Beyond clinical trials: social outcomes of structured stakeholder engagement in biomedical HIV prevention trials in China.
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SUBMITTER: Liu C
PROVIDER: S-EPMC7205565 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesBroad 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.MethodsFrom 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.ResultsAcross 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.ConclusionsThis 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.
| S-EPMC4546590 | biostudies-literature
Project description:In the field of biomedical HIV prevention, researchers have meaningfully incorporated behavioral and social sciences research (BSSR) into numerous clinical trials, though the timing and degree of integration have been highly variable. The literature offers few frameworks that systematically characterize these collaborations. To fill this gap, we developed a typology of BSSR approaches within biomedical HIV prevention research. Focusing on trials that had safety and/or efficacy endpoints, we identified five approaches for combining BSSR and clinical research: formative, embedded, parallel, explanatory, and implications. We describe each approach and provide illustrative examples. By offering a shared vocabulary for distinguishing the timing and design of collaborative BSSR and clinical research, this typology can facilitate greater transparency in collaborators' expectations and responsibilities, and help collaborators address challenges likely to be associated with such interdisciplinary research.
| S-EPMC6647486 | biostudies-literature
Project description:INTRODUCTION:Stakeholder 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. METHODS:We 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 DISCUSSION:Of 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%). CONCLUSIONS:Our 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.
| S-EPMC6192899 | biostudies-other
Project description:Adherence is a critical component of the success of antiretroviral-based pre-exposure prophylaxis (PrEP) in averting new HIV-infections. Ensuring drug availability at the time of potential HIV exposure relies on self-directed product use. A deeper understanding of how to best support sustained PrEP adherence remains critical to current and future PrEP efforts. This paper provides a succinct synthesis of the adherence support experiences from four pivotal PrEP trials--Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, FEM-PrEP, Iniciativa Prophylaxis (iPrEx), and Vaginal and Oral Interventions to Control the Epidemic (VOICE). Notwithstanding variability in the design, population/cohort, formulation, drug, dosing strategy, and operationalization of adherence approaches utilized in each trial, the theoretical basis and experiences in implementation and monitoring of the approaches used by these trials provide key lessons for optimizing adherence in future research and programmatic scale-up of PrEP. Recommendations from across these trials include participant-centered approaches, separating measurement of adherence from adherence counseling, incorporating tailored strategies that go beyond education, fostering motivation, and addressing the specific context in which an individual incorporates and negotiates PrEP use.
| S-EPMC3672509 | biostudies-literature
Project description:South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders' perspectives on ethical guidance related to prevention and care in HIV vaccine trials.Site staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n?=?98) rated each recommendation on five dimensions: "Familiarity with", "Ease of Understanding", "Ease of Implementing", "Perceived Protection", and "Agreement with" each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups.Both care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was "Ease of Implementing," and the least problematic was "Agreement with," suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations.We propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for "Ease of Implementing", and/ or "Ease of Understanding" in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.
| S-EPMC4104735 | biostudies-literature
Project description:In 2004 and 2005, the first clinical trials were launched to investigate the use of tenofovir for HIV prevention in Cambodia,Cameroon, Nigeria and Thailand. Controversies erupted over the ethical integrity of the research protocol. We reflect on the events that ledto the controversies and identified that scientific and ethical concerns raised by members of local communities at each of these sites wereerased by trialists, causing crisis that led to premature shut down the early PrEP trials. In the aftermath of these trials, the World HealthOrganisation, UNAIDS, and AVAC developed ethics guidelines intended to recognize the concerns as authentic, and developed guidelines toimprove researchers' engagement of communities in biomedical HIV prevention trial design and implementation. Our findings suggest thatthe ethics guidelines are limited in its ability to address power inequalities that leads to voice erasures and non-recognition of localcompetencies. Rather the ethical documents enabled trialists to gain a new sense of authority through the interpretations of ethical researchconduct enabling trialists regain power that can further entrench inequality and voice erasures. To address concerns with what seems anintractable problem, we suggested models of engagement for off-shored research may be the option.
| S-EPMC7448920 | biostudies-literature
Project description:Background-to guide the implementation of patient centricity and engagement in cancer clinical trials (CTs) and to operationalize the Canadianized version of the Clinical Trials Transformation Initiative (C-CTTI) model, the development of a charter was identified by cancer CT stakeholders. Methods-the Canadian Cancer Trial Stakeholder Charter (the Charter) was initiated by Colorectal Cancer Canada (CCC) and developed via the-1-formation of an inclusive working group (WG) that drafted the document using recommendations collected during the development of the C-CTTI model; 2-socialization of the draft Charter to solicit feedback from cancer CT stakeholders, including those who attended the 2019 CCC Conference; and 3-incorporation of stakeholders' feedback and finalization of the Charter by the WG. Results-the Charter was built around five guiding principles-1-patient centricity; 2-commitment to education and training; 3-collaboration as equal and independent partners in research; 4-transparency and accountability; and 5-high standards in data collection integrity and honesty. These principles led to the Charter's five tenets, which stipulate stakeholder commitments, aiming to make CTs accessible to all patients, improve the design and implementation of CTs to benefit patients, expand recruitment and retention of patients in CTs, and further advance cancer research and treatment. Conclusions-the Charter is intended to integrate the patient voice into the Canadian cancer CT continuum. The next phases of the C-CTTI model include the adoption and implementation of the Charter, the establishment of a patient group training program, and the development of real-world evidence/real-world data methodologies.
| S-EPMC8167642 | biostudies-literature
Project description:International trials have shown that CD4+ T-cell-guided structured treatment interruptions (STI) of antiretroviral therapy (ART) lead to worse outcomes than continuous treatment. We simulated continuous ART and STI strategies with higher CD4+ T-cell interruption/reintroduction thresholds than those assessed in actual trials.Using a model of HIV, we simulated cohorts of African adults with different baseline CD4+ T-cell counts (< or = 200; 201-350; and 351-500 cells/microl). We varied ART initiation criteria (immediate; CD4+ T-cell count < 350 cells/microl or > or = 350 cells/microl with severe HIV-related disease; and CD4+ T-cell count <200 cells/microl or > or = 200 cells/microl with severe HIV-related disease), and ART interruption/reintroduction thresholds (350/250; 500/350; and 700/500 cells/microl). First-line therapy was non-nucleoside reverse transcriptase inhibitor (NNRTI)-based and second-line therapy was protease inhibitor (PI)-based.STI generally reduced life expectancy compared with continuous ART. Life expectancy increased with earlier ART initiation and higher interruption/reintroduction thresholds. STI reduced life expectancy by 48-69 and 11-30 months compared with continuous ART when interruption/reintroduction thresholds were 350/250 and 500/350 cells/microl, depending on ART initiation criteria. When patients interrupted/reintroduced ART at 700/500 cells/microl, life expectancies ranged from 2 months lower to 1 month higher than continuous ART. STI-related life expectancy increased with decreased risk of virological resistance after ART interruptions.STI with NNRTI-based regimens was almost always less effective than continuous treatment, regardless of interruption/reintroduction thresholds. The risks associated with STI decrease only if patients start ART earlier, interrupt/reintroduce treatment at very high CD4+ T-cell thresholds (700/500 cells/microl) and use first-line medications with higher resistance barriers, such as PIs.
| S-EPMC3220615 | biostudies-other
Project description:For the past 50 years, acknowledgments have been studied as important paratextual traces of research practices, collaboration, and infrastructure in science. Since 2008, funding acknowledgments have been indexed by Web of Science, supporting large-scale analyses of research funding. Applying advanced linguistic methods as well as Correspondence Analysis to more than one million acknowledgments from research articles and reviews published in 2015, this paper aims to go beyond funding disclosure and study the main types of contributions found in acknowledgments on a large scale and through disciplinary comparisons. Our analysis shows that technical support is more frequently acknowledged by scholars in Chemistry, Physics and Engineering. Earth and Space, Professional Fields, and Social Sciences are more likely to acknowledge contributions from colleagues, editors, and reviewers, while Biology acknowledgments put more emphasis on logistics and fieldwork-related tasks. Conflicts of interest disclosures (or lack of thereof) are more frequently found in acknowledgments from Clinical Medicine, Health and, to a lesser extent, Psychology. These results demonstrate that acknowledgment practices truly do vary across disciplines and that this can lead to important further research beyond the sole interest in funding.
| S-EPMC5627922 | biostudies-literature
Project description:BackgroundReducing harm associated with selling and purchasing sex is an important public health priority in China, yet there are few examples of sustainable, successful programs to promote sexual health among female sex workers. The limited civil society and scope of nongovernmental organizations circumscribe the local capacity of female sex workers to collectively organize, advocate for their rights, and implement STI/HIV prevention programs. The purpose of this study was to examine social networks among low-income female sex workers in South China to determine their potential for sexual health promotion.Methods/principal findingsSemi-structured interviews with 34 low-income female sex workers and 28 health outreach members were used to examine how social relationships affected condom use and negotiation, STI/HIV testing and health-seeking behaviors, and dealing with violent clients. These data suggested that sex worker's laoxiang (hometown social connections) were more powerful than relationships between women selling sex at the same venue in establishing the terms and risk of commercial sex. Female sex workers from the same hometown often migrated to the city with their laoxiang and these social connections fulfilled many of the functions of nongovernmental organizations, including collective mobilization, condom promotion, violence mitigation, and promotion of health-seeking behaviors. Outreach members observed that sex workers accompanied by their laoxiang were often more willing to accept STI/HIV testing and trust local sexual health services.Conclusions/significanceOrganizing STI/HIV prevention services around an explicitly defined laoxiang social network may provide a strong foundation for sex worker health programs. Further research on dyadic interpersonal relationships between female sex workers, group dynamics and norm establishment, and the social network characteristics are needed.
| S-EPMC3172283 | biostudies-literature