TB Modeling and Translational Epi Group

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- August 2020 -

Policy Implications of Mathematical Modeling of Latent Tuberculosis Infection Testing and Treatment Strategies to Accelerate Tuberculosis Elimination. (2020). Marks SM., Dowdy DW., Menzies NA., Shete PB., Salomon JA., Parriott A., Shrestha S., Flood J., Hill AN, Public health reports (Washington, D.C. : 1974), 135, 38S-43S

- July 2020 -

Willingness to accept reimbursement for visits to an HIV clinic for tuberculosis preventive therapy. (2020). Kadota JL., Katamba A., Musinguzi A., Welishe F., Nabunje J., Ssemata JL., Berger CA., Kamya MR., Namusobya J., Semitala FC., Cattamanchi A., Dowdy DW, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 24, 729-731

- June 2020 -

Model-Based Cost-Effectiveness of State-level Latent Tuberculosis Interventions in California, Florida, New York and Texas. (2020). Jo Y., Shrestha S., Gomes I., Marks S., Hill A., Asay G., Dowdy D, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

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BACKGROUND: Targeted testing and treatment (TTT) for latent tuberculosis infection (LTBI) is a recommended strategy to accelerate TB reductions and further tuberculosis elimination in the United States (US). Evidence on cost-effectiveness of TTT for key populations can help advance this goal. METHODS: We used a model of TB transmission to estimate the numbers of individuals who could be tested by interferon-γ release assay (IGRA) and treated for LTBI with three months of self-administered rifapentine and isoniazid (3HP) under various TTT scenarios. Specifically, we considered rapidly scaling up TTT among people who are non-US-born, diabetic, HIV-positive, homeless or incarcerated in California, Florida, New York, and Texas - states where more than half of US TB cases occur. We projected costs (from the healthcare system perspective, in 2018 dollars), thirty-year reductions in TB incidence, and incremental cost effectiveness (cost per quality-adjusted life year [QALY] gained) for TTT in each modeled population. RESULTS: The projected cost effectiveness of TTT differed substantially by state and population, while the health impact (number of TB cases averted) was consistently greatest among the non-US-born. TTT was most cost-effective among persons living with HIV (from $2,828/QALY gained in Florida to $11,265/QALY gained in New York) and least cost-effective among people with diabetes (from $223,041/QALY gained in California to $817,753 /QALY in New York). CONCLUSIONS: The modeled cost-effectiveness of TTT for LTBI varies across states but was consistently greatest among people living with HIV, moderate among people who are non-US-born, incarcerated, or homeless, and least cost-effective among people living with diabetes.

Spatial distribution of people diagnosed with tuberculosis through routine and active case finding: a community-based study in Kampala, Uganda. (2020). Robsky KO., Kitonsa PJ., Mukiibi J., Nakasolya O., Isooba D., Nalutaaya A., Salvatore PP., Kendall EA., Katamba A., Dowdy D, Infectious diseases of poverty, 9, 73

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BACKGROUND: Routine tuberculosis (TB) notifications are geographically heterogeneous, but their utility in predicting the location of undiagnosed TB cases is unclear. We aimed to identify small-scale geographic areas with high TB notification rates based on routinely collected data and to evaluate whether these areas have a correspondingly high rate of undiagnosed prevalent TB. METHODS: We used routinely collected data to identify geographic areas with high TB notification rates and evaluated the extent to which these areas correlated with the location of undiagnosed cases during a subsequent community-wide active case finding intervention in Kampala, Uganda. We first enrolled all adults who lived within 35 contiguous zones and were diagnosed through routine care at four local TB Diagnosis and Treatment Units. We calculated average monthly TB notification rates in each zone and defined geographic areas of "high risk" as zones that constituted the 20% of the population with highest notification rates. We compared the observed proportion of TB notifications among residents of these high-risk zones to the expected proportion, using simulated estimates based on population size and random variation alone. We then evaluated the extent to which these high-risk zones identified areas with high burdens of undiagnosed TB during a subsequent community-based active case finding campaign using a chi-square test. RESULTS: We enrolled 45 adults diagnosed with TB through routine practices and who lived within the study area (estimated population of 49 527). Eighteen zones reported no TB cases in the 9-month period; among the remaining zones, monthly TB notification rates ranged from 3.9 to 39.4 per 100 000 population. The five zones with the highest notification rates constituted 62% (95% CI: 47-75%) of TB cases and 22% of the population-significantly higher than would be expected if population size and random chance were the only determinants of zone-to-zone variation (48%, 95% simulation interval: 40-59%). These five high-risk zones accounted for 42% (95% CI: 34-51%) of the 128 cases detected during the subsequent community-based case finding intervention, which was significantly higher than the 22% expected by chance (P < 0.001) but lower than the 62% of cases notified from those zones during the pre-intervention period (P = 0.02). CONCLUSIONS: There is substantial heterogeneity in routine TB notification rates at the zone level. Using facility-based TB notification rates to prioritize high-yield areas for active case finding could double the yield of such case-finding interventions.

Longitudinal analysis of alcohol use and intimate partner violence perpetration among men with HIV in northern Vietnam. (2020). Hershow RB., Reyes HLM., Ha TV., Chander G., Mai NVT., Sripaipan T., Frangakis C., Dowdy DW., Latkin C., Hutton HE., Pettifor A., Maman S., Go VF, Drug and alcohol dependence, 213, 108098

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BACKGROUND: Alcohol use is a known risk factor for male-perpetrated intimate partner violence (IPV), although few studies have been conducted globally and among men with HIV (MWH). We estimated the longitudinal effects of alcohol use on IPV perpetration among MWH. METHODS: This study is a secondary analysis of randomized controlled trial data among male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam. Analyses were restricted to male participants who were married/cohabitating (N = 313). Alcohol use was assessed as proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire. Multilevel modeling was used to estimate the effects of higher versus lower average alcohol use on IPV perpetration (between-person effects) and the effects of time-specific deviations in alcohol use on IPV perpetration (within-person effects). RESULTS: Participants with higher average proportion days alcohol abstinent had decreased odds of IPV perpetration (adjusted Odds Ratio [aOR] = 0.43, p = 0.03) and those with higher average heavy drinking and AUD had increased odds of IPV perpetration (Heavy drinking: aOR = 1.05, p = 0.002; AUD: aOR = 4.74, p < 0.0001). Time-specific increases in proportion days alcohol abstinent were associated with decreased odds of IPV perpetration (aOR = 0.39, p = 0.02) and time-specific increases in AUD were associated with increased odds of IPV perpetration (aOR = 2.95, p = 0.001). Within-person effects for heavy drinking were non-significant. CONCLUSIONS: Alcohol use is associated with IPV perpetration among Vietnamese men with HIV. In this context, AUD and frequent drinking are stronger correlates of IPV perpetration as compared to heavy drinking.

Towards evidence-based integration of services for HIV, non-communicable diseases and substance use: insights from modelling. (2020). Dowdy DW., Powers KA., Hallett TB, Journal of the International AIDS Society, 23 Suppl 1, e25525

Integrated screening and treatment services for HIV, hypertension and diabetes in Kenya: assessing the epidemiological impact and cost-effectiveness from a national and regional perspective. (2020). Kasaie P., Weir B., Schnure M., Dun C., Pennington J., Teng Y., Wamai R., Mutai K., Dowdy D., Beyrer C, Journal of the International AIDS Society, 23 Suppl 1, e25499

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INTRODUCTION: As people with HIV age, prevention and management of other communicable and non-communicable diseases (NCDs) will become increasingly important. Integration of screening and treatment for HIV and NCDs is a promising approach for addressing the dual burden of these diseases. The aim of this study was to assess the epidemiological impact and cost-effectiveness of a community-wide integrated programme for screening and treatment of HIV, hypertension and diabetes in Kenya. METHODS: Coupling a microsimulation of cardiovascular diseases (CVDs) with a population-based model of HIV dynamics (the Spectrum), we created a hybrid HIV/CVD model. Interventions were modelled from year 2019 (baseline) to 2023, and population was followed to 2033. Analyses were carried at a national level and for three selected regions (Nairobi, Coast and Central). RESULTS: At a national level, the model projected 7.62 million individuals living with untreated hypertension, 692,000 with untreated diabetes and 592,000 individuals in need of ART in year 2018. Improving ART coverage from 68% at baseline to 88% in 2033 reduced HIV incidence by an estimated 64%. Providing NCD treatment to 50% of diagnosed cases from 2019 to 2023 and maintaining them on treatment afterwards could avert 116,000 CVD events and 43,600 CVD deaths in Kenya over the next 15 years. At a regional level, the estimated impact of expanded HIV services was highest in Nairobi region (averting 42,100 HIV infections compared to baseline) while Central region experienced the highest impact of expanded NCD treatment (with a reduction of 22,200 CVD events). The integrated HIV/NCD intervention could avert 7.76 million disability-adjusted-life-years (DALYs) over 15 years at an estimated cost of $6.68 billion ($445.27 million per year), or $860.30 per DALY averted. At a cost-effectiveness threshold of $2,010 per DALY averted, the probability of cost-effectiveness was 0.92, ranging from 0.71 in Central to 0.92 in Nairobi region. CONCLUSIONS: Integrated screening and treatment of HIV and NCDs can be a cost-effective and impactful approach to save lives of people with HIV in Kenya, although important variation exists at the regional level. Containing the substantial costs required for scale-up will be critical for management of HIV and NCDs on a national scale.

The public health response to COVID-19: balancing precaution and unintended consequences. (2020). Baral SD., Mishra S., Diouf D., Phanuphak N., Dowdy D, Annals of epidemiology, 46, 12-13

Is distance associated with tuberculosis treatment outcomes? A retrospective cohort study in Kampala, Uganda. (2020). Robsky KO., Hughes S., Kityamuwesi A., Kendall EA., Kitonsa PJ., Dowdy DW., Katamba A, BMC infectious diseases, 20, 406

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BACKGROUND: Challenges accessing nearby health facilities may be a barrier to initiating and completing tuberculosis (TB) treatment. We aimed to evaluate whether distance from residence to health facility chosen for treatment is associated with TB treatment outcomes. METHODS: We conducted a retrospective cohort study of all patients initiating TB treatment at six health facilities in Kampala from 2014 to 2016. We investigated associations between distance to treating facility and unfavorable TB treatment outcomes (death, loss to follow up, or treatment failure) using multivariable Poisson regression. RESULTS: Unfavorable treatment outcomes occurred in 20% (339/1691) of TB patients. The adjusted relative risk (aRR) for unfavorable treatment outcomes (compared to treatment success) was 0.87 (95% confidence interval [CI] 0.70, 1.07) for patients living ≥2 km from the facility compared to those living closer. When we separately compared each type of unfavorable treatment outcome to favorable outcomes, those living ≥2 km from the facility had increased risk of death (aRR 1.42 [95%CI 0.99, 2.03]) but decreased risk for loss to follow-up (aRR 0.57 [95%CI 0.41, 0.78]) than those living within 2 km. CONCLUSIONS: Distance from home residence to TB treatment facility is associated with increased risk of death but decreased risk of loss to follow up. Those who seek care further from home may have advanced disease, but once enrolled may be more likely to remain in treatment.

- May 2020 -

Measuring Stigma to Assess the Social Justice Implications of Health-Related Policy Decisions: Application to Novel Treatment Regimens for Multidrug-Resistant Tuberculosis. (2020). Dowdy DW., Zwerling AA., Stennett A., Searle A., Dukhanin V., Taylor HA., Merritt MW, MDM policy & practice, 5, 2381468320915239

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In making policy decisions with constrained resources, an important consideration is the impact of alternative policy options on social justice. Social justice considers interactions between individuals and society and can be conceptualized across domains of agency, association, and respect. Despite its importance, social justice is rarely considered formally in health policy decision making, partially reflecting challenges in its measurement. We define three criteria for considering social justice in health-related policy decisions: 1) linkage of social justice to a measurable construct; 2) ability to reproducibly and feasibly estimate the impacts of a policy decision on the selected construct; and 3) appropriate presentation to decision makers of the expected social justice implications using that construct. We use preliminary data from qualitative interviews from three groups of respondents in South Africa and Uganda to demonstrate that stigma meets the first of these criteria. We then use the example of policy addressing novel treatment regimens for multidrug-resistant tuberculosis and a validated tuberculosis stigma scale to illustrate how policy effects on stigma could be estimated (criterion 2) and presented to decision makers in the form of justice-enhanced cost-effectiveness analysis (criterion 3). Finally, we provide a point-by-point guide for conducting similar assessments to facilitate consideration of social justice in health-related policy decisions. Our case study and guide for how to make social justice impacts more apparent to decision makers also illustrates the importance of local data and local capacity. Performing social justice assessments alongside more traditional evaluations of cost-effectiveness, budget impact, and burden of disease could help represent data-informed considerations of social justice in health care decision making more broadly.

Secure Delivery of HIV-Related and Tuberculosis Laboratory Results to Patient Cell Phones: A Pilot Comparative Study. (2020). DiAndreth L., Jarrett BA., Elf JL., Nishath T., Donville B., Heidari O., Cox S., Moreton J., Ramnath A., Lebina L., Variava E., Golub JE., Martinson NA, AIDS and behavior, 24, 3511-3521

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South Africa processes 5.1 million HIV CD4, viral load (VL), and tuberculosis (TB) tests annually. This pilot non-randomized trial in South Africa explored an intervention ("MatlaMobile") to deliver laboratory results via mobile phone. Adults completing CD4, VL, and/or TB laboratory tests were enrolled-either receiving results by returning to clinic (control, n = 174) or mobile phone (intervention, n = 226). Study staff instructed control participants to return within 6 days (standard-of-care). MatlaMobile instructed intervention participants with clinically actionable results requiring intervention or treatment change (i.e., < 200 CD4 cells per milliliter, ≥ 400 viral copies per milliliter, or TB positive) to return immediately. A greater proportion of intervention participants than controls saw their results within 7 days of enrollment (73% vs. 8.6%, p < 0.001). Among participants instructed to return, more intervention participants (20%, n = 14/70) returned than controls (8.6%, n = 15/174, p = 0.02). MatlaMobile demonstrated that patients can quickly receive and respond appropriately to digital delivery of health information.

- April 2020 -

Prevalence of Pre-Existing Hearing Loss Among Patients With Drug-Resistant Tuberculosis in South Africa. (2020). Hong H., Dowdy DW., Dooley KE., Francis HW., Budhathoki C., Han HR., Farley JE, American journal of audiology, 29, 199-205

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Purpose Hearing loss, resulting from aminoglycoside ototoxicity, is common among patients with drug-resistant tuberculosis (DR-TB). Those with pre-existing hearing loss are at particular risk of clinically important hearing loss with aminoglycoside-containing treatment than those with normal hearing at baseline. This study aimed to identify factors associated with pre-existing hearing loss among patients being treated for DR-TB in South Africa. Method Cross-sectional analysis nested within a cluster-randomized trial data across 10 South African TB hospitals. Patients ≥ 13 years old received clinical and audiological evaluations before DR-TB treatment initiation. Results Of 936 patients, average age was 35 years. One hundred forty-two (15%) reported pre-existing auditory symptoms. Of 482 patients tested by audiometry, 290 (60%) had pre-existing hearing loss. The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]). Having HIV with cluster of differentiation 4 cell count < 200 cells/mm(3) and malnutrition were risk factors but did not reach statistical significance in adjusted analyses. Conclusion Pre-existing hearing loss is common among patients presenting for DR-TB treatment in South Africa, and those older than the age of 50 years or who had prior second-line TB treatment history were at highest risk.

Priorities among HIV-positive individuals for tuberculosis preventive therapies. (2020). Kim HY., Hanrahan CF., Dowdy DW., Martinson NA., Golub JE., Bridges JFP, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 24, 396-402

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BACKGROUND: There has been slow uptake of isoniazid preventive therapy (IPT) among people living with HIV (PLWH).METHODS: We surveyed adults recently diagnosed with HIV in 14 South African primary health clinics. Based on the literature and qualitative interviews, sixteen potential barriers and facilitators related to preventive therapy among PLWH were selected. Best-worst scaling (BWS) was used to quantify the relative importance of the attributes. BWS scores were calculated based on the frequency of participants' selecting each attribute as the best or worst among six options (across multiple choice sets) and rescaled from 0 (always selected as worst) to 100 (always selected as best) and compared by currently receiving IPT or not.RESULTS: Among 342 patients surveyed, 33% (n = 114) were currently taking IPT. Having the same standard of life as someone without HIV was most highly prioritized (BWS score = 67.3, SE = 0.6), followed by trust in healthcare providers (score, 66.3 ± 0.6). Poor standard of care in public clinics (score, 30.6 ± 0.6) and side effects of medications (score, 33.7 ± 0.6) were least prioritized. BWS scores differed by IPT status for few attributes, but overall ranking was similar (spearman's rho = 0.9).CONCLUSION: Perceived benefits of preventive therapy were high among PLWH. IPT prescription by healthcare providers should be encouraged to enhance IPT uptake among PLWH.

Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB). (2020). Reza TF., Nalugwa T., Farr K., Nantale M., Oyuku D., Nakaweesa A., Musinguzi J., Vangala M., Shete PB., Tucker A., Ferguson O., Fielding K., Sohn H., Dowdy D., Moore DAJ., Davis JL., Ackerman SL., Handley MA., Katamba A., Cattamanchi A, Implementation science : IS, 15, 24

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BACKGROUND: Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear. METHODS: The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy. DISCUSSION: The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB. TRIAL REGISTRATION: US National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016.

The urgent need to improve clinical practice guidelines for pediatric tuberculosis. (2020). Dowdy DW, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 24, 264

- March 2020 -

Prevalence and risk factors for latent tuberculosis infection among household contacts of index cases in two South African provinces: Analysis of baseline data from a cluster-randomised trial. (2020). MacPherson P., Lebina L., Motsomi K., Bosch Z., Milovanovic M., Ratsela A., Lala S., Variava E., Golub JE., Webb EL., Martinson NA, PloS one, 15, e0230376

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INTRODUCTION: Household contacts of patients with active pulmonary tuberculosis (TB) often have latent TB infection, and are at risk of progression to disease. We set out to investigate whether index TB case HIV status was linked to a higher probability of latent TB infection among household contacts. MATERIALS AND METHODS: Data were collected prospectively from participants in the intervention arm of a household cluster-randomised trial in two South Africa provinces (Mangaung, Free State, and Capricorn, Limpopo). In intervention group households, TB contacts underwent HIV testing and tuberculin skin testing (TST). TST induration was estimated at two cut-offs (≥5mm, ≥10mm). Multilevel Bayesian regression models estimated posterior distributions of the percentage of household contacts with TST induration ≥5mm and ≥10mm by age group, and compared the odds of latent TB infection by key risk factors including HIV status index case age and study province. RESULTS: A total of 2,985 household contacts of 924 index cases were assessed, with most 2,725 (91.3%) undergoing TST. HIV prevalence in household contacts was 14% and 10% in Mangaung and Capricorn respectively. Overall, 16.8% (458/2,725) had TST induration of ≥5mm and 13.1% (359/2,725) ≥10mm. In Mangaung, children aged 0-4 years had a high TST positivity prevalence compared to their peers in Capricorn (22.0% vs. 7.6%, and 20.5% vs. 2.3%, using TST thresholds of ≥5mm and ≥10mm respectively). Compared to contacts from Capricorn, household contacts living in Mangaung were more likely to have TST induration ≥5mm (odds ratio [OR]: 3.08, 95% credibility interval [CI]: 2.13-4.58) and ≥10mm (OR: 4.52, 95% CI: 3.03-6.97). There was a 90% and 92% posterior probability that the odds of TST induration ≥5mm (OR: 0.79, 95% CI: 0.56-1.14) and ≥10mm (OR: 0.77, 95% CI: 0.53-1.10) respectively were lower in household contacts of HIV-positive compared to HIV-negative index cases. CONCLUSIONS: High TST induration positivity, especially among young children and people living in Mangaung indicates considerable TB transmission despite high antiretroviral therapy coverage. Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.

Challenges with scale-up of GeneXpert MTB/RIF® in Uganda: a health systems perspective. (2020). Nalugwa T., Shete PB., Nantale M., Farr K., Ojok C., Ochom E., Mugabe F., Joloba M., Dowdy DW., Moore DAJ., Davis JL., Cattamanchi A., Katamba A, BMC health services research, 20, 162

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BACKGROUND: Many high burden countries are scaling-up GeneXpert® MTB/RIF (Xpert) testing for tuberculosis (TB) using a hub-and-spoke model. However, the effect of scale up on reducing TB has been limited. We sought to characterize variation in implementation of referral-based Xpert TB testing across Uganda, and to identify health system factors that may enhance or prevent high-quality implementation of Xpert testing services. METHODS: We conducted a cross-sectional study triangulating quantitative and qualitative data sources at 23 community health centers linked to one of 15 Xpert testing sites between November 2016 and May 2017 to assess health systems infrastructure for hub-and-spoke Xpert testing. Data sources included a standardized site assessment survey, routine TB notification data, and field notes from site visits. RESULTS: Challenges with Xpert implementation occurred at every step of the diagnostic evaluation process, leading to low overall uptake of testing. Of 2192 patients eligible for TB testing, only 574 (26%) who initiated testing were referred for Xpert testing. Of those, 54 (9.4%) were Xpert confirmed positive just under half initiated treatment within 14 days (n = 25, 46%). Gaps in required infrastructure at 23 community health centers to support the hub-and-spoke system included lack of refrigeration (n = 14, 61%) for sputum testing and lack of telephone/mobile communication (n = 21, 91%). Motorcycle riders responsible for transporting sputum to Xpert sites operated variable with trips once, twice, or three times a week at 10 (43%), nine (39%) and four (17%) health centers, respectively. Staff recorded Xpert results in the TB laboratory register at only one health center and called patients with positive results at only two health centers. Of the 15 Xpert testing sites, five (33%) had at least one non-functioning module. The median number of tests per day was 3.57 (IQR 2.06-4.54), and 10 (67%) sites had error/invalid rates > 5%. CONCLUSIONS: Although Xpert devices are now widely distributed throughout Uganda, health system factors across the continuum from test referral to results reporting and treatment initiation preclude effective implementation of Xpert testing for patients presenting to peripheral health centers. Support for scale up of innovative technologies should include support for communication, coordination and health systems integration.

- February 2020 -

Redefining and revisiting cost estimates of routine ART care in Zambia: an analysis of ten clinics. (2020). Tucker A., Tembo T., Tampi RP., Mutale J., Mukumba-Mwenechanya M., Sharma A., Dowdy DW., Moore CB., Geng E., Holmes CB., Sikazwe I., Sohn H, Journal of the International AIDS Society, 23, e25431

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INTRODUCTION: Accurate costing is key for programme planning and policy implementation. Since 2011, there have been major changes in eligibility criteria and treatment regimens with price reductions in ART drugs, programmatic changes resulting in clinical task-shifting and decentralization of ART delivery to peripheral health centres making existing evidence on ART care costs in Zambia out-of-date. As decision makers consider further changes in ART service delivery, it is important to understand the current drivers of costs for ART care. This study provides updates on costs of ART services for HIV-positive patients in Zambia. METHODS: We evaluated costs, assessed from the health systems perspective and expressed in 2016 USD, based on an activity-based costing framework using both top-down and bottom-up methods with an assessment of process and capacity. We collected primary site-level costs and resource utilization data from government documents, patient chart reviews and time-and-motion studies conducted in 10 purposively selected ART clinics. RESULTS: The cost of providing ART varied considerably among the ten clinics. The average per-patient annual cost of ART service was $116.69 (range: $59.38 to $145.62) using a bottom-up method and $130.32 (range: $94.02 to $162.64) using a top-down method. ART drug costs were the main cost driver (67% to 7% of all costs) and are highly sensitive to the types of patient included in the analysis (long-term vs. all ART patients, including those recently initiated) and the data sources used (facility vs. patient level). Missing capacity costs made up 57% of the total difference between the top-down and bottom-up estimates. Variability in cost across the ten clinics was associated with operational characteristics. CONCLUSIONS: Real-world costs of current routine ART services in Zambia are considerably lower than previously reported estimates and sensitive to operational factors and methods used. We recommend collection and monitoring of resource use and capacity data to periodically update cost estimates.

Patient-incurred cost of inpatient treatment for Tuberculosis in rural Malawi. (2020). Shin H., Ngwira LG., Tucker A., Chaisson RE., Corbett EL., Dowdy DW, Tropical medicine & international health : TM & IH, 25, 624-634

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OBJECTIVES: To mitigate the economic burden of tuberculosis (TB), it is important to fully understand the costs of TB treatment from the patient perspective. We therefore sought to quantify the patient-incurred cost of TB treatment in rural Malawi, with specific focus on costs borne by patients requiring inpatient hospitalisation. METHODS: We conducted a cross-sectional survey of 197 inpatients and 156 outpatients being treated for TB in rural Malawi. We collected data on out-of-pocket costs and lost wages, including costs to guardians. Costs for inpatient TB treatment were estimated and compared to costs for outpatient TB treatment. We then explored the equity distribution of inpatient TB treatment cost using concentration curves. RESULTS: Despite free government services, inpatients were estimated to incur a mean of $137 (standard deviation: $147) per initial TB episode, corresponding to >50% of annual household spending among patients in the lowest expenditure quintile. Non-medical hospitalisation costs accounted for 88% of this total. Patients treated entirely as outpatients incurred estimated costs of $25 (standard deviation: $15) per episode. The concentration curves showed that, among individuals hospitalised for an initial TB episode, poorer patients shouldered a much greater proportion of inpatient TB treatment costs than wealthier ones (concentration index: -0.279). CONCLUSION: Patients hospitalised for TB in resource-limited rural Malawi experience devastating costs of TB treatment. Earlier diagnosis and treatment must be prioritised if we are to meet goals of effective TB control, avoidance of catastrophic costs and provision of appropriate patient-centred care in such settings.

Risk of hearing loss among multidrug-resistant tuberculosis patients according to cumulative aminoglycoside dose. (2020). Hong H., Dowdy DW., Dooley KE., Francis HW., Budhathoki C., Han HR., Farley JE, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 24, 65-72

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SETTING: The ototoxic effects of aminoglycosides (AGs) lead to permanent hearing loss, which is one of the devastating consequences of multidrug-resistant tuberculosis (MDR-TB) treatment. As AG ototoxicity is dose-dependent, the impact of a surrogate measure of AG exposure on AG-induced hearing loss warrants close attention for settings with limited therapeutic drug monitoring.OBJECTIVE: To explore the prognostic impact of cumulative AG dose on AG ototoxicity in patients following initiation of AG-containing treatment for MDR-TB.DESIGN: This prospective cohort study was nested within an ongoing cluster-randomized trial of nurse case management intervention across 10 MDR-TB hospitals in South Africa.RESULTS: The adjusted hazard of AG regimen modification due to ototoxicity in the high-dose group (≥75 mg/kg/week) was 1.33 times higher than in the low-dose group (<75 mg/kg/week, 95%CI 1.09-1.64). The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77). Pre-existing hearing loss (adjusted hazard ratio [aHR] 1.71, 95%CI 1.29-2.26) and age (aHR 1.16 per 10 years of age, 95%CI 1.01-1.33) were also associated with an increased risk of hearing loss.CONCLUSION: MDR-TB patients with high AG dose, advanced age and pre-existing hearing loss have a significantly higher risk of AG-induced hearing loss. Those at high risk may be candidates for more frequent monitoring or AG-sparing regimens.

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