Test and Treat TB: A Proof of Concept Trial in South Africa

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: Test-and-Treat TB

• Registration Number: NCT02298309
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Study Start: 2015-04
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4815

Inclusion Criteria

• English or Zulu speaking
• presenting for screening at mobile unit
• voluntarily undergoing HIV testing
• able and willing to give informed consent
• willing to share HIV and TB test results
• willing to attend one of six local clinics for treatment
• access to a mobile phone

Exclusion Criteria

• pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test-and-Treat Intervention	Test-and-Treat TB	Patients in the intervention arm will partake in a Test-and-Treat TB strategy involving mobile GeneXpert MTB/RIF testing, facilitated TB treatment initiation, SMS reminders for clinic visits, and cashless incentives.

Primary Outcome Measures

Name	Time	Method
Number of patients who complete tuberculosis treatment	6 months

Secondary Outcome Measures

Name	Time	Method
Prevalence of TB among those tested	20 months
Proportion of mobile testers screened for tuberculosis	20 months
Prevalence of tuberculosis and rifampin resistance	20 months	The GeneXpert test can detect rifampin resistant strains of tuberculosis
ART initiation date as documented by clinic record for those HIV co-infected	6 months
Distribution of TB symptoms ascertained from TB symptom screen questionnaire	20 months
Proportion of eligible participants able to produce sputum samples	20 months
Proportion returning to the mobile tester for TB test result	20 months
Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record)	1 month

Trial Locations

Locations (1)

iThembalabantu Clinic/AIDS Healthcare Foundation; 🇿🇦 Durban, KwaZulu-Natal, South Africa