Cali Sin Tos Aim 2

Mobile Health and Oral Testing to Optimize Tuberculosis Contact Tracing in Colombia

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).

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Device: Chatbot; Diagnostic test: Oral testing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Santiago de Cali, Colombia
    • Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For index persons with TB:

• assigned by the SoPH to receive contact investigation services from the study community health worker
• may be of any age (represented by a parent or legal guardian for those age<18)

For contacts of index persons with TB:

• include the index person's named household contacts, defined as those spending one or more days or nights within the past 3 months sleeping under the same roof as the index person;
• may be of any age (represented by a parent or legal guardian for those age<18).

Exclusion Criteria:

For index persons with TB:

• who are living outside the city of Cali;
• who lack capacity to agree to testing.

For contacts of index persons with TB:

• who have already been diagnosed with and treated for active TB within the past two years;
• who lack capacity to agree to testing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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.; Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: J. Lucian Davis, MD, Yale School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): September 11, 2024
• Study Completion (Actual): September 11, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 2000034128; R21AI174129 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data arising from the project will be stored at Dryad, an online, open-access data repository.
• IPD Sharing Time Frame: The data will be made available immediately at the time of publication of the results. Data will be available for at least 5 years.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No