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ACTIVE NOT RECRUITING
NCT04557176
NA

TB Screening Improves Preventive Therapy Uptake

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Official title: TB Screening Improves Preventive Therapy Uptake Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1719

Start Date

2020-11-16

Completion Date

2025-09-30

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

DEVICE

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).

Locations (1)

Kampala Capital City Authority Clinic

Kampala, Uganda