Clinical trial NCT05341791: Paper Versus Cartoon Video-based Administration of Study Information Notice for Participant Consent
Official title: Comparing Novel Methods of Study Information Notice Administration to the Standard Approach in Enhancing Clinical Studies Understanding in Resource Limited Settings: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Information Disclosure
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2022-04-22
Enrollment: 350
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Detailed 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

Eligibility criteria: Inclusion Criteria:

* All adults \> = 21 years of age, or emancipated minors (persons between 15-17 years who are married or pregnant/have children or head of a household)
* Are able to speak, read and write English or French
* Bringing their children for routine consultation or immunization in the selected study sites
* Give their written consent to take part to the study

Exclusion Criteria:

- Participants with visual or hearing challenges which prevent them from reading written forms or viewing/listening to a video content will be excluded Selection of participants

Primary outcomes:
measure: The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: HD SOA
state: Centre
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Boris K Tchounga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: