaquoi 2009;McGuire 2012), two in various settings including urban, peri-urban and rural Ethiopia (Assefa 2012; Balcha 2010), two in rural Uganda (Jaffar 2009; Kipp 2010), one in rural and urban Kenya (Selke 2010), one in rural Swaziland (Humphreys 2010); four in various settings including urban, peri-urban and rural settings in South Africa (Bedelu 2007; Bock 2008; Brennan 2011; Fatti 2010). One study examined data from five countries in Africa (Kenya, Lesotho, Mozambique, Rwanda and Tanzania (Fayorsey 2013) and one from Thailand (Hansudewechakul 2012)
All studies evaluated decentralisation of care from hospital level to more basic levels of care. In addition, eight studies included task shifting from doctors to non-doctors (either nurses or clinical officers): Assefa 2012; Bedelu 2007; Brennan 2011; Humphreys 2010; Jaffar 2009; Kipp 2010; Massaquoi 2009; and Selke 2010.
Finally, one additional study from Nigeria was included that compared treatment at tertiary and secondary hospital care (Odafe 2012). Whilst it met our inclusion criteria, the model evaluated was not considered directly relevant to the review question. Results from this study are reported separately.
The three models of decentralisation of care that were pre-specified in the protocol ( Table 2) were further elaborated while reviewing the included studies as follows:
1. Partial decentralisation, in which ART is initiated in a hospital setting and patients are down referred for follow-up at the health centre (also sometimes referred to as "down referral")
2. Full decentralisation, in which ART is initiated and maintained at a health centre rather than a hospital
In both of these models of care the health care provider at the health centre, or more basic level of care, was usually a nurse of clinical officer (health officer), except in the case of the paediatric studies in which doctors were generally providing care.
3. A community model, in which ART is initiated at the health centre or hospital, but maintenance occurs at the home, supported by community health workers
In this model, HIV care was delivered by community volunteers or field officers with specific training, to ensure they could monitor adherence, adverse effects and clinical symptoms at the home (e.g. computer aided devices or checklists).
The models of care in included studies are described in detail ( Table 3) including relevant co-interventions such as additional adherence support through peer educators, supervision on-site or training for health workers.
See Excluded studies
There were 13 excluded studies, nine of which were excluded on the basis of their study design (cross-sectional surveys, qualitative or no contemporary arm for comparison), and two because they were conducted in high income countries.
Risk of bias in included studies
Modified risk of bias criteria were used to evaluate the included studies. The criteria were developed to reflect the study designs included in this review - prospective and retrospective cohort studies and randomised controlled trials (including cluster randomised controlled trials). See summary of risk of bias by study in Figure 2.
|Figure 2. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.|
Randomised controlled trials
The two randomised controlled trials assigned interventions by cluster (Jaffar 2009; Selke 2010). They were both well balanced for baseline CD4+ cell count, an important indicator of baseline morbidity, and were therefore rated as having a low risk of bias, they were also balanced for other baseline characteristics, including sex, age and WHO clinical stage, also rated as contributing a low risk of bias. Co-interventions used to support participants (such as adherence support) were similar for both groups in the Jaffar 2009 and Selke 2010 trials and this was rated as having a low risk of bias. Sequence generation was not described in either included trial and therefore was rated as presenting an unclear risk of bias. Allocation concealment was well described and was unlikely to introduce bias, rated as a low risk of bias. Neither trial had any indication of contamination and it was unlikely that those in the control group were at risk of receiving the intervention. Overall, risk of bias was low, as judged by the modified risk of bias assessment tool.
Only two of the 14 cohort studies were prospective (Humphreys 2010, Kipp 2010). The other 12 studies were retrospective cohort studies, and therefore classified as high risk of bias for data collection.
Stated selection differential:
Chan 2010 stated that only stable patients were selected to receive ART at the health centre; this study was therefore rated as having a high risk of bias. No other selection bias was detected in any of the other cohorts.
For partial decentralisation, four cohort studies had comparable CD4+ cell counts at baseline, with sicker children in the Bock 2008 study remaining at the hospital, and CD4+ cell count not reported in Chan 2010. For other baseline variables, two studies were not comparable, and one study did not report on other baseline characteristics (Bock 2008). In Chan 2010, patients at peripheral units were "healthier", which could lead to an erroneous conclusion that peripheral units were just as good as hospitals; and in Fatti 2010, where patients at peripheral units were sicker.
For full decentralisation, two cohort studies had comparable CD4+ cell counts, three did not report this, and in two the CD4+ cell counts indicated the patients were healthier at the peripheral units (Bedelu 2007; McGuire 2012). For other baseline factors, four did not report this, and three were not comparable as they reported that they included patients that were healthier at peripheral units (Massaquoi 2009; McGuire 2012; Odafe 2012).
For decentralisation from facility to community, all three studies were ranked as low risk of bias for CD4+ cell count and other baseline factors.
Effects of interventions
See: Summary of findings for the main comparison Antiretroviral therapy initiated in a hospital, maintained at a health centre for HIV infected patients; Summary of findings 2 Antiretroviral therapy started and maintained in a health centre for HIV infected patients; Summary of findings 3 Decentralisation from the facility to the community for antiretroviral maintenance therapy for HIV-infected patients on antiretroviral therapy
Studies reported retention variably, sometimes including patients who were transferred out, but still in care, but this was not always clearly reported. We were more consistently able to extract data on whether patients were lost to care (defined within studies as failure to attend clinic follow-up 3 months or 6 months after the expected appointment date), and this was therefore chosen as a more reliable measure than its inverse, retention. We also sought data on mortality; however, the majority of the included studies did not trace patients who were lost to care to determine if they were dead (and therefore classified as mortality) or alive and truly lost to follow-up. This is a known problem with antiretroviral treatment programs with varying rates of mortality among patients who default from care. A recent systematic review showed a pooled mortality estimate of around 40% among HIV patients on antiretroviral programs who were successfully traced following default from care (Brinkhof 2009). We therefore report as our primary outcome the composite outcome of attrition (i.e. death or lost to care).
MAIN ANALYSIS BY THE THREE DECENTRALISATION MODELS
1. Partial decentralisation - Initiated antiretroviral therapy at hospital and maintained in a health centre
There were no trials that examined this comparison. Data come from six observational cohorts reporting outcomes for three time points, including two cohorts of paediatric patients.
Attrition (death or lost to care)
Partial decentralisation reduced attrition at 12 months (RR 0.46, 95% CI 0.29 to 0.71, four cohort studies, 39 090 patients, moderate quality evidence, Figure 3). This benefit was consistent across all the four studies included in this analysis.
|Figure 3. Forest plot of comparison: 1 Partial decentralisation - initiation in hospital, maintenance at health centre, outcome: 1.1 Death or lost to care (12 months).|
Lost to care
|Figure 4. Forest plot of comparison: 1 Partial decentralisation - initiation in hospital, maintenance at health centre, outcome: 1.2 Lost to care.|
Overall, partial decentralisation was found to lead to fewer numbers of patients lost to care at 12 months.
Two retrospective (Bock 2008; Fatti 2010) and one prospective cohort (Humphreys 2010) contributed to the 6 month data, including 28 699 patients in rural, peri-urban and urban settings. Overall, from our unadjusted pooled analysis the relative risk of patients lost to care is RR 0.99 (95% CI 0.56 to 1.76; I
Four retrospective cohorts contributed data on patients lost to care at 12 months (Bock 2008; Brennan 2011; Chan 2010; Fatti 2010) including 39 090 patients. Bock 2008 and Chan 2010 included children in their study. Overall, patients were 45% less likely to be lost to care at the decentralised site (RR 0.55, 95% CI 0.45 to 0.69; I
Finally, one retrospective study in children reported data on children at 24 months (Hansudewechakul 2012), with no difference between models of care (no patients lost to care at any site).
|Figure 5. Forest plot of comparison: 1 Partial decentralisation - initiation in hospital, maintenance at health centre, outcome: 1.3 Death.|
Overall, there is low quality evidence that partial decentralisation of care after initiation at a hospital may reduce death at 12 months.
The three cohorts reporting on patients lost to care at the clinic, also provide data for mortality at six months (Bock 2008; Fatti 2010; Humphreys 2010) The pooled risk of death at six months was RR 0.52 (95% CI 0.19 to 1.41; I
The risk of bias inherent and reported in the cohort studies would be expected to favour the intervention in all studies, except in Fatti 2010. There is overall very low quality data for this outcome at six months, with wide confidence intervals.
The same four cohorts reporting losses to care at 12 months provide data for this outcome, with the same high potential risk of bias. The relative risk of mortality at 12 months was RR 0.34 (95% CI 0.13 to 0.87). There was substantial quantitative and qualitative heterogeneity, and an I
Thus, overall there is low quality evidence that partial decentralisation of care reduces death at 12 months. This should be seen in the context of substantial heterogeneity in the studies and high risk of bias. Overall, there was no excess of deaths seen in any of the studies with care decentralised to the health centres, after initiation at hospital level.
Finally, one study, done among children, reported lower mortality at the decentralised site at 24 months (RR 0.04, 95%CI 0.00 to 0.58) (Hansudewechakul 2012).
2. Full decentralisation - Initiated and maintained antiretroviral therapy at a health centre
No trials examined this comparison. Data come from six observational cohorts reported outcomes at three time points, including one cohort of paediatric patients.
All studies included patients in rural settings. Antiretroviral therapy was initiated and maintained at the health centres and delivered by nurses or clinical officers, not doctors.
Attrition (Death or lost to care)
Overall, decentralisation to heath centres for initiation and maintenance of care appeared to reduce attrition at 12 months (RR 0.70, 95% CI 0.47 to 1.02, four cohort studies, 56 360 patients, very low quality evidence, Figure 6). This result was consistent across three of the studies included in the analysis while the fourth study showed no difference in attrition.
|Figure 6. Forest plot of comparison: 2 Full decentralisation - initiation and maintenance in health centre, outcome: 2.1 Death or lost to care (12 months).|
Lost to care
|Figure 7. Forest plot of comparison: 2 Full decentralisation - initiation and maintenance in health centre, outcome: 2.2 Lost to care.|
Overall there was moderate quality evidence that full decentralisation of care from hospitals to health centres for both initiation and maintenance of HIV care probably reduces the numbers of patients lost to care at 12 months.
Two large retrospective cohorts, one from Ethiopia (Assefa 2012) and another from Malawi (McGuire 2012) both reported a statistically significant reduction in patients lost to care at decentralised sites at six months, and the pooled relative risk, indicated a large reduction of 47% in the risk of being lost to care (RR 0.53, 95% CI 0.26 to 1.10, 51 261 patients).
There was also a reduction in the risk of patients being lost to care at decentralised sites at 12 months, with consistent reductions reported across four cohorts and a strong association reporting a reduction of 70% (RR 0.3, 95% CI 0.17 to 0.54, 56 360 patients) when pooling the data. A consistent benefit was also reported by four studies that reported lost to care at 24 months (RR 0.50, 95%CI 0.36 to 0.71, 61 445 patients).
|Figure 8. Forest plot of comparison: 2 Full decentralisation - initiation and maintenance in health centre, outcome: 2.3 Death.|
Overall, there is very low quality evidence that there was no difference in mortality for patients treated at the health centre or the hospital at 12 months.
The pooled risk of death in decentralised sites was (RR 0.84, 95%CI 0.35 to 2.00, two studies, 50 000 patients) at six months, (RR 1.10, 95%CI 0.63 to 1.92, four studies, 55 099 patients) at 12 months, and (RR 0.64, 95%CI 0.39 to 1.06, four studies, 60 184 patients) at 24 months. Although baseline CD4+ cell counts were similar between some groups, the studies were judged to have unclear bias related to co-interventions and other baseline characteristics, as these were not well reported. In the sensitivity analysis, mortality at 12 months remained similar between sites (RR 0.86, 95% CI 0.58 to 1.29).
Other models of full decentralisation
Odafe 2012 examined attrition, death and loss to follow-up of patients treated in secondary and tertiary providers in Nigeria. Whilst this loosely could be a study of "decentralisation" it was at a higher level of care and is not a current question for most health care systems in countries of Africa, where HIV treatment is currently standard at secondary level.
3. Decentralisation to the community - maintained on antiretroviral therapy in the community
Two trials examined this comparison. Data come from these two trials and one observational cohort reporting outcomes at three time points.
All studies included patients in rural settings. Antiretroviral therapy was initiated at the health centres and maintained in the community with a trained community health worker.
Attrition (Death or lost to care):
Neither trial provided adjusted rates for analysis, therefore in order to adjust for the design effect, we required an intra-cluster co-efficient (ICC). We made a statistical assumption and used a liberal ICC of 0.05. Following this adjustment, the included studies had small sample sizes and wide confidence intervals, the evidence was thus downgraded for imprecision. Overall, there is moderate quality evidence that there is probably no difference in attrition rates at 12 months comparing community and facility-based maintenance care (RR 0.95, 95% CI 0.62 to 1.46, two trials, 1453 participants, Figure 9).
|Figure 9. Forest plot of comparison: 3 Decentralisation - from the facility to the community for antiretroviral maintenance therapy, outcome: 3.1 Death or lost to care (12 months).|
Lost to care
|Figure 10. Forest plot of comparison: 3 Decentralisation - to community from facility, outcome: 3.2 lost to care.|
Two cluster randomised controlled trials (Jaffar 2009; Selke 2010) and a single cohort (Kipp 2010) provided the 6 and 12 month data for patients who were lost to follow-up in the community. Overall, there was moderate quality evidence from the two cluster trials reporting that there was no difference at 12 months.
One prospective cohort reported on lost to care at 6 months (Kipp 2010). Overall the risk of bias in this included study was low. There was no difference in the rate of failure to attend follow-up between the groups (RR 1.49, 95% CI 0.81 to 2.74, 385 participants).The same cohort also reported data at 24 months, and again the result was not significantly different between models (RR 0.74, 95%CI 0.46 to 1.20, 385 participants).
This lack of difference was also supported by data from the two randomised controlled trials at 12 months (RR 0.81, 95% CI 0.3 to 2.21, 1453 participants).The quality of the evidence was downgraded for imprecision due to the low event rates in both arms of both trials and wide confidence interval when combining these two trials.
|Figure 11. Forest plot of comparison: 3 Decentralisation - to community from facility, outcome: 3.1 Death.|
There was moderate quality evidence that rates of death at 12 months were similar whether maintenance care was delivered at the facility or in the community (RR 1.03, 95% CI 0.64 to 1.65, two trials, 1453 participants). Similarly, the risk of death was not significantly different in the cohort study at six months (RR 1.44, 95%CI 0.81 to 2.57, one study, 385 participants) and 24 months (RR 1.50, 95%CI 0.91 to 2.47, one study). All results of the sensitivity analysis were non-significant (results not shown).
Studies reported on a variety of other outcomes that are reported below.
Immunological changes - CD4+ cell count
Twelve cohorts report on change in CD4+ count, six provide median change at either six or 12 months (Assefa 2012; Balcha 2010; Brennan 2011; Jaffar 2009; Hansudewechakul 2012; Kipp 2010). As the studies reporting this outcome differed by model of care, time of reporting or threshold, this outcome is reported narratively. For all of these studies there is a consistent report of an increase in CD4+ cell count, with no statistical difference between decentralised or standard hospital treated groups.
Viral load suppression
Eight studies report the proportion of patients who are virologically suppressed (Bedelu 2007; Brennan 2011; Fatti 2010; Hansudewechakul 2012; Jaffar 2009; Kipp 2010; Selke 2010). The reported virological suppression rates were similar across the decentralised and control groups across these varied studies which could not be meta-analysed.
Cost to providers and patients
One prospective cohort, Humphreys 2010, reports specifically on the cost of travel for patients ( Analysis 1.4). The average cost for a decentralised patient was USD 0.74 compared to USD 1.5 for a patient seen at the hospital (P = 0.001).
Two studies provided data on overall cost to patient ( Analysis 3.4). Both reports come from community-based treatment compared to standard hospital-based treatment (Jaffar 2009; Kipp 2010). Both studies indicate substantial increase in cost to patient when they are required to travel to the hospital, which is usually further from their homes. Kipp 2010 reports a doubling of cost to patients when accounting for transport only. Jaffar 2009, the cluster trial, reports a three times increase in costs, including transport, lost work time, child-care costs and food.
Costs to the health service are also reported. Jaffar 2009 reported costs to health service for community versus hospital-based groups. These included staff, transport, drugs, laboratory, training, supervision, capital and utilities costs and was a mean of US$ 793 / year for each patient in the home-based group compared to US$ 838 / year / patient in the hospital-based group.
Initiation of tuberculosis treatment, time to initiation of ART, new AIDS defining illness, any negative impact on the health delivery
No study reported data on initiation of tuberculosis treatment, or time to initiation of antiretroviral treatment. Selke 2010 reported on new WHO clinical stage 3 or 4 diseases, indicating no difference between groups in these reported clinical events. No study reported information indicating a negative impact on healthcare delivery.
Patient satisfaction with care
Assefa 2012 evaluated patient satisfaction with care by conducting two hour long focused group discussions (57 patients in 7 groups). This study looked predominantly at the issue of task shifting and its acceptability amongst patients and healthcare providers. Patients reported that nurse and health officer (clinical officer) services were 'generally well accepted, and reduced waiting time', they also reported that they were 'more comfortable with nurses than with physicians because nurses were friendlier and more supportive'. Patients emphasised that nurses and health officers spent more time with them discussing their medical problems and took enough time examining them. Patients identified three additional benefits of being involved in ART delivery: their life experience helped them to provide appropriate counselling; it helped combat stigma and discrimination in society; and it provided them with an opportunity for employment. In the same study, focused-group discussions were held with programme managers and healthcare providers who agreed the model including task shifting provided a timely solution for Ethiopias needs. They also agreed that nurses and health officers can provide high quality care given adequate training and supervision.
Humphreys 2010 was a prospective cohort that used the model of down referral and included the assessment of patient satisfaction as a primary outcome. Those attending the intervention clinic were asked about their level of satisfaction, and 25 of the 31 respondents said that they were very satisfied with the care received. Reasons provided included the reduced cost of transport, being nearer to home, shorter queue, being treated better by staff, receiving better care and that they would not be talked about. The two respondents who were not satisfied with the care complained about the lack of doctor, saying they did not have money to get to the main clinic, and that there was a delay because staff from the hospital arrived late at the health centre.
Summary of main results
Three models of care were assessed in the included studies of this review.
In the first model, antiretroviral therapy is initiated at a hospital, and maintained at a health centre (partial decentralisation). When pooling the data, we found moderate quality evidence, favouring lower rates of patient attrition, and low quality evidence of lower rates of patients lost to care and mortality at 12 months (four observational studies). Although the results of the meta-analysis report lower risk of death and better follow up rates at the health centres, there is substantial uncertainty about these results.
In the second model antiretroviral therapy is initiated and maintained at the health centre (full decentralisation). Our meta-analysis found moderate quality evidence of lower rates of patients lost to care at the health centre compared to the hospital at 12 months (four observational cohorts). The observational cohort data was upgraded due to the large association reporting a 70% (95% CI 0.17 to 0.54) relative risk reduction in patients lost to care if they attended the health centre, rather than the hospital, for HIV services. There is however the possibility that additional evidence will substantially alter this result. There is very low quality evidence that attrition or death differed between arms whether care was delivered at the hospital or health centre. The quality of the data was downgraded for methodological limitations, as patients tended to be sicker at the hospital, favouring the intervention. These results were also consistent for paediatric populations.
For the third model, community volunteers with basic training delivered antiretroviral healthcare to participants at their homes (two cluster randomised controlled trials). We found moderate quality evidence reporting no difference for death or losses to care at 12 months of follow-up. The risk of bias in the trials was overall low. Overall we have moderate confidence that there is no difference in these outcomes when community care is introduced, but there is the possibility that further trials may change the results.
With respect to other relevant outcomes, the cohorts reporting CD4+ cell counts showed increases in immunological status, but no difference between models of care was found. Similar results were found for changes in viral load, a marker of the effectiveness of antiretroviral therapy, with studies reporting comparable virological suppression regardless of the model of care employed.
Costs, reported by three studies are considerably reduced in decentralised care for both the patient and provider making decentralisation an attractive option for patients, and possibly assisting in uptake of care closer to home. This is also reflected in the high level of acceptability to patients reported by the two studies in which this was assessed.
Overall completeness and applicability of evidence
There is a recognised need to address HIV health service delivery backlogs and ensure expanded access to HIV care. For this reason, several governments and implementing partners have implemented a decentralised approach to care. The majority of the data included in this review were from retrospective cohorts describing programmes that have rolled out across sub-Saharan Africa using facility-based models utilising lower levels of health care, and often accompanied by task shifting to non-doctors for ART provision.
Retrospective data have several inherent biases. A key concern for the interpretation of these studies is that individuals could choose whether to be down-referred or not, or their healthcare provider could allocate them according to both objective and subjective assessments, but the methods for this decision was not always clearly reported. In addition, the quality of data collection in these studies is variable, and generally based on a secondary analysis of routinely collected programme data. Another concern is that the models of care, including healthcare provider, training, supervision and mentoring provided and the necessary organisational planning that is required, were likely to differ across the studies. Even within the cohorts, there is a possibility that decentralisation did not occur in a systematic way. These are pragmatic issues that a study design that includes randomisation and concealed allocation of the intervention could address to provide higher quality evidence. The community models of care were evaluated using the cluster trial design which provides moderate quality evidence that community ART delivery can result in acceptable outcomes.
An important limitation of the evidence base, particularly for observational studies, is the potential for misclassification of deaths among patients who are reported as lost to care. A meta-analysis assessing this issue found that in studies that traced patients who were lost to care to determine their outcomes, 20% to 60% had in fact died (Brinkhof 2009). For this reason we include sensitivity analyses to account for possible deaths amongst those described as lost to care.
Finally, more information is needed on the package of care provided, including training and supervision, to support decentralisation of ART services, particularly to the community.
Quality of the evidence
In the GRADE system, well-conducted randomised controlled trials (without additional limitations) provide high quality evidence, and observational studies without any special strengths (and without additional limitations) provide low-quality evidence. The quality of evidence provided by a body of literature comprised exclusively of observational studies would thus generally be graded as low, except in circumstances where observational studies are upgraded.
This review largely comprises observational data, and we found that the quality of evidence reported for the facility based models of decentralisation of care was generally low or very low. Two exceptions to this were the outcome describing attrition in partial decentralisation and patients lost to care utilising the full decentralisation model where there was moderate quality evidence. This data was upgraded from 'low' due to the large effect size.
The model of care evaluating community follow-up by trained field officers, including two high quality cluster randomised controlled trials provided moderate quality evidence that the care provided by clinicians or field officers was similar in terms of the rate of patients lost to care and death. The data was downgraded due to the low event rate across arms.
Potential biases in the review process
Biases in the review process were minimised by performing a comprehensive search of databases and conference proceedings, not limiting for language or time. In addition, we contacted expert researchers in the field and other experts associated with relevant organisations (e.g. WHO, MSF) for unpublished and ongoing studies. We did not explore publication bias by using funnel plots as there were too few studies to draw conclusions from this analysis.
Agreements and disagreements with other studies or reviews
To date this is the first systematic review evaluating decentralisation of ART care. Prior and ongoing reviews have evaluated task shifting, which is related to decentralisation in that lower-level health services are generally staffed by lesser-trained health workers. The findings of this review broadly agree with the task shifting reviews which have found similar outcomes comparing physician and non-physician led care.
Implications for practice
The research to date provides no evidence that any model of decentralisation leads to a deterioration in health outcomes. Thus clinicians can be reassured that provision of HIV treatment at lower levels in the health system does not necessarily lead to a serious reduction in the quality of clinical care.
What is more, the findings of this review indicate that in some settings the loss to care is reduced, which is consistent with treatment being more accessible.
More broadly, studies show that decentralisation to lower levels in the health care system is feasible. The studies were of a reasonable size. Nevertheless, they were in the context of a range of support structures and investments to ensuring delivery, including training, supervision and additional devices such as computer-aided or checklist-based decision aids. Thus, policy makers and programme managers need to take into account adequate supervision and support when organising widespread delivery of HIV care through the more basic tiers in the health system. This would include referral systems to facilities being in place for those patients who experience complications. Importantly, several studies provide data indicating reduced costs for both patients and services when patients attend facilities closer to their homes.
Implications for research
Additional high quality evidence from trials and prospective cohorts would provide valuable insight on the key outcomes including retention in care, survival, quality of care and costs of decentralising care from hospitals to other tiers of the health care system. Implementation science research, using pragmatic trial designs would be helpful in testing the types of packages of care that best suit various settings and provide high quality care at decentralised sites.
The Effective Health Care Research Consortium, including Paul Garner, are funded by UKaid from the UK Government for the benefit of developing countries. We would also like to acknowledge the assistance of the South African Cochrane Centre. Thanks for the support from the Cochrane HIV/AIDS Review Group, University of California, San Francisco.
Data and analyses
- Top of page
- Summary of findings [Explanations]
- Authors' conclusions
- Data and analyses
- Contributions of authors
- Declarations of interest
- Sources of support
- Differences between protocol and review
- Index terms
Appendix 1. Central search strategy
Database: CLIB Issue 4 of 12, April 2012 (1996 - 2012)
Date: 3 May 2012
Appendix 2. Medline search strategy
Database: PubMed (1996 - 2012
Date: 2 May 2012
Appendix 3. Embase search strategy
Database: EMBASE (1996 - 2012)
Date: 3 May 2012
Appendix 4. GRADE Evidence profile for partial decentralisation model
Question: Should antiretroviral therapy initiated in a hospital, maintained at a health centre be used in HIV infected patients?
Settings: Lower- and middle-income countries
Appendix 5. GRADE Evidence profile for full decentralisation model
Question: Should antiretroviral therapy be started and maintained in health centre be used in HIV infected patients?
Settings: Lower- and middle-income countries
Appendix 6. GRADE evidence profile community model of care
Question: Should decentralisation from the facility to the community for antiretroviral maintenance therapy be used in HIV-infected patients on antiretroviral therapy?
Settings: Lower- and middle-income countries
Protocol first published: Issue 7, 2012
Review first published: Issue 6, 2013
Contributions of authors
TK and FBA conducted eligibility of the searches, and together with NF did data extraction, and quality assessment. PG resolved differences when needed. TK entered the data and conducted the analyses and wrote the first draft of the review. NF, FBA and PG provided regular feedback into the overall results and their interpretation. PG developed the framework for the nomenclature and models of health care delivery which were initially described in the protocol.
Declarations of interest
Sources of support
- South African Cochrane Centre, South Africa.
- World Health Organization, Department of HIV/AIDS, Switzerland.Provided some funding support towards completing this review, as a subcontract through the University of California, San Francisco (UCSF)
- UKaid from the UK Government for the benefit of developing countries (DFiD), UK.Funding received through a grant from DFiD to the Effective Health Care Research Consortium
Differences between protocol and review
Newcastle-Ottawa tool for assessing quality of cohort studies was not used in the review as it did not adequately address the relevant items of quality included studies.
Medical Subject Headings (MeSH)
*Developing Countries; Anti-HIV Agents [*supply & distribution]; Cohort Studies; Community Health Centers [statistics & numerical data]; HIV Infections [*drug therapy]; Health Services Accessibility [*organization & administration; standards]; Medication Adherence [*statistics & numerical data]; Patient Dropouts [statistics & numerical data]; Randomized Controlled Trials as Topic
MeSH check words
* Indicates the major publication for the study