Dataset Information

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

ABSTRACT:

Objectives

Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations.

Methods

From 2008-2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement.

Results

Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of "community"; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted.

Conclusions

This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making.

SUBMITTER: Newman PA

PROVIDER: S-EPMC4546590 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

Newman Peter A PA Rubincam Clara C Slack Catherine C Essack Zaynab Z Chakrapani Venkatesan V Chuang Deng-Min DM Tepjan Suchon S Shunmugam Murali M Roungprakhon Surachet S Logie Carmen C Koen Jennifer J Lindegger Graham G

PloS one 20150821 8

<h4>Objectives</h4>Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight ...[more]

PMID: 26295159

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Project description:IntroductionStakeholder engagement is an essential component of HIV clinical trials. We define stakeholder engagement as an input by individuals or groups with an interest in HIV clinical trials to inform the design or conduct of said trials. Despite its value, stakeholder engagement to inform HIV clinical trials has not been rigorously examined. The purpose of our systematic review is to examine stakeholder engagement for HIV clinical trials and compare it to the recommendations of the UNAIDS/AVAC Good Participatory Practice (GPP) guidelines.MethodsWe used the PRISMA checklist and identified English language studies describing stakeholder engagement to inform HIV clinical trials. Four databases (PubMed, Ovid, CINAHL and Web of Science) and six journals were searched, with additional studies identified using handsearching and expert input. Two independent reviewers examined citations, abstracts and full texts. Data were extracted on country, engagement methods, stakeholder types and purpose of stakeholder engagement. Based on the GPP guidelines, we examined how frequently stakeholder engagement was conducted to inform clinical trial research question development, protocol development, recruitment, enrolment, follow-up, results and dissemination.Results and discussionOf the 917 citations identified, 108 studies were included in the analysis. Forty-eight studies (44.4%) described stakeholder engagement in high-income countries, thirty (27.8%) in middle-income countries and nine (8.3%) in low-income countries. Fourteen methods for stakeholder engagement were identified, including individual (e.g. interviews) and group (e.g. community advisory boards) strategies. Thirty-five types of stakeholders were engaged, with approximately half of the studies (60; 55.6%) engaging HIV-affected community stakeholders (e.g. people living with HIV, at-risk or related populations of interest). We observed greater frequency of stakeholder engagement to inform protocol development (49 studies; 45.4%) and trial recruitment (47 studies; 43.5%). Fewer studies described stakeholder engagement to inform post-trial processes related to trial results (3; 2.8%) and dissemination (11; 10.2%).ConclusionsOur findings identify important directions for future stakeholder engagement research and suggestions for policy. Most notably, we found that stakeholder engagement was more frequently conducted to inform early stages of HIV clinical trials compared to later stages. In order to meet recommendations established in the GPP guidelines, greater stakeholder engagement across all clinical trial stages is needed.

Project description:BackgroundAlthough paternal involvement in the perinatal period is associated with benefits for maternal-child health and reduced obesity risk, fathers are seldom included in perinatal or obesity prevention efforts. Engaging community leaders and fathers as stakeholders in intervention development is a critical step in designing a father-inclusive intervention that is efficacious and responsive to their needs.MethodsWe conducted a structured engagement study, including community stakeholder engagement and qualitative interviews with new fathers, to inform the development of a prospective randomized controlled trial that includes mothers and fathers as equal partners in infant obesity prevention. We interpreted stakeholder feedback through the Consolidated Framework for Implementation Research (CFIR) framework.ResultsBetween September 2019 and April 2020, we held a Community Engagement meeting, formed a Community Advisory Board, and conducted 16 qualitative interviews with new fathers. Stakeholder engagement revealed insights across CFIR domains including intervention characteristics (relative advantage, complexity, design quality & packaging), outer setting factors (cosmopolitanism and culture), individual characteristics (including self-efficacy, state of change, identification with the organization) and process (engagement and adaptation). Stakeholders discussed the diverse challenges and rewards of fatherhood, as well as the intrinsic paternal motivation to be a loving, supportive father and partner. Both community leaders and fathers emphasized the importance of tailoring program delivery and content to meet specific parental needs, including a focus on the social-emotional needs of new parents.ConclusionsA structured process of multidimensional stakeholder engagement was successful in improving the design of a father-inclusive perinatal obesity prevention interventions. Father engagement was instrumental in both reinforcing community ties and increasing our understanding of fathers' needs, resulting in improvements to program values, delivery strategies, personnel, and content. This study provides a practical approach for investigators looking to involve key stakeholders in the pre-implementation phase of intervention development.Trial registrationClinicalTrials.gov, NCT04477577 . Registered 20 July 2020.

Project description:BackgroundThe effects of stakeholder engagement, particularly in comparative effectiveness trials, have not been widely reported. In 2014, eight comparative effectiveness studies targeting African Americans and Hispanics/Latinos with uncontrolled asthma were funded by the Patient-Centered Outcomes Research Institute (PCORI) as part of its Addressing Disparities Program. Awardees were required to meaningfully involve patients and other stakeholders. Using specific examples, we describe how these stakeholders substantially changed the research protocols and in other ways participated meaningfully as full partners in the development and conduct of the eight studies.MethodsUsing the method content analysis of cases, we identified themes regarding the types of stakeholders, methods of engagement, input from the stakeholders, changes made to the research protocols and processes, and perceived benefits and challenges of the engagement process. We used summaries from meetings of the eight teams, results from an engagement survey, and the final research reports as our data source to obtain detailed information. The descriptive data were assessed by multiple reviewers using inductive and deductive qualitative methods and discussed in the context of engagement literature.ResultsStakeholders participated in the planning, conduct, and dissemination phases of all eight asthma studies. All the studies included clinicians and community representatives as stakeholders. Other stakeholders included patients with asthma, their caregivers, advocacy organizations, and health-system representatives. Engagement was primarily by participation in advisory boards, although six of the eight studies (75%) also utilized focus groups and one-on-one interviews. Difficulty finding a time and location to meet was the most reported challenge to engagement, noted by four of the eight teams (50%). Other reported challenges and barriers to engagement included recruitment of stakeholders, varying levels of enthusiasm among stakeholders, controlling power dynamics, and ensuring that stakeholder involvement was reflected and had true influence on the project.ConclusionEngagement-driven modifications led to specific changes in study design and conduct that were felt to have increased enrollment and the general level of trust and support of the targeted communities. The level of interaction described, between investigators and stakeholders in each study and between investigator-stakeholder groups, is-we believe-unprecedented and may provide useful guidance for other studies seeking to improve the effectiveness of community-driven research.

Dataset Information

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

Objectives

Methods

Results

Conclusions

Publications

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

Similar Datasets

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