Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
1719 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-11-16
Study Completion Date
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
HIV-infected people have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among people living with HIV (PLHIV), the World Health Organization (WHO) recommends systematic TB screening followed by 1) confirmatory TB testing for all those who screen positive and 2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative.
The objective of the TB Screening Improves Preventive Therapy Uptake (TB SCRIPT) trial is to determine whether TB screening based on C-reactive protein (CRP) levels, measured using a rapid and low-cost point-of-care (POC) assay, improves TPT uptake and clinical outcomes of PLHIV, relative to symptom-based TB screening.
The objective of the TB Screening Improves Preventive Therapy Uptake (TB SCRIPT) trial is to determine whether TB screening based on C-reactive protein (CRP) levels, measured using a rapid and low-cost point-of-care (POC) assay, improves TPT uptake and clinical outcomes of PLHIV, relative to symptom-based TB screening.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
NCT00763295
Latent Tuberculosis
HIV Infections
COMPLETED
Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
NCT03492216
HIV/AIDS
Tuberculosis
COMPLETED
NA
Screening of Children in Household Contact With Adult TB Patients in Mbarara Hospital, Uganda
NCT01492595
Tuberculosis
COMPLETED
SMF to Improve Performance of Microscopy for the Diagnosis of PTB in a High HIV Prevalence Setting
NCT02701439
Tuberculosis
COMPLETED
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
NCT03044158
Tuberculosis, Pulmonary
Rifampicin Resistant Tuberculosis
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The overall objective of the TB SCRIPT trial is to evaluate the effectiveness and cost-effectiveness of POC CRP-based TB screening, which is the next step required for successful scale-up of both systematic TB screening and TPT. The study's central hypothesis is that compared to symptom-based TB screening, a TB screening strategy based on CRP levels measured at the point-of-care will improve TPT uptake, thereby reducing TB incidence and its associated mortality among PLHIV.
To test this hypothesis, the investigators will conduct an individual randomized control trial enrolling PLHIV presenting to clinics in Uganda for routine antiretroviral therapy (ART) initiation. Eligible participants will be randomized to either POC CRP-based TB screening (intervention arm) or symptom-based TB screening (control arm). In both arms, screen-positive participants will undergo confirmatory TB testing; participants found to have prevalent TB will be initiated on standard TB treatment. In both arms, screen-negative participants will be assessed for TPT eligibility; TPT-eligible participants will be initiated on standard TPT. All participants will be followed for 2 years.
To test this hypothesis, the investigators will conduct an individual randomized control trial enrolling PLHIV presenting to clinics in Uganda for routine antiretroviral therapy (ART) initiation. Eligible participants will be randomized to either POC CRP-based TB screening (intervention arm) or symptom-based TB screening (control arm). In both arms, screen-positive participants will undergo confirmatory TB testing; participants found to have prevalent TB will be initiated on standard TB treatment. In both arms, screen-negative participants will be assessed for TPT eligibility; TPT-eligible participants will be initiated on standard TPT. All participants will be followed for 2 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Tuberculosis
Latent Tuberculosis
Tuberculosis Prevention
HIV
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SCREENING
Blinding Strategy
DOUBLE
Participants
Investigators
Masking will be maintained by administering finger prick tests to all participants, irrespective of trial arm. Intervention arm participants will have CRP levels measured from blood obtained by finger prick. Control arm participants will have beta-human chorionic gonadotropin (beta-hCG) levels measured from blood obtained by finger prick.
Only participants, study investigators and routine clinical care providers will be masked. Study staff performing TB screening in accordance with the participant's randomization assignment and activities downstream of TB screening (i.e., confirmatory TB testing, TPT eligibility assessment) will not be masked. The database administrator will have access to the randomized assignments.
Only participants, study investigators and routine clinical care providers will be masked. Study staff performing TB screening in accordance with the participant's randomization assignment and activities downstream of TB screening (i.e., confirmatory TB testing, TPT eligibility assessment) will not be masked. The database administrator will have access to the randomized assignments.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
POC CRP-based TB screening
Participants randomized to the intervention arm will undergo POC CRP-based TB screening at study entry. Participants with elevated POC CRP levels (≥8 mg/L) will be regarded as screen-positive and will be referred for confirmatory TB testing. Participants with non-elevated POC CRP levels (\<8 mg/L) will be regarded as screen-negative and will be assessed for TPT eligibility.
Group Type
EXPERIMENTAL
CRP, point-of-care assay
Intervention Type
DEVICE
CRP is a non-specific marker of inflammation whose levels rise in the setting of interleukin 6 (IL-6)-mediated inflammation, such as active TB. In clinical settings, CRP is used to identify patients with systemic inflammation from infection or non-infectious cases. In settings with high TB prevalence, the investigators hypothesize that CRP can be used to accurately screen individuals for active TB (i.e., distinguish individuals with high likelihood of having active TB from those individuals unlikely to have active TB).
Symptom-based TB screening
Participants randomized to the control arm will undergo symptom-based TB screening at study entry. Participants reporting ≥1 TB symptom (current cough, fever, night sweats, weight loss) will be regarded as screen-positive and will be referred for confirmatory TB testing, in accordance with WHO guidelines. Participants with none of the 4 TB symptoms will be regarded as screen-negative and will be assessed for TPT eligibility.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRP, point-of-care assay
CRP is a non-specific marker of inflammation whose levels rise in the setting of interleukin 6 (IL-6)-mediated inflammation, such as active TB. In clinical settings, CRP is used to identify patients with systemic inflammation from infection or non-infectious cases. In settings with high TB prevalence, the investigators hypothesize that CRP can be used to accurately screen individuals for active TB (i.e., distinguish individuals with high likelihood of having active TB from those individuals unlikely to have active TB).
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
iCHROMA CRP reader
Boditech Med Inc.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
* Confirmed HIV+ test result
* CD4 T lymphocyte count of ≤ 350 cells/μL
* Capacity to provide written (or witnessed verbal, if illiterate) informed consent
* Confirmed HIV+ test result
* CD4 T lymphocyte count of ≤ 350 cells/μL
* Capacity to provide written (or witnessed verbal, if illiterate) informed consent
Exclusion Criteria
* Completed treatment for active pulmonary or extra-pulmonary TB within the past 2 years
* Completed a full course of TPT within the past year
* Actively taking any internationally-approved medication for TB treatment for any reason, within 2 weeks of study entry
* Prior history of combined ART for HIV treatment for any duration (does not include single-dose ART for prevention of vertical transmission of HIV)
* Currently resides 25 km outside their enrollment site, plans to move 25 km outside their enrollment site in the next 2 years, or plans to transfer their HIV care from their current enrollment site
* Completed a full course of TPT within the past year
* Actively taking any internationally-approved medication for TB treatment for any reason, within 2 weeks of study entry
* Prior history of combined ART for HIV treatment for any duration (does not include single-dose ART for prevention of vertical transmission of HIV)
* Currently resides 25 km outside their enrollment site, plans to move 25 km outside their enrollment site in the next 2 years, or plans to transfer their HIV care from their current enrollment site
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Makerere University
OTHER
Sponsor Role
collaborator
Infectious Diseases Research Collaboration, Uganda
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
collaborator
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christina Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kampala Capital City Authority Clinic
Kampala, , Uganda
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Uganda
References
Explore related publications, articles, or registry entries linked to this study.
WHO. Global Tuberculosis Report 2017. Geneva, Switzerland. World Health Organization 2017.
Reference Type
BACKGROUND
Durovni B, Saraceni V, Moulton LH, Pacheco AG, Cavalcante SC, King BS, Cohn S, Efron A, Chaisson RE, Golub JE. Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial. Lancet Infect Dis. 2013 Oct;13(10):852-8. doi: 10.1016/S1473-3099(13)70187-7. Epub 2013 Aug 16.
Reference Type
BACKGROUND
TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
Reference Type
BACKGROUND
Rangaka MX, Wilkinson RJ, Boulle A, Glynn JR, Fielding K, van Cutsem G, Wilkinson KA, Goliath R, Mathee S, Goemaere E, Maartens G. Isoniazid plus antiretroviral therapy to prevent tuberculosis: a randomised double-blind, placebo-controlled trial. Lancet. 2014 Aug 23;384(9944):682-90. doi: 10.1016/S0140-6736(14)60162-8. Epub 2014 May 13.
Reference Type
BACKGROUND
Grant AD, Charalambous S, Fielding KL, Day JH, Corbett EL, Chaisson RE, De Cock KM, Hayes RJ, Churchyard GJ. Effect of routine isoniazid preventive therapy on tuberculosis incidence among HIV-infected men in South Africa: a novel randomized incremental recruitment study. JAMA. 2005 Jun 8;293(22):2719-25. doi: 10.1001/jama.293.22.2719.
Reference Type
BACKGROUND
Churchyard GJ, Fielding KL, Lewis JJ, Coetzee L, Corbett EL, Godfrey-Faussett P, Hayes RJ, Chaisson RE, Grant AD; Thibela TB Study Team. A trial of mass isoniazid preventive therapy for tuberculosis control. N Engl J Med. 2014 Jan 23;370(4):301-10. doi: 10.1056/NEJMoa1214289.
Reference Type
BACKGROUND
WHO. Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. Geneva, Switzerland. World Health Organization 2011.
Reference Type
BACKGROUND
Latent tuberculosis infection: updated and consolidated guidelines for programmatic management [Internet]. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK531235/
Reference Type
BACKGROUND
Getahun H, Kittikraisak W, Heilig CM, Corbett EL, Ayles H, Cain KP, Grant AD, Churchyard GJ, Kimerling M, Shah S, Lawn SD, Wood R, Maartens G, Granich R, Date AA, Varma JK. Development of a standardized screening rule for tuberculosis in people living with HIV in resource-constrained settings: individual participant data meta-analysis of observational studies. PLoS Med. 2011 Jan 18;8(1):e1000391. doi: 10.1371/journal.pmed.1000391.
Reference Type
BACKGROUND
WHO. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva, Switzerland. World Health Organization 2014.
Reference Type
BACKGROUND
Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, Bekker LG, Wood R. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011 Jul;8(7):e1001067. doi: 10.1371/journal.pmed.1001067. Epub 2011 Jul 26.
Reference Type
BACKGROUND
Kufa T, Mngomezulu V, Charalambous S, Hanifa Y, Fielding K, Grant AD, Wada N, Chaisson RE, Churchyard GJ, Gounder CR. Undiagnosed tuberculosis among HIV clinic attendees: association with antiretroviral therapy and implications for intensified case finding, isoniazid preventive therapy, and infection control. J Acquir Immune Defic Syndr. 2012 Jun 1;60(2):e22-8. doi: 10.1097/QAI.0b013e318251ae0b.
Reference Type
BACKGROUND
Swindells S, Komarow L, Tripathy S, Cain KP, MacGregor RR, Achkar JM, Gupta A, Veloso VG, Asmelash A, Omoz-Oarhe AE, Gengiah S, Lalloo U, Allen R, Shiboski C, Andersen J, Qasba SS, Katzenstein DK; AIDS Clinical Trials Group 5253 Study Team. Screening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group Protocol A5253. Int J Tuberc Lung Dis. 2013 Apr;17(4):532-9. doi: 10.5588/ijtld.12.0737.
Reference Type
BACKGROUND
Henostroza G, Harris JB, Chitambi R, Siyambango M, Turnbull ER, Maggard KR, Kruuner A, Kapata N, Reid SE. High prevalence of tuberculosis in newly enrolled HIV patients in Zambia: need for enhanced screening approach. Int J Tuberc Lung Dis. 2016 Aug;20(8):1033-9. doi: 10.5588/ijtld.15.0651.
Reference Type
BACKGROUND
DERBES VJ, JACOBS S, LINN RH, TURNER M, WALSH JJ. C-reactive protein in pulmonary tuberculosis. Am Rev Tuberc. 1956 Sep;74(3):464-7. doi: 10.1164/artpd.1956.74.3.464. No abstract available.
Reference Type
BACKGROUND
Ganter U, Arcone R, Toniatti C, Morrone G, Ciliberto G. Dual control of C-reactive protein gene expression by interleukin-1 and interleukin-6. EMBO J. 1989 Dec 1;8(12):3773-9. doi: 10.1002/j.1460-2075.1989.tb08554.x.
Reference Type
BACKGROUND
Ogawa T, Uchida H, Kusumoto Y, Mori Y, Yamamura Y, Hamada S. Increase in tumor necrosis factor alpha- and interleukin-6-secreting cells in peripheral blood mononuclear cells from subjects infected with Mycobacterium tuberculosis. Infect Immun. 1991 Sep;59(9):3021-5. doi: 10.1128/iai.59.9.3021-3025.1991.
Reference Type
BACKGROUND
Saunders R, Robson S, Soule S, Kirsch RE. Secretion of interleukin-6 by peripheral blood mononuclear cells from patients with pulmonary tuberculosis and their contacts. J Clin Lab Immunol. 1993;40(1):19-28.
Reference Type
BACKGROUND
Flesch IE, Kaufmann SH. Role of cytokines in tuberculosis. Immunobiology. 1993 Nov;189(3-4):316-39. doi: 10.1016/S0171-2985(11)80364-5.
Reference Type
BACKGROUND
Weinhold B, Ruther U. Interleukin-6-dependent and -independent regulation of the human C-reactive protein gene. Biochem J. 1997 Oct 15;327 ( Pt 2)(Pt 2):425-9. doi: 10.1042/bj3270425.
Reference Type
BACKGROUND
Gabay C, Kushner I. Acute-phase proteins and other systemic responses to inflammation. N Engl J Med. 1999 Feb 11;340(6):448-54. doi: 10.1056/NEJM199902113400607. No abstract available.
Reference Type
BACKGROUND
Lawn SD, Wiktor S, Coulibaly D, Ackah AN, Lal RB. Serum C-reactive protein and detection of tuberculosis in persons co-infected with the human immunodeficiency virus. Trans R Soc Trop Med Hyg. 2001 Jan-Feb;95(1):41-2. doi: 10.1016/s0035-9203(01)90328-1. No abstract available.
Reference Type
BACKGROUND
Kihara M, Kamakura M, Feldman MD. Introduction: HIV/AIDS surveillance in a new era. J Acquir Immune Defic Syndr. 2003 Feb;32 Suppl 1:S1-2. doi: 10.1097/00126334-200302011-00001. No abstract available.
Reference Type
BACKGROUND
Drain PK, Kupka R, Msamanga GI, Urassa W, Mugusi F, Fawzi WW. C-reactive protein independently predicts HIV-related outcomes among women and children in a resource-poor setting. AIDS. 2007 Oct 1;21(15):2067-75. doi: 10.1097/QAD.0b013e32826fb6c7.
Reference Type
BACKGROUND
Kuller LH, Tracy R, Belloso W, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. PLoS Med. 2008 Oct 21;5(10):e203. doi: 10.1371/journal.pmed.0050203.
Reference Type
BACKGROUND
Tien PC, Schneider MF, Cox C, Cohen M, Karim R, Lazar J, Young M, Glesby MJ. HIV, HAART, and lipoprotein particle concentrations in the Women's Interagency HIV Study. AIDS. 2010 Nov 27;24(18):2809-17. doi: 10.1097/QAD.0b013e32833fcb3b.
Reference Type
BACKGROUND
Neuhaus J, Jacobs DR Jr, Baker JV, Calmy A, Duprez D, La Rosa A, Kuller LH, Pett SL, Ristola M, Ross MJ, Shlipak MG, Tracy R, Neaton JD. Markers of inflammation, coagulation, and renal function are elevated in adults with HIV infection. J Infect Dis. 2010 Jun 15;201(12):1788-95. doi: 10.1086/652749.
Reference Type
BACKGROUND
Shikuma CM, Ribaudo HJ, Zheng Y, Gulick RM, Meyer WA, Tashima KT, Bastow B, Kuritzkes DR, Glesby MJ; AIDS Clinical Trials Group A5095 Study Team. Change in high-sensitivity c-reactive protein levels following initiation of efavirenz-based antiretroviral regimens in HIV-infected individuals. AIDS Res Hum Retroviruses. 2011 May;27(5):461-8. doi: 10.1089/aid.2010.0154. Epub 2010 Nov 23.
Reference Type
BACKGROUND
Lawn SD, Obeng J, Acheampong JW, Griffin GE. Resolution of the acute-phase response in West African patients receiving treatment for pulmonary tuberculosis. Int J Tuberc Lung Dis. 2000 Apr;4(4):340-4.
Reference Type
BACKGROUND
Polzin A, Pletz M, Erbes R, Raffenberg M, Mauch H, Wagner S, Arndt G, Lode H. Procalcitonin as a diagnostic tool in lower respiratory tract infections and tuberculosis. Eur Respir J. 2003 Jun;21(6):939-43. doi: 10.1183/09031936.03.00055103.
Reference Type
BACKGROUND
Schleicher GK, Herbert V, Brink A, Martin S, Maraj R, Galpin JS, Feldman C. Procalcitonin and C-reactive protein levels in HIV-positive subjects with tuberculosis and pneumonia. Eur Respir J. 2005 Apr;25(4):688-92. doi: 10.1183/09031936.05.00067604.
Reference Type
BACKGROUND
Choi CM, Kang CI, Jeung WK, Kim DH, Lee CH, Yim JJ. Role of the C-reactive protein for the diagnosis of TB among military personnel in South Korea. Int J Tuberc Lung Dis. 2007 Feb;11(2):233-6.
Reference Type
BACKGROUND
Breen RA, Leonard O, Perrin FM, Smith CJ, Bhagani S, Cropley I, Lipman MC. How good are systemic symptoms and blood inflammatory markers at detecting individuals with tuberculosis? Int J Tuberc Lung Dis. 2008 Jan;12(1):44-9.
Reference Type
BACKGROUND
Kang YA, Kwon SY, Yoon HI, Lee JH, Lee CT. Role of C-reactive protein and procalcitonin in differentiation of tuberculosis from bacterial community acquired pneumonia. Korean J Intern Med. 2009 Dec;24(4):337-42. doi: 10.3904/kjim.2009.24.4.337. Epub 2009 Nov 27.
Reference Type
BACKGROUND
Sage EK, Noursadeghi M, Evans HE, Parker SJ, Copas AJ, Edwards SG, Miller RF. Prognostic value of C-reactive protein in HIV-infected patients with Pneumocystis jirovecii pneumonia. Int J STD AIDS. 2010 Apr;21(4):288-92. doi: 10.1258/ijsa.2010.009551.
Reference Type
BACKGROUND
Wilson D, Badri M, Maartens G. Performance of serum C-reactive protein as a screening test for smear-negative tuberculosis in an ambulatory high HIV prevalence population. PLoS One. 2011 Jan 10;6(1):e15248. doi: 10.1371/journal.pone.0015248.
Reference Type
BACKGROUND
Lawn SD, Kerkhoff AD, Vogt M, Wood R. Diagnostic and prognostic value of serum C-reactive protein for screening for HIV-associated tuberculosis. Int J Tuberc Lung Dis. 2013 May;17(5):636-43. doi: 10.5588/ijtld.12.0811.
Reference Type
BACKGROUND
Yoon C, Davis JL, Huang L, Muzoora C, Byakwaga H, Scibetta C, Bangsberg DR, Nahid P, Semitala FC, Hunt PW, Martin JN, Cattamanchi A. Point-of-care C-reactive protein testing to facilitate implementation of isoniazid preventive therapy for people living with HIV. J Acquir Immune Defic Syndr. 2014 Apr 15;65(5):551-6. doi: 10.1097/QAI.0000000000000085.
Reference Type
BACKGROUND
Yoon C, Chaisson LH, Patel SM, Allen IE, Drain PK, Wilson D, Cattamanchi A. Diagnostic accuracy of C-reactive protein for active pulmonary tuberculosis: a meta-analysis. Int J Tuberc Lung Dis. 2017 Sep 1;21(9):1013-1019. doi: 10.5588/ijtld.17.0078.
Reference Type
BACKGROUND
Shapiro AE, Hong T, Govere S, Thulare H, Moosa MY, Dorasamy A, Wallis CL, Celum CL, Grosset J, Drain PK. C-reactive protein as a screening test for HIV-associated pulmonary tuberculosis prior to antiretroviral therapy in South Africa. AIDS. 2018 Aug 24;32(13):1811-1820. doi: 10.1097/QAD.0000000000001902.
Reference Type
BACKGROUND
Yoon C, Semitala FC, Atuhumuza E, Katende J, Mwebe S, Asege L, Armstrong DT, Andama AO, Dowdy DW, Davis JL, Huang L, Kamya M, Cattamanchi A. Point-of-care C-reactive protein-based tuberculosis screening for people living with HIV: a diagnostic accuracy study. Lancet Infect Dis. 2017 Dec;17(12):1285-1292. doi: 10.1016/S1473-3099(17)30488-7. Epub 2017 Aug 25.
Reference Type
BACKGROUND
Yoon C, Semitala FC, Asege L, Katende J, Mwebe S, Andama AO, Atuhumuza E, Nakaye M, Armstrong DT, Dowdy DW, McCulloch CE, Kamya M, Cattamanchi A. Yield and Efficiency of Novel Intensified Tuberculosis Case-Finding Algorithms for People Living with HIV. Am J Respir Crit Care Med. 2019 Mar 1;199(5):643-650. doi: 10.1164/rccm.201803-0490OC.
Reference Type
BACKGROUND
Rajan JV, Semitala FC, Mehta T, Seielstad M, Montalvo L, Andama A, Asege L, Nakaye M, Katende J, Mwebe S, Kamya MR, Yoon C, Cattamanchi A. A Novel, 5-Transcript, Whole-blood Gene-expression Signature for Tuberculosis Screening Among People Living With Human Immunodeficiency Virus. Clin Infect Dis. 2019 Jun 18;69(1):77-83. doi: 10.1093/cid/ciy835.
Reference Type
BACKGROUND
Chaisson LH, Semitala FC, Asege L, Mwebe S, Katende J, Nakaye M, Andama AO, Marquez C, Atuhumuza E, Kamya M, Cattamanchi A, Yoon C. Point-of-care C-reactive protein and risk of early mortality among adults initiating antiretroviral therapy. AIDS. 2019 Apr 1;33(5):895-902. doi: 10.1097/QAD.0000000000002130.
Reference Type
BACKGROUND
Semitala FC, Cattamanchi A, Andama A, Atuhumuza E, Katende J, Mwebe S, Asege L, Nakaye M, Kamya MR, Yoon C. Brief Report: Yield and Efficiency of Intensified Tuberculosis Case-Finding Algorithms in 2 High-Risk HIV Subgroups in Uganda. J Acquir Immune Defic Syndr. 2019 Dec 1;82(4):416-420. doi: 10.1097/QAI.0000000000002162.
Reference Type
BACKGROUND
Uganda Ministry of Health. Report on the Population-based survey of prevalence of tuberculosis disease in Uganda 2014-2015. Kampala: MOH, 2017.
Reference Type
BACKGROUND
PEPFAR Uganda Program data. (https://www.pepfar.gov/documents/organization/285851.)
Reference Type
BACKGROUND
Yung-Pin C. Biased coin design with imbalance tolerance. Stochastic Models. 1999 Jan 1;15(5):953-75. doi: 10.1080/15326349908807570
Reference Type
BACKGROUND
Pfafflin A, Schleicher E. Inflammation markers in point-of-care testing (POCT). Anal Bioanal Chem. 2009 Mar;393(5):1473-80. doi: 10.1007/s00216-008-2561-3. Epub 2008 Dec 23.
Reference Type
BACKGROUND
Claus DR, Osmand AP, Gewurz H. Radioimmunoassay of human C-reactive protein and levels in normal sera. J Lab Clin Med. 1976 Jan;87(1):120-8.
Reference Type
BACKGROUND
Gupta A, Montepiedra G, Aaron L, Theron G, McCarthy K, Bradford S, Chipato T, Vhembo T, Stranix-Chibanda L, Onyango-Makumbi C, Masheto GR, Violari A, Mmbaga BT, Aurpibul L, Bhosale R, Mave V, Rouzier V, Hesseling A, Shin K, Zimmer B, Costello D, Sterling TR, Chakhtoura N, Jean-Philippe P, Weinberg A; IMPAACT P1078 TB APPRISE Study Team. Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. N Engl J Med. 2019 Oct 3;381(14):1333-1346. doi: 10.1056/NEJMoa1813060.
Reference Type
BACKGROUND
Uganda Ministry of Health. Isoniazid preventive therapy in Uganda: a health worker's guide. Kampala: MOH, 2014.
Reference Type
BACKGROUND
Semitala FC, Chaisson LH, Dowdy DW, Armstrong DT, Opira B, Aman K, Kamya M, Phillips PPJ, Yoon C. Tuberculosis screening improves preventive therapy uptake (TB SCRIPT) trial among people living with HIV in Uganda: a study protocol of an individual randomized controlled trial. Trials. 2022 May 12;23(1):399. doi: 10.1186/s13063-022-06371-0.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-25623
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
NCT01622140
COMPLETED
Tuberculosis Prevention for HIV Infected Adults
NCT00057122
COMPLETED
PHASE3
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
NCT05007795
NOT_YET_RECRUITING
NA
Improving the Diagnostic of Tuberculosis
NCT02861768
COMPLETED
NA
Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB
NCT03350048
COMPLETED
Clinic-based Versus Hotspot-focused Active TB Case Finding
NCT05285202
RECRUITING
NA
Testing for Tuberculosis in the United Kingdom HIV Infected Population
NCT02712671
UNKNOWN
Chepetsa TB - Reducing TB Among HIV-Infected Malawians
NCT01450085
COMPLETED
NA
Assessing Diagnostics At Point-of-care for Tuberculosis
NCT05941052
RECRUITING
NA
Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
NCT00647205
COMPLETED
PHASE4
Detection of Mycobacterium Tuberculosis in Blood of TB Patients and Their Contacts in Uganda
NCT06751706
ENROLLING_BY_INVITATION
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
NCT00805272
COMPLETED
NA
Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB
NCT04752592
COMPLETED
NA
Utility of Sputum Induction and Novel Technologies to Improve TB Diagnosis in a High HIV Prevalence Primary Care Setting
NCT01545661
COMPLETED
NA
Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy
NCT03982277
COMPLETED
PHASE2
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
NCT04494516
COMPLETED
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
NCT02057796
COMPLETED
PHASE4
Evaluation of an Innovative Tuberculosis Diagnostic Test
NCT02573623
UNKNOWN
A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi
NCT03519425
UNKNOWN
NA
Tuberculosis Prophylaxis in the Homeless--A Controlled Trial
NCT00005737
COMPLETED
Host Blood RNA Signatures for Diagnosis of TB
NCT05542511
ACTIVE_NOT_RECRUITING
Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
NCT03074799
COMPLETED
NA
Start Taking Action For TB Diagnosis
NCT05845112
COMPLETED
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People
NCT00959088
COMPLETED
An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
NCT01422798
COMPLETED