N/A
Completed N=269
Cali Sin Tos Aim 2
Source: ClinicalTrials.gov NCT06338462 ↗Enrolled (actual)
269
Serious AEs
—
Results posted
Aug 2025
Primary outcomePrimary: Implementation of the mHealth Strategy to Assess Feasibility. — 112 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implementation of the mHealth Strategy to Assess Feasibility. |
112 | — |
| PRIMARY Oral Specimen Collection to Assess Feasibility. |
— | — |
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. Informational only — not medical advice.