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Tirivayi N.,Maastricht University | Koethe J.R.,Center for Infectious Diseases Research in Zambia | Koethe J.R.,Vanderbilt University | Groot W.,Maastricht University
Journal of AIDS and Clinical Research

Background: There has been limited research to date on the effects of food assistance provided to HIV-infected adults in resource-constrained settings with a high prevalence of malnutrition and chronic food insecurity. We compare antiretroviral therapy (ART) adherence, weight gain, and CD4+ lymphocyte count change among HIVinfected adults enrolled in a clinic-based food assistance program in Lusaka, Zambia versus a control group of non-recipients. Methods: We conducted a cohort study incorporating interviewer-administered surveys and retrospective clinical data to compare ART patients receiving food assistance with a control group of non-recipients. Medication adherence was assessed using pharmacy dispensation records. We use propensity score matching to assess the effect of food assistance on outcome measures. Results: After 6 months, food assistance recipients (n=145) had higher ART adherence compared to nonrecipients (n=147, 98.3% versus 88.8%, respectively; p<0.01), but no significant effects were observed for weight or CD4+ lymphocyte count change. The improvement in adherence rates was greater for participants on ART for less than 230 days, and those with BMI<18.5 kg/m2, a higher HIV disease stage, or a CD4+ lymphocyte count ≤ 350 cells/μl. Conclusions: Promoting optimal medication adherence among persons on ART is relevant to public health and the success of HIV control efforts. The provision of food assistance to HIV-infected adults on ART may have an incentivizing effect which can improve medication adherence, particularly among patients recently initiated on treatment and those with poor nutrition or advanced disease. The effects on body weight and immune reconstitution appear minimal. © 2012 Tirivayi N, et al. Source

Koethe J.R.,Center for Infectious Diseases Research in Zambia | Koethe J.R.,Vanderbilt University | Marseille E.,Health Strategies International | Giganti M.J.,Center for Infectious Diseases Research in Zambia | And 7 more authors.
Cost Effectiveness and Resource Allocation

Background: Low body mass index (BMI) individuals starting antiretroviral therapy (ART) for HIV infection in sub-Saharan Africa have high rates of death and loss to follow-up in the first 6 months of treatment. Nutritional supplementation may improve health outcomes in this population, but the anticipated benefit of any intervention should be commensurate with the cost given resource limitations and the need to expand access to ART in the region.Methods: We used Markov models incorporating historical data and program-wide estimates of treatment costs and health benefits from the Zambian national ART program to estimate the improvements in 6-month survival and program retention among malnourished adults necessary for a combined nutrition support and ART treatment program to maintain cost-effectiveness parity with ART treatment alone. Patients were stratified according to World Health Organization criteria for severe (BMI <16.0 kg/m2), moderate (16.00-16.99 kg/m2), and mild (17.00-18.49 kg/m2) malnutrition categories.Results: 19,247 patients contributed data between May 2004 and October 2010. Quarterly survival and retention were lowest in the BMI <16.0 kg/m2 category compared to higher BMI levels, and there was less variation in both measures across BMI strata after 180 days. ART treatment was estimated to cost $556 per year and averted 7.3 disability-adjusted life years. To maintain cost-effectiveness parity with ART alone, a supplement needed to cost $10.99 per quarter and confer a 20% reduction in both 6-month mortality and loss to follow-up among BMI <16.0 kg/m2 patients. Among BMI 17.00-18.49 kg/m2 patients, supplement costs accompanying a 20% reduction in mortality and loss to follow-up could not exceed $5.18 per quarter. In sensitivity analyses, the maximum permitted supplement cost increased if the ART program cost rose, and fell if patients classified as lost to follow-up at 6 months subsequently returned to care.Conclusions: Low BMI adults starting ART in sub-Saharan Africa are at high risk of early mortality and loss to follow-up. The expense of providing nutrition supplementation would require only modest improvements in survival and program retention to be cost-effective for the most severely malnourished individuals starting ART, but interventions are unlikely to be cost-effective among those in higher BMI strata. © 2014 Koethe et al.; licensee BioMed Central Ltd. Source

Hosseinipour M.C.,UNC Project | Hosseinipour M.C.,University of North Carolina at Chapel Hill | Bisson G.P.,University of Pennsylvania | Miyahara S.,Harvard University | And 25 more authors.
The Lancet

Summary Background Mortality within the first 6 months after initiating antiretroviral therapy is common in resource-limited settings and is often due to tuberculosis in patients with advanced HIV disease. Isoniazid preventive therapy is recommended in HIV-positive adults, but subclinical tuberculosis can be difficult to diagnose. We aimed to assess whether empirical tuberculosis treatment would reduce early mortality compared with isoniazid preventive therapy in high-burden settings. Methods We did a multicountry open-label randomised clinical trial comparing empirical tuberculosis therapy with isoniazid preventive therapy in HIV-positive outpatients initiating antiretroviral therapy with CD4 cell counts of less than 50 cells per μL. Participants were recruited from 18 outpatient research clinics in ten countries (Malawi, South Africa, Haiti, Kenya, Zambia, India, Brazil, Zimbabwe, Peru, and Uganda). Individuals were screened for tuberculosis using a symptom screen, locally available diagnostics, and the GeneXpert MTB/RIF assay when available before inclusion. Study candidates with confirmed or suspected tuberculosis were excluded. Inclusion criteria were liver function tests 2·5 times the upper limit of normal or less, a creatinine clearance of at least 30 mL/min, and a Karnofsky score of at least 30. Participants were randomly assigned (1:1) to either the empirical group (antiretroviral therapy and empirical tuberculosis therapy) or the isoniazid preventive therapy group (antiretroviral therapy and isoniazid preventive therapy). The primary endpoint was survival (death or unknown status) at 24 weeks after randomisation assessed in the intention-to-treat population. Kaplan-Meier estimates of the primary endpoint across groups were compared by the z-test. All participants were included in the safety analysis of antiretroviral therapy and tuberculosis treatment. This trial is registered with ClinicalTrials.gov, number NCT01380080. Findings Between Oct 31, 2011, and June 9, 2014, we enrolled 850 participants. Of these, we randomly assigned 424 to receive empirical tuberculosis therapy and 426 to the isoniazid preventive therapy group. The median CD4 cell count at baseline was 18 cells per μL (IQR 9-32). At week 24, 22 (5%) participants from each group died or were of unknown status (95% CI 3·5-7·8) for empirical group and for isoniazid preventive therapy (95% CI 3·4-7·8); absolute risk difference of -0·06% (95% CI -3·05 to 2·94). Grade 3 or 4 signs or symptoms occurred in 50 (12%) participants in the empirical group and 46 (11%) participants in the isoniazid preventive therapy group. Grade 3 or 4 laboratory abnormalities occurred in 99 (23%) participants in the empirical group and 97 (23%) participants in the isoniazid preventive therapy group. Interpretation Empirical tuberculosis therapy did not reduce mortality at 24 weeks compared with isoniazid preventive therapy in outpatient adults with advanced HIV disease initiating antiretroviral therapy. The low mortality rate of the trial supports implementation of systematic tuberculosis screening and isoniazid preventive therapy in outpatients with advanced HIV disease. Funding National Institutes of Allergy and Infectious Diseases through the AIDS Clinical Trials Group. © 2016 Elsevier Ltd. Source

Koethe J.R.,Center for Infectious Diseases Research in Zambia | Koethe J.R.,Vanderbilt University | Blevins M.,Vanderbilt University | Bosire C.,University of Alabama at Birmingham | And 12 more authors.
Public Health Nutrition

Objective Low BMI is a major risk factor for early mortality among HIV-infected persons starting antiretrovial therapy (ART) in sub-Saharan Africa and the common patient belief that antiretroviral medications produce distressing levels of hunger is a barrier to treatment adherence. We assessed relationships between appetite, dietary intake and treatment outcome 12 weeks after ART initiation among HIV-infected adults with advanced malnutrition and immunosuppression. Design A prospective, observational cohort study. Dietary intake was assessed using a 24 h recall survey. The relationships of appetite, intake and treatment outcome were analysed using time-varying Cox models. Setting A public-sector HIV clinic in Lusaka, Zambia. Subjects One hundred and forty-two HIV-infected adults starting ART with BMI <16 kg/m2 and/or CD4+ lymphocyte count <50 cells/μl. Results Median age, BMI and CD4+ lymphocyte count were 32 years, 16 kg/m2 and 34 cells/μl, respectively. Twenty-five participants (18 %) died before 12 weeks and another thirty-three (23 %) were lost to care. A 500 kJ/d higher energy intake at any time after ART initiation was associated with an approximate 16 % reduction in the hazard of death (adjusted hazard ratio = 0·84; P = 0·01), but the relative contribution of carbohydrate, protein or fat to total energy was not a significant predictor of outcome. Appetite normalized gradually among survivors and hunger was rarely reported. Conclusions Poor early ART outcomes were strikingly high in a cohort of HIV-infected adults with advanced malnutrition and mortality was predicted by lower dietary intake. Intervention trials to promote post-ART intake in this population may benefit survival and are warranted. © 2012 The Authors. Source

Koethe J.R.,Center for Infectious Diseases Research in Zambia | Koethe J.R.,Vanderbilt University | Koethe J.R.,West Health Institute | Blevins M.,Vanderbilt University | And 10 more authors.
Journal of Nutrition and Metabolism

Background. Low body mass index (BMI) at antiretroviral therapy (ART) initiation is associated with early mortality, but the etiology is not well understood. We hypothesized that low pretreatment serum phosphate, a critical cellular metabolism intermediate primarily stored in skeletal muscle, may predict mortality within the first 12 weeks of ART. Methods. We prospectively studied 352 HIV-infected adults initiating ART in Lusaka, Zambia to estimate the odds of death for each 0.1 mmol/L decrease in baseline phosphate after adjusting for established predictors of mortality. Results. The distribution of phosphate values was similar across BMI categories (median value 1.2 mmol/L). Among the 145 participants with BMI <18.5 kg/m2, 28 (19%) died within 12 weeks. Lower pretreatment serum phosphate was associated with increased mortality (odds ratio (OR) 1.24 per 0.1 mmol/L decrement, 95% CI: 1.05 to 1.47; P=0.01) after adjusting for sex, age, and CD4+ lymphocyte count. A similar relationship was not observed among participants with BMI ≥18.5 kg/m2 (OR 0.96, 95% CI: 0.76 to 1.21; P=0.74). Conclusions. The association of low pretreatment serum phosphate level and early ART mortality among undernourished individuals may represent a variant of the refeeding syndrome. Further studies of cellular metabolism in this population are needed. © 2013 John R. Koethe et al. Source

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