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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02298309

Collaborator

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

4,815

Enrollment

Location

Arms

Actual Duration (Months)

155.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Other: Test-and-Treat TB	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4815 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of patients who complete tuberculosis treatment [6 months]

Secondary Outcome Measures

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]
The GeneXpert test can detect rifampin resistant strains of tuberculosis
Distribution of TB symptoms ascertained from TB symptom screen questionnaire [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]
ART initiation date as documented by clinic record for those HIV co-infected [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	iThembalabantu Clinic/AIDS Healthcare Foundation	Durban	KwaZulu-Natal	South Africa

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

Study Protocol - May 26, 2017

More Information

Publications

None provided.

Responsible Party:

Ingrid V. Bassett, MD, MPH, Associate Professor of Medicine, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02298309

Other Study ID Numbers:

2014P001173/MGH
R21AI110264

First Posted:

Nov 21, 2014

Last Update Posted:

Apr 4, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Ingrid V. Bassett, MD, MPH, Associate Professor of Medicine, Massachusetts General Hospital

HIV

Test and Treat

Linkage

Additional relevant MeSH terms:

Tuberculosis

Study Results

No Results Posted as of Apr 4, 2018