Dataset Information

High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.

ABSTRACT: The 2015 WHO recommendation of antiretroviral therapy (ART) for all HIV-positive persons calls for treatment initiation in millions of persons newly eligible with high CD4+ counts. Efficient and effective care models are urgently needed for this population. We evaluated clinical outcomes of asymptomatic HIV-positive adults and children starting ART with high CD4+ counts using a novel streamlined care model in rural Uganda and Kenya.In the 16 intervention communities of the HIV test-and-treat Sustainable East Africa Research for Community Health Study (NCT01864603), all HIV-positive individuals irrespective of CD4 were offered ART (efavirenz [EFV]/tenofovir disoproxil fumarate + emtricitabine (FTC) or lamivudine (3TC). We studied adults (?fifteen years) with CD4 ? 350/?L and children (two to fourteen years) with CD4 > 500/?L otherwise ineligible for ART by country guidelines. Clinics implemented a patient-centred streamlined care model designed to reduce patient-level barriers and maximize health system efficiency. It included (1) nurse-conducted visits with physician referral of complex cases, (2) multi-disease chronic care (including for hypertension/diabetes), (3) patient-centred, friendly staff, (4) viral load (VL) testing and counselling, (5) three-month return visits and ART refills, (6) appointment reminders, (7) tiered tracking for missed appointments, (8) flexible clinic hours (outside routine schedule) and (9) telephone access to clinicians. Primary outcomes were 48-week retention in care, viral suppression (% with measured week 48 VL ? 500 copies/mL) and adverse events. Results Overall, 972 HIV-positive adults with CD4+ ? 350/?L initiated ART with streamlined care. Patients were 66% female and had median age thirty-four years (IQR, 28-42), CD4+ 608/?L (IQR, 487-788/?L) and VL 6775 copies/mL (IQR, <500-37,003 c/mL). At week 48, retention was 92% (897/972; 2 died/40 moved/8 withdrew/4 transferred care/21/964 [2%] were lost to follow-up). Viral suppression occurred in 778/838 (93%) and 800/972 (82%) in intention-to-treat analysis. Grade III/IV clinical/laboratory adverse events were rare: 95 occurred in 74/972 patients (7.6%). Only 8/972 adults (0.8%) switched ART from EFV to lopinavir (LPV) (n = 2 for dizziness, n = 2 for gynaecomastia, n = 4 for other reasons). Among 83 children, week 48 retention was 89% (74/83), viral suppression was 92% (65/71) and grade III/IV adverse events occurred in 4/83 (4.8%).Using a streamlined care model, viral suppression, retention and ART safety were high among asymptomatic East African adults and children with high CD4+ counts initiating treatment.NCT01864603.

SUBMITTER: Kwarisiima D

PROVIDER: S-EPMC5577724 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.

Kwarisiima Dalsone D Kamya Moses R MR Owaraganise Asiphas A Mwangwa Florence F Byonanebye Dathan M DM Ayieko James J Plenty Albert A Black Doug D Clark Tamara D TD Nzarubara Bridget B Snyman Katherine K Brown Lillian L Bukusi Elizabeth E Cohen Craig R CR Geng Elvin H EH Charlebois Edwin D ED Ruel Theodore D TD Petersen Maya L ML Havlir Diane D Jain Vivek V

Journal of the International AIDS Society 20170701 Suppl 4

<h4>Introduction</h4>The 2015 WHO recommendation of antiretroviral therapy (ART) for all HIV-positive persons calls for treatment initiation in millions of persons newly eligible with high CD4+ counts. Efficient and effective care models are urgently needed for this population. We evaluated clinical outcomes of asymptomatic HIV-positive adults and children starting ART with high CD4+ counts using a novel streamlined care model in rural Uganda and Kenya.<h4>Methods</h4>In the 16 intervention comm ...[more]

PMID: 28770596

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Project description:ObjectivesAlmost 13 million people are estimated to be on antiretroviral therapy in Eastern and Southern Africa, and their disease course and program effectiveness could be significantly affected by the concurrent use of alcohol. Screening for alcohol use may be important to assess the prevalence of alcohol consumption and its impact on patient and programmatic outcomes.MethodsAs part of this observational study, data on patient characteristics and alcohol consumption were collected on a cohort of 765 adult patients enrolling in HIV care in East Africa. Alcohol consumption was assessed with the AUDIT questionnaire at enrollment. Subjects were classified as consuming any alcohol (AUDIT score >0), hazardous drinkers (AUDIT score ≥8) and hyper drinkers (AUDIT score ≥16). The effects of alcohol consumption on retention in care, death and delays in antiretroviral therapy (ART) initiation were assessed through competing risk (Fine & Gray) models.ResultsOf all study participants, 41.6% consumed alcohol, 26.7% were classified as hazardous drinkers, and 16.0% as hyper drinkers. Depending on alcohol consumption classification, men were 3-4 times more likely to consume alcohol compared to women. Hazardous drinkers (median age 32.8 years) and hyper drinkers (32.7 years) were slightly older compared to non-hazardous drinkers (30.7 years) and non-hyper drinkers (30.8 years), (p-values = 0.014 and 0.053 respectively). Median CD4 at enrollment was 330 cells/μl and 16% were classified World Health Organization (WHO) stage 3 or 4. There was no association between alcohol consumption and CD4 count or WHO stage at enrollment. Alcohol consumption was associated with significantly lower probability of ART initiation (adjusted sub-distribution hazard ratio aSHR = 0.77 between alcohol consumers versus non-consumers; p-value = 0.008), and higher patient non-retention in care (aSHR = 1.77, p-value = 0.023).DiscussionAlcohol consumption is associated with significant delays in ART initiation and reduced retention in care for patients enrolling in HIV care and treatment programs in East Africa. Consequently, interventions that target alcohol consumption may have a significant impact on the HIV care cascade.

Project description:BackgroundEvidence favoring earlier HIV ART initiation at high CD4+ T-cell counts (CD4>350/uL) has grown, and guidelines now recommend earlier HIV treatment. However, the cost of providing ART to individuals with CD4>350 in Sub-Saharan Africa has not been well estimated. This remains a major barrier to optimal global cost projections for accelerating the scale-up of ART. Our objective was to compute costs of ART delivery to high CD4+count individuals in a typical rural Ugandan health center-based HIV clinic, and use these data to construct scenarios of efficient ART scale-up.MethodsWithin a clinical study evaluating streamlined ART delivery to 197 individuals with CD4+ cell counts >350 cells/uL (EARLI Study: NCT01479634) in Mbarara, Uganda, we performed a micro-costing analysis of administrative records, ART prices, and time-and-motion analysis of staff work patterns. We computed observed per-person-per-year (ppy) costs, and constructed models estimating costs under several increasingly efficient ART scale-up scenarios using local salaries, lowest drug prices, optimized patient loads, and inclusion of viral load (VL) testing.FindingsAmong 197 individuals enrolled in the EARLI Study, median pre-ART CD4+ cell count was 569/uL (IQR 451-716). Observed ART delivery cost was $628 ppy at steady state. Models using local salaries and only core laboratory tests estimated costs of $529/$445 ppy (+/-VL testing, respectively). Models with lower salaries, lowest ART prices, and optimized healthcare worker schedules reduced costs by $100-200 ppy. Costs in a maximally efficient scale-up model were $320/$236 ppy (+/- VL testing). This included $39 for personnel, $106 for ART, $130/$46 for laboratory tests, and $46 for administrative/other costs. A key limitation of this study is its derivation and extrapolation of costs from one large rural treatment program of high CD4+ count individuals.ConclusionsIn a Ugandan HIV clinic, ART delivery costs--including VL testing--for individuals with CD4>350 were similar to estimates from high-efficiency programs. In higher efficiency scale-up models, costs were substantially lower. These favorable costs may be achieved because high CD4+ count patients are often asymptomatic, facilitating more efficient streamlined ART delivery. Our work provides a framework for calculating costs of efficient ART scale-up models using accessible data from specific programs and regions.

Dataset Information

High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.

Publications

High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.

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