Outcome assessment of decentralization of antiretroviral therapy provision in a rural district of Malawi using an integrated primary care model. Implementing antiretroviral therapy in rural communities: the Lusikisiki model of decentralized HIV/AIDS care. Effectiveness and acceptability of delivery of antiretroviral treatment in health centres by health officers and nurses in Ethiopia. Results of a community-based antiretroviral treatment program for HIV-1 infection in Western Uganda. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Task-shifting of antiretroviral delivery from health care workers to persons living with HIV/AIDS: clinical outcomes of a community-based program in Kenya. Nurse led, primary care based antiretroviral treatment versus hospital care: a controlled prospective study in Swaziland. Patient retention and attrition on antiretroviral treatment at district level in rural Malawi. A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection.
To assess the effect of decentralization (DC) of antiretroviral therapy (ART) provision in a rural district of Malawi using an integrated primary care model.
                Between October 2004 and December 2008, 8093 patients (63% women) were registered for ART. Of these, 3440 (43%) were decentralized to health centres for follow-up ART care. We applied multivariate regression analysis that adjusted for sex, age, clinical stage at initiation, type of regimen, presence of side effects because of ART, and duration of treatment and follow-up at site of analysis.
                Patients managed at health centres had lower mortality [adjusted OR 0.19 (95% C.I. 0.15-0.25)] and lower loss to follow-up (defaulted from treatment) [adjusted OR 0.48 (95% C.I. 0.40-0.58)]. During the first 10 months of follow-up, those decentralized to health centres were approximately 60% less likely to default than those not decentralized; and after 10 months of follow-up, 40% less likely to default. DC was significantly associated with a reduced risk of death from 0 to 25 months of follow-up. The lower mortality may be explained by the selection of stable patients for DC, and the mentorship and supportive supervision of lower cadre health workers to identify and refer complicated cases.
                Decentralization of follow-up ART care to rural health facilities, using an integrated primary care model, appears a safe and effective way to rapidly scale-up ART and improves both geographical equity in access to HIV-related services and adherence to ART. Health worker shortages are a major bottleneck to scaling up antiretroviral therapy (ART), particularly in rural areas. In Lusikisiki, a rural area of South Africa with a population of 150,000 serviced by 1 hospital and 12 clinics, Médecins Sans Frontières has been supporting a program to deliver human immunodeficiency virus (HIV) services through decentralization to primary health care clinics, task shifting (including nurse-initiated as opposed to physician-initiated treatment), and community support. This approach has allowed for a rapid scale-up of treatment with satisfactory outcomes. Although the general approach in South Africa is to provide ART through hospitals-which seriously limits access for many people, if not the majority of people-1-year outcomes in Lusikisiki are comparable in the clinics and hospital. The greater proximity and acceptability of services at the clinic level has led to a faster enrollment of people into treatment and better retention of patients in treatment (2% vs. 19% lost to follow-up). In all, 2200 people were receiving ART in Lusikisiki in 2006, which represents 95% coverage. Maintaining quality and coverage will require increased resource input from the public sector and full acceptance of creative approaches to implementation, including task shifting and community involvement. The World Health Organization (WHO) recommends shifting tasks from physicians to lower cadres for the delivery of antiretroviral treatment (ART) for countries short of physicians. Our objective was to evaluate the effectiveness and acceptability of ART delivery by health officers and nurses in Ethiopia.
                A retrospective cohort study to evaluate outcomes of ART services in 25 health centres staffed with health officers and/or nurses and 30 hospitals staffed with physicians in 2009. Median CD4-cell counts, mortality, loss to follow-up and retention were the primary outcomes. Interviews and focus group discussions were conducted with people living with HIV/AIDS, AIDS programme managers and health care providers to identify the types and acceptability of the tasks conducted by the health officers, nurses and community health workers.
                Health officers and nurses were providing ART, including ART prescription, for non-severe cases. The management of severe cases was exclusively the task of physicians. Community health workers were involved in adherence counselling and defaulter tracing. The baseline median CD4-cell counts per micro-liter of blood were 117 (interquartiles [IQ] 64,188) and 119 (IQ 67,190) at health centres and hospitals respectively. After 24 months on ART, the median CD4-cell counts per micro-liter of blood increased to 321 (IQ 242, 414) and 301 (IQ 217, 411) at health centres and hospitals respectively. Retention in care was higher in health centres (76%, 95% confidence interval [CI] [73%-79%]) than hospitals (67%, 95% CI [66%-68%]). This difference is mainly due to the higher loss to follow-up rate in hospitals (25% versus 13%). Mortality was higher in health centres than hospitals (11% versus 8%), but the difference is not statistically significant. Service delivery by non-physicians was accepted by patients, health care providers and programme managers. However, the absence of a regulatory framework for task shifting, the lack of extra remuneration for the additional roles assumed by nurses and health officers, and the high cost for training and mentorship were identified as weaknesses.
                ART delivery in health centres, based on health officers and nurses is feasible, effective and acceptable in Ethiopia. However, issues related to regulation, remuneration and cost need to be addressed for the sustainable implementation of these delivery models. To compare the treatment outcomes and mortality in a rural community-based ART (CBART) program with a hospital-based ART program in the same district.
                The study design was a non-randomized cohort study consisting of 185 persons living with HIV (PLWHIV) in the CBART cohort and 200 PLWHIV in the hospital cohort. Eligibility for both cohorts was: being HIV-infected and eligible for ART, being treatment naïve, age 18 years or older, and being a resident of Rwimi sub-county. The intervention consisted of a community-based program which included weekly home visits to patients by trained volunteers who delivered antiretroviral drugs (ARVs), monitored and supported adherence to treatment, and identified and reported adverse reactions and other clinical symptoms. Outcome variables were compared to patients in a hospital-based cohort who received the standard care delivered to all other HIV patients in the hospital. The main outcome measures were HIV-1 RNA viral load (VL), CD4 cell count and mortality after six months of treatment.
                Successful ART treatment outcome as measured by virological suppression (VL<400 copies/ml) in the CBART cohort were similar to those in the hospital-based cohort (90.1% vs 89.3%, p=0.47). The median CD4 cell count increased significantly in both cohorts (community-based cohort 159 cells/microl vs 145 cells/microl in the hospital-based cohort). Mortality was not significantly different in both cohorts (community-based cohort 11.9%, hospital-based cohort 9.0%).
                The findings show that outcomes of a CBART intervention in a rural area compare favorably to outcomes of hospital-based care. If the study results are sustainable over a longer time period, this model could be considered for ART roll-out to impoverished rural/remote populations in Uganda and elsewhere. Identification of new ways to increase access to antiretroviral therapy in Africa is an urgent priority. We assessed whether home-based HIV care was as effective as was facility-based care.
                We undertook a cluster-randomised equivalence trial in Jinja, Uganda. 44 geographical areas in nine strata, defined according to ratio of urban and rural participants and distance from the clinic, were randomised to home-based or facility-based care by drawing sealed cards from a box. The trial was integrated into normal service delivery. All patients with WHO stage IV or late stage III disease or CD4-cell counts fewer than 200 cells per microL who started antiretroviral therapy between Feb 15, 2005, and Dec 19, 2006, were eligible, apart from those living on islands. Follow-up continued until Jan 31, 2009. The primary endpoint was virological failure, defined as RNA more than 500 copies per mL after 6 months of treatment. The margin of equivalence was 9% (equivalence limits 0.69-1.45). Analyses were by intention to treat and adjusted for baseline CD4-cell count and study stratum. This trial is registered at http://isrctn.org, number ISRCTN 17184129.
                859 patients (22 clusters) were randomly assigned to home and 594 (22 clusters) to facility care. During the first year, 93 (11%) receiving home care and 66 (11%) receiving facility care died, 29 (3%) receiving home and 36 (6%) receiving facility care withdrew, and 8 (1%) receiving home and 9 (2%) receiving facility care were lost to follow-up. 117 of 729 (16%) in home care had virological failure versus 80 of 483 (17%) in facility care: rates per 100 person-years were 8.19 (95% CI 6.84-9.82) for home and 8.67 (6.96-10.79) for facility care (rate ratio [RR] 1.04, 0.78-1.40; equivalence shown). Two patients from each group were immediately lost to follow-up. Mortality rates were similar between groups (0.95 [0.71-1.28]). 97 of 857 (11%) patients in home and 75 of 592 (13%) in facility care were admitted at least once (0.91, 0.64-1.28).
                This home-based HIV-care strategy is as effective as is a clinic-based strategy, and therefore could enable improved and equitable access to HIV treatment, especially in areas with poor infrastructure and access to clinic care.
                Copyright 2009 Elsevier Ltd. All rights reserved. To assess whether community-based care delivered by people living with HIV/AIDS (PLWAs) could replace clinic-based HIV care.
                Prospective cluster randomized controlled clinical trial.
                Villages surrounding 1 rural clinic in western Kenya.
                HIV-infected adults clinically stable on antiretroviral therapy (ART).
                The intervention group received monthly Personal Digital Assistant supported home assessments by PLWAs with clinic appointments every 3 months. The control group received standard of care monthly clinic visits.
                Viral load, CD4 count, Karnofsky score, stability of ART regimen, opportunistic infections, pregnancies, and number of clinic visits.
                After 1 year, there were no significant intervention-control differences with regard to detectable viral load, mean CD4 count, decline in Karnofsky score, change in ART regimen, new opportunistic infection, or pregnancy rate. Intervention patients made half as many clinic visits as did controls (P < 0.001).
                Community-based care by PLWAs resulted in similar clinical outcomes as usual care but with half the number of clinic visits. This pilot study suggests that task-shifting and mobile technologies can deliver safe and effective community-based care to PLWAs, expediting ART rollout and increasing access to treatment while expanding the capacity of health care institutions in resource-constrained environments. Antiretroviral treatment services delivered in hospital settings in Africa increasingly lack capacity to meet demand and are difficult to access by patients. We evaluate the effectiveness of nurse led primary care based antiretroviral treatment by comparison with usual hospital care in a typical rural sub Saharan African setting.
                We undertook a prospective, controlled evaluation of planned service change in Lubombo, Swaziland. Clinically stable adults with a CD4 count > 100 and on antiretroviral treatment for at least four weeks at the district hospital were assigned to either nurse led primary care based antiretroviral treatment care or usual hospital care. Assignment depended on the location of the nearest primary care clinic. The main outcome measures were clinic attendance and patient experience.
                Those receiving primary care based treatment were less likely to miss an appointment compared with those continuing to receive hospital care (RR 0.37, p < 0.0001). Average travel cost was half that of those receiving hospital care (p = 0.001). Those receiving primary care based, nurse led care were more likely to be satisfied in the ability of staff to manage their condition (RR 1.23, p = 0.003). There was no significant difference in loss to follow-up or other health related outcomes in modified intention to treat analysis. Multilevel, multivariable regression identified little inter-cluster variation.
                Clinic attendance and patient experience are better with nurse led primary care based antiretroviral treatment care than with hospital care; health related outcomes appear equally good. This evidence supports efforts of the WHO to scale-up universal access to antiretroviral treatment in sub Saharan Africa. We report on rates of patient retention and attrition in the context of scaling-up antiretroviral treatment (ART) within a district hospital and its primary health centres in rural Malawi. 'Retention' was defined as being alive and on ART or transferred out, whereas 'attrition' was defined as died, lost to follow-up or stopped treatment. A total of 4074 patients were followed-up for 1803 person-years: 2904 were at the hospital and 1170 at health centres. Approximately 85% of patients were retained in care, both at hospital and health centres, with a retention rate per 100 person-years of 185 and 211, respectively [adjusted hazard ratio (HR) 1.18, 95% CI 1.10-1.28, P=0.001). Attrition rates per 100 person-years were similar: 33 and 36, respectively (adjusted HR 1.17, 95% CI 0.97-1.4, P=0.1). At health centres the incidence of loss to follow-up was significantly lower than at the hospital (adjusted HR 0.24, P<0.001, risk reduction 77%), but the rate of reported deaths was higher at health centres (adjusted HR 2.2, 95% CI 1.76-2.72, P<0.001). As Malawi continues to extend the coverage (and equity) of ART, including in rural areas, attention is needed to reduce losses to follow-up at hospital level and reduce mortality at primary care level. Structured treatment interruption was evaluated in 74 patients who had been pretreated with antiretrovirals, consisting of 2 nucleoside reverse-transcriptase inhibitors (NRTIs) for 1 year followed by 3 years of highly active antiretroviral therapy containing a protease inhibitor.
                Patients with a CD4 cell count of > or =350 cells/microL and a plasma viral load of <50 copies/mL were randomized to 3 therapy arms: (1) continuous therapy, (2) CD4 cell count-guided theory, and (3) week-on/week-off (WOWO) therapy. The efficacy and safety of structured treatment interruption and antiretroviral use were evaluated in human immunodeficiency type 1 (HIV-1)-infected patients. The study end points were percentage of patients who developed AIDS or who died and a CD4 cell count of > or =350 cells/microL. Intergroup differences were analyzed using analysis of variance and Kruskal-Wallis tests.
                Baseline characteristics at the start of the structured treatment interruption were similar. At week 48, no patient had died, and 1 patient in the WOWO group had an AIDS-defining condition. The proportions of patients with a CD4 cell count of > or =350 cells/microL were 100%, 87%, and 96% in treatment arms 1, 2, and 3, respectively. The percentages of weeks of antiretroviral use were 100%, 41.1%, and 69.8% in arms 1, 2, and 3, respectively. The adverse events were not significantly different among arms (P=.27). Thirty-one percent of patients in the WOWO group experienced virological failure.
                WOWO therapy maintained a CD4 cell count of > or =350 cells/microL in almost all patients but was associated with high virological failures rates (possibly resulting from previous dual-NRTI therapy), indicating that this strategy is less useful. Receipt of CD4 cell count-guided therapy resulted in comparable clinical outcomes to continuous therapy and may save antiretroviral-associated costs, but this needs to be confirmed by a larger trial.
Decentralisation of HIV care aims to improve patient access and retention in care. Most data were from good quality cohort studies but confounding between site of treatment and outcomes cannot be excluded. Nevertheless, this review found that attrition appears to be lower in partial decentralisation models of treatment, where antiretrovirals were started at hospital and continued in the health centre; with antiretroviral drugs started and continued at health centres, no difference in attrition was detected, but there were fewer patients lost to care. For antiretroviral therapy provided at home by trained volunteers, no difference in outcomes were detected when compared to facility-based care.