‘We had to manage what we had on hand, in whatever way we could’: Adaptive responses in policy for decentralized drug-resistant tuberculosis care in South Africa

In 2011, the South African National TB Programme launched a policy of decentralized management of drug-resistant tuberculosis (DR-TB) in order to expand the capacity of facilities to treat patients with DR-TB, minimize delays to access care and improve patient outcomes. This policy directive was implemented to varying degrees within a rapidly evolving diagnostic and treatment landscape for DR-TB, placing new demands on already-stressed health systems. The variable readiness of district-level systems to implement the policy prompted questions not only about differences in health systems resources but also front-line actors’ capacity to implement change in resourceconstrained facilities

Delays and loss to follow-up before treatment of drug-resistant tuberculosis following implementation of Xpert MTB/RIF in South Africa: A retrospective cohort study.

BACKGROUND: South Africa has a large burden of rifampicin-resistant tuberculosis (RR-TB), with 18,734 patients diagnosed in 2014. The number of diagnosed patients has increased substantially with the introduction of the Xpert MTB/RIF test, used for tuberculosis (TB) diagnosis for all patients with presumptive TB. Routine aggregate data suggest a large treatment gap (pre-treatment loss to follow-up) between the numbers of patients with laboratory-confirmed RR-TB and those reported to have started second-line treatment. We aimed to assess the impact of Xpert MTB/RIF implementation on the delay to treatment initiation and loss to follow-up before second-line treatment for RR-TB across South Africa. METHODS AND FINDINGS: A nationwide retrospective cohort study was conducted to assess second-line treatment initiation and treatment delay among laboratory-diagnosed RR-TB patients. Cohorts, including approximately 300 sequentially diagnosed RR-TB patients per South African province, were drawn from the years 2011 and 2013, i.e., before and after Xpert implementation. Patients with prior laboratory RR-TB diagnoses within 6 mo and currently treated patients were excluded. Treatment initiation was determined through data linkage with national and local treatment registers, medical record review, interviews with health care staff, and direct contact with patients or household members. Additional laboratory data were used to track cases. National estimates of the percentage of patients who initiated treatment and time to treatment were weighted to account for the sampling design. There were 2,508 and 2,528 eligible patients in the 2011 and 2013 cohorts, respectively; 92% were newly diagnosed with RR-TB (no prior RR-TB diagnoses). Nationally, among the 2,340 and 2,311 new RR-TB patients in the 2011 and 2013 cohorts, 55% (95% CI 53%-57%) and 63% (95% CI 61%-65%), respectively, started treatment within 6 mo of laboratory receipt of their diagnostic specimen (p < 0.001). However, in 2013, there was no difference in the percentage of patients who initiated treatment at 6 mo between the 1,368 new RR-TB patients diagnosed by Xpert (62%, 95% CI 59%-65%) and the 943 diagnosed by other methods (64%, 95% CI 61%-67%) (p = 0.39). The median time to treatment decreased from 44 d (interquartile range [IQR] 20-69) in 2011 to 22 d (IQR 2-43) in 2013 (p < 0.001). In 2013, across the nine provinces, there were substantial variations in both treatment initiation (range 51%-73% by 6 mo) and median time to treatment (range 15-36 d, n = 1,450), and only 53% of the 1,448 new RR-TB patients who received treatment were recorded in the national RR-TB register. This retrospective study is limited by the lack of information to assess reasons for non-initiation of treatment, particularly pre-treatment mortality data. Other limitations include the use of names and dates of birth to locate patient-level data, potentially resulting in missed treatment initiation among some patients. CONCLUSIONS: In 2013, there was a large treatment gap for RR-TB in South Africa that varied significantly across provinces. Xpert implementation, while reducing treatment delay, had not contributed substantially to reducing the treatment gap in 2013. However, given improved case detection with Xpert, a larger proportion of RR-TB patients overall have received treatment, with reduced delays. Nonetheless, strategies to further improve linkage to treatment for all diagnosed RR-TB patients are urgently required

"We had to manage what we had on hand, in whatever way we could": Adaptive responses in policy for decentralised drug-resistant tuberculosis care in South Africa

Karina Kielmann - ORCID: 0000-0001-5519-1658 https://orcid.org/0000-0001-5519-1658Replaced AM with VoR 2021-02-19.In 2011, the South African National TB Programme launched a policy of decentralized management of drug-resistant tuberculosis (DR-TB) in order to expand the capacity of facilities to treat patients with DR-TB, minimize delays to access care and improve patient outcomes. This policy directive was implemented to varying degrees within a rapidly evolving diagnostic and treatment landscape for DR-TB, placing new demands on already-stressed health systems. The variable readiness of district-level systems to implement the policy prompted questions not only about differences in health systems resources but also front-line actors’ capacity to implement change in resource-constrained facilities. Using a grounded theory approach, we analysed data from indepth interviews and small group discussions conducted between 2016 and 2018 with managers (n = 9), co-ordinators (n = 15), doctors (n = 7) and nurses (n = 18) providing DR-TB care. Data were collected over two phases in district-level decentralized sites of three South African provinces. While health systems readiness assessments conventionally map the availability of ‘hardware’, i.e. resources and skills to deliver an intervention, a notable absence of systems ‘hardware’ meant that systems ‘software’, i.e. health care workers (HCWs) agency, behaviours and interactions provided the basis of locally relevant strategies for decentralized DR-TB care. ‘Software readiness’ was manifest in four areas of DR-TB care: re-organization of service delivery, redressal of resource shortages, creation of treatment adherence support systems and extension of care parameters for vulnerable patients. These strategies demonstrate adaptive capacity and everyday resilience among HCW to withstand the demands of policy change and innovation in stressed systems. Our work suggests that a useful extension of health systems ‘readiness’ assessments would include definition and evaluation of HCW ‘software’ and adaptive capacities in the face of systems hardware gaps.The work presented in this paper was supported by the Joint Health Systems Research Initiative, jointly supported by the Department for International Development (DFID), the Economic and Social Research Council (ESRC), the Medical Research Council (MRC) and the Wellcome Trust (Grant# MR/N015924/1). This UK funded award is part of the EDCTP2 programme supported by the European Union. Ethical approval for the project was obtained through the University of Cape Town Human Research Ethics Committee (HREC REF 350/2016). HC is supported by a Wellcome Trust Fellowship. The authors wish to thank and acknowledge Dr. Norbert Ndjeka (SA NDOH), the provinces of the W Cape, E Cape, KZN for all their input and assistance.https://doi.org/10.1093/heapol/czaa14736pubpub

“A very humiliating illness”: a qualitative study of patient-centered Care for Rifampicin-Resistant Tuberculosis in South Africa

Abstract Background Patient-centered care is pillar 1 of the “End TB” strategy, but little has been documented in the literature about what this means for people living with rifampicin-resistant (RR-TB). Optimizing care for such individuals requires a better understanding of the challenges they face and the support they need. Methods A qualitative study was done among persons living with RR-TB and members of their support network. A purposive sample was selected from a larger study population and open-ended interviews were conducted using a semi-standard interview guide. Interviews were recorded and transcribed and the content analyzed using an iterative thematic analysis based in grounded theory. Results 16 participants were interviewed from three different provinces. Four distinct periods in which support was needed were identified: 1) pre-diagnosis; 2) pre-treatment; 3) treatment; and 4) post-treatment. Challenges common in all four periods included: socioeconomic issues, centralized care, and the need for better counseling at multiple levels. Conclusions Beyond being a “very humiliating illness”, RR-TB robs people of their physical, social, economic, psychological, and emotional well-being far beyond the period when treatment is being administered. Efforts to tackle these issues are as important as new drugs and diagnostics in the fight against TB

Data from: Delays and loss to follow up before treatment of drug-resistant TB following implementation of Xpert MTB/RIF in South Africa: a retrospective cohort study

Background: South Africa has a large burden of rifampicin-resistant tuberculosis (RR-TB), with 18,734 patients diagnosed in 2014. The number of diagnosed patients has increased substantially with the introduction of the Xpert MTB/RIF test, used for TB diagnosis for all patients with presumptive TB. Routine aggregate data suggest a large treatment gap (pre-treatment loss to follow up) between the numbers of laboratory confirmed RR-TB patients and those reported to have started second-line treatment. We aimed to assess the impact of Xpert MTB/RIF implementation on the delay to treatment initiation and loss to follow-up before second-line treatment for RR-TB across South Africa. Methods and findings: A nationwide retrospective cohort study was conducted to assess second-line treatment initiation and treatment delay among laboratory diagnosed RR-TB patients. Cohorts, including approximately 300 sequentially diagnosed RR-TB patients per South African province, were drawn from 2011 and 2013, before and after Xpert implementation. Patients with prior laboratory RR-TB diagnoses within 6 months and currently treated patients were excluded. Treatment initiation was determined through data linkage with national and local treatment registers, medical record review, interviews with healthcare staff, and direct contact with patients or household members. Additional laboratory data were used to track cases. National estimates of percentage treatment initiation and time to treatment were weighted to account for the sampling design. There were 2,508 and 2,528 eligible patients in the 2011 and 2013 cohorts respectively; 92% were newly diagnosed with RR-TB (new RR-TB, no prior RR-TB diagnoses). Nationally, among 2,340 and 2,311 new RR-TB patients in the 2011 and 2013 cohorts, 55% (95% CI 53-57) and 63% (95% CI 61-65) respectively started treatment within 6 months of their diagnostic specimen being sent (p<0.001). However, in 2013, there was no difference in the percentage of patients who initiated treatment at six months between the 1,368174 new RR-TB patients diagnosed by Xpert (62%, 95% CI 59-65) and the 943ose diagnosed by other methods (64%, 95% CI 61-67) (p=0.39). The median time to treatment decreased from 44 (IQR 20-69) days in 2011 to 22 (IQR 2-43) days in 2013 (p<0.001). In 2013, across the nine provinces, there were substantial variations in both treatment initiation (range 51-73% by six months) and median time to treatment (range 15-36 days, N=1,450), and only 53% of 1,448 new RR-TB who received treatmented patients were recorded on the national RR-TB register. This retrospective study is limited by the lack of information to assess reasons for non-initiation of treatment, particularly pre-treatment mortality data. Other limitations include the use of names and dates of birth to locate patient-level data, potentially resulting in missed treatment initiation among some patients. Conclusions: In 2013, there was a large treatment gap for RR-TB in South Africa which varied significantly across provinces. Xpert implementation, while reducing treatment delay, had not contributed substantially to reducing the treatment gap in 2013. However, given improved case detection with Xpert, overall a larger proportion of the total RR-TB burden has received treatment, with reduced delays. Nonetheless, strategies to further improve linkage to treatment for all diagnosed RR-TB patients are urgently required

Time to treatment initiation from diagnostic specimen for new rifampicin-resistant tuberculosis patients in the 2013 cohort diagnosed with Xpert compared to other methods (<i>p <</i> 0.001).

<p>Solid line: diagnosed with Xpert; dashed line: diagnosed by other method.</p

Demographic and clinical data by cohort.

<p>Demographic and clinical data by cohort.</p

Time to treatment initiation from diagnostic specimen for new rifampicin-resistant tuberculosis patients from the 2011 and 2013 cohorts (<i>p <</i> 0.001).

<p>Solid line: 2011 cohort; dashed line: 2013 cohort.</p

Second-line treatment initiation within 6 mo, time to treatment, and site of treatment initiation by age, sex, HIV status, diagnostic facility, and diagnostic test (new rifampicin-resistant tuberculosis patients, 2013 cohort).

<p>Second-line treatment initiation within 6 mo, time to treatment, and site of treatment initiation by age, sex, HIV status, diagnostic facility, and diagnostic test (new rifampicin-resistant tuberculosis patients, 2013 cohort).</p