Outcomes and implementation challenges of using daily treatment regimens with an innovative adherence support tool among HIV-infected tuberculosis patients in Karnataka, India: a mixed-methods study

ABSTRACT

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.

KEYWORDS:

• Self-administered treatment
• m-health
• e-health
• 99DOTS
• SORT IT
• operational research

Responsible Editor

Peter Byass, Umeå University, Sweden

Responsible Editor

Peter Byass, Umeå University, Sweden

Acknowledgments

This research was conducted through the Structured Operational Research and Training Initiative (SORT IT), a global partnership led by the Special Programme for Research and Training in Tropical Diseases at the World Health Organization (WHO/TDR). The model is based on a course developed jointly by the International Union Against Tuberculosis and Lung Disease (The Union) and Medécins Sans Frontières (MSF/Doctors Without Borders). The specific SORT IT programme which resulted in this publication was jointly developed and implemented by: The Union South-East Asia Office, New Delhi, India; the Centre for Operational Research, The Union, Paris, France; Médecins Sans Frontières, Operational Research Unit, Luxembourg; Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India; Department of Community Medicine, GMERS Medical College, Vadodara, India; Department of Community Medicine, ESIC Medical College and PGIMSR, Bengaluru, India; Department of Community Medicine, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, India; Department of Community Medicine, Velammal Medical College Hospital and Research Institute, Madurai, Tamil Nadu; and National Institute for Research in Tuberculosis, Chennai, India.

We are grateful to the District Tuberculosis Officers, District Program Supervisors and ART staff of study districts in state of Karnataka.

Disclosure statement

No potential conflict of interest was reported by the authors.

Ethics and consent

Permission to access data was obtained from the State tuberculosis programme office. Ethics approval was obtained from the Ethics Advisory Group of the International Union Against Tuberculosis and Lung Disease, Paris, France. For qualitative component, written informed consent was obtained from the participants. A separate consent for audio recording of the interviews was also obtained.

Paper context

This is the first study assessing the TB treatment outcomes and implementation challenges of new care package (self-administered daily regimen with fixed-dose combination, ‘one stop service’ at Antiretroviral Treatment (ART) centre and 99DOTS) for treatment of HIV-infected TB patients. The new care package had 30 percent higher chance of having unsuccessful treatment outcomes compared to conventional care. The implementation challenges need to be addressed before scaling up this strategy.

Supplemental Material

Supplemental material for this article can be accessed here.

Additional information

Funding

The training program, within which this paper was developed, and the open access publication costs were funded by the Department for International Development (DFID), UK and La Fondation Veuve Emile Metz-Tesch (Luxembourg). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Notes on contributors

Pruthu Thekkur

PT was the principal investigator; PC, SS, AR were the SORT IT mentors; AMVK and SS are the senior authors. KS, VV and AN were involved in data collection; PT, PC, AMVK analyzed the data and prepare the first draft of paper. All authors were involved in conception, design, inference of results, providing critical review to the manuscript and approval of the manuscript from this protocol.