Clinical trial NCT06338462: Cali Sin Tos Aim 2
Official title: Mobile Health and Oral Testing to Optimize Tuberculosis Contact Tracing in Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-03-29
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: target sample size is an anticipated 120 index persons with TB enrolled over three design cycles
Primary purpose: PREVENTION

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 (i.e., 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.

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.

Primary outcomes:
measure: Implementation of the mHealth strategy to assess feasibility.
timeFrame: within 14 days of invitation
measure: Oral specimen collection to assess feasibility.
timeFrame: within 7 days of screening
Secondary outcomes:
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM)
Study officials:
affiliation: Yale School of Public Health
name: J. Lucian Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: