Test and Treat TB: A Proof of Concept Trial in South Africa
Siyasiza
2 other identifiers
interventional
4,815
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedApril 4, 2018
April 1, 2018
2.6 years
November 18, 2014
April 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who complete tuberculosis treatment
6 months
Secondary Outcomes (8)
Proportion of mobile testers screened for tuberculosis
20 months
Proportion of eligible participants able to produce sputum samples
20 months
Prevalence of TB among those tested
20 months
Prevalence of tuberculosis and rifampin resistance
20 months
Distribution of TB symptoms ascertained from TB symptom screen questionnaire
20 months
- +3 more secondary outcomes
Study Arms (2)
Usual Care
NO INTERVENTIONPatients in the usual care arm will be screened for tuberculosis (TB) on a mobile unit and referred for treatment according to the current standard of care in South Africa
Test-and-Treat Intervention
ACTIVE COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
iThembalabantu Clinic/AIDS Healthcare Foundation
Durban, KwaZulu-Natal, South Africa
Related Publications (1)
Bassett IV, Forman LS, Govere S, Thulare H, Frank SC, Mhlongo B, Losina E. Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa. BMC Infect Dis. 2019 Feb 4;19(1):110. doi: 10.1186/s12879-019-3738-4.
PMID: 30717693DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingrid V Bassett, MD, MPH
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
November 18, 2014
First Posted
November 21, 2014
Study Start
April 1, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
April 4, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share