Ethical challenges in developing an educational video to empower potential participants during consent processes in HIV cure research in South Africa

Staunton, Ciara; Roubaix, Malcolm de; Baatjies, D.; Black, Gill; Hendricks, M; Rossouw, Theresa M.; Moodley, Keymanthri

doi:10.1016/s2055-6640(20)30251-x

Cited by 4 publications

(2 citation statements)

References 24 publications

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“…32 Still, previous studies have suggested that engaging community and research stakeholders in the development of educational materials may foster empowerment of participants and contribute to communication between researchers and community. 33,34 The development of novel forms to convey information related to investigational products and trials is all the more important considering that consent forms in federally funded HIV trials are often long and dense. 35 Educational materials that target the specific needs of trial participants, rather than those imposed by regulatory requirements, may be an effective tool to overcome the difficulty in conveying information about study procedures and risks to participants in HIV research.…”

Section: Discussionmentioning

confidence: 99%

Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention

Valente

Cohen

et al. 2020

Clinical Trials

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Background/Aims Early integration of behavioral and social sciences research into clinical trials can improve trial conduct and facilitate future implementation of biomedical interventions. We sought to examine participants’ experiences in clinical trials with broadly neutralizing antibodies and describe the development of educational materials for use in future broadly neutralizing antibody research. Methods We conducted semi-structured interviews with trial participants in phase 1 trials evaluating safety and efficacy of broadly neutralizing antibodies for HIV prevention and treatment and key informants (i.e. trial staff involved in broadly neutralizing antibody research). Semi-structured interviews were transcribed and analyzed thematically. Based on findings from the interviews, we developed educational materials addressing concerns and misconceptions identified among trial participants with input from community and research stakeholders. Educational materials were used in subsequent clinical trials with broadly neutralizing antibodies. We evaluated trial staff’s experiences with newly developed educational materials in follow-up key informant interviews. Results Although most participants were concerned about long-term harms related to the investigational product upon enrollment, absence of severe side effects in the trial led to an underestimation of risks related to the study during trial participation. Participants showed a poor understanding of what broadly neutralizing antibodies are and the differences between broadly neutralizing antibodies and other HIV prevention and treatment products, such as antiretrovirals. Many trial participants overestimated the possible public health impact of the broadly neutralizing antibody trials in which they were enrolled, associating broadly neutralizing antibody research with the development of vaccine or cure for HIV in the near future. Based on these concerns and misconceptions among trial participants, we developed a frequently asked questions document and adapted an existing educational video about broadly neutralizing antibodies. In follow-up interviews, key informants reported that materials helped address trial participants’ concerns and questions related to the trial. Key informants reported using the educational materials not only during informed consent but also throughout trial participation, which contributed to making informed consent an “ongoing” process. Conclusion Integration of behavioral research into clinical trials with broadly neutralizing antibodies is key to identify and address key concerns among trial participants. Behavioral and social sciences research promotes communication between trial participants and biomedical researchers, facilitates engagement of participants and trial staff, and strengthens trial conduct. Development of educational materials collaboratively by behavioral and clinical scientists, trial staff, and community stakeholders is feasible and may help to address trial participants’ concerns and misconceptions. Future research should evaluate the impact of educational materials in recruitment and retention of trial participants.

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Section: Discussionmentioning

confidence: 99%

Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention

Valente

Cohen

et al. 2020

Clinical Trials

View full text Add to dashboard Cite

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“…In the papers reviewed, we identified four categories of interventions used to improve comprehension in the consent process. These included translation of consent forms [7,[23][24][25][26][27][28][29][30][31][32], and multimedia medium [21,[33][34][35][36][37][38][39], IC assessment tools and a combination of these strategies [40].…”

Section: Strategies Used To Improve Participants' Understanding Of Icmentioning

confidence: 99%

Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review

et al. 2023

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Background Literature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries. Methods From November 2021 to January 2022, we conducted a literature search using a PRISMA tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC. Results Out of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC. Conclusion Our review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process.

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‘My Tablets are on Top of the Fridge’: The Roles of Relationship Desire and Medical Mistrust in ART Adherence for HIV-Positive MSM and Transgender Women Living in Rural South Africa

et al. 2019

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Ethical challenges in developing an educational video to empower potential participants during consent processes in HIV cure research in South Africa

Cited by 4 publications

References 24 publications

Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention

Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention

Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review

‘My Tablets are on Top of the Fridge’: The Roles of Relationship Desire and Medical Mistrust in ART Adherence for HIV-Positive MSM and Transgender Women Living in Rural South Africa

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