Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence

Abstract

Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS’ good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

Keywords::

• clinical trials
• community engagement
• community participation
• ethics
• HIV prevention
• HIV vaccines
• low-income countries
• mistrust
• social sciences
• stakeholder engagement

Acknowledgements

The authors wish to thank their research collaborators in India (Venkatesan Chakrapani) and South Africa (Graham Lindegger and Catherine Slack) for helpful insights regarding the content of this article.

Financial & competing interests disclosure

This work was supported by Canadian Institutes of Health Research (THA-118570). PA Newman is also supported by the Canada Foundation for Innovation and the Canada Research Chairs Program. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Ethical guidelines for stakeholder engagement in clinical HIV prevention trials emphasize the importance of respect, mutual understanding, integrity, transparency, accountability and community stakeholder autonomy.

• Social and behavioral science research suggests broad and pervasive challenges to community stakeholder engagement, including:

  • – bringing together diverse perspectives and experiences between researchers and community members;

  •  – ensuring a common understanding of the research design, implementation and analysis process;

  •  – addressing mistrust between local communities and medical researchers based on personal experience and historical discrimination; and,

  •  – developing a shared understanding and agreement about what health services will be provided to participants during and after a trial.

• Social science research can provide clinical researchers with insights into the multifaceted ethical and practical implications of conducting trials in various locales and with diverse community stakeholders.

• Trial research teams need to be fully aware of the broad array of community engagement challenges so that they do not begin implementing a clinical trial without adequately considering how to address common stakeholder concerns.