Cali Sin Tos Aim 2

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Device: Chatbot; Diagnostic Test: Oral testing

• Registration Number: NCT06338462
• Lead Sponsor: Yale University

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).

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 Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Study Start: 2024-03-28
• Study First Posted: 2024-03-29
• Primary Completion: 2024-09-11
• Study Completion: 2024-09-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mobile Health and Oral Testing	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
Mobile Health and Oral Testing	Chatbot	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

Primary Outcome Measures

Name	Time	Method
Implementation of the mHealth strategy to assess feasibility.	within 14 days of invitation	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.
Oral specimen collection to assess feasibility.	within 7 days of screening	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

Trial Locations

Locations (1)

Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM); 🇨🇴 Cali, Colombia