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Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.

ABSTRACT: BACKGROUND:Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART. METHODS:We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992. FINDINGS:Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07-1·29; psuperiority=0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98-1·19; pnon-inferiority=0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16-1·55; psuperiority<0·0001) as did the hybrid approach (66%, RR 1·19, 1·02-1·40; psuperiority=0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275-452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events. INTERPRETATION:In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load. FUNDING:The Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.

SUBMITTER: Barnabas RV

PROVIDER: S-EPMC7527697 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.

Barnabas Ruanne V RV Szpiro Adam A AA van Rooyen Heidi H Asiimwe Stephen S Pillay Deenan D Ware Norma C NC Schaafsma Torin T TT Krows Meighan L ML van Heerden Alastair A Joseph Philip P Shahmanesh Maryam M Wyatt Monique A MA Sausi Kombi K Turyamureeba Bosco B Sithole Nsika N Morrison Susan S Shapiro Adrienne E AE Roberts D Allen DA Thomas Katherine K KK Koole Olivier O Bershteyn Anna A Ehrenkranz Peter P Baeten Jared M JM Celum Connie C

The Lancet. Global health 20201001 10

<h4>Background</h4>Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ...[more]

PMID: 32971053

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Project description:BackgroundWith an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care.MethodsNewly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses.ResultsBetween February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001).ConclusionThis study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services.Trial registrationClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

Project description:INTRODUCTION:Warfarin is the most commonly prescribed oral anticoagulant in sub-Saharan Africa and requires ongoing monitoring. The burden of both infectious diseases and non-communicable diseases is high and medicines used to treat comorbidities may interact with warfarin. We describe service provision, patient characteristics, and anticoagulation control at selected anticoagulation clinics in Uganda and South Africa. METHODS:We evaluated two outpatient anticoagulation services in Kampala, Uganda and three in Cape Town, South Africa between 1 January and 31 July 2018. We collected information from key staff members about the clinics' service provision and extracted demographic and clinical data from a sample of patients' clinic records. We calculated time in therapeutic range (TTR) over the most recent 3-month period using the Rosendaal interpolation method. RESULTS:We included three tertiary level, one secondary level and one primary level anticoagulation service, seeing between 30 and 800 patients per month. Care was rendered by nurses, medical officers, and specialists. All healthcare facilities had on-site pharmacies; laboratory INR testing was off-site at two. Three clinics used warfarin dose-adjustment protocols; these were not validated for local use. We reviewed 229 patient clinical records. Most common indications for warfarin were venous thrombo-embolism in 112/229 (49%), atrial fibrillation in 74/229 (32%) and valvular heart disease in 30/229 (13%). Patients were generally followed up monthly. HIV prevalence was 20% and 5% at Ugandan and South African clinics respectively. Cardiovascular comorbidity predominated. Furosemide, paracetamol, enalapril, simvastatin, and tramadol were the most common concomitant drugs. Anticoagulation control was poor at all included clinics with median TTR of 41% (interquartile range 14% to 69%). CONCLUSIONS:TTR was suboptimal at all included sites, despite frequent patient follow-up. Strategies to improve INR control in sub-Saharan patients taking warfarin are needed. Locally validated warfarin dosing algorithms in Uganda and South Africa may improve INR control.

Project description:BackgroundIn South Africa the ever increasing demand for antiretroviral treatment (ART) runs the risk of leading to sub-optimal care in public sector ART clinics that are overburdened and under resourced. This study assessed the quality of ART services to identify service areas that require improvement.MethodsA cross-sectional study was carried out at 16 of 17 public ART clinics in the target area in greater Pretoria, South Africa. Trained participant observers presented as ART qualifying HIV positive patients that required a visit to assess treatment readiness. They evaluated each facility on five different occasions between June and November 2009, assessing the time it took to get an appointment, the services available and accessed, service quality and the duration of the visit. Services (reception area, clinician's consultation, HIV counselling, pharmacy, nutrition counselling and social worker's assessment) were assessed against performance standards that apply to all clinics. Service quality was expressed as scores for clinic performance (CPS) and service performance (SPS), defined as the percentage of performance standards met per clinic and service area.ResultsIn most of the clinics (62.5%) participant observers were able to obtain an appointment within one week, although on the day of their visit essential services could not always be accessed. The median CPS of the assessed facilities was 68.5 with four clinics not meeting minimum standards (CPS > 60). The service areas that performed least well were the clinician's consultation (SPS 67.3) and HIV counselling (SPS 70.7). Most notably, clinicians performed a physical examination in only 41.1% of the visits and rarely did a complete TB symptom screening. Counsellors frequently failed to address prevention of HIV transmission.ConclusionsOverall public sector ART clinics in greater Pretoria were easily accessible and their services were of an acceptable quality. However, the time spent at the clinic to complete the services was found to be very long and there was considerable variation in adherence to performance standards within the services, particularly in respect of clinician's consultation and counselling. Clinic management needs to ensure efficient clinic organisation and to improve adherence to performance standards in key service areas.

Project description:Considerable debate exists concerning the effects of antiretroviral therapy (ART) service scale-up on non-HIV services and overall health system performance in sub-Saharan Africa. In this study, we examined whether ART services affected trends in non-ART outpatient department (OPD) visits in Kenya and Uganda.Using a nationally representative sample of health facilities in Kenya and Uganda, we estimated the effect of ART programs on OPD visits from 2007 to 2012. We modeled the annual percent change in non-ART OPD visits using hierarchical mixed-effects linear regressions, controlling for a range of facility characteristics. We used four different constructs of ART services to capture the different ways in which the presence, growth, overall, and relative size of ART programs may affect non-ART OPD services.Our final sample included 321 health facilities (140 in Kenya and 181 in Uganda). On average, OPD and ART visits increased steadily in Kenya and Uganda between 2007 and 2012. For facilities where ART services were not offered, the average annual increase in OPD visits was 4·2% in Kenya and 13·5% in Uganda. Among facilities that provided ART services, we found average annual OPD volume increases of 7·2% in Kenya and 5·6% in Uganda, with simultaneous annual increases of 13·7% and 12·5% in ART volumes. We did not find a statistically significant relationship between annual changes in OPD services and the presence, growth, overall, or relative size of ART services. However, in a subgroup analysis, we found that Ugandan hospitals that offered ART services had statistically significantly less growth in OPD visits than Ugandan hospitals that did not provide ART services.Our findings suggest that ART services in Kenya and Uganda did not have a statistically significant deleterious effects on OPD services between 2007 and 2012, although subgroup analyses indicate variation by facility type. Our findings are encouraging, particularly given recent recommendations for universal access to ART, demonstrating that expanding ART services is not inherently linked to declines in other health services in sub-Saharan Africa.

Dataset Information

Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.

Publications

Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.

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