Background of GPP MAP
The Audience
The Theory behind GPP MAP
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.orem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.orem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.orem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Who Created the GPP MAP Project?
- The GPP MAP study was one component of a larger USAID-funded project led by AVAC and known as the Coalition to Accelerate and Support Prevention Research (CASPR). CASPR supports advocacy, literacy, policy, communications, community engagement, and regulatory activities for biomedical HIV prevention research and development globally, with a particular focus on relevant strategic partnerships in low- and lower middle-income countries.
What is the GPP Map Project?
- The project is an effort to evaluate how GPP works, its strengths and weaknesses, and the extent to which it aligns with participatory research principles and practices more broadly. To achieve this, stakeholders participated in 7 mixed-methods concept mapping surveys to develop a GPP Theory of Change framework
What are the main purposes of the GPP MAP Project?
- The objectives of the GPP MAP project were to:
- Develop a consensus statement on the goals of GPP in clinical trials
- Identify a core set of strategies and associated practices believed to lead to achievement of the goals
- Identify short-term and long-term GPP outcomes of importance to clinical trial stakeholders
- Identify hypothesized causal chains that form pathways from the strategies to the outcomes and the goals
- Through these objectives we sought to develop a Theory of Change framework that reflects how global stakeholders perceive the long-term goals of GPP in clinical trials and the preconditions necessary for achieving those goals.
Survey Overview and Results
Who were surveyed?
Clinical trial stakeholders engaged with biomedical trials for the prevention or cure of HIV, TB, Zika, and Ebola. Recruitment included a wide range of people, from trial participants to global stakeholders, such as employees of WHO, international foundations and funders. To be eligible to participate, people needed to be at least 18 years of age, sufficiently literate in English, and report active involvement in the previous two years in at least one of the roles or activities related to a biomedical prevention trial, including but not limited to HIV, TB, Zika and Ebola. Participants were age, gender, education and geographically diverse
Survey Results
Five GPP strategies were identified to create two self-reinforcing outcome loops:
- Mutuality Loop: Three identified strategies (accountability, context mapping, and continuous community engagement) generate a Mutuality Loop representing a “two-way street” of engagement, understanding, transparency, and trust between researchers and local community stakeholders.
- Ethics Loop: Two identified strategies (minimize risk & burden, maximize benefit) generate an Ethics Loop. This loop leads researchers to value community expertise, be transparent, and more fully understand research participants as people. The Ethics Loop also generates increased trust, reinforcing the Mutuality Loop.
Mutuality Loop
Ethics Loop
Section 2: Ethical Practice Loop
The Ethical Practice Loop is a reinforcing loop of practices that lead researchers to value community expertise, be transparent, and more fully understand research participants as people. The Ethical Practice Loop generates increased participant trust, which in turn reinforces the Mutual Trust Loop. Both the Mutual Trust and Ethical Practice loops share essential features of participatory research: they are centered on direct engagement between researchers and people impacted by the research; awareness of differential power dynamics; and collaborative practice to minimize the risk of exploiting power imbalances and to maximize mutual benefit. The loops differ in where they fall on the continuum of engagement, with the Ethical Practice Loop weighted toward informing research participants and the Mutual Trust Loop weighted toward empowering research stakeholders.
The Ethical Practice Loop highlights GPP practices that are specific to project protocols implemented within a single research site.
The Ethical Practice Loop reflects the language and practices outlined in research ethics documents and related regulatory requirements for clinical trials. It is also aligned with public health-focused and patient-centered frameworks for engaged research.
Examples of measurable components along these pathways include practices reflective of GPP strategies; stakeholder knowledge, attitudes, and perceptions; stakeholder engagement and participation in trials and trial-related activities; research team efficiencies and knowledge/experience with populations; participant adherence, openness, risk reduction and decreased stress; and community acceptance/trust of research and decreased stigma.