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NCT06338462Completed

Cali Sin Tos Aim 2

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
269 (actual)
First submitted
22 Mar 2024
Start date
28 Mar 2024
Primary completion date
11 Sept 2024
Lead sponsor
Yale University
Diseases
Tuberculosis
NCT number
NCT06338462

What you commit to

  • Study type: Interventional
  • Participants enrolled: 269
  • From 28 Mar 2024 to the primary completion date, 11 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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).

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM)
Coordinator of this site? Confirm its status
CaliColombiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.