HIV-1-infectionD²EFT-GICNCT04668443
D²EFT Graphical Informed Consent
An observational study of HIV-1-infection, run by Kirby Institute at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Graphical Informed Consent (GIC)
- How many people
- 12 participants
- Where
- 1 siteNigeria
- Study dates
- 22 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective participants for D²EFT study and researchers obtening the informed consent process.
Who may be able to join
- 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.
Who cannot join
- Unwilling to comply with the substudy requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Feasibility of a Graphical Informed Consent in the Informed Consent Process of D²EFT Study
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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- Graphical Informed Consent (GIC)
- Keywords
- Informed consent process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Graphical Informed Consent (GIC) | |
| Researchers obtaining informed consent for D²EFT study | Healthcare givers involved in the participant informed consent process of D²EFT Receives: Other: Graphical Informed Consent (GIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Secondary outcomes (3)
Proportion of participants who find the illustrations helpful (Stage 1)
A five-point Likert scale will be used in a questionnaire administered to the participants after they underwent the D²EFT informed consent process with the GIC, during Stage 1. "Overall, supplementing the written information explained by the doctor with illustrations is": multiple answers will range from "Extremely troublesome" (worst outcome) to "Very interesting (helpful)" (best outcome).
Measured: Up to 3 months
Proportion of researchers who think there are issues in using the GIC (Stage 1)
A questionnaire with a three-point Likert scale will be used: "Yes" (worst outcome) to "No" (best outcome).
Measured: Up to 3 months
Proportion of participants who accept to undergo the D²EFT informed consent process with GIC (Stage 2)
Participants' acceptance (uptake) during stage 2. The number of participants who accept/decline the use of illustrations when the researcher offered the GIC with the written informed consent will be recorded
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start22 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Institute of Human Virology, Nigeria
- Responsible party
- Sponsor
- Investigators
- Mark Polizzotto, MD, PhD, Principal investigator, The Kirby Institute, UNSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668443
- Sponsor's protocol ID
- 2020-02-DEFT-GIC
- Acronym
- D²EFT-GIC
- Status last verified
- Jan 2022
- First submitted
- 3 Dec 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Graphical Informed Consent in the Informed Consent Process of D²EFT Study
- ClinicalTrials.gov ID
- NCT04668443
- Acronym / sponsor ID
- D²EFT-GIC / 2020-02-DEFT-GIC
- Conditions
- HIV-1-infection
- Keywords
- Informed consent process
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Institute of Human Virology, Nigeria
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective participants in D²EFT study | – | Other: Graphical Informed Consent (GIC)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) |
| Researchers obtaining informed consent for D²EFT study | – | Other: Graphical Informed Consent (GIC)Healthcare givers involved in the participant informed consent process of D²EFT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective participants for D²EFT study and researchers obtening the informed consent process.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwilling to comply with the substudy requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Prospective participants in D²EFT study, Researchers obtaining informed consent for D²EFT study |
Primary outcome
Proportion of prospective D²EFT participants to whom researchers offered the supplemental GIC during the informed consent process (Stage 2)
Time frame: Up to 1 year
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
3 secondary outcomes
Proportion of participants who find the illustrations helpful (Stage 1)
Time frame: Up to 3 months
Proportion of researchers who think there are issues in using the GIC (Stage 1)
Time frame: Up to 3 months
Proportion of participants who accept to undergo the D²EFT informed consent process with GIC (Stage 2)
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Polizzotto, MD, PhD principal investigator
The Kirby Institute, UNSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Kirby Institute at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of prospective D²EFT participants to whom researchers offered the supplemental GIC during the informed consent process (Stage 2) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022; AzTrials last refreshed its copy on 28 Oct 2026.