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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00011124 | Other Identifier | JHSPH IRB |
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| Name | Class |
|---|---|
| Perinatal HIV Research Unit of the University of the Witswatersrand | OTHER |
| Setshaba Research Centre | UNKNOWN |
| The National Institute for Communicable Diseases | UNKNOWN |
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The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations
The investigators propose a randomized trial of two novel TB case-finding interventions among household members of patients diagnosed with active TB: holiday-based screening in a rural South African province (Limpopo) and off-peak (weekend/evening) screening in an urban settlement into which many residents of Limpopo migrate for work. The investigators will enroll index cases of TB plus their household contacts in each setting and randomize them to novel versus standard contact investigation. In Specific Aim 1, investigators will use whole genome sequencing of all cases, overlaying transmission trees with data on human movement, to evaluate associations between mobility and TB transmission in this population. In Specific Aim 2, investigators will employ a multidisciplinary approach to compare novel versus standard contact investigation in each setting along the following dimensions: (a) effectiveness (number of secondary TB cases diagnosed and starting treatment); (b) implementation (reach, fidelity, and maintenance of contact investigation outside of business hours); (c) cost-effectiveness (cost per disability-adjusted life year) and budget impact; and (d) projected population-level impact on TB incidence. Successful completion of these aims will have long-term impact by characterizing the role of mobility in fueling TB epidemics and testing two tailored approaches to improve TB control in highly mobile populations - an underserved group that is increasingly recognized as playing a major role in global TB transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Tracing | Active Comparator | Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours. |
|
| Holiday Tracing | Experimental | Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter). |
|
| Evening / Weekend Tracing | Experimental | Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Household contact tracing | Behavioral | Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm | The mean number of secondary TB cases identified and started on treatment per index case for each arm. | Up to 35 months |
| Measure | Description | Time Frame |
|---|---|---|
| The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients | 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). | Duration of study (30 months) |
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TB index cases:
Inclusion criteria:
Exclusion criteria:
Contacts:
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Dowdy, MD, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perinatal HIV Research Unit (PHRU) | Johannesburg | South Africa | ||||
| Setshaba Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41911256 | Derived | Mlambo LM, Milovanovic M, Hanrahan CF, Motsomi K, Morolo MT, Mohlamonyane MM, Albaugh NW, Ahmed K, Martinson N, Dowdy DW, West NS. The impact of ethical implications intertwined with tuberculosis household contact investigation: A qualitative study. PLoS One. 2026 Mar 30;21(3):e0306848. doi: 10.1371/journal.pone.0306848. eCollection 2026. | |
| 41607590 | Derived | Hanrahan CF, Nonyane BAS, Biche P, Mohlamonyane M, Morolo M, Omar SV, Ahmed K, Martinson N, Dowdy DW. Timing of household contact investigation for tuberculosis among rural and urban populations in South Africa (Kharituwe study): a pragmatic individually randomized controlled trial. EClinicalMedicine. 2026 Jan 16;91:103744. doi: 10.1016/j.eclinm.2025.103744. eCollection 2026 Jan. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Index TB and contact person participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm | The mean number of secondary TB cases identified and started on treatment per index case for each arm. | Posted | Mean | 95% Confidence Interval | mean secondary TB cases | Up to 35 months |
|
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Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colleen Hanrahan | Johns Hopkins Bloomberg School of Public Health | 410-502-9289 | chanrah1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2021 | Nov 21, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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The principal investigators are blinded as to the assignment of treatment to participants
| TB Strain Relatedness Using Maximum Likelihood Transmission Trees. | 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. | Duration of study (30 months) |
| Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation | 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. | Duration of study (30 months) |
| Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted | 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). | Duration of study (30 months( |
| Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation | 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. | Duration of study (30 months) |
| Sustainability of Each Novel Strategy Relative to Standard Contact Tracing | 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. | Duration of study (30 months) |
| Incremental Cost-effectiveness Ratio for Each Novel Strategy Relative to Standard Contact Tracing | 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. | Duration of study (30 months) |
| Soshanguve |
| South Africa |
| 40503514 | Derived | Young N, Biche P, Mohlamonyane M, Morolo M, Maholwana B, Ahmed K, Martinson N, Hanrahan CF, Dowdy DW. Innovative timing strategies for tuberculosis household contact investigation: cost-effectiveness analysis from a randomized trial in rural and urban South Africa (Kharituwe Study). EClinicalMedicine. 2025 May 26;84:103259. doi: 10.1016/j.eclinm.2025.103259. eCollection 2025 Jun. |
| 38978659 | Derived | Mlambo LM, Milovanovic M, Hanrahan CF, Motsomi KW, Morolo MT, Mohlamonyane MP, Albaugh NW, Ahmed K, Martinson NA, Dowdy DW, West NS. The impact of ethical implications intertwined with tuberculosis household contact investigation: a qualitative study. medRxiv [Preprint]. 2024 Jun 28:2024.06.27.24309538. doi: 10.1101/2024.06.27.24309538. |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | The rows detail the two populations who make up the overall population-- TB index participants and Contact person participants | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Evening / Weekend Tracing | 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. |
| OG003 | 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. |
|
|
| Secondary | The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients | 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). | Not Posted | Duration of study (30 months) | Participants |
| Secondary | TB Strain Relatedness Using Maximum Likelihood Transmission Trees. | 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. | Not Posted | Duration of study (30 months) | Participants |
| Secondary | Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation | 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. | Not Posted | Duration of study (30 months) | Participants |
| Secondary | Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted | 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). | Not Posted | Duration of study (30 months( | Participants |
| Secondary | Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation | 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. | Not Posted | Duration of study (30 months) | Participants |
| Secondary | Sustainability of Each Novel Strategy Relative to Standard Contact Tracing | 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. | Not Posted | Duration of study (30 months) | Participants |
| Secondary | Incremental Cost-effectiveness Ratio for Each Novel Strategy Relative to Standard Contact Tracing | 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. | Not Posted | Duration of study (30 months) | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Male |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Contact person participants |
|