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

Abstract

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.

Do private providers initiate anti-tuberculosis therapy on the basis of chest radiographs? A standardised patient study in urban India

“… 6 Existing evidence regarding its impact is primarily from the public sector, and studies examining the integration of Xpert into clinical decision-making are limited. 52 Compared to smear microscopy, this study found that Xpert increased the number and proportion of microbiologically confirmed TB case notifications and reduced the delay in treatment initiation. However, it did not significantly increase overall case notifications and did not have a significant impact on patient-relevant health outcomes such as mortality, TB-related morbidity, and successful treatment completion.…”

“…However, it did not significantly increase overall case notifications and did not have a significant impact on patient-relevant health outcomes such as mortality, TB-related morbidity, and successful treatment completion. 52 These mixed findings are believed to be driven by high levels of empirical treatment, which may be partially reduced by a wider uptake of Xpert testing. 52 , 53 , 54 Inability to do microscopy or Xpert (as in sputum-scarce patients), substandard clinical training, and high likelihood of one-off encounters with patients might also drive the initiation of empirical treatment.…”

“… 52 These mixed findings are believed to be driven by high levels of empirical treatment, which may be partially reduced by a wider uptake of Xpert testing. 52 , 53 , 54 Inability to do microscopy or Xpert (as in sputum-scarce patients), substandard clinical training, and high likelihood of one-off encounters with patients might also drive the initiation of empirical treatment. 6 , 55 , 56 As health systems transition to assays with higher sensitivity, such as Xpert Ultra MTB/RIF, clinicians may benefit from guidance on how to adapt their diagnostic intuition accordingly and recalibrate their own threshold for empiric treatment.…”

Operational priorities for engaging with India’s private healthcare sector for the control of tuberculosis: a modelling study

“…2 A major challenge in India is the presence of a vast, fragmented private healthcare sector, which manages the majority of patients with TB in the country. [3][4][5] The past decade has seen increasing recognition of the importance of engaging effectively with this sector [6][7][8][9][10] : not only in notifying TB to public health authorities, but also in offering high-quality diagnostics and treatment adherence support for patients being managed by private providers. Early efforts to engage effectively with the private sector faced substantial challenges, principally arising from a lack of trust.…”

Understanding dynamics of private tuberculosis pharmacy market: a qualitative inquiry from a South Indian district

“…Though the government of India offers free quality-assured TB diagnosis and treatment through the National TB Elimination Programme (NTEP), which was earlier known as Revised National TB Control Program,2 more than half of TB cases are managed by private practitioners (PPs) in the country 3 4. Evidence shows that PPs rarely follow standard TB management guidelines5 6 and thus pose a threat of severe forms of drug-resistant TB.…”