Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04668443 |
| Other study ID # |
2020-02-DEFT-GIC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 22, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Kirby Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
site(s) - 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.
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.
