Cali Sin Tos Aim 2

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338462
• Other study ID #: 2000034128
• Secondary ID: R21AI174129
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: J. Lucian Davis, MD
• Phone: 203-785-3665
• Email: Lucian.davis[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Colombia	Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM)	Cali

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation of the mHealth strategy to assess feasibility.	Feasibility of the mHealth strategy defined as the proportion of invited index persons with TB who engage with the chatbot, defined as responding to at least one message from the chatbot.	within 7 days of invitation
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	within 7 days of screening