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TuberculosisTB SCRIPTNCT04557176

TB Screening Improves Preventive Therapy Uptake

A study testing CRP, point-of-care assay in people with Tuberculosis and Latent Tuberculosis, run by University of California, San Francisco at 1 site in Uganda.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CRP, point-of-care assay
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,719 participants
Where
1 siteUganda
Study dates
16 Nov 2020to 30 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Kampala Capital City Authority Clinic

    Kampala

Other trials in Uganda

About this study

Official title: TB Screening Improves Preventive Therapy Uptake Trial

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.

Read the detailed description

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.

Being tested
CRP, point-of-care assay
Keywords
Tuberculosis, Latent tuberculosis, Tuberculosis preventive therapy, HIV, C-reactive protein, Symptom screening, Intensified case finding
Medical subject headings
Tuberculosis, Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRP, point-of-care assayDevice

    Also called iCHROMA CRP reader, Boditech Med Inc.

    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).

Study groups in NCT04557176
Study groupRoleWhat they receive
POC CRP-based TB screeningExperimentalParticipants 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.
Receives: Device: CRP, point-of-care assay
Symptom-based TB screeningNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiologically-confirmed incident TB and all-cause mortality

    Time to first diagnosis of microbiologically-confirmed incident TB or death from any cause

    Measured: two years

Secondary outcomes (21)

  1. TB incidence: number diagnosed

    Number diagnosed with microbiologically-confirmed incident TB

    Measured: two years

  2. TB incidence: incidence

    Incidence of microbiologically-confirmed TB (excluding prevalent TB cases)

    Measured: two years

  3. TB incidence: Time to microbiologically-confirmed incident TB diagnosis

    Days from three months post-enrollment to incident TB diagnosis (or censoring)

    Measured: two years

  4. TB incidence: incidence rate

    Incident rate of microbiologically-confirmed TB

    Measured: two years

  5. TB incidence: drug resistant TB

    Number diagnosed with drug-resistant incident TB

    Measured: two years

  6. TB incidence: drug resistant TB among people receiving TPT

    Proportion of participants receiving TPT diagnosed with incident drug resistant TB

    Measured: two years

  7. Mortality: number of deaths from any cause

    Number who died from any cause

    Measured: two years

  8. Mortality: time to death from any cause

    Number of days from enrollment to death from any cause

    Measured: two years

  9. Mortality: all-cause death rate

    Rate of deaths from any cause

    Measured: two years

  10. Mortality: number who died from TB

    Number who died from confirmed or probable TB

    Measured: two years

  11. TPT uptake: number screen-negatives prescribed TPT

    Number of screen-negatives prescribed TPT

    Measured: two years

  12. TPT uptake: number screen-positives prescribed TPT

    Number screen-positives prescribed TPT

    Measured: two years

  13. TPT uptake: number initiated on TPT

    Number screen-negatives prescribed TPT + number screen-positives prescribed TPT

    Measured: two years

  14. TPT uptake: time to TPT initiation

    Days from baseline TB screening to initiation of TPT

    Measured: two years

  15. TPT uptake: number completing TPT

    Number initiated on TPT who completed ≥90% of treatment over prescribed TPT period

    Measured: two years

  16. Prevalent TB diagnosis: number microbiologically-confirmed prevalent TB cases detected by screening test

    Number screen-positives diagnosed with prevalent TB

    Measured: two years

  17. Prevalent TB diagnosis: number microbiologically-confirmed prevalent TB cases missed by screening test

    Number screen-negatives diagnosed with prevalent TB

    Measured: two years

  18. Prevalent TB diagnosis: number diagnosed with microbiologically-confirmed prevalent TB

    Number screen-positives diagnosed with prevalent TB + number screen-negatives diagnosed with prevalent TB

    Measured: two years

  19. Prevalent TB treatment: Number treated for prevalent TB

    Number initiated on TB treatment 3 months or less after study entry

    Measured: two years

  20. Prevalent TB treatment: number with microbiologically-confirmed prevalent TB completing treatment

    Number diagnosed and treated who completed treatment

    Measured: two years

  21. Prevalent TB treatment: time to treatment of microbiologically-confirmed prevalent TB

    Days from prevalent TB diagnosis to initiation of TB treatment

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start16 Nov 2020
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,719 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557176
Sponsor's protocol ID
18-25623
Other IDs
1R61HL146365-01A1
Acronym
TB SCRIPT
Status last verified
Jun 2025
First submitted
14 Sep 2020
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • WHO. Global Tuberculosis Report 2017. Geneva, Switzerland. World Health Organization 2017.

  • 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.

    PubMed 23954450

  • 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.

    PubMed 26193126

  • 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.

    PubMed 24835842

  • 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.

    PubMed 15941800

  • 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.

    PubMed 24450889

  • 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.

  • 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/

    PubMed 30277688

  • 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.

    PubMed 21267059

  • WHO. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva, Switzerland. World Health Organization 2014.

  • 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.

    PubMed 21818180

  • 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.

    PubMed 22627184

  • 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.

    PubMed 23485388

  • 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.

    PubMed 27393536

  • 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.

    PubMed 13354933

Questions about this trial

What is this clinical trial studying?

A study testing CRP, point-of-care assay in people with Tuberculosis and Latent Tuberculosis, run by University of California, San Francisco at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiologically-confirmed incident TB and all-cause mortality (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04557176, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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