“Training for Language Comfort”: Enhancing the Informed Consent Process at TB/HIV Clinical Research Sites
The HCRU is formally part of the South African Medical Research Council (SAMRC) funded Advancing Care & Treatment for TB/HIV (ACT4TB/HIV) consortium, in collaboration with the Aurum Institute. Several molecular, clinical and social researchers, multiple sites and projects are involved in this consortium, with the HCRU’s focusing on enhancing the informed consent process (ICP) at TB/HIV clinical research sites using qualitative methodologies.
During the consent process of a clinical trial, participants are provided with a large amount of information. Understanding this information may be difficult in a context of cultural and linguistic diversity, poverty and limited scientific literacy. Achieving successful trial retention and adherence may depend in part on how information is conveyed to, and understood by participants. For this collaboration, the HCRU focused on enrollers and recruiters' accounts of the ICP, since little literature exists on their experiences’ even though they are an integral part of the process. While patient and community members’ experiences of informed consent (IC) is useful, to improve interactions between patients/participants and healthcare professionals (HCPs), and enhance participant understanding of information, a greater focus on the experience and skills of the HCPs involved, is thought important.
The HCRU has worked closely with the recruiters and enrollers at a clinical research site in Rustenburg, North West Province. During this time, we aimed to assess what the communicative barriers and facilitators during consent and enrollment in two clinical trials are. Data was gathered in the form of reflective diaries, focus group discussions and ethnographic field notes. Challenges highlighted include: terminology, jargon, the length and format of the consent documents, procedure related challenges such as blood withdrawal, as well as contextual challenges. Based on the findings, the HCRU held communication training workshops with the recruiters and enrollers in order to jointly develop a more flexible, user- friendly and contextually appropriate ICP. When comparing the existing standardised ICP versus the new modified ICP in two TB/HIV clinical studies at the site, findings revealed that a contextually tailored approach can improve participant comprehension, decrease length taken to explain concepts, as well as increase overall level of language comfort during the interaction. Recruiters and enrollers provided positive feedback on the experience, and particularly valued the opportunity to have been part of the development of the new ICP.
The study emphasises the valuable role that recruiters and enrollers play in TB/HIV clinical research and their invaluable insight into contextual factors. The inclusion of community advisory boards and local experts in the development of clinical research protocols and consent documents has the potential to increase the yield of trial enrolment, enhance trust amongst researchers and communities, as well as ensure positive communication outcomes.
Some of the findings from this project were presented at the International Critical Health Psychology Conference (ISCHP) in Loughborough, United Kingdom (UK) in July 2017.