D²EFT Graphical Informed Consent

NCT04668443 | Completed DMC

• 1 other identifier: 2020-02-DEFT-GIC
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 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

HIV-1-infection

Keywords

Informed consent process

Outcome Measures

Primary Outcomes (1)

• Proportion of prospective D²EFT participants to whom researchers offered the supplemental GIC during the informed consent process (Stage 2)

  Utilisation (uptake) of the GIC by researchers: number of times researchers offered the supplemental GIC during the informed consent process of D²EFT divided by the total number of prospective participants who underwent informed consent for D²EFT during the substudy period when the GIC is freely available

  Up to 1 year

Secondary Outcomes (3)

• Proportion of participants who find the illustrations helpful (Stage 1)

  Up to 3 months

• Proportion of researchers who think there are issues in using the GIC (Stage 1)

  Up to 3 months

• Proportion of participants who accept to undergo the D²EFT informed consent process with GIC (Stage 2)

  Up to 1 year

Study Arms (2)

Prospective participants in D²EFT study

HIV-positive persons who are eligible for the D²EFT study will be proposed to receive the research-related information with the set of pictures (GIC)

Other: Graphical Informed Consent (GIC)

Researchers obtaining informed consent for D²EFT study

Healthcare givers involved in the participant informed consent process of D²EFT

Other: Graphical Informed Consent (GIC)

Interventions

Graphical Informed Consent (GIC) OTHER

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.

Prospective participants in D²EFT study; Researchers obtaining informed consent for D²EFT study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective participants for D²EFT study and researchers obtening the informed consent process.

You may qualify if:

• Fulfil the eligibility criteria for D²EFT and willing to undertake D²EFT informed consent process;
• Being able to give a verbal consent for the D²EFT-GIC.

You may not qualify if:

• Unwilling to comply with the substudy requirements.

Sponsors & Collaborators

• Kirby Institute: lead
• Institute of Human Virology, Nigeria: collaborator

Study Sites (1)

Institute of Human Virology Nigeria (IHVN)

Abuja, Nigeria

Location

Study Officials

• Mark Polizzotto, MD, PhD

  The Kirby Institute, UNSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 16, 2020
• Study Start: March 22, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

NG (1)