Tuberculosis Clinical Trial
— Kharitode TBOfficial title:
Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Verified date | May 2023 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
South Africa | Vhembe health subdistrict | Louis Trichardt | Limpopo |
South Africa | Waterberg health subdistrict | Mokopane | Limpopo |
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 |
South Africa,
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 |
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