TB Screening Improves Preventive Therapy Uptake (TB SCRIPT)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2025
  • participants needed
    1720
  • sponsor
    University of California, San Francisco
Updated on 10 May 2022
tuberculosis

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 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.

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.

Details
Condition Tuberculosis, Latent Tuberculosis, Tuberculosis Prevention, HIV
Treatment CRP, point-of-care assay
Clinical Study IdentifierNCT04557176
SponsorUniversity of California, San Francisco
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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