Tuberculosis
Conditions
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.
Interventions
DEVICEChatbot
The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes.
DIAGNOSTIC_TESTOral testing
Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
target sample size is an anticipated 120 index persons with TB enrolled over three design cycles
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation of the mHealth Strategy to Assess Feasibility. | within 14 days of invitation | Feasibility of the mHealth strategy was defined as the proportion of index persons with TB and household contacts at risk of TB who engaged with the chatbot, defined as responding to at least one message from the chatbot. |
| Oral Specimen Collection to Assess Feasibility. | within 7 days of screening | Feasibility of the oral testing strategy defined as the proportion of eligible and enrolled contacts of the index person with TB with successful collection of an oral sample |
Countries
Colombia
Participant flow
Pre-assignment details
No randomization in this trial. Single arm interventional study.
Participants by arm
| Arm | Count |
|---|---|
| Mobile Health and Oral Testing to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design
Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes.
Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis | 269 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No intervention received due to inaccurate contact info, no WhatsApp, no internet, or no smartphone | 52 |
Baseline characteristics
| Characteristic | Mobile Health and Oral Testing | — |
|---|---|---|
| Age, Continuous | 43 years | — |
| Contact of person with tuberculosis | 78 Participants | — |
| Person living with HIV | 17 Participants | — |
| Person with tuberculosis | 191 Participants | — |
| Pulmonary tuberculosis | 166 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Colombia | 269 participants | — |
| Sex: Female, Male Female | 109 Participants | — |
| Sex: Female, Male Male | 160 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Implementation of the mHealth Strategy to Assess Feasibility.
Feasibility of the mHealth strategy was defined as the proportion of index persons with TB and household contacts at risk of TB who engaged with the chatbot, defined as responding to at least one message from the chatbot.
Time frame: within 14 days of invitation
Population: Number of individuals who successfully received the chatbot. 52 did not receive the chatbot. We did not collect reasons why the chatbot was not received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health and Oral Testing | Implementation of the mHealth Strategy to Assess Feasibility. | 112 Participants |
Primary
Oral Specimen Collection to Assess Feasibility.
Feasibility of the oral testing strategy defined as the proportion of eligible and enrolled contacts of the index person with TB with successful collection of an oral sample
Time frame: within 7 days of screening
Population: Investigators were unable to pilot the oral testing strategy within contacts of persons with tuberculosis as the Ministry of Health cancelled the contract with the community health workers. Without the community health workers in place, this strategy was infeasible and will not be collected in the future.