Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials 2011, Second Edition - PowerPoint PPT Presentation

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Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials 2011, Second Edition

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Title: Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials 2011, Second Edition


1
Good Participatory Practice (GPP)Guidelines for
Biomedical HIV Prevention Trials 2011, Second
Edition

2
Why were the GPP guidelines created?
  • In response to the pre-exposure prophylaxis
    (PrEP) trial controversies in Cambodia and
    Cameroon in 2004 and 2005
  • To help prevent misunderstanding and
    miscommunication among research stakeholders
  • Based on the idea that what happens with one
    product, in one trial, in one region affects all
    biomedical HIV prevention stakeholders trial
    participants, research teams, funders, sponsors,
    community stakeholders, and product developers

3
GPP guidelines development
  • Just as other aspects of clinical trial conduct
    are informed by guidelines, the relationship
    between research entities and stakeholders should
    be informed by a set of guidelines.
  • The GPP guidelines were developed to facilitate
    the building of effective partnerships among all
    research stakeholders.

4
GPP guidelines development
  • The first edition of the guidelines was developed
    by an international, multidisciplinary working
    group, with input from stakeholders around the
    globe.
  • The second edition incorporates feedback gathered
    through global consultations and piloting.

5
GPP guidelines development
  • The guidelines are meant to serve as a companion
    to the UNAIDS/WHO publication Ethical
    Considerations in Biomedical HIV Prevention
    Trials.
  • More specifically, they are intended to explain
    how Guidance Point 2 Community Participation
    can be applied.

6
GPP guidelines, second edition

7
  • What is the objective of the 2011 GPP guidelines?

8
Objective of the GPP guidelines
  • To set global standard practices for stakeholder
    engagement.
  • To provide trial funders, sponsors, and
    implementers with systematic guidance on how to
    effectively engage with stakeholders in the
    design, conduct, and outcome of biomedical HIV
    prevention trials.

9
  • Who should use the GPP guidelines?

10
Intended audience of the GPP guidelines
  • The GPP guidelines are primarily written for
    trial funders, sponsors, and implementers.
  • Stakeholders, such as NGOs, policymakers, and
    CABs, can use the GPP guidelines to understand
    the methods of stakeholder engagement and to
    evaluate the engagement efforts of research teams.

11
  • How is GPP different from
  • Good Clinical Practice (GCP)?

12
How is GPP different from GCP?
GPP is about working with stakeholders.
Research Investigator
Trial participants
GCP
Stakeholders
Research teams (and trial sponsors and funders)
Stakeholders
Stakeholders
GPP
Stakeholders
Stakeholders
Stakeholders
13
  • What is in the second edition of the
  • GPP guidelines?

14
Contents of the GPP guidelines, second edition
15
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16
  • The Topic Areas are divided into subsections
  • Definition
  • Relevance to good participatory practice
  • Special considerations
  • Good participatory practices
  • Additional guidance

17
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18
  • How does GPP define stakeholders?

19
Definition of stakeholders
  • The GPP guidelines define stakeholders as
    individuals, groups, organizations, government
    bodies, or any other individuals or collections
    of individuals who can influence or are affected
    by the conduct or outcome of a biomedical HIV
    prevention trial.
  • In the guidelines, the term stakeholders is
    all-encompassing and includes any individual or
    collection of individuals who have a stake in a
    biomedical HIV prevention trial.

20
Examples of stakeholders
21
  • How do the GPP guidelines
  • define stakeholder engagement?

22
Definition of stakeholder engagement
  • It is a process through which trial funders,
    sponsors, and implementers build meaning
    relationships with stakeholders.
  • Its goal is to shape the research process by
    using the expertise of stakeholders.
  • It is not recruitment!

23
  • Why is stakeholder engagement
  • necessary in the research process?

24
Why stakeholder engagement?
  • Stakeholder engagement improves research quality
  • Stakeholders, especially community stakeholders,
    have critical knowledge about local cultures and
    dynamics of the HIV epidemic that trial entities
    may lack. Their feedback can help ensure that the
    research and procedures are culturally sensitive
    and appropriate.
  • A wide range of stakeholders can give research
    teams advice about research questions,
    procedures, and conduct.
  • Stakeholders advice can lead to better
    recruitment, better retention, better adherence,
    better data, and greater likelihood of uptake,
    should HIV prevention interventions prove safe
    and effective.

25
Why stakeholder engagement?
  • Stakeholder engagement not only makes the
    research better it is also ethical.
  • If stakeholders will be affected by the research,
    even if only in an indirect or a minor way, they
    have the right to be meaningfully engaged and to
    help shape the process.

26
  • How can research teams engage
  • with external stakeholders?

27
Stakeholder advisory mechanisms
Engaging with CABs is only one of many, many ways
in which research teams can engage with
stakeholders.
28
Stakeholder advisory mechanisms
Engaging with CABs is often necessary but is
seldom sufficient for adequate stakeholder
engagement. Many mechanisms exist for effective
engagement between researchers and the wide array
of research stakeholders.
29
  • How can the GPP guidelines
  • be used most effectively?

30
They must be adopted and implemented
31
Ensuring GPP uptake
  • Implement
  • Trial sponsors and research teams should follow
    the practices outlined in subsection D for each
    GPP topic area.
  • Implementation should be tailored to individual
    site and research environment.
  • Monitor
  • Stakeholders can assess.
  • Research teams can assess themselves.
  • Community stakeholders, such as community groups
    or CABs, can assess research teams.
  • Trial monitors can conduct assessments.

32
Ensuring GPP uptake
  • Evaluate
  • How did the engagement improve the research?
  • Did stakeholders provide useful feedback during
    the research lifecycle?
  • How do various stakeholders feel about the
    quality of the engagement process and their
    relationships with the research team?
  • Can an association be made between engagement and
    trial outcomes?
  • Note As with monitoring, all stakeholders can be
    involved in the evaluation process and share
    their perspectives.

33
  • How will the GPP guidelines be adopted?

34
How will GPP be adopted?
  • Investment in building relationships is a
    long-term process!
  • Adoption of the guidelines will be different in
    every setting. There isnt one answer or formula.
    It will depend on the country, institution,
    sponsor, and trial site.

35
Who can require adherence to GPP guidelines?
  • Funders and sponsors
  • National governments
  • Ethics Committees or IRBs
  • NGOs/civil society
  • Research teams
  • Community stakeholders
  • Or ... increased awareness may cause GPP to
    become standard practice for conducting research.

36
  • Thank you!
  • www.avac.org/gpp
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