Cali Sin Tos Aim 2

NCT06338462 | Completed Results

• 2 other identifiers: 2000034128R21AI174129
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Device: Chatbot; Diagnostic Test: Oral testing

Interventions

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.

Mobile Health and Oral Testing

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

Mobile Health and Oral Testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM)

Cali, Colombia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. J. Lucian Davis
• Organization: Yale School of Public Health

lucian.davis@yale.edu

203-785-3665

Study Officials

• J. Lucian Davis, MD

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: target sample size is an anticipated 120 index persons with TB enrolled over three design cycles

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: March 28, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: October 9, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

CO (1)