Integrating Xpert MTB/RIF for TB diagnosis in the private sector: evidence from large-scale pilots in Patna and Mumbai, India.

BACKGROUND: Xpert MTB/RIF (Xpert) has been recommended by WHO as the initial diagnostic test for TB and rifampicin-resistance detection. Existing evidence regarding its uptake is limited to public health systems and corresponding resource and infrastructure challenges. It cannot be readily extended to private providers, who treat more than half of India's TB cases and demonstrate complex diagnostic behavior. METHODS: We used routine program data collected from November 2014 to April 2017 from large-scale private sector engagement pilots in Mumbai and Patna. It included diagnostic vouchers issued to approximately 150,000 patients by about 1400 providers, aggregated to 18,890 provider-month observations. We constructed three metrics to capture provider behavior with regards to adoption of Xpert and studied their longitudinal variation: (i) Uptake (ordering of test), (ii) Utilization for TB diagnosis, and (iii) Non-adherence to negative results. We estimated multivariate linear regression models to assess heterogeneity in provider behavior based on providers' prior experience and Xpert testing volumes. RESULTS: Uptake of Xpert increased considerably in both Mumbai (from 36 to 60.4%) and Patna (from 12.2 to 45.1%). However, utilization of Xpert for TB diagnosis and non-adherence to negative Xpert results did not show systematic trends over time. In regression models, cumulative number of Xpert tests ordered was significantly associated with Xpert uptake in Patna and utilization for diagnosis in Mumbai (p-value< 0.01). Uptake of Xpert and its utilization for diagnosis was predicted to be higher in high-volume providers compared to low-volume providers and this gap was predicted to widen over time. CONCLUSIONS: Private sector engagement led to substantial increase in uptake of Xpert, especially among high-volume providers, but did not show strong evidence of Xpert results being integrated with TB diagnosis. Increasing availability and affordability of a technically superior diagnostic tool may not be sufficient to fundamentally change diagnosis and treatment of TB in the private sector. Behavioral interventions, specifically aimed at, integrating Xpert results into clinical decision making of private providers may be required to impact patient-level outcomes.

Risk Stratification for Early Detection of Diabetes and Hypertension in Resource-Limited Settings: Machine Learning Analysis.

BACKGROUND: The impending scale up of noncommunicable disease screening programs in low- and middle-income countries coupled with limited health resources require that such programs be as accurate as possible at identifying patients at high risk. OBJECTIVE: The aim of this study was to develop machine learning-based risk stratification algorithms for diabetes and hypertension that are tailored for the at-risk population served by community-based screening programs in low-resource settings. METHODS: We trained and tested our models by using data from 2278 patients collected by community health workers through door-to-door and camp-based screenings in the urban slums of Hyderabad, India between July 14, 2015 and April 21, 2018. We determined the best models for predicting short-term (2-month) risk of diabetes and hypertension (a model for diabetes and a model for hypertension) and compared these models to previously developed risk scores from the United States and the United Kingdom by using prediction accuracy as characterized by the area under the receiver operating characteristic curve (AUC) and the number of false negatives. RESULTS: We found that models based on random forest had the highest prediction accuracy for both diseases and were able to outperform the US and UK risk scores in terms of AUC by 35.5% for diabetes (improvement of 0.239 from 0.671 to 0.910) and 13.5% for hypertension (improvement of 0.094 from 0.698 to 0.792). For a fixed screening specificity of 0.9, the random forest model was able to reduce the expected number of false negatives by 620 patients per 1000 screenings for diabetes and 220 patients per 1000 screenings for hypertension. This improvement reduces the cost of incorrect risk stratification by US $1.99 (or 35%) per screening for diabetes and US $1.60 (or 21%) per screening for hypertension. CONCLUSIONS: In the next decade, health systems in many countries are planning to spend significant resources on noncommunicable disease screening programs and our study demonstrates that machine learning models can be leveraged by these programs to effectively utilize limited resources by improving risk stratification.

An Unstructured Supplementary Service Data System for Daily Tracking of Patient Samples and Diagnostic Results in a Diagnostic Network in Malawi: System Development and Field Trial.

BACKGROUND: Diagnostics in many low- and middle-income countries are conducted through centralized laboratory networks. Samples are collected from patients at remote point-of-care health facilities, and diagnostic tests are performed at centralized laboratories. Sample transportation systems that deliver diagnostic samples and test results are crucial for timely diagnosis and treatment in such diagnostic networks. However, they often lack the timely and accurate data (eg, the quantity and location of samples prepared for collection) required for efficient operation. OBJECTIVE: This study aims to demonstrate the feasibility, adoption, and accuracy of a distributed data collection system that leverages basic mobile phone technology to gather reports on the quantity and location of patient samples and test results prepared for delivery in the diagnostic network of Malawi. METHODS: We designed a system that leverages unstructured supplementary service data (USSD) technology to enable health workers to submit daily reports describing the quantity of transportation-ready diagnostic samples and test results at specific health care facilities, free of charge with any mobile phone, and aggregate these data for sample transportation administrators. We then conducted a year-long field trial of this system in 51 health facilities serving 3 districts in Malawi. Between July 2019 and July 2020, the participants submitted daily reports containing the number of patient samples or test results designated for viral load, early infant diagnosis, and tuberculosis testing at each facility. We monitored daily participation and compared the submitted USSD reports with program data to assess system feasibility, adoption, and accuracy. RESULTS: The participating facilities submitted 37,771 reports over the duration of the field trial. Daily facility participation increased from an average of 50% (26/51) in the first 2 weeks of the trial to approximately 80% (41/51) by the midpoint of the trial and remained at or above 80% (41/51) until the conclusion of the trial. On average, more than 80% of the reports submitted by a facility for a specific type of sample matched the actual number of patient samples collected from that facility by a courier. CONCLUSIONS: Our findings suggest that a USSD-based system is a feasible, adoptable, and accurate solution to the challenges of untimely, inaccurate, or incomplete data in diagnostic networks. Certain design characteristics of our system, such as the use of USSD, and implementation characteristics, such as the supportive role of the field team, were necessary to ensure high participation and accuracy rates without any explicit financial incentives.

Predicting the impact of patient and private provider behavior on diagnostic delay for pulmonary tuberculosis patients in India: A simulation modeling study.

BACKGROUND: Tuberculosis (TB) incidence in India continues to be high due, in large part, to long delays experienced by patients before successful diagnosis and treatment initiation, especially in the private sector. This diagnostic delay is driven by patients' inclination to switch between different types of providers and providers' inclination to delay ordering of accurate diagnostic tests relevant to TB. Our objective is to quantify the impact of changes in these behavioral characteristics of providers and patients on diagnostic delay experienced by pulmonary TB patients. METHODS AND FINDINGS: We developed a discrete event simulation model of patients' diagnostic pathways that captures key behavioral characteristics of providers (time to order a test) and patients (time to switch to another provider). We used an expectation-maximization algorithm to estimate the parameters underlying these behavioral characteristics, with quantitative data encoded from detailed interviews of 76 and 64 pulmonary TB patients in the 2 Indian cities of Mumbai and Patna, respectively, which were conducted between April and August 2014. We employed the estimated model to simulate different counterfactual scenarios of diagnostic pathways under altered behavioral characteristics of providers and patients to predict their potential impact on the diagnostic delay. Private healthcare providers including chemists were the first point of contact for the majority of TB patients in Mumbai (70%) and Patna (94%). In Mumbai, 45% of TB patients first approached less-than-fully-qualified providers (LTFQs), who take 28.71 days on average for diagnosis. About 61% of these patients switched to other providers without a diagnosis. Our model estimates that immediate testing for TB by LTFQs at the first visit (at the current level of diagnostic accuracy) could reduce the average diagnostic delay from 35.53 days (95% CI: 34.60, 36.46) to 18.72 days (95% CI: 18.01, 19.43). In Patna, 61% of TB patients first approached fully qualified providers (FQs), who take 9.74 days on average for diagnosis. Similarly, immediate testing by FQs at the first visit (at the current level of diagnostic accuracy) could reduce the average diagnostic delay from 23.39 days (95% CI: 22.77, 24.02) to 11.16 days (95% CI: 10.52, 11.81). Improving the diagnostic accuracy of providers per se, without reducing the time to testing, was not predicted to lead to any reduction in diagnostic delay. Our study was limited because of its restricted geographic scope, small sample size, and possible recall bias, which are typically associated with studies of patient pathways using patient interviews. CONCLUSIONS: In this study, we found that encouraging private providers to order definitive TB diagnostic tests earlier during patient consultation may have substantial impact on reducing diagnostic delay in these urban Indian settings. These results should be combined with disease transmission models to predict the impact of changes in provider behavior on TB incidence.

The importance of implementation strategy in scaling up Xpert MTB/RIF for diagnosis of tuberculosis in the Indian health-care system: a transmission model.

BACKGROUND: India has announced a goal of universal access to quality tuberculosis (TB) diagnosis and treatment. A number of novel diagnostics could help meet this important goal. The rollout of one such diagnostic, Xpert MTB/RIF (Xpert) is being considered, but if Xpert is used mainly for people with HIV or high risk of multidrug-resistant TB (MDR-TB) in the public sector, population-level impact may be limited. METHODS AND FINDINGS: We developed a model of TB transmission, care-seeking behavior, and diagnostic/treatment practices in India and explored the impact of six different rollout strategies. Providing Xpert to 40% of public-sector patients with HIV or prior TB treatment (similar to current national strategy) reduced TB incidence by 0.2% (95% uncertainty range [UR]: -1.4%, 1.7%) and MDR-TB incidence by 2.4% (95% UR: -5.2%, 9.1%) relative to existing practice but required 2,500 additional MDR-TB treatments and 60 four-module GeneXpert systems at maximum capacity. Further including 20% of unselected symptomatic individuals in the public sector required 700 systems and reduced incidence by 2.1% (95% UR: 0.5%, 3.9%); a similar approach involving qualified private providers (providers who have received at least some training in allopathic or non-allopathic medicine) reduced incidence by 6.0% (95% UR: 3.9%, 7.9%) with similar resource outlay, but only if high treatment success was assured. Engaging 20% of all private-sector providers (qualified and informal [providers with no formal medical training]) had the greatest impact (14.1% reduction, 95% UR: 10.6%, 16.9%), but required >2,200 systems and reliable treatment referral. Improving referrals from informal providers for smear-based diagnosis in the public sector (without Xpert rollout) had substantially greater impact (6.3% reduction) than Xpert scale-up within the public sector. These findings are subject to substantial uncertainty regarding private-sector treatment patterns, patient care-seeking behavior, symptoms, and infectiousness over time; these uncertainties should be addressed by future research. CONCLUSIONS: The impact of new diagnostics for TB control in India depends on implementation within the complex, fragmented health-care system. Transformative strategies will require private/informal-sector engagement, adequate referral systems, improved treatment quality, and substantial resources. Please see later in the article for the Editors' Summary.

Modeling the impact of alternative strategies for rapid molecular diagnosis of tuberculosis in Southeast Asia.

Novel diagnostic tests hold promise for improving tuberculosis (TB) control, but their epidemiologic impact remains uncertain. Using data from the World Health Organization (2011-2012), we developed a transmission model to evaluate the deployment of 3 hypothetical TB diagnostic tests in Southeast Asia under idealized scenarios of implementation. We defined diagnostics by their sensitivity for smear-negative TB and proportion of patients testing positive who initiate therapy ("point-of-care amenability"), with tests of increasing point-of-care amenability having lower sensitivity. Implemented in the public sector (35% of care-seeking attempts), each novel test reduced TB incidence by 7%-9% (95% uncertainty range: 4%-13%) and mortality by 20%-22% (95% uncertainty range: 14%-27%) after 10 years. If also deployed in the private sector (65% of attempts), these tests reduced incidence by 13%-16%, whereas a perfect test (100% sensitivity and treatment initiation) reduced incidence by 20%. Annually detecting 20% of prevalent TB cases through targeted screening (70% smear-negative sensitivity, 85% treatment initiation) also reduced incidence by 19%. Sensitivity and point-of-care amenability are equally important considerations when developing novel diagnostic tests for TB. Novel diagnostics can substantially reduce TB incidence and mortality in Southeast Asia but are unlikely to transform TB control unless they are deployed actively and in the private sector.

Outcomes of a hypertension care program based on task-sharing with private pharmacies: a retrospective study from two blocks in rural India.

Low density of formal care providers in rural India results in restricted and delayed access to standardized management of hypertension. Task-sharing with pharmacies, typically the first point of contact for rural populations, can bridge the gap in access to formal care and improve health outcomes. In this study, we implemented a hypertension care program involving task-sharing with twenty private pharmacies between November 2020 and April 2021 in two blocks of Bihar, India. Pharmacists conducted free hypertension screening, and a trained physician offered free consultations at the pharmacy. We calculated the number of subjects screened, initiated on treatment (enrolled) and the change in blood pressure using the data collected through the program application. Of the 3403 subjects screened at pharmacies, 1415 either reported having a history of hypertension or had elevated blood pressure during screening. Of these, 371 (26.22%) were enrolled in the program. Of these, 129 (34.8%) made at least one follow-up visit. For these subjects, the adjusted average difference in systolic and diastolic blood pressure between the screening and follow-up visits was -11.53 (-16.95 to -6.11, 95% CI) and -4.68 (-8.53 to -0.82, 95% CI) mmHg, respectively. The adjusted odds of blood pressure being under control in this group during follow-up visits compared to screening visit was 7.07 (1.29 to 12.85, 95% CI). Task-sharing with private pharmacies can lead to early detection and improved control of blood pressure in a resource-constrained setting. Additional strategies to increase patient screening and retention rates are needed to ensure sustained health benefits.

Impact of a financial incentive scheme on purchase of fruits and vegetables from unorganised retailers in rural India: a cluster-randomised controlled trial.

Background: Inadequate intake of fruits and vegetables is prevalent in rural areas of India, where around 65% of the population reside. Financial incentives have been shown to increase the purchase of fruits and vegetables in urban supermarkets, but their feasibility and effectiveness with unorganised retailers in rural India is unclear. Methods: A cluster-randomised controlled trial of a financial incentive scheme involving ∼20% cashback on purchase of fruits and vegetables from local retailers was conducted in six villages (3535 households). All households in three intervention villages were invited to participate in the scheme which ran for three months (February-April 2021), while no intervention was offered in control villages. Self-reported (pre-intervention and post-intervention) data on purchase of fruits and vegetables were collected from a random sub-sample of households in control and intervention villages. Findings: A total of 1109 households (88% of those invited) provided data. After the intervention, the weekly quantity of self-reported fruits and vegetables purchased were (i) 18.6 kg (intervention) and 14.2 kg (control), baseline-adjusted mean difference 4 kg (95% CI: -6.4 to 14.4) from any retailer (primary outcome); and (ii) 13.1 kg (intervention) and 7.1 kg (control), baseline-adjusted mean difference 7.4 kg (95% CI: 3.8-10.9) from local retailers participating in the scheme (secondary outcome). There was no evidence of differential effects of the intervention by household food security or by socioeconomic position, and no unintended adverse consequences were noted. Interpretation: Financial incentive schemes are feasible in unorganised food retail environments. Effectiveness in improving diet quality of the household likely hinges on the percentage of retailers willing to participate in such a scheme. Funding: This research has been funded by the Drivers of Food Choice (DFC) Competitive Grants Program, which is funded by the UK Government's Department for International Development and the Bill & Melinda Gates Foundation, and managed by the University of South Carolina, Arnold School of Public Health, USA; however, the views expressed do not necessarily reflect the UK Government's official policies.

Impact of organizational factors on adherence to laboratory testing protocols in adult HIV care in Lusaka, Zambia.

BACKGROUND: Previous operational research studies have demonstrated the feasibility of large-scale public sector ART programs in resource-limited settings. However, organizational and structural determinants of quality of care have not been studied. METHODS: We estimate multivariate regression models using data from 13 urban HIV treatment facilities in Zambia to assess the impact of structural determinants on health workers' adherence to national guidelines for conducting laboratory tests such as CD4, hemoglobin and liver function and WHO staging during initial and follow-up visits as part of Zambian HIV care and treatment program. RESULTS: CD4 tests were more routinely ordered during initial history and physical (IHP) than follow-up (FUP) visits (93.0 % vs. 85.5 %; p < 0.01). More physical space, higher staff turnover and greater facility experience with ART was associated with greater odds of conducting tests. Higher staff experience decreased the odds of conducting CD4 tests in FUP (OR 0.93; p < 0.05) and WHO staging in IHP visit (OR 0.90; p < 0.05) but increased the odds of conducting hemoglobin test in IHP visit (OR 1.05; p < 0.05). Higher staff burnout increased the odds of conducting CD4 test during FUP (OR 1.14; p < 0.05) but decreased the odds of conducting hemoglobin test in IHP visit (0.77; p < 0.05) and CD4 test in IHP visit (OR 0.78; p < 0.05). CONCLUSION: Physical space plays an important role in ensuring high quality care in resource-limited setting. In the context of protocolized care, new staff members are likely to be more diligent in following the protocol verbatim rather than relying on memory and experience thereby improving adherence. Future studies should use prospective data to confirm the findings reported here.

Routine childhood vaccination in India from 2005-2006 to 2015-2016: Temporal trends and geographic variation.

OBJECTIVE: India has experienced a substantial increase in the coverage of routine childhood vaccines in recent years. However, a large fraction of these vaccines is not delivered in a timely manner, i.e., at the recommended age. Further, substantial disparities exist in both coverage and timeliness across states. We aim to quantify the changes in coverage and timeliness of routine childhood vaccination in India over time, their variation across states, and changes in these variations over time. METHODS: We used data from two rounds of India's National Family Health Surveys, NFHS-3 (2005-06) and NFHS-4 (2015-16) on bacille Calmette-Guerin vaccine (BCG), three doses of diphtheria, pertussis, and tetanus vaccine (DPT1, DPT2, DPT3), and measles-containing vaccine (MCV). We used the Turnbull estimator to estimate the cumulative distribution function (CDF) of administering each vaccine by a certain age while accounting for two-sided censoring in the survey data. We then used these estimated CDFs to calculate coverage and timeliness at the national and state levels. FINDINGS: At the national level, both vaccination coverage and timeliness estimates increased from NFHS-3 to NFHS-4 for all vaccines. The increase in timeliness ranging from 27.3% for DPT3 to 74.0% for MCV continued to be lower than coverage, ranging from 75.3% (95% CI 57.7-87.2) for DPT3 to 74.0% (95% CI 42.2-33.0) for MCV, for all vaccines. Cross-state variation in timeliness was greater than the variation in coverage. Variation in both timeliness and coverage reduced from NFHS-3 to NFHS-4. However, this reduction was greater for timeliness than for coverage. CONCLUSIONS: A large fraction of the children in India receive vaccines later than the recommended age thereby keeping them exposed to vaccine-preventable diseases. Interventions that specifically focus on improving the timely delivery of vaccines are needed to improve the overall effectiveness of the routine immunization program.

Community health worker-led, technology-enabled private sector intervention for diabetes and hypertension management among urban poor: a retrospective cohort study from large Indian metropolitan city.

OBJECTIVES: We assessed the effectiveness of community health workers (CHWs)-led, technology-enabled programme as a large-scale, real-world solution for screening and long-term management of diabetes and hypertension in low-income and middle-income countries. DESIGN: Retrospective cohort design. SETTING: Forty-seven low-income neighbourhoods of Hyderabad, a large Indian metropolis. PARTICIPANTS: Participants (aged ≥20 years) who subscribed to an ongoing community-based chronic disease management programme employing CHWs and technology to manage diabetes and hypertension. PRIMARY AND SECONDARY OUTCOME MEASURES: We used deidentified programme data between 1 March 2015 and 8 October 2018 to measure participants' pre-enrolment and post-enrolment retention rate and within time-interval mean difference in participants' fasting blood glucose and blood pressure using Kaplan-Meier and mixed-effect regression models, respectively. RESULTS: 51 126 participants were screened (median age 41 years; 65.2% women). Participant acquisition rate (screening to enrolment) was 4%. Median (IQR) retention period was 163.3 days (87.9-288.8), with 12 months postenrolment retention rate as 16.5% (95% CI 14.7 to 18.3). Reduction in blood glucose and blood pressure levels varied by participants' retention in the programme. Adjusted mean difference from baseline ranged from -14.0 mg/dL (95% CI -18.1 to -10.0) to -27.9 mg/dL (95% CI -47.6 to -8.1) for fasting blood glucose; -2.7 mm Hg (95% CI -7.2 to 2.7) to -7.1 mm Hg (95% CI -9.1 to -4.9) for systolic blood pressure and -1.7 mm Hg (95% CI -4.6 to 1.1) to -4.2 mm Hg (95% CI -4.9 to -3.6) for diastolic blood pressure. CONCLUSIONS: CHW-led, technology-enabled private sector interventions can feasibly screen individuals for non-communicable diseases and effectively manage those who continue on the programme in the long run. However, changes in the model (eg, integration with the public health system to reduce out-of-pocket expenditure) may be needed to increase its adoption by individuals and thereby improve its cost-effectiveness.

Combining serology with case-detection, to allow the easing of restrictions against SARS-CoV-2: a modelling-based study in India.

India's lockdown and subsequent restrictions against SARS-CoV-2, if lifted without any other mitigations in place, could risk a second wave of infection. A test-and-isolate strategy, using PCR diagnostic tests, could help to minimise the impact of this second wave. Meanwhile, population-level serological surveillance can provide valuable insights into the level of immunity in the population. Using a mathematical model, consistent with an Indian megacity, we examined how seroprevalence data could guide a test-and-isolate strategy, for fully lifting restrictions. For example, if seroprevalence is 20% of the population, we show that a testing strategy needs to identify symptomatic cases within 5-8 days of symptom onset, in order to prevent a resurgent wave from overwhelming hospital capacity in the city. This estimate is robust to uncertainty in the effectiveness of the lockdown, as well as in immune protection against reinfection. To set these results in their economic context, we estimate that the weekly cost of such a PCR-based testing programme would be less than 2.1% of the weekly economic loss due to the lockdown. Our results illustrate how PCR-based testing and serological surveillance can be combined to design evidence-based policies, for lifting lockdowns in Indian cities and elsewhere.

Improving vaccination coverage and timeliness through periodic intensification of routine immunization: evidence from Mission Indradhanush.

Only an estimated 62% of Indian children under the age of 2 years are fully immunized. We examined the association between India's Mission Indradhanush (MI)-a periodic intensification of the routine immunization program-which was implemented in phases across districts between March 2015 and July 2017, and routine vaccination coverage and timeliness among children. We used data from a 2015 to 2016 national survey of children (n = 29,532) and employed difference-in-difference regressions to examine binary indicators of receipt of 11 vaccines and whether vaccines were received at recommended ages. The full immunization rate was 27% higher among children under 2 years old residing in MI phase 1 and 2 districts (intervention group) as compared with those residing elsewhere (control group). The rate of receiving all vaccines at recommended ages was 8% higher in the intervention group. Receiving doses of oral polio vaccine (OPV) birth dose, OPV dose 1 (OPV1), OPV2, OPV3, bacillus Calmette-Guérin, and hepatitis B birth dose vaccines were 9%, 9%, 11%, 16%, 5%, and 19% higher in the intervention group than the control group, respectively. More research is required on the cost-effectiveness of investing in MI-type programs as compared with routine immunization.

Cost-Effectiveness of Improved Hypertension Management in India through Increased Treatment Coverage and Adherence: A Mathematical Modeling Study.

Background: Despite the availability of effective and affordable treatments, only 14% of hypertensive Indians have controlled blood pressure. Increased hypertension treatment coverage (the proportion of individuals initiated on treatment) and adherence (proportion of patients taking medicines as recommended) promise population health gains. However, governments and other payers will not invest in a large-scale hypertension control program unless it is both affordable and effective. Objective: To investigate if a national hypertension control intervention implemented across the private and public sector facilities in India could save overall costs of CVD prevention and treatment. Methods: We developed a discrete-time microsimulation model to assess the cost-effectiveness of population-level hypertension control intervention in India for combinations of treatment coverage and adherence targets. Input clinical parameters specific to India were obtained from large-scale surveys such as the Global Burden of Disease as well as local clinical trials. Input hypertensive medication cost parameters were based on government contracts. The model projected antihypertensive treatment costs, avoided CVD care costs, changes in disability-adjusted life year (DALYs) and incremental cost per DALY averted (represented as incremental cost-effectiveness ratio or ICER) over 20 years. Results: Over 20 years, at 70% coverage and adherence, the hypertension control intervention would avert 1.68% DALYs and be cost-saving overall. Increasing adherence (while keeping coverage constant) resulted in greater improvement in cost savings compared to increasing coverage (while keeping adherence constant). Results were most sensitive to the cost of antihypertensive medication, but the intervention remained highly cost-effective under all one-way sensitivity analyses. Conclusion: A national hypertension control intervention in India would most likely be budget neutral or cost-saving if the intervention can achieve and maintain high levels of both treatment coverage and adherence.

Role of community health workers in improving cost efficiency in an active case finding tuberculosis programme: an operational research study from rural Bihar, India.

OBJECTIVES: Cost-efficient active case finding (ACF) approaches are needed for their large-scale adoption in national tuberculosis (TB) programmes. Our aim was to assess if community health workers' (CHW) knowledge about families' health status can improve the cost efficiency of the ACF programme without adversely affecting the delivery of other health services for which they are responsible. DESIGN: Quasi-experimental design. INTERVENTIONS: We evaluated an ACF programme in the Samastipur district in Bihar, India, between July 2017 and June 2018. CHWs called Accredited Social Health Activists generated referrals of individuals at risk of TB and conducted symptom-based screening to identify patients with presumptive TB. They also helped them undergo testing and provided treatment support for confirmed TB cases. PRIMARY AND SECONDARY OUTCOME MEASURES: We compared the notification rate from the intervention region with that from a control region in the same district with similar characteristics. We analysed operational data to calculate the cost per TB case diagnosed. We used routine programmatic data from the public health system to estimate the impact on other services provided by CHWs. FINDINGS: CHWs identified 9895 patients with presumptive TB. Of these, 5864 patients were tested for TB, and 1236 were confirmed as TB cases. Annual public case notification rate increased sharply in the intervention region from 45.8 to 105.8 per 100 000 population, whereas it decreased from 50.7 to 45.3 in the control region. There was no practically or statistically significant impact on other output indicators of the CHWs, such as institutional deliveries (-0.04%). The overall cost of the intervention was about US$134 per diagnosed case. Main cost drivers were human resources, and commodities (drugs and diagnostics), which contributed 37.4% and 32.5% of the cost, respectively. CONCLUSIONS: ACF programmes that use existing CHWs in the health system are feasible, cost efficient and do not adversely affect other healthcare services delivered by CHWs.

Did India's price control policy for coronary stents create unintended consequences?

In February 2017, India capped the retail price of coronary stents and restricted the channel margin to bring Percutaneous Transluminal Coronary Angioplasty (PTCA) procedure, which uses coronary stents, within reach of millions of patients who previously could not afford it. Prior research shows that care providers respond to such regulations in a way that compensates for their loss in profits because of price control. Therefore, price control policies often introduce unintended consequences, such as distortions in clinical decision making. We investigate such distortions through empirical analysis of claims data from a representative public insurance program in the Indian state of Karnataka. Our data comprises 25,769 insurance claims from 69 private and seven public hospitals from February 2016 to February 2018. The public insurance context is ideal for investigating distortions in clinical decisions as the price paid by patients, and thereby access to the treatment, does not change after price control. We find that the change in the average volume of PTCA procedures per hospital per month after price control disproportionately increased when compared to the change in the clinical alternative - Coronary Artery Bypass Graft (CABG) procedures. This increase corresponds to 6% of the average number of PTCA procedures and 28% of the average number of CABG procedures before the price control. In addition, disproportionate increase in PTCA procedures occurred only among private hospitals, indicating the possibility of profit-maximization intentions driving the clinical choices. Such clinical distortions can have negative implications for patient health outcomes in the long run. We discuss alternative policies to improve access and affordability to healthcare products and services which are likely to not suffer from similar distortions.

Leveraging Providers' Preferences to Customize Instructional Content in Information and Communications Technology-Based Training Interventions: Retrospective Analysis of a Mobile Phone-Based Intervention in India.

BACKGROUND: Many public health programs and interventions across the world increasingly rely on using information and communications technology (ICT) tools to train and sensitize health professionals. However, the effects of such programs on provider knowledge, practice, and patient health outcomes have been inconsistent. One of the reasons for the varied effectiveness of these programs is the low and varying levels of provider engagement, which, in turn, could be because of the form and mode of content used. Tailoring instructional content could improve engagement, but it is expensive and logistically demanding to do so with traditional training. OBJECTIVE: This study aimed to discover preferences among providers on the form (articles or videos), mode (featuring peers or experts), and length (short or long) of the instructional content; to quantify the extent to which differences in these preferences can explain variation in provider engagement with ICT-based training interventions; and to compare the power of content preferences to explain provider engagement against that of demographic variables. METHODS: We used data from a mobile phone-based intervention focused on improving tuberculosis diagnostic practices among 24,949 private providers from 5 specialties and 1734 cities over 1 year. Engagement time was used as the primary outcome to assess provider engagement. K-means clustering was used to segment providers based on the proportion of engagement time spent on content formats, modes, and lengths to discover their content preferences. The identified clusters were used to predict engagement time using a linear regression model. Subsequently, we compared the accuracy of the cluster-based prediction model with one based on demographic variables of providers (eg, specialty and geographic location). RESULTS: The average engagement time across all providers was 7.5 min (median 0, IQR 0-1.58). A total of 69.75% (17,401/24,949) of providers did not consume any content. The average engagement time for providers with nonzero engagement time was 24.8 min (median 4.9, IQR 2.2-10.1). We identified 4 clusters of providers with distinct preferences for form, mode, and length of content. These clusters explained a substantially higher proportion of the variation in engagement time compared with demographic variables (32.9% vs 1.0%) and yielded a more accurate prediction for the engagement time (root mean square error: 4.29 vs 5.21 and mean absolute error: 3.30 vs 4.26). CONCLUSIONS: Providers participating in a mobile phone-based digital campaign have inherent preferences for instructional content. Targeting providers based on individual content preferences could result in higher provider engagement as compared to targeting providers based on demographic variables.

Field sales force model to increase adoption of a novel tuberculosis diagnostic test among private providers: evidence from India.

BACKGROUND: Impact of novel high-quality tuberculosis (TB) tests such as Xpert MTB/RIF has been limited due to low uptake among private providers in high-burden countries including India. Our objective was to assess the impact of a demand generation intervention comprising field sales force on the uptake of high-quality TB tests by providers and its financial sustainability for private labs in the long run. METHODS: We implemented a demand generation intervention across five Indian cities between October 2014 and June 2016 and compared the change in the quantity of Xpert cartridges ordered by labs in these cities from before (February 2013-September 2014) to after intervention (October 2014-December 2015) to corresponding change in labs in comparable non-intervention cities. We embedded this difference-in-differences estimate within a financial model to calculate the internal rate of return (IRR) if the labs were to invest in an Xpert machine with or without the demand generation intervention. RESULTS: The intervention resulted in an estimated 60 additional Xpert cartridges ordered per lab-month in the intervention group, which yielded an estimated increase of 11 500 tests over the post-intervention period, at an additional cost of US$13.3-US$17.63 per test. Further, we found that investing in this intervention would increase the IRR from 4.8% to 5.5% for hospital labs but yield a negative IRR for standalone labs. CONCLUSIONS: Field sales force model can generate additional demand for Xpert at private labs, but additional strategies may be needed to ensure its financial sustainability.

Associations between organizational characteristics and quality improvement activities of clinics participating in a quality improvement collaborative.

BACKGROUND: Few studies have rigorously evaluated the associations between organizational characteristics and intervention activities of health care organizations participating in quality improvement collaboratives (QICs). OBJECTIVE: To examine the relationship between clinic characteristics and intervention activities by primary care clinics that provide HIV care and that participated in a QIC. DESIGN: Cross-sectional study of Ryan White CARE Act (now called Ryan White HIV/AIDS Treatment Modernization Act) funded clinics that participated in a QIC over 16 months in 2000 and 2001. The QIC was originally planned to be a more typical 12 months long, but was extended to increase the likelihood of success. Data were collected using surveys of clinicians and administrators in participating clinics and monthly reports of clinic improvement activities. MEASURES: Number of interventions attempted, percent of interventions repeated, percent of interventions evaluated, and organizational characteristics. RESULTS: Clinics varied significantly in their intervention choices. Organizations with a more open culture and a greater emphasis on quality improvement attempted more interventions (P < 0.01, P < 0.05) and interventions that were more comprehensive (P < 0.01, P < 0.10). Presence of multidisciplinary teams and measurement of progress toward quantifiable goals also were associated with comprehensiveness of interventions (P < 0.01, P < 0.05). CONCLUSION: Clinic characteristics predicted intervention activities during a QIC. Further research is needed on how these organizational characteristics affect quality of care through their influence on intervention activities.