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To start or to complete? - Challenges in implementing tuberculosis preventive therapy among people living with HIV: a mixed-methods study from Karnataka, India.

ABSTRACT: Background: Isoniazid preventive therapy (IPT) has been shown to reduce the risk of tuberculosis (TB) among people living with HIV (PLHIV). In 2017, India began a nationwide roll-out of IPT, but there is a lack of evidence on the implementation and the challenges.Objectives: Among PLHIV newly initiated on antiretroviral therapy (ART) from January 2017 to June 2018, to: (i) assess the proportion who started and completed IPT and (ii) explore reasons for non-initiation and non-completion from health-care providers' and patients' perspectives.Methods: An explanatory mixed-methods study was conducted in two selected districts of Karnataka, South India. A quantitative phase (cohort analysis of routinely collected program data) was followed by a qualitative phase involving thematic analysis of in-depth interviews with providers (n = 22) and patients (n = 8).Results: Of the 4020 included PLHIV, 3780 (94%) were eligible for IPT, of whom, 1496 (40%, 95% CI: 38%-41%) were initiated on IPT. Among those initiated, 423 (28.3%) were still on IPT at the time of analysis. Among 1073 patients with declared IPT outcomes 870 (81%, 95% CI: 79%-83%) had completed the six-month course of IPT. The main reason for IPT non-initiation and non-completion was frequent drug stock-outs. This required health-care providers to restrict IPT initiation in selected patient subgroups and earmark six-monthly courses for each patient to ensure that, once started, treatment was not interrupted. The other reasons for non-completion were adverse drug effects and loss to follow-up.Conclusion: The combined picture of 'low IPT initiation and high completion' seen in our study mirrors findings from other countries. Drug stock-out was the key challenge, which obliged health-care providers to prioritize 'IPT completion' over 'IPT initiation'. There is an urgent need to improve the procurement and supply chain management of isoniazid.

SUBMITTER: Reddy MM

PROVIDER: S-EPMC7006687 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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To start or to complete? - Challenges in implementing tuberculosis preventive therapy among people living with HIV: a mixed-methods study from Karnataka, India.

Reddy Mahendra M MM Thekkur Pruthu P Ramya Nagesh N Kamath Prasanna B T PBT Shastri Suresh G SG Kumar Ravi B N RBN Chinnakali Palanivel P Nirgude Abhay S AS Rangaraju Chethana C Somashekar Narasimhaiah N Kumar Ajay M V AMV

Global health action 20200101 1

<b>Background</b>: Isoniazid preventive therapy (IPT) has been shown to reduce the risk of tuberculosis (TB) among people living with HIV (PLHIV). In 2017, India began a nationwide roll-out of IPT, but there is a lack of evidence on the implementation and the challenges.<b>Objectives</b>: Among PLHIV newly initiated on antiretroviral therapy (ART) from January 2017 to June 2018, to: (i) assess the proportion who started and completed IPT and (ii) explore reasons for non-initiation and non-comple ...[more]

PMID: 31937200

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Project description:IntroductionConsidering limited global access to affordable insulin, we evaluated insulin access in public and private health sectors in Bengaluru, India.MethodsEmploying modified WHO/HAI methodology, we used mixed-methods analysis to study insulin access and factors influencing insulin supply and demand in Bengaluru in December 2017. We assessed insulin availability, price and affordability in a representative sample of 5 public-sector hospitals, 5 private-sector hospitals and 30 retail pharmacies. We obtained insulin price data from websites of government Jan Aushadhi scheme (JAS) and four online private-sector retail pharmacies. We interviewed wholesalers in April 2018 to understand insulin market dynamics.ResultsMean availability of insulins on India's 2015 Essential Medicine List was 66.7% in the public sector, lower than private-sector retail (76.1%) and hospital pharmacies (93.3%). Among private retailers, mean availability was higher among chain (96.7%) than independent pharmacies (68.3%). Non-Indian companies supplied 67.3% products in both sectors. 79.1% products were manufactured in India, of which 60% were marketed by non-Indian companies.In private retail pharmacies, median consumer prices of human insulin cartridges and pens were 2.5 and 3.6 times, respectively, that of human insulin vials. Analogues depending on delivery device were twice as expensive as human insulin. Human insulin vials were 18.3% less expensive in JAS pharmacies than private retail pharmacies. The lowest paid unskilled worker would pay 1.4 to 9.3 days' wages for a month's supply, depending on insulin type and health sector. Wholesaler interviews suggest that challenges constraining patient insulin access include limited market competition, physicians' preference for non-Indian insulins, and the ongoing transition from human to analogue insulin. Rising popularity of online and chain pharmacies may influence insulin access.ConclusionInsulin availability in Bengaluru's public sector falls short of WHO's 80% target. Insulin remains unaffordable in both private and public sectors. To improve insulin availability and affordability, government should streamline insulin procurement and supply chains at different levels, mandate biosimilar prescribing, educate physicians to pursue evidence-based prescribing, and empower pharmacists with brand substitution. Patients must be encouraged to shop around for lower prices from subsidized schemes like JAS. While non-Indian companies dominate Bengaluru's insulin market, rising market competition from Indian companies may improve access.

Project description:BACKGROUND:In India, a new care package consisting of (i) daily regimen with fixed-dose combination drugs, collected once-a-month and self-administered by the patient, (ii) 'one stop service' at antiretroviral treatment (ART) centre for both HIV and tuberculosis (TB) treatment and (iii) technology-enabled adherence support (99DOTS, which required patients to give a missed phone call after consuming drugs) was piloted for treatment of TB among HIV-infected TB patients. Conventional care included intermittent regimen (drugs consumed thrice-weekly) delivered under direct observation of treatment supporter and the patients needing to visit TB and HIV care facilities, separately for treatment. OBJECTIVE:To assess the effect of new care package on TB treatment outcomes among HIV-TB patients registered during January-December 2016, as compared to conventional care and explore the implementation challenges. METHODS:A mixed-methods study was conducted in four districts of Karnataka, India where new care package was piloted in few ART centres while the rest provided conventional care. Quantitative component involved a secondary cohort analysis of routine programme data. Adjusted relative risk(aRR) was calculated using Poisson regression to measure association between new care package and unsuccessful treatment outcome. We conducted in-depth interviews with healthcare providers and patients to understand the challenges. RESULTS:Unsuccessful TB treatment outcomes (death, loss to follow-up and failure) were higher in new care package (n = 871) compared to conventional care (n = 961) (30.5% vs 23.4%; P value<0.001) and aRR was 1.3(95% CI: 1.1-1.7). Key challenges included patients' inability to give missed call, increased work load for ART staff, reduced patient-provider interaction, deficiencies in training and lack of role clarity among providers and reduced involvement of TB program staff. CONCLUSION:With new care package, TB treatment outcomes did not improve as expected and conversely declined compared to conventional care. TB and HIV programs need to address the operational challenges to improve the outcomes.

Project description:BackgroundTuberculosis (TB) preventive therapy (TPT) is an essential component of care for people living with HIV (PLHIV). We compared efficacy, safety, completion, and drug-resistant TB risk for currently recommended TPT regimens through a systematic review and network meta-analysis (NMA) of randomized trials.Methods and findingsWe searched MEDLINE, Embase, and the Cochrane Library from inception through June 9, 2020 for randomized controlled trials (RCTs) comparing 2 or more TPT regimens (or placebo/no treatment) in PLHIV. Two independent reviewers evaluated eligibility, extracted data, and assessed the risk of bias. We grouped TPT strategies as follows: placebo/no treatment, 6 to 12 months of isoniazid, 24 to 72 months of isoniazid, and rifamycin-containing regimens. A frequentist NMA (using graph theory) was carried out for the outcomes of development of TB disease, all-cause mortality, and grade 3 or worse hepatotoxicity. For other outcomes, graphical descriptions or traditional pairwise meta-analyses were carried out as appropriate. The potential role of confounding variables for TB disease and all-cause mortality was assessed through stratified analyses. A total of 6,466 unique studies were screened, and 157 full texts were assessed for eligibility. Of these, 20 studies (reporting 16 randomized trials) were included. The median sample size was 616 (interquartile range [IQR], 317 to 1,892). Eight were conducted in Africa, 3 in Europe, 3 in the Americas, and 2 included sites in multiple continents. According to the NMA, 6 to 12 months of isoniazid were no more efficacious in preventing microbiologically confirmed TB than rifamycin-containing regimens (incidence rate ratio [IRR] 1.0, 95% CI 0.8 to 1.4, p = 0.8); however, 6 to 12 months of isoniazid were associated with a higher incidence of all-cause mortality (IRR 1.6, 95% CI 1.2 to 2.0, p = 0.02) and a higher risk of grade 3 or higher hepatotoxicity (risk difference [RD] 8.9, 95% CI 2.8 to 14.9, p = 0.004). Finally, shorter regimens were associated with higher completion rates relative to longer regimens, and we did not find statistically significant differences in the risk of drug-resistant TB between regimens. Study limitations include potential confounding due to differences in posttreatment follow-up time and TB incidence in the study setting on the estimates of incidence of TB or all-cause mortality, as well as an underrepresentation of pregnant women and children.ConclusionsRifamycin-containing regimens appear safer and at least as effective as isoniazid regimens in preventing TB and death and should be considered part of routine care in PLHIV. Knowledge gaps remain as to which specific rifamycin-containing regimen provides the optimal balance of efficacy, completion, and safety.

Project description:BackgroundTobacco use and alcohol abuse are associated with higher risk of tuberculosis (TB) infection, progression to active TB and adverse treatment outcomes among patients with TB. Revised National Tuberculosis Control Programme (RNTCP) treatment guidelines (2016) require the documentation of tobacco and alcohol use among patients with TB and their linkage to tobacco and alcohol abuse treatment services. This study aimed to assess the extent of documentation of tobacco and alcohol usage data in the TB treatment card and to explore in-depth, the operational issues involved in linkage.MethodsA convergent parallel mixed methods study was conducted. All new TB treatment cards of adult patients registered under RNTCP between January and June 2017 in Dakshina Kannada district were reviewed to assess documentation. Document review was done to understand the process of linkage (directing patients to tobacco and alcohol abuse treatment services). In-depth interview of health care providers (n = 7) and patients with TB (n = 5) explored into their perspectives on linkage.ResultsAmong 413 treatment cards reviewed, tobacco use was documented in 322 (78%), of whom 86 (21%) were documented as current tobacco users. Sixteen (19%) out of these 86 patients were linked to tobacco cessation services. Alcohol usage status was documented in 319 (77%) cards of whom 71(17%) were documented as alcohol users. Eleven (16%) out of these 71 patients were linked to alcohol abuse treatment services. The questions in the treatment card lacked clarity. Guidelines on eliciting history of substance abuse and criteria for linkage were not detailed. Perceived enablers for linkage included family support, will power of the patients and fear of complications. Challenges included patient's lack of motivation, financial and time constraints, inadequate guidelines and lack of co-ordination mechanisms between TB programme and tobacco/alcohol abuse treatment services.ConclusionDocumentation was good but not universally done. Clear operational guidelines on linkage and treatment guidelines for health care providers to appropriately manage the patients with comorbidities are lacking. Lack of coordination between the TB treatment programme and tobacco cessation as well as alcohol treatment services was considered a major challenge in effective implementation of the linkage services.

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To start or to complete? - Challenges in implementing tuberculosis preventive therapy among people living with HIV: a mixed-methods study from Karnataka, India.

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To start or to complete? - Challenges in implementing tuberculosis preventive therapy among people living with HIV: a mixed-methods study from Karnataka, India.

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