Standard Implementation Strategy Period vs Enhanced Contact Investigation Intervention Period: Initiation of TB Preventative Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0431 | 0.0362 | 0.0513 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0475 | 0.0422 | 0.0534 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00436 | -0.0134 | 0.00534 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.908 | 0.736 | 1.12 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.904 | 0.726 | 1.13 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Standard Implementation Strategy Period than on Enhanced Contact Investigation Intervention Period | 230 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Standard Implementation Strategy Period | During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.~Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person. | 122 | 2,829 | OG000 | ClinicalTrials.gov |
| Group 2 | Enhanced Contact Investigation Intervention Period | The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.~User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.~2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs. | 264 | 5,560 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Initiation of TB Preventative Therapy | ClinicalTrials.gov |
| Description | The difference between study periods in percentage of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation | ClinicalTrials.gov |
| Time frame | 60 days | ClinicalTrials.gov |
| Population | Only those eligible for TPT are included in this analysis. Those that have been newly diagnosed with TB, regardless of treatment status, are not eligible for TPT and are therefore excluded from this analysis | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda | ClinicalTrials.gov |
| NCT number | NCT05640648 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Tuberculosis, Tuberculosis, Pulmonary | ClinicalTrials.gov |
| Interventions | User-Centered Implementation Strategy, Standard Implementation Strategy | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Results first posted | 2025-03-30 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05640648?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.