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Active, Not Recruiting

NCT Number: NCT04557176

TB Screening Improves Preventive Therapy Uptake

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections HIV Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kampala Capital City Authority Clinic

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

CRP, point-of-care assay

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).

Other names: iCHROMA CRP reader, Boditech Med Inc.

Primary outcomes

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

    Time frame: two years

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

Secondary outcomes

  1. TB incidence: number diagnosed

    Time frame: two years

    Number diagnosed with microbiologically-confirmed incident TB

  2. TB incidence: incidence

    Time frame: two years

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

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

    Time frame: two years

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

  4. TB incidence: incidence rate

    Time frame: two years

    Incident rate of microbiologically-confirmed TB

  5. TB incidence: drug resistant TB

    Time frame: two years

    Number diagnosed with drug-resistant incident TB

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

    Time frame: two years

    Proportion of participants receiving TPT diagnosed with incident drug resistant TB

  7. Mortality: number of deaths from any cause

    Time frame: two years

    Number who died from any cause

  8. Mortality: time to death from any cause

    Time frame: two years

    Number of days from enrollment to death from any cause

  9. Mortality: all-cause death rate

    Time frame: two years

    Rate of deaths from any cause

  10. Mortality: number who died from TB

    Time frame: two years

    Number who died from confirmed or probable TB

  11. TPT uptake: number screen-negatives prescribed TPT

    Time frame: two years

    Number of screen-negatives prescribed TPT

  12. TPT uptake: number screen-positives prescribed TPT

    Time frame: two years

    Number screen-positives prescribed TPT

  13. TPT uptake: number initiated on TPT

    Time frame: two years

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

  14. TPT uptake: time to TPT initiation

    Time frame: two years

    Days from baseline TB screening to initiation of TPT

  15. TPT uptake: number completing TPT

    Time frame: two years

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

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

    Time frame: two years

    Number screen-positives diagnosed with prevalent TB

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

    Time frame: two years

    Number screen-negatives diagnosed with prevalent TB

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

    Time frame: two years

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

  19. Prevalent TB treatment: Number treated for prevalent TB

    Time frame: two years

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

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

    Time frame: two years

    Number diagnosed and treated who completed treatment

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

    Time frame: two years

    Days from prevalent TB diagnosis to initiation of TB treatment

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Infectious Diseases Research Collaboration, Uganda
  • Johns Hopkins University
  • Makerere University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

TB Screening Improves Preventive Therapy Uptake Trial

Acronym: TB SCRIPT

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2020
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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