Cali Sin Tos Aim 2

Yale University

Status: Completed

Conditions: Tuberculosis

Treatments: Diagnostic Test: Oral testing; Device: Chatbot

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06338462

R21AI174129 (U.S. NIH Grant/Contract)

2000034128

Details and patient eligibility

About

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).

Full 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.

Enrollment: 269 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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269 participants in 1 patient group

Mobile Health and Oral Testing

Experimental group

Description:

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

Treatment:

Device: Chatbot

Diagnostic Test: Oral testing