Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04668443
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2020-12-03
Brief Title:
D²EFT Graphical Informed Consent
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
Acceptability and Feasibility of a Graphical Informed Consent in the Informed Consent Process of D²EFT Study
Status:
COMPLETED
Status Verified Date:
2022-01
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:
D²EFT-GIC
Brief Summary:
D²EFT-GIC is a substudy of D²EFT study NCT03017872 a randomised clinical trial of second-line antiretroviral therapies The goal of D²EFT-GIC is to evaluate a novel tool the Graphical Informed Consent GIC within D²EFT
The GIC is designed to supplement the informed consent process with a set of culturally- and gender-adapted illustrations with an explanatory script for researchers that complements the mandatory written participant information sheet and consent form
The investigators propose to assess the acceptability and feasibility of this tool from the participants and researchers perspectives The GIC will be first pre-tested in one or more sites - where the informed consent process is challenging because of literacy language or culture barriers - in 10 prospective participants for D²EFT If this stage shows there is no negative impact of the GIC on the consent process the second stage will study the feasibility of implementing the GIC in the usual practice
The GIC is designed to supplement the informed consent process with a set of culturally- and gender-adapted illustrations with an explanatory script for researchers that complements the mandatory written participant information sheet and consent form
The investigators propose to assess the acceptability and feasibility of this tool from the participants and researchers perspectives The GIC will be first pre-tested in one or more sites - where the informed consent process is challenging because of literacy language or culture barriers - in 10 prospective participants for D²EFT If this stage shows there is no negative impact of the GIC on the consent process the second stage will study the feasibility of implementing the GIC in the usual practice
Detailed Description:
Informed consent requires provision of complex medical information in an easily understandable format During the consent process researchers may encounter potential research participants who are not thoroughly used to care services and thus may struggle to understand what clinical research is the purpose of the specific research in relation to their health research methods its risks and benefits and their options and rights Clinical trials in people living with HIV can present additional challenges due to stigma surrounding the infection as the need for a third-party witness to ensure adequate comprehension of the presented information may be concerning to the participant These barriers to an optimal informed consent are particularly significant in low and lower-middle income countries LMICs
To try to overcome these barriers and to make written information sheet and consent forms PICFs more accessible and understandable for key-populations and more user-friendly for on-site researchers tools including interactive videos have been developed for various diseases and different settings Many of these tools are study-specific or developed in high-income countries with limited reproducibility few have been studied in the consent process for HIV treatment trials or across multiple LMIC settings Data evaluating these tools and their impact on participants understanding or researchers satisfaction are limited
With the D²EFT community advisory board CAB and protocol steering committee PSC the investigators developed the Graphical Informed Consent GIC This tool is designed to supplement the informed consent process with a set of culturally- and gender-adapted illustrations with an explanatory script for researchers that complement the mandatory written PICF
The investigators propose to evaluate this novel tool within D²EFT study a randomised clinical trial of HIV second-line therapy in LMICs by undertaking a pilot study The study aims to assess acceptability and feasibility of the GIC by measuring implementation outcomes participants acceptability and acceptance and researchers utilisation and satisfaction
To try to overcome these barriers and to make written information sheet and consent forms PICFs more accessible and understandable for key-populations and more user-friendly for on-site researchers tools including interactive videos have been developed for various diseases and different settings Many of these tools are study-specific or developed in high-income countries with limited reproducibility few have been studied in the consent process for HIV treatment trials or across multiple LMIC settings Data evaluating these tools and their impact on participants understanding or researchers satisfaction are limited
With the D²EFT community advisory board CAB and protocol steering committee PSC the investigators developed the Graphical Informed Consent GIC This tool is designed to supplement the informed consent process with a set of culturally- and gender-adapted illustrations with an explanatory script for researchers that complement the mandatory written PICF
The investigators propose to evaluate this novel tool within D²EFT study a randomised clinical trial of HIV second-line therapy in LMICs by undertaking a pilot study The study aims to assess acceptability and feasibility of the GIC by measuring implementation outcomes participants acceptability and acceptance and researchers utilisation and satisfaction
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