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  1. Article ; Online: Obstetric violence as immigration injustice: A view from the United States and Colombia.

    Wolf, Allison B

    Developing world bioethics

    2022  Volume 23, Issue 2, Page(s) 176–184

    Abstract: In September 2020, Project South, along with numerous other organizations, released a report detailing abuses in a Georgia Detention Center - including forced hysterectomies. Whatever other factors are at play, one of them is an intrinsic connection ... ...

    Abstract In September 2020, Project South, along with numerous other organizations, released a report detailing abuses in a Georgia Detention Center - including forced hysterectomies. Whatever other factors are at play, one of them is an intrinsic connection between obstetric violence against pregnant migrants and immigration injustice. It is not incidental that these acts - in US detention centers, along the US-Mexico border, in Colombian hospitals and clinics - are being perpetrated on immigrant bodies. And it is not accidental or random which immigrant bodies are vulnerable to these violations. Understanding and confronting obstetric violence directed at pregnant migrants, though, requires reconceptualizing the nature of obstetric violence itself. In particular, we must recognize that obstetric violence against pregnant Latin American migrants in the United States and Colombia is a type of immigration injustice, a means to perpetrate immigration injustice, and a product of immigration injustice. As such, bioethicists need to collaborate with immigration scholars to resist it. After providing some background on the nature of obstetric violence and some ways it is perpetuated against pregnant migrants in the United States and Colombia, I will give a brief overview of how I conceptualize immigration justice. From there, I explain how this type of obstetric violence constitutes a type of immigration injustice, a means to perpetrate immigration injustice, and a product of immigration injustice. My hope is that this analysis motivates bioethicists throughout the Americas to engage with immigration scholars and activists to confront the issue more forcefully.
    MeSH term(s) Female ; Humans ; Pregnancy ; Colombia/epidemiology ; Emigration and Immigration ; Transients and Migrants ; United States/ethnology ; Violence ; Pregnant Women/psychology ; Venezuela/epidemiology
    Language English
    Publishing date 2022-08-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2049034-3
    ISSN 1471-8847 ; 1471-8731
    ISSN (online) 1471-8847
    ISSN 1471-8731
    DOI 10.1111/dewb.12365
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  2. Article ; Online: Effects of stochastic resonance stimulation on manual function in children with hemiplegic cerebral palsy: A pilot clinical trial.

    Lynn, Jessica / Wolf, Allison / Bridges, Travis / Pottanat, Zachary / Spivey, Suzanne / Rolin, Olivier

    PM & R : the journal of injury, function, and rehabilitation

    2022  Volume 15, Issue 3, Page(s) 302–313

    Abstract: Objective: To investigate the effect of stochastic resonance stimulation (SRS) on manual abilities in children with hemiplegic cerebral palsy.: Design: This pilot study is a randomized, sham-controlled, one-period, crossover trial.: Setting: A ... ...

    Abstract Objective: To investigate the effect of stochastic resonance stimulation (SRS) on manual abilities in children with hemiplegic cerebral palsy.
    Design: This pilot study is a randomized, sham-controlled, one-period, crossover trial.
    Setting: A neuroscience clinic with specialty therapy programs at an urban, university-based children's hospital.
    Participants: Sixteen children ages 3 to 16 years who were diagnosed with hemiplegic cerebral palsy and had hand Manual Abilities Classification scale score of I to III with sufficient cognitive abilities to follow instructions.
    Interventions: Children donned wrist and arm bands that delivered SRS via embedded piezoelectric actuators in two randomly assigned conditions: sham (devices powered off) and subthreshold stimulation (SBT-SRS). Following the randomized protocol, a subset of participants also completed an open-label, above-threshold stimulation (AT-SRS) condition. Children carried out the same uni-manual and bimanual tasks during the randomized and open-label protocols; all data were collected in a single session.
    Main outcome measure(s): Box and Blocks (B&B) test, a uni-manual function test, and the Shriners Hospital Upper Extremity Evaluation (SHUEE). The SHUEE was video recorded and scored by two raters who were blinded to the experimental condition.
    Results: Thirteen children completed the B&B task and 14 children completed the SHUEE. Children in the SBT-SRS condition relative to sham condition moved an average of 1.8 more blocks in 1 minute (p = .08); scored an average of 3 points higher on SHUEE spontaneous functional analysis (p < .002); and scored an average of 2.7 points higher on SHUEE dynamic positional analysis (p = .20). In the open-label protocol, children in the AT-SRS condition relative to sham moved 3.9 more blocks than in the sham condition (n = 8, p < .001); scored an average of 4.5 points higher on SHUEE spontaneous functional analysis (n = 6, p = .08); and scored an average of 10.5 points higher on SHUEE dynamic positional analysis (n = 6, p = .01).
    Conclusion(s): In this pilot study, we found preliminary evidence that children with hemiplegic cerebral palsy demonstrated improved uni-manual abilities and increased function of the impaired hand on bimanual tasks when receiving a single session of SBT-SRS. Preliminary evidence also suggests that some children with hemiplegic cerebral palsy may improve more when receiving a single session of AT-SRS. Future research using larger, controlled studies should evaluate the optimal intensity, duration, and long-term effect of SRS for improving impaired manual abilities.
    MeSH term(s) Humans ; Child ; Child, Preschool ; Adolescent ; Cerebral Palsy/diagnosis ; Hemiplegia/etiology ; Pilot Projects ; Upper Extremity ; Hand
    Language English
    Publishing date 2022-04-08
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2608988-9
    ISSN 1934-1563 ; 1934-1482
    ISSN (online) 1934-1563
    ISSN 1934-1482
    DOI 10.1002/pmrj.12788
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  3. Article ; Online: Opportunities and limitations of genomics for diagnosing bedaquiline-resistant tuberculosis: a systematic review and individual isolate meta-analysis.

    Nimmo, Camus / Bionghi, Neda / Cummings, Matthew J / Perumal, Rubeshan / Hopson, Madeleine / Al Jubaer, Shamim / Naidoo, Kogieleum / Wolf, Allison / Mathema, Barun / Larsen, Michelle H / O'Donnell, Max

    The Lancet. Microbe

    2024  Volume 5, Issue 2, Page(s) e164–e172

    Abstract: Background: Clinical bedaquiline resistance predominantly involves mutations in mmpR5 (Rv0678). However, mmpR5 resistance-associated variants (RAVs) have a variable relationship with phenotypic Mycobacterium tuberculosis resistance. We did a systematic ... ...

    Abstract Background: Clinical bedaquiline resistance predominantly involves mutations in mmpR5 (Rv0678). However, mmpR5 resistance-associated variants (RAVs) have a variable relationship with phenotypic Mycobacterium tuberculosis resistance. We did a systematic review to assess the maximal sensitivity of sequencing bedaquiline resistance-associated genes and evaluate the association between RAVs and phenotypic resistance, using traditional and machine-based learning techniques.
    Methods: We screened public databases for articles published from database inception until Oct 31, 2022. Eligible studies performed sequencing of at least mmpR5 and atpE on clinically sourced M tuberculosis isolates and measured bedaquiline minimum inhibitory concentrations (MICs). A bias risk scoring tool was used to identify bias. Individual genetic mutations and corresponding MICs were aggregated, and odds ratios calculated to determine association of mutations with resistance. Machine-based learning methods were used to define test characteristics of parsimonious sets of diagnostic RAVs, and mmpR5 mutations were mapped to the protein structure to highlight mechanisms of resistance. This study was registered in the PROSPERO database (CRD42022346547).
    Findings: 18 eligible studies were identified, comprising 975 M tuberculosis isolates containing at least one potential RAV (mutation in mmpR5, atpE, atpB, or pepQ), with 201 (20·6%) showing phenotypic bedaquiline resistance. 84 (29·5%) of 285 resistant isolates had no candidate gene mutation. Sensitivity and positive predictive value of taking an any mutation approach was 69% and 14%, respectively. 13 mutations, all in mmpR5, had a significant association with a resistant MIC (adjusted p<0·05). Gradient-boosted machine classifier models for predicting intermediate or resistant and resistant phenotypes both had receiver operator characteristic c statistic of 0·73 (95% CI 0·70-0·76). Frameshift mutations clustered in the α1 helix DNA-binding domain, and substitutions in the α2 and α3 helix hinge region and in the α4 helix-binding domain.
    Interpretation: Sequencing candidate genes is insufficiently sensitive to diagnose clinical bedaquiline resistance, but where identified, some mutations should be assumed to be associated with resistance. Genomic tools are most likely to be effective in combination with rapid phenotypic diagnostics. This study was limited by selective sampling in contributing studies and only considering single genetic loci as causative of resistance.
    Funding: Francis Crick Institute and National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
    MeSH term(s) United States ; Humans ; Antitubercular Agents/pharmacology ; Antitubercular Agents/therapeutic use ; Diarylquinolines/pharmacology ; Diarylquinolines/therapeutic use ; Tuberculosis/drug therapy ; Mycobacterium tuberculosis/genetics ; Genomics
    Chemical Substances bedaquiline (78846I289Y) ; Antitubercular Agents ; Diarylquinolines
    Language English
    Publishing date 2024-01-09
    Publishing country England
    Document type Systematic Review ; Meta-Analysis ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ISSN 2666-5247
    ISSN (online) 2666-5247
    DOI 10.1016/S2666-5247(23)00317-8
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  4. Article ; Online: Whose Values? Whose Risk? Exploring Decision Making About Trial of Labor After Cesarean.

    Charles, Sonya / Wolf, Allison B

    The Journal of medical humanities

    2016  Volume 39, Issue 2, Page(s) 151–164

    Abstract: In this article, we discuss decision making during labor and delivery, specifically focusing on decision making around offering women a trial of labor after cesarean section (TOLAC). Many have discussed how humans are notoriously bad at assessing risks ... ...

    Abstract In this article, we discuss decision making during labor and delivery, specifically focusing on decision making around offering women a trial of labor after cesarean section (TOLAC). Many have discussed how humans are notoriously bad at assessing risks and how we often distort the nature of various risks surrounding childbirth. We will build on this discussion by showing that physicians make decisions around TOLAC not only based on distortions of risk, but also based on personal values (i.e. what level of risk are you comfortable with or what types of risks are you willing to take) rather than medical data (or at least medical data alone). As a result of this, we will further suggest that the party who is best epistemically situated to make decisions about TOLAC is the woman herself.
    MeSH term(s) Decision Making ; Female ; Humans ; Pregnancy ; Risk Assessment ; Trial of Labor ; Vaginal Birth after Cesarean
    Language English
    Publishing date 2016-10-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2017000-2
    ISSN 1573-3645 ; 1041-3545
    ISSN (online) 1573-3645
    ISSN 1041-3545
    DOI 10.1007/s10912-016-9410-8
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  5. Article ; Online: Differentiated service delivery framework for people with multidrug-resistant tuberculosis and HIV co-infection.

    Reis, Karl / Wolf, Allison / Perumal, Rubeshan / Seepamore, Boitumelo / Guzman, Kevin / Ross, Jesse / Cheung, Ken / Amico, K Rivet / Brust, James C M / Padayatchi, Nesri / Friedland, Gerald / Naidoo, Kogieleum / Daftary, Amrita / Zelnick, Jennifer / O'Donnell, Max

    Journal of acquired immune deficiency syndromes (1999)

    2024  

    Abstract: Introduction: For people living with HIV/AIDS, care is commonly delivered through Differentiated Service Delivery (DSD). Although people with multidrug-resistant tuberculosis (MDR-TB) and HIV/AIDS experience severe treatment associated challenges, there ...

    Abstract Introduction: For people living with HIV/AIDS, care is commonly delivered through Differentiated Service Delivery (DSD). Although people with multidrug-resistant tuberculosis (MDR-TB) and HIV/AIDS experience severe treatment associated challenges, there is no DSD model to support their treatment. In this study, we defined patterns of medication adherence and characterized longitudinal barriers to inform development of an MDR-TB/HIV DSD framework.
    Methods: Adults with MDR-TB and HIV initiating bedaquiline (BDQ) and receiving antiretroviral therapy (ART) in KwaZulu-Natal, South Africa, were enrolled and followed through the end of MDR-TB treatment. Electronic dose monitoring devices (EDM) measured BDQ and ART adherence. Longitudinal focus groups were conducted and transcripts analyzed thematically to describe discrete treatment stage-specific and cross-cutting treatment challenges.
    Results: 283 participants were enrolled and followed through treatment completion (median 17.8 months [IQR 16.5-20.2]). Thirteen focus groups were conducted. Most participants (82.7%, 234/283) maintained high adherence (mean BDQ adherence 95.3%; mean ART adherence 85.5%), but an adherence-challenged subpopulation with <85% cumulative adherence (17.3%, 49/283) had significant declines in mean weekly BDQ adherence from 94.9% to 39.9% (p<0.0001) and mean weekly ART adherence from 83.9% to 26.6% (p<0.0001) over 6 months. Psychosocial, behavioral, and structural obstacles identified in qualitative data were associated with adherence deficits in discrete treatment stages, and identified potential stage specific interventions.
    Conclusion: A DSD framework for MDR-TB/HIV should intensify support for adherence-challenged subpopulations, provide multi-modal support for adherence across the treatment course and account for psychosocial, behavioral, and structural challenges linked to discrete treatment stages.
    Language English
    Publishing date 2024-02-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 645053-2
    ISSN 1944-7884 ; 1077-9450 ; 0897-5965 ; 0894-9255 ; 1525-4135
    ISSN (online) 1944-7884 ; 1077-9450
    ISSN 0897-5965 ; 0894-9255 ; 1525-4135
    DOI 10.1097/QAI.0000000000003394
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  6. Article ; Online: Spatiotemporal Clustering of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis Is Associated With Human Immunodeficiency Virus Status and Drug-Susceptibility Patterns in KwaZulu-Natal, South Africa.

    Wolf, Allison / Padayatchi, Nesri / Naidoo, Kogieleum / Master, Iqbal / Mathema, Barun / O'Donnell, Max R

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2020  Volume 70, Issue 10, Page(s) 2224–2227

    Abstract: Using an open-access spatiotemporal analytics program, we mapped spatiotemporal heterogeneity loci in tuberculosis (TB) cases (clusters) and dynamic changes, and characterized the drug-resistant TB clustering risk using routine microbiological data from ... ...

    Abstract Using an open-access spatiotemporal analytics program, we mapped spatiotemporal heterogeneity loci in tuberculosis (TB) cases (clusters) and dynamic changes, and characterized the drug-resistant TB clustering risk using routine microbiological data from KwaZulu-Natal, South Africa. The data may provide insight into transmission dynamics and support efficient deployment of public health resources.
    MeSH term(s) Antitubercular Agents/pharmacology ; Antitubercular Agents/therapeutic use ; Cluster Analysis ; Extensively Drug-Resistant Tuberculosis/drug therapy ; Extensively Drug-Resistant Tuberculosis/epidemiology ; HIV ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; Humans ; Mycobacterium tuberculosis/genetics ; Pharmaceutical Preparations ; South Africa/epidemiology ; Tuberculosis, Multidrug-Resistant/drug therapy ; Tuberculosis, Multidrug-Resistant/epidemiology
    Chemical Substances Antitubercular Agents ; Pharmaceutical Preparations
    Language English
    Publishing date 2020-02-13
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciz913
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  7. Article: Opportunities and limitations of genomics for diagnosing bedaquiline-resistant tuberculosis: an individual isolate metaanalysis.

    Nimmo, Camus / Bionghi, Neda / Cummings, Matthew J / Perumal, Rubeshan / Hopson, Madeleine / Al Jubaer, Shamim / Wolf, Allison / Mathema, Barun / Larsen, Michelle H / O'Donnell, Max

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Background: Clinical bedaquiline resistance predominantly involves mutations in : Methods: We screened public databases for articles published until October 2022. Eligible studies performed sequencing of at least : Results: Eighteen eligible ... ...

    Abstract Background: Clinical bedaquiline resistance predominantly involves mutations in
    Methods: We screened public databases for articles published until October 2022. Eligible studies performed sequencing of at least
    Results: Eighteen eligible studies were identified, comprising 975
    Discussion: Sequencing candidate genes is insufficiently sensitive to diagnose clinical bedaquiline resistance, but where identified a limited number of mutations should be assumed to be associated with resistance. Genomic tools are most likely to be effective in combination with rapid phenotypic diagnostics.
    Language English
    Publishing date 2023-05-05
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.05.04.23289023
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  8. Article ; Online: Baseline and treatment-emergent bedaquiline resistance in drug-resistant tuberculosis: a systematic review and meta-analysis.

    Perumal, Rubeshan / Bionghi, Neda / Nimmo, Camus / Letsoalo, Marothi / Cummings, Matthew J / Hopson, Madeleine / Wolf, Allison / Jubaer, Shamim Al / Padayatchi, Nesri / Naidoo, Kogieleum / Larsen, Michelle H / O'Donnell, Max

    The European respiratory journal

    2023  Volume 62, Issue 6

    MeSH term(s) Humans ; Diarylquinolines/therapeutic use ; Tuberculosis, Multidrug-Resistant/drug therapy ; Antitubercular Agents/therapeutic use ; Mycobacterium tuberculosis
    Chemical Substances bedaquiline (78846I289Y) ; Diarylquinolines ; Antitubercular Agents
    Language English
    Publishing date 2023-12-14
    Publishing country England
    Document type Meta-Analysis ; Systematic Review ; Letter
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.00639-2023
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  9. Article: 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.
    Language English
    Publishing date 2023-06-09
    Publishing country United States
    Document type Preprint
    DOI 10.21203/rs.3.rs-2841179/v1
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  10. Article ; 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  Volume 24, Issue 1, Page(s) 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 term(s) 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
    Language English
    Publishing date 2023-12-01
    Publishing country England
    Document type 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
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