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      Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa

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          Abstract

          Background

          Community-based GeneXpert MTB/RIF testing may increase detection of prevalent TB in the community and improve rates of TB treatment completion.

          Methods

          We conducted a pilot randomized trial to evaluate the impact of GeneXpert screening on a mobile HIV testing unit. Adults (≥18y) underwent rapid HIV testing and TB symptom screening and were randomized to usual mobile unit care (providing sputum on the mobile unit sent out for GeneXpert testing) or the “Test & Treat TB” intervention with immediate GeneXpert testing. Symptomatic participants in usual care produced sputum that was sent for hospital-based GeneXpert testing; participants were contacted ~ 7 days later with results. In the “Test & Treat TB” intervention, HIV-infected or HIV-uninfected/TB symptomatic participants underwent GeneXpert testing on the mobile unit. GeneXpert+ participants received expedited TB treatment initiation, monthly SMS reminders and non-cash incentives. We assessed 6-month TB treatment outcomes.

          Results

          4815 were eligible and enrolled; median age was 27 years (IQR 22 to 35). TB symptoms included cough (5%), weight loss (4%), night sweats (4%), and fever (3%). 42% of eligible participants produced sputum (intervention: 56%; usual care: 26%). Seven participants tested GeneXpert+, six in the intervention (3%, 95% CI 1%, 5%) and one in usual care (1%, 95% CI 0%, 6%). 5 of 6 intervention participants completed TB treatment; the GeneXpert+ participant in usual care did not.

          Conclusion

          GeneXpert MTB/RIF screening on a mobile HIV testing unit is feasible. Yield for GeneXpert+ TB was low, however, the “Test & Treat TB” strategy led to high rates of TB treatment completion.

          Trial registration

          This study was registered on November 21, 2014 at ClinicalTrials.gov ( NCT02298309).

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          Most cited references14

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          Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

          An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.
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            Early mortality among adults accessing a community-based antiretroviral service in South Africa: implications for programme design.

            To determine rates, risk factors and causes of death among patients accessing a community-based antiretroviral treatment (ART) programme both prior to and following initiation of treatment. All in-programme deaths were ascertained between September 2002 and March 2005 among treatment-naive patients enrolled into a prospective community-based ART cohort in Cape Town, South Africa. Of 712 patients (median CD4 cell count, 94 cells/microl), 578 (81%) started triple ART a median of 29 days after enrollment. 68 (9.5%) patients died during 563 person-years of observation. The high pretreatment mortality rate of 35.6 deaths/100 person-years [95% confidence interval (CI), 23.0-55.1) decreased to 2.5/100 person-years (95% CI, 0.9-6.6) at 1 year among those who received ART. However, within the first 90 days from enrollment, 29 of 44 (66%) deaths occurred among patients awaiting ART; these would not be identified by an on-treatment analysis. Multivariate analysis showed that risk of death (both pre-treatment and on-treatment) was independently associated with baseline CD4 cell count and World Health Organization (WHO) clinical stage; stage 4 disease was the strongest risk factor. Major attributed causes of death were wasting syndrome, tuberculosis, acute bacterial infections, malignancy and immune reconstitution disease. Most early in-programme deaths occurred among patients with advanced immunodeficiency but who had not yet started ART. Programme evaluation using on-treatment analyses greatly underestimated early mortality. This mortality would be reduced by minimizing unnecessary in-programme delays in treatment initiation and by starting ART before development of WHO stage 4 disease.
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              Leveraging Rapid Community-Based HIV Testing Campaigns for Non-Communicable Diseases in Rural Uganda

              Background The high burden of undiagnosed HIV in sub-Saharan Africa limits treatment and prevention efforts. Community-based HIV testing campaigns can address this challenge and provide an untapped opportunity to identify non-communicable diseases (NCDs). We tested the feasibility and diagnostic yield of integrating NCD and communicable diseases into a rapid HIV testing and referral campaign for all residents of a rural Ugandan parish. Methods A five-day, multi-disease campaign, offering diagnostic, preventive, treatment and referral services, was performed in May 2011. Services included point-of-care screening for HIV, malaria, TB, hypertension and diabetes. Finger-prick diagnostics eliminated the need for phlebotomy. HIV-infected adults met clinic staff and peer counselors on-site; those with CD4≤100/µL underwent intensive counseling and rapid referral for antiretroviral therapy (ART). Community participation, case-finding yield, and linkage to care three months post-campaign were analyzed. Results Of 6,300 residents, 2,323/3,150 (74%) adults and 2,020/3,150 (69%) children participated. An estimated 95% and 52% of adult female and male residents participated respectively. Adult HIV prevalence was 7.8%, with 46% of HIV-infected adults newly diagnosed. Thirty-nine percent of new HIV diagnoses linked to care. In a pilot subgroup with CD4≤100, 83% linked and started ART within 10 days. Malaria was identified in 10% of children, and hypertension and diabetes in 28% and 3.5% of adults screened, respectively. Sixty-five percent of hypertensives and 23% of diabetics were new diagnoses, of which 43% and 61% linked to care, respectively. Screening identified suspected TB in 87% of HIV-infected and 19% of HIV-uninfected adults; 52% percent of HIV-uninfected TB suspects linked to care. Conclusions In an integrated campaign engaging 74% of adult residents, we identified a high burden of undiagnosed HIV, hypertension and diabetes. Improving male attendance and optimizing linkage to care require new approaches. The campaign demonstrates the feasibility of integrating hypertension, diabetes and communicable diseases into HIV initiatives.
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                Author and article information

                Contributors
                +1 617 726 0637 , ibassett@partners.org
                lsforman@bu.edu
                Sabina.Govere@aidshealth.org
                Hilary.Thulare@aidshealth.org
                scfrank@partners.org
                sigwili@msn.com
                elosina@bwh.harvard.edu
                Journal
                BMC Infect Dis
                BMC Infect. Dis
                BMC Infectious Diseases
                BioMed Central (London )
                1471-2334
                4 February 2019
                4 February 2019
                2019
                : 19
                : 110
                Affiliations
                [1 ]ISNI 0000 0004 0386 9924, GRID grid.32224.35, Division of Infectious Disease, , Massachusetts General Hospital, ; Boston, MA USA
                [2 ]ISNI 0000 0004 0386 9924, GRID grid.32224.35, Medical Practice Evaluation Center, Department of Medicine, , Massachusetts General Hospital, ; 100 Cambridge Street, 16th Floor, Boston, MA 02114 USA
                [3 ]Harvard University Center for AIDS Research (CFAR), Boston, MA USA
                [4 ]ISNI 000000041936754X, GRID grid.38142.3c, Harvard Medical School, ; Boston, MA USA
                [5 ]ISNI 0000 0004 1936 7558, GRID grid.189504.1, Data Coordinating Center, , Boston University School of Public Health, ; Boston, MA USA
                [6 ]GRID grid.490744.a, AIDS Healthcare Foundation, ; Durban, South Africa
                [7 ]ISNI 0000 0004 0386 9924, GRID grid.32224.35, Division of General Internal Medicine, , Massachusetts General Hospital, ; Boston, MA USA
                [8 ]ISNI 0000 0004 1936 7558, GRID grid.189504.1, Department of Biostatistics, , Boston University School of Public Health, ; Boston, MA USA
                [9 ]ISNI 0000 0004 0378 8294, GRID grid.62560.37, Division of Rheumatology, Department of Medicine, and Department of Orthopedic Surgery, , Brigham and Women’s Hospital, ; Boston, MA USA
                Author information
                http://orcid.org/0000-0001-6920-6080
                Article
                3738
                10.1186/s12879-019-3738-4
                6360783
                30717693
                6aef450c-1f23-48b5-8711-adcb9152849a
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 18 January 2018
                : 23 January 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
                Award ID: R21 AI110264-01A1
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Infectious disease & Microbiology
                tuberculosis,test & treat,genexpert mtb/rif,community-based screening

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