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.

Mixed methods systematic review and metasummary about barriers and facilitators for the implementation of cotrimoxazole and isoniazid – preventive therapies for people living with HIV

“…The most serious, very rarely reported adverse reactions to INH were seizures, psychiatric symptoms [48,64], (peripheral) neuropathy [60,62] and mild to moderate hepatoxicity [46,60]. Very few patients experienced adverse reactions that required therapy interruption [48,60,63].…”

“…Lacking financial and organisational feasibility frequently emerged as barrier theme [15,34,38,44,46,48,50,54,58,[60][61][62][63]65]. Evidence synthesis revealed that long distance to the clinic [44,60], lacking transport [15,44], and the with transportation associated costs [44,46,48,50,54,63] routinely comprised an obstacle for patients to access therapy and care.…”

“…Patients revealed they received ART, medications for hypertension and diabetes, or asthma in addition to IPT [64]. Pill burden affected patients adherence, providers believed [62,68]. Some patients feared adding to the pill burden [62]; others completely declined to take IPT due to the high number of pills prescribed to PLHIV [68].…”

“…Pill burden affected patients adherence, providers believed [62,68]. Some patients feared adding to the pill burden [62]; others completely declined to take IPT due to the high number of pills prescribed to PLHIV [68]. Studies from Uganda and South Africa reported that patients presumed side effects [44], found IPT unnecessary [63] or were just not interested in taking IPT [44].…”

“…Although there was some consensus that younger age was positively associated with the use of IPT) [48,55,59,62,66], some subgroups lagged behind. In particular, children (and adolescents) had a lower probability of initiating (or receiving) IPT compared to their adult counterparts [14,59,62].…”