Trial Outcomes & Findings for Kharituwe TB Contact Tracing Study (NCT NCT04520113)
NCT ID: NCT04520113
Last Updated: 2025-04-08
Results Overview
The mean number of secondary TB cases identified and started on treatment per index case for each arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10579 participants
Primary outcome timeframe
Up to 35 months
Results posted on
2025-04-08
Participant Flow
Consecutive eligible index participants with TB were recruited from among 12 public hospitals in Limpopo and 33 primary health care clinics and 2 public hospitals in Soshanguve.
The actual enrollment in the study contains the 4417 index TB cases, and within the index participants' households, 6162 contact persons, for a total of 10579 enrolled individuals. Only the 4417 index TB cases were randomized to arms.
Participant milestones
| Measure |
Standard Tracing- Limpopo
This arm was located in the Limpopo site. Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Holiday Tracing
Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Evening / Weekend Tracing
Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Standard Tracing- Soshanguve
This arm was located in the Soshanguve site. Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4368
|
1952
|
1320
|
2939
|
|
Overall Study
TB Index Cases
|
1335
|
666
|
804
|
1612
|
|
Overall Study
Contact Persons
|
3033
|
1286
|
516
|
1327
|
|
Overall Study
COMPLETED
|
4368
|
1952
|
1320
|
2939
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
Baseline characteristics by cohort
| Measure |
Standard Tracing- Limpopo
n=4368 Participants
This arm was located in the Limpopo site. Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Holiday Tracing
n=1952 Participants
Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Evening / Weekend Tracing
n=1320 Participants
Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Standard Tracing- Soshanguve
n=2939 Participants
This arm was located in the Soshanguve site. Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Total
n=10579 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Contact person participants · More than one race
|
13 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
1 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
2 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
2 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
18 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Age, Continuous
Index TB participants
|
41 years
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
42 years
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
42 years
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
41 years
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
41 years
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Age, Continuous
Contact person participants
|
18 years
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
18 years
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
33 years
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
34 years
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
27 years
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Sex: Female, Male
Index TB participants · Female
|
584 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
286 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
330 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
566 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
1766 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Sex: Female, Male
Index TB participants · Male
|
751 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
380 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
474 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
1046 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
2651 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Sex: Female, Male
Contact person participants · Female
|
1884 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
785 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
346 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
849 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
3864 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Sex: Female, Male
Contact person participants · Male
|
1149 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
501 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
170 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
478 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
2298 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · American Indian or Alaska Native
|
0 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · Asian
|
0 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · Black or African American
|
1325 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
666 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
801 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
1601 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
4393 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · White
|
0 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · More than one race
|
10 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
3 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
11 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
24 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Index TB Participants · Unknown or Not Reported
|
0 Participants
n=1335 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=666 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=804 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1612 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=4417 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Contact person participants · American Indian or Alaska Native
|
0 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Contact person participants · Asian
|
0 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Contact person participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Contact person participants · Black or African American
|
3020 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
1285 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
514 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
1325 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
6144 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Contact person participants · White
|
0 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Race (NIH/OMB)
Contact person participants · Unknown or Not Reported
|
0 Participants
n=3033 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1286 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=516 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=1327 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
0 Participants
n=6162 Participants • The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants
|
|
Region of Enrollment
South Africa · Index TB Participants
|
1335 Participants
n=4368 Participants
|
666 Participants
n=1952 Participants
|
804 Participants
n=1320 Participants
|
1612 Participants
n=2939 Participants
|
4417 Participants
n=10579 Participants
|
|
Region of Enrollment
South Africa · Contact person participants
|
3033 Participants
n=4368 Participants
|
1286 Participants
n=1952 Participants
|
516 Participants
n=1320 Participants
|
1327 Participants
n=2939 Participants
|
6162 Participants
n=10579 Participants
|
PRIMARY outcome
Timeframe: Up to 35 monthsThe mean number of secondary TB cases identified and started on treatment per index case for each arm.
Outcome measures
| Measure |
Standard Tracing- Limpopo
n=4368 Participants
This arm was located in the Limpopo site. Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Holiday Tracing
n=1952 Participants
This arm was located in the Limpopo site. Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Evening / Weekend Tracing
n=1320 Participants
This arm was located in the Soshanguve site. Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
Standard Tracing- Soshanguve
n=2939 Participants
This arm was located in the Soshanguve site. Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Household contact tracing: Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
|
|---|---|---|---|---|
|
Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm
|
1.7 mean secondary TB cases
Interval 0.9 to 2.5
|
1.2 mean secondary TB cases
Interval 0.5 to 1.9
|
2.3 mean secondary TB cases
Interval 1.0 to 3.2
|
2.4 mean secondary TB cases
Interval 1.8 to 3.0
|
SECONDARY outcome
Timeframe: Duration of study (30 months)The TB prevalence ratio, comparing highly mobile to less mobile individuals, measuring mobility on two scales (neighborhood/intra-urban and regional/intra-national). For the analysis: amount of time spent in transit, truncating long excursions at 50km (one hour).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (30 months)TB natural history, epidemiological, and whole genome sequencing (WGS)-derived phylogenetic data will be integrated into a statistical modeling framework to draw probabilistic conclusions about the likelihood of transmission between persons. "Transmitters" will be defined as individuals from whom at least one secondary case most likely originated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (30 months)Relative acceptability of each novel strategy, compared against routine contact investigation. Acceptability of the intervention will be measured among index cases and contacts using a short questionnaire given to a randomly selected participant at a randomly selected 15% of the households visited. The interview will cover acceptability of the visit timing, notification, visit activities (TB screening, HIV testing) and study team interaction among others.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (30 months(Feasibility of each strategy as the proportion of potentially eligible index cases for whom a household visit was conducted. All reasons why visits were unable to be conducted will be recorded (e.g. could not find household, no one ever home, visit not conducted during expected off-peak period).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (30 months)Relative fidelity of each novel strategy using a process checklist for each index case and household, including whether the household visit was offered and accepted, whether the visit was attempted, whether the visit was successful (i.e., enrolled at least one contact), whether symptom screening and sputum collection were completed and whether newly identified TB cases were notified and referred for treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (30 months)Sustainability of each novel strategy by reporting the primary outcome and fidelity measures according to six-month time period over the course of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (30 months)Defined as (cost of contact tracing strategy 2 - cost of strategy 1)/(effectiveness of strategy 2 - effectiveness of strategy 1), where effectiveness is modeled as the number of disability-adjusted life years (DALYs) averted by the intervention. The primary cost-effectiveness measures will be the incremental cost per DALY averted using novel strategies (holiday and off-hours contact tracing) compared to routine contact tracing in each setting separately.
Outcome measures
Outcome data not reported
Adverse Events
Standard Tracing- Limpopo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Holiday Tracing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evening / Weekend Tracing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Tracing- Soshanguve
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Colleen Hanrahan
Johns Hopkins Bloomberg School of Public Health
Phone: 410-502-9289
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place