TB Screening Improves Preventive Therapy Uptake

NCT04557176 | Active Not Recruiting DMC

• 2 other identifiers: 18-256231R61HL146365-01A1
• Study Type: interventional
• Target: 1,719
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis; Latent Tuberculosis; Tuberculosis Prevention; HIV

Keywords

Tuberculosis; Latent tuberculosis; Tuberculosis preventive therapy; HIV; C-reactive protein; Symptom screening; Intensified case finding

Outcome Measures

Primary Outcomes (1)

• Microbiologically-confirmed incident TB and all-cause mortality

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

  two years

Secondary Outcomes (21)

• TB incidence: number diagnosed

  two years

• TB incidence: incidence

  two years

• TB incidence: Time to microbiologically-confirmed incident TB diagnosis

  two years

• TB incidence: incidence rate

  two years

• TB incidence: drug resistant TB

  two years

Study Arms (2)

POC CRP-based TB screening

EXPERIMENTAL

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.

Device: CRP, point-of-care assay

Symptom-based TB screening

NO INTERVENTION

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.

Interventions

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).

Also known as: iCHROMA CRP reader, Boditech Med Inc.

POC CRP-based TB screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Makerere University: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Johns Hopkins University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Kampala Capital City Authority Clinic

Kampala, Uganda

Location

Related Publications (53)

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MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Christina Yoon, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: November 16, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)