Good Participatory Practice (GPP) Guidelines

The Good Participatory Practice Guidelines (GPP) provide trial funders, sponsors and implementers with systematic guidance on how to effectively engage with all stakeholders in the design and conduct of clinical trials for biomedical HIV prevention.

GPP is a linchpin to the ethical conduct of clinical trials, global health equity and pandemic preparedness. 

Overview

In 2004, Cambodia’s Prime Minister halted planned PrEP efficacy trials set to take place in Cambodia and Cameroon. Local, national, and international stakeholders had raised concerns, highlighting a disconnect with research teams and divergent perspectives on the ethics of the trials’ design. Although the proposed trials had been designed in accordance with international guidance on ethics and clinical research, there was no common document or guideline for conducting or evaluating stakeholder engagement. The ensuing controversies crystallized the need for a reference guide, inclusively created with all relevant stakeholders, on ethical and effective stakeholder engagement related to clinical trials for HIV prevention.

About This Project

In response, AVAC and UNAIDS convened a multidisciplinary international group including community advocates, research staff and NGO representatives, who drafted the initial edition of GPP. This work drew from foundational documents covering ethical guidance and core principles on research ethics.  

The draft guidelines were further refined through broad consultation involving a wide range of stakeholders. In 2007 the Joint United Nations Programme on HIV/AIDS (UNAIDS) and AVAC published the first edition of the Good Participatory Practice Guidelines for biomedical HIV prevention trials. The second edition, including stakeholder input, was published in 2011.

Since the publication of the guidelines for HIV prevention trials, the guidelines have also been adapted for research on tuberculosis (TB) drugs and vaccines, COVID-19 research, and emerging pathogens. We believe they will be further adapted to other areas of clinical research aimed at global disease threats.

What is GPP?

The GPP guidelines were created to provide a consistent global standard for stakeholder engagement throughout the life-cycle of the research enterprise, from trial design to trial conduct to the dissemination of research results to, finally, access to proven intervention. 

GPP Guidelines are written for research entities including trial sites, funders, and sponsors of research. External stakeholders, such as advocates, policy makers, and communities are encouraged to use the guidelines to hold research entities accountable, or implement components of the guidelines directly. This ‘external’ approach to GPP is a powerful way to hold research entities responsible for community-centered trials. 

As a point of reference for how to engage stakeholders, GPP has given rise to a robust community of practice. It has created a process for deeper trust between research teams and other stakeholders and greater understanding about how trials will affect communities.  This in turn improves trial design and conduct, and improves how trial results are understood, accepted and applied, regardless of the outcome. 

GPP is a way to achieve the most community-centric results from a trial or research agenda – however, it is not a guarantee of successful trial results. GPP gives researchers a better sense of how communities will perceive trials and products and provides an opportunity to adapt and improve those perceptions. But GPP alone cannot induce participants to stay in a trial, adhere to a trial regimen, guarantee a product will be accepted, or eliminate the risk of controversy. GPP does provide a framework for navigating questions and controversy if they occur.

Online GPP Trainings and Tools for Implementation

The Engage Platform provides access to AVAC’s primary online training courses for various audiences. It also provides supplementary tools to support researchers and other stakeholders to conduct in-person GPP trainings, implement the guidelines, and join a community of practice of GPP implementers around the world.

Impact

GPP and stakeholder engagement has shifted trial design and approaches – for the better

• The CAPRISA research center in South Africa has built a long-standing relationship with the community, independent of trials, including providing benefits such as support to local schools. This has resulted in increased trust by the community, who provides honest insight into how members perceive and participate in trials.
• Gilead, a drug company, amended the protocol of an efficacy trial for a next-generation PrEP product and created new advisory mechanisms after receiving feedback from concerned advocates about the trial’s design and lack of community engagement.
• The Microbicide Trials Network conducted wide stakeholder engagement for MTN 017, the first ever global rectal microbicide study. The network has stated that participation, adherence, and thus trial results benefited from trust built within communities and amongst national stakeholders through their GPP consultation processes.
• Adapted beyond HIV to four other disease and research areas

As a community advocate, the principles and participatory tools of GPP have enabled me to be responsive and accountable to the well-being of local and global populations.

Neetha Morar

South African Medical Research Council

GPP helps the community become active partners in HIV clinical research. Before GPP, we were limited to advising on study brochures and pamphlets. Now, we have a methodology for involvement in the full research life-cycle, from planning a study to the release of data, and beyond.

Udom Likhitwonnawut

Thai NGO Coalition on AIDS/Civil Society

Good Participatory Practices have transformed the way that biomedical research is conducted around the world. While HIV researchers and communities have historically wanted to work together in meaningful partnerships, the process of actually doing this in a transparent, consistent, teachable, and metrics-driven way was impossible until GPP was developed. In the era of emerging infectious diseases such as Ebola, Zika, and pandemic influenza, GPP for HIV research has illuminated the way forward for impactful relationships between researches and communities in a growing number of fields.

Dr. Nelson L. Michael

Director, US Military HIV Research Program

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Adaptations of GPP to other disease areas 

• In 2021, AVAC launched Essential Principles & Practices for GPP Compliance: Engaging stakeholders in biomedical research during the era of COVID-19, to help guide stakeholder engagement in COVID-19 research
• In 2017, Aeras adapted GPP to TB Vaccine research and published Good Participatory Practice Guidelines for TB Vaccine Research
• The World Health Organization published Good Participatory Practice Guidelines for Trials of Emerging Pathogens in 2016
• Critical Path to TB Drug Regimens adapted AVAC’s GPP to develop Good Participatory Practice guidelines for TB Drug Trials in 2012
• In 2012, Thai Treatment Action Group published Stakeholder Input and Recommendations for Good Participatory Practices in Biomedical HIV Prevention Trials in Thailand

US President Barack Obama’s Commission for the Study of Bioethical Issues referenced GPP as a key resource for ensuring ethical research in its 2011 report.

Contact

For more information on GPP or the online course, reach out to gpp@avac.org.