Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
[Preprint]. 2023 Jun 9:rs.3.rs-2841179.
doi: 10.21203/rs.3.rs-2841179/v1.

Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): Study protocol for an adaptive randomized controlled trial

Jesse E Ross  1 , Rubeshan Perumal  2 , Allison Wolf  3 , Mbali Zulu  2 , Kevin Guzman  3 , Boitumelo Seepamore  2 , Karl Reis  4 , Hlengiwe Nyilana  2 , Senzo Hlathi  2 , Radhamoney Narasimmulu  2 , Ying Keun K Cheung  3 , K Rivet Amico  5 , Gerald Friedland  6 , Amrita Daftary  7 , Jennifer Zelnick  8 , Kogieleum Naidoo  2 , Max R O'Donnell  3
Affiliations

Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): Study protocol for an adaptive randomized controlled trial

Jesse E Ross et al. Res Sq. .

Update in

Abstract

Background: Highly effective, short course, bedaquiline-containing treatment regimens for multidrug-resistant tuberculosis (MDR-TB) and integrase strand transfer inhibitor (INSTI)-containing fixed dose combination antiretroviral therapy (ART) have radically transformed treatment for MDR-TB and HIV. However, without advances in adherence support, we may not realize the full potential of these therapeutics. The primary objective of this study is to compare the effect of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.

Methods: This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of four adherence support strategies on a composite clinical outcome in adults with MDR-TB and HIV initiating bedaquiline-containing MDR-TB treatment regimens and receiving ART in KwaZulu-Natal, South Africa. Trial arms include 1) enhanced standard of care; 2) psychosocial support; 3) mHealth using cellular- enabled electronic dose monitoring; 4) combined mHealth and psychosocial support. The level of support will be titrated using a differentiated service delivery (DSD)-informed assessment of treatment support needs. The composite primary outcome will be include survival, negative TB culture, retention in care and undetectable HIV viral load at month 12. Secondary outcomes will include individual components of the primary outcome and quantitative evaluation of adherence on TB and HIV treatment outcomes.

Discussion: This trial will evaluate the contribution of different modes of adherence support on MDR-TB and HIV outcomes with WHO recommended all-oral MDR-TB regimens and ART in a high-burden operational setting. We will also assess the utility of a DSD framework to pragmatically adjust levels of MDR-TB and HIV treatment support.

Keywords: Adherence support; Antiretrovirals; Bedaquiline; HIV/AIDS; MDR-TB; South Africa; Tuberculosis; mHealth.

PubMed Disclaimer

Conflict of interest statement

Competing interests The authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Study design overview
Figure 2
Figure 2
Schedule of Study Evaluations
See this image and copyright information in PMC

References

    1. WHO. World Health Organization. Global tuberculosis report 2022. 2022.
    1. WHO. World Health Organization. The End TB Strategy. 2015.
    1. Mirzayev Fuad, Viney Kerri, Linh Nguyen Nhat, Gonzalez-Angulo Licé, Gegia Medea, Jaramillo Ernesto, Zignol Matteo, Kasaeva Tereza. World Health Organization recommendations on the treatment of drug-resistant tuberculosis, 2020 update. European Respiratory Journal Jun 2021, 57 (6) 2003300; DOI: 10.1183/13993003.03300-2020 - DOI - PMC - PubMed
    1. Isaakidis P, Casas EC, Das M, Tseretopoulou X, Ntzani EE, Ford N. Treatment outcomes for HIV and MDR-TB co-infected adults and children: systematic review and meta-analysis. Int J Tuberc Lung Dis. 2015;19(8):969–78. - PubMed
    1. Conradie Francesca, Diacon Andreas H., Ngubane Nosipho, Howell Pauline, Everitt Daniel, Crook Angela M., Mendel Carl M., et al. “Treatment of Highly Drug-Resistant Pulmonary Tuberculosis.” New England Journal of Medicine 382, no. 10 (March 5, 2020): 893–902. 10.1056/NEJMoa1901814. - DOI - PMC - PubMed

Publication types

LinkOut - more resources