Trial · NCT02808507
Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
NCT02808507, Not applicable, Completed, Johns Hopkins Bloomberg School of Public Health; results first posted 2022-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa. Trials, record NCT02808507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02808507
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
- NCT number
- NCT02808507
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,852 participants, actual
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Conditions
- Tuberculosis
- Interventions
- Active TB case finding
- First posted
- 2016-06-21
- Last updated
- 2024-09-05
- Results first posted
- 2022-12-02
- Limitations and caveats
* Clinics were purposively chosen based on having larger historical TB patient volume; findings may not generalize to smaller, more remote clinics.~* Clinics and patients not blinded to allocation, so cannot rule out possibility of resultant bias.~* 1/3 of the index patients with TB whom we approached for enrollment refused or were unable to be enrolled, and cannot rule out that they may have differed in some way associated with TB incidence among their contacts from those able to be enrolled.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics | 18 months | 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. |
| Primary | Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms | 36 months | 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. |
| Secondary | Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing | 36 months | The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts ("secondary cases") by arm. |
| Secondary | Total Cost of Household Contact Investigation Strategies | 36 months | This measure is the total cost of household contact investigation in both the household-based and incentive-based arms in 2018 United States dollar (USD) collected from the societal perspective (including both health systems and patient-level costs). As these are actual measured (not estimated) costs, no 95% confidence interval is reported. |
| Secondary | Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms | 36 months | These are estimated costs in 2018 USD for the cost per contact person screened in each arm, collected from the societal perspective including health system and patient-level costs. |
| Secondary | Cost Per Secondary Case of TB Identified Among Contacts, Per Arm | 36 months | Cost were measured in 2018 US dollars from the societal perspective, including both health systems and patient level costs. Total costs per arm were divided by the number of secondary TB cases identified among contacts in that arm. |
| Secondary | Incremental Cost-effectiveness Ratio | 36 months | (Total costs of incentive-based contact investigation-total costs of household-based contact investigation)/(effectiveness of incentive-based contact investigation-effectiveness of household-based contact investigation) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics | 18 months | The population for this outcome consists of a sub-group of the total study population (those enrolled during the intervention period of July 18,2015 - January 17, 2018). All participants from the facility-based screening arm are included (n=1929), and the participants of the contact screening arm (n=1726) are included (this is a combination from the household-based and incentive-based screening arms). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms | 36 months | This analysis population includes all participants enrolled in the two contact tracing sub-arms during the total study period of 36 months. It excludes participants from the facility-based screening arm. A total of 2,923 patients were started on TB treatment during the study period: 1,413 in clinics allocated to household-based contact investigation and 1,510 in clinics allocated to incentive-based contact investigation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing | 36 months | The number of TB contacts screened in each contact investigation arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Cost of Household Contact Investigation Strategies | 36 months | This population includes all enrolled index participants with TB and their enrolled contacts, per arm. | 2018 US dollars | NUMBER |
| SECONDARY | Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms | 36 months | These populations include all contact persons enrolled into each arm. | 2018 US dollars | MEAN |
| SECONDARY | Cost Per Secondary Case of TB Identified Among Contacts, Per Arm | 36 months | Individuals included in this population were the total number of secondary TB cases identified among contacts enrolled in each arm. | 2018 US dollars | MEAN |
| SECONDARY | Incremental Cost-effectiveness Ratio | 36 months | Though the difference in total costs by arm is positive, the difference in effectiveness by arm is zero, therefore we cannot calculate the incremental cost effectiveness ratio as it would require dividing by zero. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics | Facility-based Screening | 1929 | Participants | ||
| Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics | Contact Screening | 1726 | Participants | ||
| Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms | Contact Tracing Household-based Sub-arm | 1413 | Participants | ||
| Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms | Contact Tracing Incentive-based Sub-arm | 1510 | Participants | ||
| Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing | Contact Tracing Household-based Sub-arm | 17 | Participants | ||
| Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing | Contact Tracing Incentive-based Sub-arm | 17 | Participants | ||
| Total Cost of Household Contact Investigation Strategies | Contact Tracing Household-based Sub-arm | 48760 | 2018 US dollars | ||
| Total Cost of Household Contact Investigation Strategies | Contact Tracing Incentive-based Sub-arm | 58070 | 2018 US dollars | ||
| Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms | Contact Tracing Household-based Sub-arm | 26.44 | 95% Confidence Interval 15.17 to 102.28 | 2018 US dollars | |
| Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms | Contact Tracing Incentive-based Sub-arm | 29.93 | 95% Confidence Interval 20.32 to 114.66 | 2018 US dollars |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Facility-based Screening Arm | 1,929 | |
| Overall Study | STARTED | Contact Tracing Household-based Sub-arm | 1,413 | |
| Overall Study | STARTED | Contact Tracing Incentive-based Sub-arm | 1,510 | |
| Overall Study | COMPLETED | Facility-based Screening Arm | 1,929 | |
| Overall Study | COMPLETED | Contact Tracing Household-based Sub-arm | 1,413 | |
| Overall Study | COMPLETED | Contact Tracing Incentive-based Sub-arm | 1,510 | |
| Overall Study | NOT COMPLETED | Facility-based Screening Arm | 0 | |
| Overall Study | NOT COMPLETED | Contact Tracing Household-based Sub-arm | 0 | |
| Overall Study | NOT COMPLETED | Contact Tracing Incentive-based Sub-arm | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Facility-based Screening Arm | 0 | 1,929 |
| Total, all-cause mortality | Contact Tracing Household-based Sub-arm | 0 | 1,413 |
| Total, all-cause mortality | Contact Tracing Incentive-based Sub-arm | 0 | 1,510 |
| Total, other adverse events | Facility-based Screening Arm | 0 | 1,929 |
| Total, other adverse events | Contact Tracing Household-based Sub-arm | 0 | 1,413 |
| Total, other adverse events | Contact Tracing Incentive-based Sub-arm | 0 | 1,510 |
| Total, serious adverse events | Facility-based Screening Arm | 0 | 1,929 |
| Total, serious adverse events | Contact Tracing Household-based Sub-arm | 0 | 1,413 |
| Total, serious adverse events | Contact Tracing Incentive-based Sub-arm | 0 | 1,510 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AI116787 | Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa | DOWDY, DAVID WESLEY | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Contact Tracing Household-based Sub-arm vs Contact Tracing Incentive-based Sub-arm: Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms | Trial comparisons |
| Facility-based Screening vs Contact Screening: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics | Trial comparisons |
| Contact Tracing Household-based Sub-arm vs Contact Tracing Incentive-based Sub-arm: Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02808507
GET https://conductscience.org/api/trials/v1/NCT02808507/registered