ArticleTrials2023
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.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05633056 (Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa), which is not on this map. Cited by 7 papers.
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Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa
Who cites it
7 citing papers in PubMed, 3 citations in OpenAlex.
- Manualised package intervention to achieve treatment adherence in people with tuberculosis: the IMPACT pilot cluster-RCT.Health technology assessment (Winchester, England) · 2026Trial
- Early adherence predicts treatment outcomes and mortality in people living with HIV and multidrug-resistant tuberculosis.Annals of epidemiology · 2026Article
- Association of Positive mHealth Engagement with Knowledge, Attitude, Practice, and Total KAP Among Patients with Multidrug-Resistant Tuberculosis.Healthcare (Basel, Switzerland) · 2026Article
- A Multi-Modal Mobile Phone-Based Communication Strategy to Maximize Retention in a Post-Intensive Care Follow-up Study of Acute Respiratory Distress Syndrome Survivors.Research square · 2026Article
- Socio-ecological vulnerability subgroups predict adherence and treatment outcomes in multidrug-resistant tuberculosis and HIV: a latent class analysis.BMC infectious diseases · 2026Article
- New drugs are not enough: addressing social determinants as a critical component of drug-resistant TB care.IJTLD open · 2025Article
- Differentiated service delivery framework for people with multidrug-resistant tuberculosis and HIV co-infection.Journal of acquired immune deficiency syndromes (1999) · 2024Article
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Authors and funding
17 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundHighly 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.
methodsThis 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, and (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 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.
trial registrationClinicalTrials.gov NCT05633056. Registered on 1 December 2022.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.