N/A
Completed N=4,852
Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Source: ClinicalTrials.gov NCT02808507 ↗Enrolled (actual)
4,852
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics — 1929; 1726 Participants — p=0.73
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics |
1929; 1726 | 0.73 |
| PRIMARY Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms |
1413; 1510 | 0.68 |
| SECONDARY Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing |
17; 17 | 0.80 |
| SECONDARY Total Cost of Household Contact Investigation Strategies |
48760; 58070 | — |
| SECONDARY Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms |
26.44; 29.93 | — |
| SECONDARY Cost Per Secondary Case of TB Identified Among Contacts, Per Arm |
2927; 2416 | — |
| SECONDARY Incremental Cost-effectiveness Ratio |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02808507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.