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  1. AU="Narasimmulu, Radhamoney"
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  1. Artikel: Drug-Resistant TB, HIV and COVID-19 Co-Infection: Case Reviews from Kwa-Zulu Natal, South Africa.

    Hassan-Moosa, Razia / Motsomi, Kegaugetswe Wilhemina / Narasimmulu, Radhamoney / Sivro, Aida / Naidu, Kevindra K / Kharsany, Ayesha B M / Samsunder, Natasha / Perumal, Rubeshan / Naidoo, Kogieleum

    Infection and drug resistance

    2023  Band 16, Seite(n) 7663–7670

    Abstract: Background: Coronavirus disease (COVID-19) potentially exacerbates drug-resistant tuberculosis (DR-TB). We describe the clinical presentation and outcomes of three patients with human immunodeficiency virus (HIV), DR-TB and COVID-19.: Case one: A ... ...

    Abstract Background: Coronavirus disease (COVID-19) potentially exacerbates drug-resistant tuberculosis (DR-TB). We describe the clinical presentation and outcomes of three patients with human immunodeficiency virus (HIV), DR-TB and COVID-19.
    Case one: A virologically suppressed 31-year-old man on antiretroviral therapy (ART) and multidrug-resistant (MDR)-TB treatment presented with mild COVID-19 and was hospitalised for 10 days of clinical monitoring, despite being clinically stable with normal baseline inflammatory markers. Severe acute respiratory syndrome coronavirus polymerase chain reaction (SARS-CoV-2 PCR) positivity persisted at Day 28.
    Case two: A virologically suppressed 37-year-old woman on ART and MDR-TB treatment presented with moderate COVID-19. Baseline inflammatory markers were raised, and dexamethasone and azithromycin were initiated with good clinical improvement. SARS-CoV-2 PCR positivity persisted at Day 28.
    Case three: A viraemic 24-year-old woman on second-line ART and MDR-TB treatment, presented with mild COVID-19 disease, normal oxygenation and normal inflammatory markers, and remained clinically stable with negative SARS-CoV-2 PCR at Days 14 and 28.
    Conclusion: Screening for SARS-CoV-2 infection is advised for DR-TB patients with new or worsening respiratory symptoms.
    Sprache Englisch
    Erscheinungsdatum 2023-12-15
    Erscheinungsland New Zealand
    Dokumenttyp Case Reports
    ZDB-ID 2494856-1
    ISSN 1178-6973
    ISSN 1178-6973
    DOI 10.2147/IDR.S433695
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel: 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.

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

    Research square

    2023  

    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 ... ...

    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.
    Sprache Englisch
    Erscheinungsdatum 2023-06-09
    Erscheinungsland United States
    Dokumenttyp Preprint
    DOI 10.21203/rs.3.rs-2841179/v1
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: 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.

    Ross, Jesse / Perumal, Rubeshan / Wolf, Allison / Zulu, Mbali / Guzman, Kevin / Seepamore, Boitumelo / Reis, Karl / Nyilana, Hlengiwe / Hlathi, Senzo / Narasimmulu, Radhamoney / Cheung, Ying Kuen K / Amico, K Rivet / Friedland, Gerald / Daftary, Amrita / Zelnick, Jennifer R / Naidoo, Kogieleum / O'Donnell, Max R

    Trials

    2023  Band 24, Heft 1, Seite(n) 776

    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 ... ...

    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, 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 registration: ClinicalTrials.gov NCT05633056. Registered on 1 December 2022.
    Mesh-Begriff(e) Adult ; Humans ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; HIV Infections/complications ; Prospective Studies ; Randomized Controlled Trials as Topic ; South Africa/epidemiology ; Treatment Outcome ; Tuberculosis, Multidrug-Resistant/diagnosis ; Tuberculosis, Multidrug-Resistant/drug therapy
    Sprache Englisch
    Erscheinungsdatum 2023-12-01
    Erscheinungsland England
    Dokumenttyp Clinical Trial Protocol ; Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-023-07520-9
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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