Cali Sin Tos Aim 2 (NCT06338462) | Clinical Trial Compass
CompletedNot Applicable
Cali Sin Tos Aim 2
Colombia269 participantsStarted 2024-03-28
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implementation of the mHealth Strategy to Assess Feasibility.