Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05341791 |
| Other study ID # |
EG0266 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 28, 2022 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Elizabeth Glaser Pediatric AIDS Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a randomized trial in which participants are assigned to one of 2 strategies of
information notice administration which include the standard approach versus a video-based
cartoon approach. An information notice about the study will be administered to each
participant individually. The study involves the integration of tuberculosis screening at all
pediatric entry points, and other activities aimed at improving pediatric tuberculosis
diagnosis and management. The understanding of participants will be assessed using a test of
understanding adapted from the Quality of Informed consent (QIC).
Description:
Objectives:
Primary Objective: is to evaluate the effectiveness of cartoon video-based study information
notice administration compared to standard study information notice administration as
assessed by the QIC Secondary Objectives: - Determine the factors associated with
effectiveness of the cartoon video-based study information notice administration.
Endpoints:
Primary Endpoint: The proportion of participants scoring more than 80% at the test of
understanding, comparing the novel and the standard strategy.
Study Population: Our population will consist of adults bringing their children for routine
care in the facilities in which the study will be conducted.
Study Sites This study will be conducted in 4 sites located in the West, Littoral and Center
regions of Cameroon. These sites are the District Hospital of Dschang, the district hospital
of Foumban, the District hospital of Loum, and the district hospital of Soa. These sites are
semi-urban sites and are selected to facilitate inclusion of participants from urban,
peri-urban and rural settings. Also, these sites conduct routine systematic and active
screening for pediatric tuberculosis of all children presenting for care in the facility, as
well as other interventions to improve pediatric tuberculosis diagnosis and management. These
tuberculosis activities, which had been implemented by EGPAF through the CaP TB program are
now part of the routine sites activities and will be used to build the information notice for
the purpose of this study.
Participant's eligibility and recruitment process Eligible participants will be adults (of at
least 21 years of age), or emancipated minors bringing their children (of less than 15 years)
for routine care in the selected facilities, and able to read and write English or French and
who accept to be part of the study. Every day, routine triage registers (and/or immunization
registers, depending on the organization of the health facility) will be used to identify
parents bringing their children for routine care. Parents whose children have a serial number
in the register which is a multiple of 3 will be screened for eligibility to the study and
enrolled if eligible and after providing a written consent. A maximum of 10 participants will
be enrolled per day. All enrolled participants will be randomly allocated to the intervention
arm (video-cartoon) or to standard consenting following a 1:1 ratio.
Description of the information notice to be administered An information notice on the
integration of tuberculosis activities at all pediatric entry points will be developed. This
information notice will include details on definition of tuberculosis, rationale and process
of systematic and active screening for tuberculosis at all pediatric entry points, sample
collection and chest X-ray procedures and indications, data collected as part of the TB
activities in the sites, risks and benefits of TB screening and diagnosis procedures, and
possibility to accept or refuse TB procedures.
Description of Study arms:
There are 2 study arms. The standard administration of information notice consists of a
paper-based study information notice which is provided to the participant during a one-to-one
conversation with a study staff. The participant either reads the study information notice or
it is read to him/her and explained section by section. The video-based study information
notice administration consists of a 20 minutes' cartoon video explaining the study which will
be played to the participant.
Study Duration: 20 months
Participant Duration in the study: 1 day
