N/A
N=269
Cali Sin Tos Aim 2
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT06338462 ↗Enrolled (actual)
269
Serious AEs
—
Results posted
Aug 2025
Primary outcome: Primary: Implementation of the mHealth Strategy to Assess Feasibility. — 112 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chatbot (Device); Oral testing (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implementation of the mHealth Strategy to Assess Feasibility. |
112 | — |
| PRIMARY Oral Specimen Collection to Assess Feasibility. |
— | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06338462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.