Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa

Tuberculosis Clinical Trial

— Kharitode TB  

Official title:

Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808507
• Other study ID #: 15-0005
• Secondary ID: R01AI116787-02
• Status: Completed
• Phase: N/A
• Start date: July 18, 2016
• Est. completion date: January 30, 2020

Study information

• Verified date: May 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare three strategies for finding TB cases in a rural Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2) Conducting household contact investigations of newly diagnosed TB cases; 3) Providing incentives to newly diagnosed TB cases and their contacts to promote contact screening for TB. For each intervention, investigators will measure comparative effectiveness in terms of cases identified as well as the cost-effectiveness and feasibility of implementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4852
• Est. completion date: January 30, 2020
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

Inclusion Criteria:

Facility-based screening arm

• Age 0-99 years
• Informed consent provided (or assent plus parent/guardian consent)
• Attending any of the study 28 study clinics in the facility-based screening arm Contact tracing arm- Index Case
• Age 0-99 years
• Informed consent provided (or assent plus parent/guardian consent)
• Newly diagnosed (last 2 months) with TB at any of the 28 study clinics in the contact tracing arm Contact tracing arm- Household Contact
• Age 0-99 years
• Informed consent provided (or assent plus parent/guardian consent)
• Living in the same household as an enrolled Index case (see above) Contact tracing arm- Non-household Close Contact
• Age 0-99 years
• Informed consent provided (or assent plus parent/guardian consent)
• Referred to the study as a close contact of an enrolled Index case (see above)

Exclusion Criteria (all arms):

• Unable to provide informed consent.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Active TB case finding
Active TB case finding (ACF) refers to any number of strategies used to identify individuals with active TB disease, outside of passive case finding. In passive case finding, individuals with symptoms present at health centers for diagnosis. In active case finding, the health system makes an effort to identify TB cases before they present passively.

Locations

Country	Name	City	State
South Africa	Vhembe health subdistrict	Louis Trichardt	Limpopo
South Africa	Waterberg health subdistrict	Mokopane	Limpopo

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Allergy and Infectious Diseases (NIAID), Perinatal HIV Research Unit of the University of the Witswatersrand

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics	The primary analysis was based on the facility- level rate ratio, and we first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% confidence interval (CI). We then adjusted for any residual confounding by district stratification and the historical annual number of people started on TB following a two-stage approach. The first step of this approach fits a Poisson regression to the facility-level counts and the district and historical volume covariates irrespective of study arm. The residuals ratios, calculated as the ratio of the observed over the expected counts, are then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.	18 months
Primary	Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms	The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics in the two contact tracing arms, excluding the six-month washout period.	36 months
Secondary	Comparative Costs and Cost-effectiveness of Active TB Case Finding Strategies	The primary outcome for this analysis will be the incremental cost-effectiveness ratio, defined as (cost of ACF strategy 2 - cost of ACF strategy 1 [or no ACF])/(effectiveness of ACF strategy 2 - effectiveness of ACF strategy 1 [or no ACF]), where effectiveness is modeled as the number of disability-adjusted life years (DALYs) averted by the intervention.	3.5 years
Secondary	Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing	The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts ("secondary cases") by arm.	36 months