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BACKGROUND/AIMS:Community engagement is widely acknowledged as an important step in clinical trials. One underexplored method for engagement in clinical trials is crowdsourcing. Crowdsourcing involves having community members attempt to solve a problem and then publicly sharing innovative solutions. We designed and conducted a pilot using a crowdsourcing approach to obtain community feedback on an HIV clinical trial, called the Acceptability of Combined Community Engagement Strategies Study. In this work, we describe and assess the Acceptability of Combined Community Engagement Strategies Study's crowdsourcing activities in order to examine the opportunities of crowdsourcing as a clinical trial community engagement strategy. METHODS:The crowdsourcing engagement activities involved in the Acceptability of Combined Community Engagement Strategies Study were conducted in the context of a phase 1 HIV antibody trial (ClinicalTrials.gov identifier: NCT03803605). We designed a series of crowdsourcing activities to collect feedback on three aspects of this clinical trial: the informed consent process, the experience of participating in the trial, and fairness/reciprocity in HIV clinical trials. All crowdsourcing activities were open to members of the general public 18 years of age or older, and participation was solicited from the local community. A group discussion was held with representatives of the clinical trial team to obtain feedback on the utility of crowdsourcing as a community engagement strategy for informing future clinical trials. RESULTS:Crowdsourcing activities made use of innovative tools and a combination of in-person and online participation opportunities to engage community members in the clinical trial feedback process. Community feedback on informed consent was collected by transforming the clinical trial's informed consent form into a series of interactive video modules, which were screened at an open public discussion. Feedback on the experience of trial participation involved designing three fictional vignettes which were then transformed into animated videos and screened at an open public discussion. Finally, feedback on fairness/reciprocity in HIV clinical trials was collected using a crowdsourcing idea contest with online and in-person submission opportunities. Our public discussion events were attended by 38 participants in total; our idea contest received 43 submissions (27 in-person, 16 online). Facebook and Twitter metrics demonstrated substantial engagement in the project. The clinical team found crowdsourcing primarily useful for enhancing informed consent and trial recruitment. CONCLUSION:There is sufficient lay community interest in open calls for feedback on the design and conduct of clinical trials, making crowdsourcing both a novel and feasible engagement strategy. Clinical trial researchers are encouraged to consider the opportunities of implementing crowdsourcing to inform trial processes from a community perspective.

Additional file 5: Table S11. Bias assessment of four non-RCT studies evaluating innovation design contests to develop sexual health messages.

Supplemental material, Supplemental_Material for Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial by Suzanne Day, Allison Mathews, Meredith Blumberg, Thi Vu, Stuart Rennie and Joseph D Tucker in Clinical Trials

Additional file 1.

Background: Goffman’s theory on stigma management has provided a useful framework for understanding the relationship between stigma, identity salience, and strategies used to reduce identity conflict. However, Goffman focused his analysis on people who only dealt with one stigma at a time. More recently, scholars have expanded on Goffman’s work to examine how people manage more than one stigma simultaneously to reduce identity conflict. These contributions focus on hidden stigmas like mental illness and disease status without consideration of the effect that having a visibly stigmatized identity may have on stigma management strategies. I argue that it is important to consider how multiple types of stigmatized identities, including those attached to stigmas attached to both visible and hidden characteristics, interact to influence identity salience. It is possible that because visibly stigmatized characteristics are harder to hide, and subsequently control, they lead to more experiences with discrimination and increase the salience of the identity related to the stigma. Additionally, few scholars have examined how identity salience may shape people’s use of particular stigma management strategies. By examining the relationship between stigma management and identity salience, this study provides insight into how salient identities influence which stigma management strategies are used in particular contexts. Objective: To better understand stigma management and the role of identity salience, this study examines the church-going decisions of Black gay men (henceforth, BGM). I focus on BGM’s church-going decisions because Black churches have long been a space of refuge as well as community for Blacks in the US. However, many Black churches also have a reputation for being firmly anti-gay. Thus, BGM’s church-going decisions, identity construction processes, and decisions about gay identity disclosure provide an opportunity to study how people manage stigma in the face of multiple stigmatized identities, one that is visible (Black) and one that is hideable (gay). While churches may provide some respite from racial discrimination for Black men, they may, on the other hand, stigmatize BGM for being gay. How, then, do BGM manage this dilemma? How do they manage the identity conflict and the stigma? Do they privilege one identity over the other? How does the visibility of the stigma influence the process? Method: To answer these questions, I conducted a multi-method study. I constructed interview and survey questions based on previously validated scales. I conducted and analyzed semi-structured interviews and online surveys with 31 self-identified BGM between 23 and 57 years old. The survey data served as supplemental data that provided a link between participants’ interview responses and standardized measures of Black identity, religious orientation, and attitudes toward homosexuality and gay identity. Lastly, I conducted 25 hours of ethnographic observation at various types of churches the men attended to provide context. Findings: Despite experiencing anti-gay stigma in some Black churches, findings reveal that BGM overwhelmingly maintain connections to Black churches. To do so, however, BGM use multiple strategies to manage stigma and identity conflict, including making distinctions between “normal” Black churches and those that endorse explicit messages about homosexuality as a way to distance themselves from the stigma associated with visible characteristics of homosexuality. BGM also find ways to manage anti-gay stigma within churches by constructing a faith-based identity that integrates their Black and gay identities. To construct a faith-based identity, BGM make distinctions between being spiritual and religious as a way to create social distance between themselves and “hypocritical” and “judgmental” religious others. Lastly, BGM use gay identity disclosure in Black churches to challenge anti-gay stigma and advocate on behalf of other BGM and boys. The pervasiveness of racial discrimination informs their decisions to continue participating in or maintain connections to predominantly Black churches, regardless of denominational affiliation and theological stance on homosexuality. Survey data further support this finding, showing that participants score highly on Black identity salience and positive attitudes toward identifying as gay as they continue to participate in and maintain connections to Black churches. These choices signal the salience of Black identity in these men’s lives and the primacy that the visibility of stigmatized characteristics associated with homosexuality plays in shaping BGM’s stigma management strategies. The study results show that people with multiple stigmatized identities may make efforts to minimize discriminatory experiences associated with the visibility of a stigma by choosing to participate in environments with individuals who share cultural similarity and do not emphasize their difference. This decision provides stigmatized BGM with more flexibility to control disclosure of their hidden stigmatized identity, challenge stigma, and claim recognition of their gay identity in Black churches.

Few sociologists have examined whether the support systems that stigmatized people use to deal with intolerance also serve as sources of strain. I address this by studying how black heterosexual and gay men handle pressures to conform to traditional masculine behaviors and how sources of support simultaneously serve as sources of strain. The sample consisted of 29 black men (8 gay, 3 bisexual, 19 heterosexual) at three major universities in the south, ages 18 to 23. I used a snowball sample of black gay and heterosexual students involved in student-led campus organizations and their friends. Through participant observation at the student organizations and open-ended interviews, I examined their strategies for dealing with pressure to conform to masculine norms and/or combat the stigma of homosexuality. This exploratory study examines the relationships between stigmatized identities, perceived social attitudes toward masculinity, and strategies to deal with pressures to conform to masculinity. The data showed a pattern of black men creating boundaries between themselves and stigmatized others in lower statuses to combat heterosexist and racist discrimination. However, the men's boundary making and defensive othering served to reproduce the inequality they opposed.