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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Test-and-Treat TB
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tuberculosis focused on measuring TB, HIV, Test and Treat, Linkage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • iThembalabantu Clinic/AIDS Healthcare Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Test-and-Treat Intervention

Arm Description

Patients 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

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.

Outcomes

Primary Outcome Measures

Number of patients who complete tuberculosis treatment

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2014
Last Updated
April 2, 2018
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), AIDS Healthcare Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02298309
Brief Title
Test and Treat TB: A Proof of Concept Trial in South Africa
Acronym
Siyasiza
Official Title
Test and Treat TB: A Proof of Concept Trial in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), AIDS Healthcare Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
TB, HIV, Test and Treat, Linkage

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4815 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients 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
Arm Title
Test-and-Treat Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Test-and-Treat TB
Primary Outcome Measure Information:
Title
Number of patients who complete tuberculosis treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of mobile testers screened for tuberculosis
Time Frame
20 months
Title
Proportion of eligible participants able to produce sputum samples
Time Frame
20 months
Title
Prevalence of TB among those tested
Time Frame
20 months
Title
Prevalence of tuberculosis and rifampin resistance
Description
The GeneXpert test can detect rifampin resistant strains of tuberculosis
Time Frame
20 months
Title
Distribution of TB symptoms ascertained from TB symptom screen questionnaire
Time Frame
20 months
Title
Proportion returning to the mobile tester for TB test result
Time Frame
20 months
Title
Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record)
Time Frame
1 month
Title
ART initiation date as documented by clinic record for those HIV co-infected
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid V Bassett, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
iThembalabantu Clinic/AIDS Healthcare Foundation
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30717693
Citation
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.
Results Reference
derived

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

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