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  1. Article: Potential Utility of C-reactive Protein for Tuberculosis Risk Stratification among Patients with Non-Meningitic Symptoms at HIV Diagnosis in Low- and Middle-Income Countries.

    Dupnik, Kathryn / Rivera, Vanessa R / Dorvil, Nancy / Akbarnejad, Hanane / Gao, Yipeng / Liu, Jingyi / Apollon, Alexandra / Dumond, Emelyne / Riviere, Cynthia / Severe, Patrice / Lavoile, Kerlyne / Duran Mendicuti, Maria Alejandra / Pierre, Samuel / Rouzier, Vanessa / Walsh, Kathleen F / Byrne, Anthony L / Joseph, Patrice / Cremieux, Pierre-Yves / Pape, Jean William /
    Koenig, Serena P

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Article summary: We assessed the association between C-reactive protein (CRP) and : Background: The World Health Organization recommends initiating same-day ART while tuberculosis testing is underway for patients with non-meningitic symptoms at HIV ... ...

    Abstract Article summary: We assessed the association between C-reactive protein (CRP) and
    Background: The World Health Organization recommends initiating same-day ART while tuberculosis testing is underway for patients with non-meningitic symptoms at HIV diagnosis, though safety data are limited. C-reactive protein (CRP) testing may improve tuberculosis risk stratification in this population.
    Methods: In this baseline analysis of 498 adults (>18 years) with tuberculosis symptoms at HIV diagnosis who were enrolled in a trial of rapid ART initiation in Haiti, we describe test characteristics of varying CRP thresholds in the diagnosis of TB. We also assessed predictors of high CRP (≥3 mg/dL) using generalized linear models.
    Results: Eighty-seven (17.5%) patients were diagnosed with baseline TB. The median CRP was 33.0 mg/L (IQR: 5.1, 85.5) in those with TB, and 2.6 mg/L (IQR: 0.8, 11.7) in those without TB. As the CRP threshold increased from ≥1 mg/L to ≥10 mg/L, the positive predictive value for TB increased from 22.4% to 35.4%, and negative predictive value decreased from 96.9% to 92.3%. With CRP thresholds varying from <1 to <10 mg/L, a range from 25.5% to 64.9% of the cohort would have been eligible for same-day ART, and 0.8% to 5.0% would have untreated TB at ART initiation.
    Conclusions: CRP concentrations can be used to improve TB risk stratification, facilitating same-day decisions about ART initiation. Depending on the CRP threshold, one-quarter to two-thirds of patients could be eligible for same-day ART, with a reduction of 3-fold to 20-fold in the proportion with untreated TB, compared with a strategy of same-day ART while awaiting TB test results.
    Language English
    Publishing date 2023-12-20
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.12.19.23300232
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti.

    Dorvil, Nancy / Rivera, Vanessa R / Riviere, Cynthia / Berman, Richard / Severe, Patrice / Bang, Heejung / Lavoile, Kerlyne / Devieux, Jessy G / Faustin, Mikerlyne / Saintyl, Giovanni / Mendicuti, Maria Duran / Pierre, Samuel / Apollon, Alexandra / Dumond, Emelyne / Forestal, Guyrlaine Pierre Louis / Rouzier, Vanessa / Marcelin, Adias / McNairy, Margaret L / Walsh, Kathleen F /
    Dupnik, Kathryn / Reif, Lindsey K / Byrne, Anthony L / Bousleiman, Stephanie / Orvis, Eli / Joseph, Patrice / Cremieux, Pierre-Yves / Pape, Jean William / Koenig, Serena P

    PLoS medicine

    2023  Volume 20, Issue 6, Page(s) e1004246

    Abstract: Background: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment ...

    Abstract Background: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population.
    Methods and findings: We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.
    Conclusions: In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes.
    Trial registration: This study is registered with ClinicalTrials.gov NCT03154320.
    MeSH term(s) Adult ; Humans ; Anti-HIV Agents/therapeutic use ; Haiti/epidemiology ; HIV Infections/complications ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; Tuberculosis/complications ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy ; RNA
    Chemical Substances Anti-HIV Agents ; RNA (63231-63-0)
    Language English
    Publishing date 2023-06-09
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2185925-5
    ISSN 1549-1676 ; 1549-1277
    ISSN (online) 1549-1676
    ISSN 1549-1277
    DOI 10.1371/journal.pmed.1004246
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Association between intimate partner violence and HIV status among Haitian Women.

    Saxena, Anshul / Deschamps, Marie-Marcelle / Dorvil, Nancy / Christophe, Irdnie / Rosenberg, Rhonda / Jean-Gilles, Michèle / Koenig, Serena / Pape, Jean W / Dévieux, Jessy G

    Global public health

    2019  Volume 14, Issue 11, Page(s) 1557–1568

    Abstract: The prevalence of intimate partner violence (IPV) among women living in Haiti increased from 25% in 2006-29% in 2012, with escalating reports of crisis in the last several years. We examined the association between IPV and HIV status among these women in ...

    Abstract The prevalence of intimate partner violence (IPV) among women living in Haiti increased from 25% in 2006-29% in 2012, with escalating reports of crisis in the last several years. We examined the association between IPV and HIV status among these women in Haiti. Participants were drawn from a larger sample of women (
    MeSH term(s) Adolescent ; Adult ; Female ; HIV Infections ; Haiti ; Humans ; Intimate Partner Violence/trends ; Logistic Models ; Mental Health ; Middle Aged ; Self Report ; Young Adult
    Language English
    Publishing date 2019-04-18
    Publishing country England
    Document type Comparative Study ; Journal Article
    ZDB-ID 2234129-8
    ISSN 1744-1706 ; 1744-1692
    ISSN (online) 1744-1706
    ISSN 1744-1692
    DOI 10.1080/17441692.2019.1602156
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Mass Spectrometric Identification of Urinary Biomarkers of Pulmonary Tuberculosis.

    Isa, Flonza / Collins, Sean / Lee, Myung Hee / Decome, Diessy / Dorvil, Nancy / Joseph, Patrice / Smith, Lauren / Salerno, Stephen / Wells, Martin T / Fischer, Steven / Bean, James M / Pape, Jean W / Johnson, Warren D / Fitzgerald, Daniel W / Rhee, Kyu Y

    EBioMedicine

    2018  Volume 31, Page(s) 157–165

    Abstract: Background: Tuberculosis (TB) is the leading infectious cause of death worldwide. A major barrier to control of the pandemic is a lack of clinical biomarkers with the ability to distinguish active TB from healthy and sick controls and potential for ... ...

    Abstract Background: Tuberculosis (TB) is the leading infectious cause of death worldwide. A major barrier to control of the pandemic is a lack of clinical biomarkers with the ability to distinguish active TB from healthy and sick controls and potential for development into point-of-care diagnostics.
    Methods: We conducted a prospective case control study to identify candidate urine-based diagnostic biomarkers of active pulmonary TB (discovery cohort) and obtained a separate blinded "validation" cohort of confirmed cases of active pulmonary TB and controls with non-tuberculous pulmonary disease for validation. Clean-catch urine samples were collected and analyzed using high performance liquid chromatography-coupled time-of-flight mass spectrometry.
    Results: We discovered ten molecules from the discovery cohort with receiver-operator characteristic (ROC) area-under-the-curve (AUC) values >85%. These 10 molecules also significantly decreased after 60 days of treatment in a subset of 20 participants followed over time. Of these, a specific combination of diacetylspermine, neopterin, sialic acid, and N-acetylhexosamine exhibited ROC AUCs >80% in a blinded validation cohort of participants with active TB and non-tuberculous pulmonary disease.
    Conclusion: Urinary levels of diacetylspermine, neopterin, sialic acid, and N-acetylhexosamine distinguished patients with tuberculosis from healthy controls and patients with non-tuberculous pulmonary diseases, providing a potential noninvasive biosignature of active TB.
    Funding: This study was funded by Weill Cornell Medicine, the National Institute of Allergy and Infectious Diseases, the Clinical and Translational Science Center at Weill Cornell, the NIH Fogarty International Center grants, and the NIH Tuberculosis Research Unit (Tri-I TBRU).
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biomarkers/urine ; Humans ; Mass Spectrometry ; Middle Aged ; Tuberculosis, Pulmonary/urine
    Chemical Substances Biomarkers
    Language English
    Publishing date 2018-04-22
    Publishing country Netherlands
    Document type Clinical Trial ; Journal Article ; Multicenter Study
    ZDB-ID 2851331-9
    ISSN 2352-3964
    ISSN (online) 2352-3964
    DOI 10.1016/j.ebiom.2018.04.014
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

    Koenig, Serena P / Dorvil, Nancy / Dévieux, Jessy G / Hedt-Gauthier, Bethany L / Riviere, Cynthia / Faustin, Mikerlyne / Lavoile, Kerlyne / Perodin, Christian / Apollon, Alexandra / Duverger, Limathe / McNairy, Margaret L / Hennessey, Kelly A / Souroutzidis, Ariadne / Cremieux, Pierre-Yves / Severe, Patrice / Pape, Jean W

    PLoS medicine

    2017  Volume 14, Issue 7, Page(s) e1002357

    Abstract: Background: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.: Methods and findings: We ...

    Abstract Background: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.
    Methods and findings: We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.
    Conclusions: Same-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease.
    Trial registration: This study is registered with ClinicalTrials.gov number NCT01900080.
    MeSH term(s) Adult ; Anti-HIV Agents/therapeutic use ; Communicable Disease Control/methods ; Female ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; Haiti ; Humans ; Male ; Middle Aged ; Time Factors
    Chemical Substances Anti-HIV Agents
    Language English
    Publishing date 2017-07
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2185925-5
    ISSN 1549-1676 ; 1549-1277
    ISSN (online) 1549-1676
    ISSN 1549-1277
    DOI 10.1371/journal.pmed.1002357
    Database MEDical Literature Analysis and Retrieval System OnLINE

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