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

Tuberculosis Clinical Trial

— Siyasiza  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298309
• Other study ID #: 2014P001173/MGH
• Secondary ID: R21AI110264
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: April 2, 2018
• Start date: April 2015
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4815
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Test-and-Treat TB

Locations

Country	Name	City	State
South Africa	iThembalabantu Clinic/AIDS Healthcare Foundation	Durban	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AIDS Healthcare Foundation, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

Outcome

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