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D²EFT Graphical Informed Consent

NCT04668443 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Graphical Informed Consent (GIC)

The GIC (set of illustrations that complement the written information and consent form) will be proposed to prospective participants by researchers, systematically during the pre-test (stage 1). If the stage 1 shows no negative impact of the GIC on the consent process, the stage 2 will be implemented and the GIC will be proposed by researchers when they feel it could be beneficial for the participant.

Sponsors & Collaborators

  • Institute of Human Virology, Nigeria

    collaborator OTHER

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Mark Polizzotto, MD, PhD · The Kirby Institute, UNSW

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668443 on ClinicalTrials.gov