The end-line studies were conducted between August 2016 and January 2017 in Patna and between March 2017 and July 2017 in Mumbai after the PPIA intervention had been in place for 27 months in Patna and 29 months in Mumbai. These studies were conducted to assess the impact of the intervention in both cities. The end-line studies were population-based, two-stage, retrospective studies conducted in the same study areas as the baseline studies in both cities ^{9, 10} . The first stage surveys conducted by a contracted survey organization in both cities involved a primary cross-sectional household (HH) survey to identify patients who had been diagnosed and initiated on TB treatment (available as Extended data ¹³ ). Within a week of identification, these patients were contacted by a trained team of researchers from FMR, and those who met the inclusion criteria and were willing to participate were included in the second stage of the study. The inclusion criteria were as follows: a) patients with only pulmonary TB, b) patients diagnosed as drug-sensitive (DS) and initiated on first-line TB treatment in their respective cities, c) patients who were initiated on treatment not earlier than six months from the time of interview. The number of participants was selected through convenience-based sampling.

The second stage consisted of in-depth interviews of willing patients, using a semi-structured interview schedule to document their TB care pathways (interview guide available as Extended data ¹³ ). Written informed consent was obtained from all patients willing to participate in the study. Consent was sought for participation in the interview, digital audio recording and note keeping of the patients’ responses, reviewing of patient’s TB care seeking-related documents and permission to publish data in any report, journal, etc. In case of minors, consent was obtained from their parents/guardians/carers.

Interviews were conducted at a location and time preferred by each participant by trained health researchers from FMR largely in patient’s homes. Family members were sometime present at the time of the interviews, which extended from 45 minutes to 1 hour. No repeat interviews were carried out. Patients were confirmed as DS based on their test results and treatment regimen at the time of interview. The end-line interview assessed the time taken by patients from onset of TB symptoms until the current/most recent treatment initiation (unlike the baseline study where only first treatment initiation was considered) ^{9, 10} , along with the type of facilities accessed.

Information provided by patients during the interview was verified as far as possible with reports prescription or other documentation provided by the patient.

The study received ethical declaration from the Institutional Ethics Committee (IEC) of the Foundation for Medical Research (vide IEC no. FMR/IEC/TB/01/2013). Written informed consent was obtained from all patients willing to participate in the study. In case of minors, consent was obtained from their parents/guardians/carers.

Quantitative data were filled on structured physical formats by the researchers at the end of the interview. For the purpose of quality check, three levels of verification were conducted by listening to recorded interviews. First, each researcher team cross-checked the quantitative data forms of interviews conducted by another research team. Subsequently 25% of interviews were cross-checked by senior researchers for errors, and finally a random set of 10% of interviews were checked by the consultants on the study. On completion of quality checks, the data were entered in CSPro v5. Open ended questions were coded and maintained in a codebook in an excel format. These data were then imported into SPSS v.19 (SPSS, Inc., Chicago, IL, USA) for analysis.

Facility classification

1. Public Facility: Facilities for control of TB which are run by the Municipal Corporation of the respective city or the state government under the RNTCP.

2. Private Facility: Facilities which are run by private allopaths, non-allopaths, informal health providers and chemists.

3. PPIA-engaged Facility (PPIA-E Facility): Facilities which consented to engage with the PPIA. In Mumbai, only private providers were a part of the PPIA intervention whereas in Patna, PPIA-E facilities included both public and private facilities.

4. PPIA-non engaged Facility (PPIA–NE Facility): Private facilities which were not engaged with the PPIA initiative.

The total pathway was divided into three components for computing durations:

First care seeking duration: Time interval between onset of symptom and first seeking care(duration of 15 days or more was considered as a first care seeking delay) ¹⁴ .

Facilities were determined as PPIA-E based on the names and addresses provided by patient interviews and documents, which were compared to the list of engaged facilities provided by PPIA in Patna and Mumbai respectively.

The total time taken from onset of TB symptoms to first care-seeking and until initiation of first line treatment was estimated by dates collected for various events and presented as medians and means (in days).

The themes for analysis were identified in advance. The median pathway durations of patients accessing different types of facilities at baseline and end-line were compared until the point of first treatment initiation to see if any difference was seen in pathways to TB care following the PPIA intervention in both cities. The prime comparison comprised of assessing the median duration from first care seeking until treatment initiation between patients accessing PPIA-E private facility at first point of care and those who did not. Other points of analysis included assessing the role of PPIA-E facilities in diagnosis and initiation of treatment, as well as the retention of the patients from the beginning of the pathway.

Median pathway differences were compared using the Mann Whitney U-test with significance established at p-values ≤ 0.05. Significant difference in the proportion of patients was estimated using Chi-square.

Since patients in the end-line study were followed until their current TB treatment, descriptive analysis for patients presenting an extended pathway is included to understand the reasons for shopping post their first diagnosis and treatment initiation.

The household survey identified 285 and 230 PTB patients in Patna and Mumbai, respectively, of which only 64 (22%) in Patna and 86 (37%) in Mumbai were included in the study. Enlisting rate was low in both cities; in Patna primarily due to patients not meeting the inclusion criteria (62%) (Refer to study design) and in Mumbai, due to patients being diagnosed with drug-resistant (DR) TB (20%). Additionally, the reasons for exclusion from the study are reflected in Table 1. Individual results of baseline and end-line surveys are available as Underlying data ^{16, 17} .

Table 2 reflects the comparison of patient profiles in both cities at baseline and end-line. Though certain trends were observed, the differences were not found to be significant. Low socio-economic status was retained in the end-line studies for both cities and higher numbers of patients were unemployed in both the cities at end-line studies.

The proportion of minor patients aged 17 years and younger was higher in Patna when compared with the baseline ( Table 2).

The proportion of income generators among the patients in Mumbai had increased at end-line (47%, n=40/86) as compared to 33% at baseline ¹⁰ .

First point of care

Had patients heard about the PPIA initiative?

Patna: In total, 52% of the patients (33/64) in Patna were aware of the PPIA initiative; 21 patients from providers they accessed along their pathways and 12 patients through media and posters.

Mumbai: In Mumbai, 42% of the patients (n=36/86) were aware of the PPIA intervention in the community, with 32 reportedly being provided information by the providers accessed along their pathways. Only 4 patients had sourced their awareness through media and posters.

What were the first care seeking facilities that patients accessed?

Table 3a, b shows the facilities first accessed by patients after the onset of symptoms, in Patna and Mumbai respectively.

Patna: The proportion of patients seeking care from public facilities (6%, n=4/64) was very similar to that reported in the baseline study ⁹ . However, the proportion of patients consulting a chemist (53%, n=34/64) was significantly more than the 25% reported in the baseline study (p=-0.001, chi square =10.64). Less than one-fourth (23%, n=15/64) of the patients had consulted a PPIA-E facility, and two-thirds of these (67%, n=10/15) a private facility. Frequently cited reasons for accessing a PPIA-E facility were as follows: good/effective medicines, someone known had been previously treated or were on treatment, and subsidized fees. Reasons for accessing a PPIA-NE private facility were as follows: close to home, good reputation of the provider, whereas for accessing a PPIA-NE public facility the reasons cited were free medicines or worsening of symptoms.

Mumbai: Close to three-fourths of the patients (74%, n=64/86) had sought help from a private facility; almost half of these (48%, n=31/64) had consulted a PPIA-E private facility. The proportion of patients accessing a public sector facility as their first point of care were 21% (n=18/86) in the end-line study.

How soon after developing symptoms did patients seek care?

Patna: The median time taken for all patients to first access care after onset of symptoms was 9.5 days ¹ in Patna which was similar to the 9 days ¹ reported for the baseline study ⁹ . The median time taken for patients accessing a PPIA-E private facility at first point was 4 days as opposed to 10 ^{# 1} days for those accessing PPIA-NE private facility and 8 days ¹ for those accessing a private facility at first point during baseline ( Table 4a).

Only 4/64 patients approached a public facility at first point of care. The median time taken for the patients who approached the public facility was 7.5 days ¹ at end-line compared to 18.5 days at baseline.

Frequently cited reasons for accessing a PPIA-E facility at end-line were as follows: good/effective medicines, someone known had been previously treated or was on treatment, and subsidized fees. Reasons for accessing a PPIA-NE private facility were as follows: close to home, good reputation of the provider, whereas for accessing a PPIA-NE public facility the reasons cited were free medicine or worsening of symptoms.

Mumbai: In Mumbai the time taken to access care had decreased significantly from 15 days at baseline ¹⁰ to 4 days ¹ at end-line (p-value = 0.00).

No significant difference was seen in the first care seeking duration for patients accessing PPIA-E private facilities vs. patients accessing PPIA-NE private facilities at Mumbai; however, both the groups had a significantly shorter first care seeking pathway as compared to baseline ( Table 4b).

The commonly cited reasons for a majority of the patients accessing a PPIA-E or a PPIA-NE private facility at first point were similar: close to home or the availability of the family doctor who practiced there. The reasons cited for accessing the public sector included: availability of effective or subsidized medicines, recommendation of a family member, and positive feedback from another patient.

TB diagnostic pathway

Patna: Patients who had accessed a PPIA-E private facility took 9.5 days ¹ to get diagnosed after first accessing care, which was similar to that for patients accessing a private facility as first point of care during the baseline study ⁹ . However, those patients who accessed a PPIA-NE private facility as the first point of care took significantly longer to get diagnosed, i.e. 20.5 days (p < 0.05). A significantly higher proportion of patients who approached a PPIA-E facility at the first point of care were diagnosed without any delay as compare to those who accessed a PPIA-NE facility (64% vs 39%; Table 5a).

In total, 90% of patients who approached a PPIA-E private facility (non-chemist) at first point of care were diagnosed by the same facility as compared to only 19% of the patients who approached a PPIA-NE private facility (chi-square =12.56, p-value = 0.0004). In the entire pathway 63% (n=40/64) of the patients were first diagnosed by a PPIA-E facility ( Table 3a). A total of 77% percent (n=49/64) of patients had approached up to two facilities before approaching the facility which diagnosed them with TB.

Mumbai: Although not significant, the median diagnostic duration for patients accessing a PPIA-E facility as the first point of care was 16 days which was lesser than the 27 days for those who accessed a PPIA-NE private facility and the 19 days reported in the baseline study ¹⁰ . Patients approaching a public facility at first point, however, showed the least diagnostic duration of 10 days ¹ (p > 0.05) which was the same as that at baseline ( Table 4b).

Two of the three patients that had accessed a PPIA-Ehub and two of the 28 patients (7%) that had accessed a PPIA-E spoke as the first point of contact were diagnosed by them. Only 9 out of 33 (27%) patients who approached a PPIA-NE private facility were diagnosed at the same facility. More than half of the total patients (52%, n=45/64) were first diagnosed by a PPIA-E facility: 23 by a PPIA-E spoke and 22 by a PPIA-E hub ( Table 3b). Among those who accessed public facilities as first point of care, 44% (n=8/18) were retained for diagnosis and three (17%) were referred for diagnosis.

A higher proportion of patients (48%, n =15/31) obtained diagnosis within the stipulated time when they first approached a PPIA-E private facility as compared to a PPIA-NE private facility (30%, n=11/37); this was also higher compared to the 41% in the baseline study who approached a private facility ⁹ . The highest proportion of patients (56%) who obtained diagnosis within the stipulated time were those who had approached a public facility as their first point of care, at both study time points ( Table 5b).

A total of 49% (n=42/86) of patients had approached up to two facilities before approaching the facility which diagnosed them with TB.

TB treatment pathway

What happens to patients after they are first diagnosed with TB?

Patna: After being diagnosed with TB for the first time, four out of the 64 patients (6%) from Patna were retested and re-diagnosed before being initiated on TB treatment ( Table 3a).

Mumbai: Seeking and obtaining a second diagnosis was far more common in Mumbai. Forty-one percent (n=35/86) of the patients were retested and re-diagnosed before being initiated on TB treatment ( Table 3b). Figure 1 shows the facilities that re-diagnosed the patients before treatment initiation. Undergoing re-diagnosis was more commonly seen among patients who were initially diagnosed by a PPIA spoke (78%, n=18/23) or by a PPIA-NE facility (62%, n=10/16) and was less common among patients who had accessed the public facility (28%, n=7/25) for diagnosis. It was noteworthy that none of 22 patients diagnosed by a PPIA-E hub facility were re-diagnosed. Of the 35 (63%) final diagnoses, 22 were made by PPIA-E facilities. Some of the common reason for leaving the first diagnosing provider was referrals by the previous provider (71%) and patient seeking of a second opinion (11%).

After how long are patients being initiated on TB treatment after their first diagnosis?

Patna: In Patna, 95% (n=61/64) of the patients were initiated on TB treatment without any delay and 74% (n=45/61) of them on the same day. A total of 61% (n=37/61) of the patients who had no treatment initiation delay, were diagnosed by PPIA-E facilities, 29% (n=18/61) by a PPIA-NE private and 10% (n=6/61) by a PPIA-NE public facility. Only three patients in Patna had a delayed TB treatment initiation, all of who had been diagnosed by a PPIA-E facility (2 private and 1 public).

In total, 92% (n=59/64) of patients were initiated on treatment by their diagnosing facility. More patients approaching a PPIA-E private facility at first point of care were initiated on treatment by the same facility (80%, n=8/10) compared to those who approached a PPIA-NE private facility (19%, n=3/16). The rapidity of initiation of treatment was compromised for the four patients who had multiple diagnosis with a median of 10 days (Range: 3–140)

Of the 64 patients in Patna, 92% of patients were initiated on treatment by their diagnosing facility and only five patients moved to a different facility to initiate TB treatment.

Overall, 80% (n=51/64) of patients in Patna had accessed up to two facilities before initiating their TB treatment.

Mumbai: In total, 71% (n=61/86) of the patients from Mumbai were initiated on treatment without any delay, one-third of these (n=20/61) on the same day of diagnosis. The proportion of patients showing no treatment initiation delay was higher among those who were diagnosed by PPIA-E facilities (56%, n=34/61),compared to those diagnosed by public facilities (30%, n=17/61) and PPIA-NE facilities (16%, n=10/61). Paradoxically, among the 25 patients who had a treatment delay, the larger proportion had been diagnosed by PPIA-E facilities (44%, n=11/25), followed by PPIA-NE facilities (24%, n=6/25) and public facilities (32%, n=8/25).

Four of the 31 (13%) patients who had accessed the PPIA-E spoke (n=2)/hub facility (n=2) ( Table 3b) as the first point of care, were diagnosed and treated by the same facility.

No patient who had accessed a PPIA-NE private facility at first point was initiated on treatment by them. Of the 18 patients that had first approached a public facility, 6 (33%) were retained with the system. Close to two-thirds of the patients (55/86) had subsequent to their diagnosis, moved to another facility for initiating their treatment, of which 25% (14/55) had accessed more than two facilities after being diagnosed.

Two-thirds of the patients (62%, n=53/86) had approached up to three facilities before getting initiated on TB treatment after their diagnosis.

Total TB pathway

Patna: The median total pathway duration (from onset of symptoms to initiation of first TB treatment) of patients in Patna was 15 days ¹ for those accessing a PPIA-E private facility at first point of care, 38days for those accessing a public facility and 40.5 days for those accessing PPIA-NE private facility ( Figure 2). The pathway duration showed a reduction from the 27.5 days ¹ for those accessing a private facility, but an increase from the 21.5 days ¹ for those accessing a public facility in the baseline study ⁹ . The total number of facilities accessed by the patients during their pathway ranged from 1–4 (median: 2).

Mumbai: In Mumbai, the total pathway duration was 43 days for patients accessing a PPIA-NE private facility at first point of care. There was a significant decrease in the median total pathway for patients accessing a PPIA-E facility (32 days) ¹ at first point of care as compared to the patients accessing a private facility at baseline (46 days) (p<= 0.05). The duration for patients accessing a public facility was similar in the end-line and baseline studies (39 and 41 days, respectively) ( Figure 2). The total number of facilities accessed by the patients during their total care pathway at end-line ranged from 1–8 (median: 3).

Does the patient pathway to TB care end once treatment is initiated?

After being initiated on TB treatment for the first time, 10 out of the 64 patients in Patna (16%) and 9 out of the 86 patients in Mumbai (10%) left the treating facilities and showed an extended pathway in the end-line study. This was further looked into to understand what made these patients leave their treating facilities.

Patna: From the 4% (n=2/51) of patients who were initiated on treatment by PPIA-E facilities and 62% (n=8/13) who were initiated on treatment by a PPIA-NE facility had an extended pathway. The median pathway duration for patients from first care seeking until first treatment initiation was 38 days (mean: 41 days, range: 5-79 days) which was extended by an additional 49 days (mean: 72 days, range: 5-187 days) due to the multiple treatment episodes. Figure 3 presents the reasons for the extended pathway for patients in Patna.

Mumbai: A total of 9 out of the 86 patients from Mumbai had an extended pathway. This group with extended pathways constituted 11% (n=6/55) of those initiated on treatment by a PPIA-E facility, 66% (n=2/3) of those initiated on treatment by a PPIA-NE facility and 4% (n=1/28) of those initiated on treatment by a public facility. The total median pathway duration for these patients from first care seeking until first treatment initiation was 62 days (mean: 50 days, range: 2-206 days). However, the median duration between first TB treatment initiation and current/final TB treatment initiation was an additional 28 days (mean: 34 days, range: 3-70 days). Figure 4 presents the reasons for the extended pathway for patients in Mumbai.

Figshare: Mumbai Patna Baseline data. https://doi.org/10.6084/m9.figshare.11949117.v1 ¹⁶ .

This project contains the following underlying data:

Mumbai_BL_DS_TB cases (XLSX). (Baseline household survey data for participants in Mumbai.)

Figshare: Mumbai Patna Endline data. https://doi.org/10.6084/m9.figshare.11949147.v1 ¹⁷ .

This project contains the following underlying data:

Mumbai_EL_DS_TB cases (XLSX). (Endline household survey data for participants in Mumbai.)

The transcripts and audio recordings of the interviews cannot be shared as patient identifiers cannot be removed. However, this information can be requested from the Institutional Ethics Committee. The decision will be taken on case to case basis. Queries and requests for data access should be directed to The Foundation for Medical Research Institutional Review and Ethics Committee at fmr-irec@fmrindia.org. Granting of access of data will be at the discretion of the FMR-IREC.

Figshare: Supplementary Data. https://doi.org/10.6084/m9.figshare.12045867.v1 ¹³ .

This project contains the following extended data:

BMGF Codebook Mumbai (XLSX). (Codebook for Mumbai surveys.)

Unrestricted data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).