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

April 2, 2018 updated by: Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4815

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
        • iThembalabantu Clinic/AIDS Healthcare Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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
Active Comparator: Test-and-Treat Intervention
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.
Other: Test-and-Treat TB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who complete tuberculosis treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
AIDS Healthcare Foundation

Investigators

  • Principal Investigator: Ingrid V Bassett, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P001173/MGH
  • R21AI110264 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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