Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338462
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Brief Title:
Cali Sin Tos Aim 2
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Mobile Health and Oral Testing to Optimize Tuberculosis Contact Tracing in Colombia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie nominal group technique
This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy ie nominal group technique
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AI174129 | NIH | None | httpsreporternihgovquickSearchR21AI174129 |