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| ID | Type | Description | Link |
|---|---|---|---|
| R21AI174129 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial.
This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique).
This study will examine the diagnostic performance of oral samples for TB molecular testing in clinic and household settings; as well as utilize a community-engaged design methodology to iteratively refine a mHealth strategy for implementing contact tracing optimized for feasibility, acceptability, usability, and appropriateness.
There is a Certificate of Confidentiality in place for this study.
After contact tracing procedures have concluded, investigators will administer study instruments to characterize the feasibility, acceptability, appropriateness, and usability of the chatbot. Investigators will also conduct up to ~12 key informant interviews with purposively sampled index persons with TB and their household contacts to elicit views on the mHealth strategy during each cycle (for a total of up to ~36 key informant interviews).
After ~40 households (index persons with TB and their household contacts) have been enrolled using these procedures, and all scales and key informant interviews have been completed, the mHealth implementation strategy will be adapted using nominal group technique. Investigators will repeat this cycle twice for a total of three rounds of design and adaptation of chatbot-facilitated contact tracing procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health and Oral Testing | Experimental | to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chatbot | Device | The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation of the mHealth Strategy to Assess Feasibility. | Feasibility of the mHealth strategy was defined as the proportion of index persons with TB and household contacts at risk of TB who engaged with the chatbot, defined as responding to at least one message from the chatbot. | within 14 days of invitation |
| Oral Specimen Collection to Assess Feasibility. | Feasibility of the oral testing strategy defined as the proportion of eligible and enrolled contacts of the index person with TB with successful collection of an oral sample | within 7 days of screening |
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Inclusion Criteria:
For index persons with TB:
For contacts of index persons with TB:
Exclusion Criteria:
For index persons with TB:
For contacts of index persons with TB:
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| Name | Affiliation | Role |
|---|---|---|
| J. Lucian Davis, MD | Yale School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM) | Cali | Colombia |
Data arising from the project will be stored at Dryad, an online, open-access data repository.
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The data will be made available immediately at the time of publication of the results. Data will be available for at least 5 years.
Data will be searchable at the Dryad repository through keyword or through a unique identifier that will be published with the manuscript or made available on request of the corresponding author.
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No randomization in this trial. Single arm interventional study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Health and Oral Testing | to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes. Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Health and Oral Testing | to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes. Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Implementation of the mHealth Strategy to Assess Feasibility. | Feasibility of the mHealth strategy was defined as the proportion of index persons with TB and household contacts at risk of TB who engaged with the chatbot, defined as responding to at least one message from the chatbot. | Number of individuals who successfully received the chatbot. 52 did not receive the chatbot. We did not collect reasons why the chatbot was not received. | Posted | Count of Participants | Participants | within 14 days of invitation |
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Adverse events were not collected as part of this pilot as the chatbot was considered to be low risk to participant
No definition of AEs
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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 | Mobile Health and Oral Testing | to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes. Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Lucian Davis | Yale School of Public Health | 203-785-3665 | lucian.davis@yale.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2023 | Aug 7, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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target sample size is an anticipated 120 index persons with TB enrolled over three design cycles
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| Oral testing | Diagnostic Test | Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Person living with HIV | Only measured among those with tuberculosis (n=191) | Only measured among those with tuberculosis (n=191) | Count of Participants | Participants |
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| Pulmonary tuberculosis | Only among those with tuberculosis (n=191) | Only among those with tuberculosis (n=191) | Count of Participants | Participants |
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| Person with tuberculosis | Count of Participants | Participants |
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| Contact of person with tuberculosis | Count of Participants | Participants |
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| Primary | Oral Specimen Collection to Assess Feasibility. | Feasibility of the oral testing strategy defined as the proportion of eligible and enrolled contacts of the index person with TB with successful collection of an oral sample | Investigators were unable to pilot the oral testing strategy within contacts of persons with tuberculosis as the Ministry of Health cancelled the contract with the community health workers. Without the community health workers in place, this strategy was infeasible and will not be collected in the future. | Posted | within 7 days of screening |
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| 0 |
| 0 |
| 0 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |