D²EFT Graphical Informed Consent
Condition: HIV-1-infection
Study type: Observational

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.
    

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.
    

Intervention name(s): Graphical Informed Consent (GIC)
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Prospective participants for D²EFT study and researchers obtening the informed consent
        process.
      
Keywords: Informed consent process