Aims and objectives
The purpose of this study is to assess the feasibility and acceptability of source plasma donation with revised eligibility criteria for gbMSM in two Canadian cities. Our specific objectives are to identify the following:
Views and experiences of gbMSM regarding source plasma donation, current eligibility criteria and revised eligibility criteria.
The acceptability of additional behavioural questions during the screening process from the perspective of gbMSM.
Potential barriers and enablers to source plasma donation from the perspective of gbMSM.
The acceptability of additional behavioural questions during the screening process from the perspective of donor centre staff.
Potential barriers and enablers from the perspective of donor centre staff in the donation clinic to implementing new eligibility criteria for gbMSM to donate and to inform the adaptations needed to centre flow and processes prior to piloting.
Consistencies and discrepancies between the two Canadian cities and implications for tailoring strategies to support gbMSM source plasma donation in each context.
An integrated knowledge approach
Consistent with an IKT approach, the initial topic was born out of Canadian Blood Services seeking to better understand the feasibly of a source plasma programme for gbMSM with more inclusive donation eligibility criteria and the broader voice of gbMSM demanding greater equality as it relates to donation. The research questions were collaboratively developed by the research team consisting of scientists and collaborators from research institutions, Canada’s two national blood operators, and a local LGBT2Q+ community organisation to ensure diverse perspectives and expertise. While our team offers both insider and outsider perspectives with respect to the donor centre working environment and identifying as gbMSM, we sought out greater inclusion of gbMSM voices in the design and conduct of the study design. We first consulted with community members through outreach and engagement activities and these activities resulted in the formation of a Local Advisory Group of gbMSM. Local advisors are key members of the research team (rather than participants) who provide ongoing input in monthly group meetings and in individual exchanges by email or phone as needed. They provide feedback on study design, contribute to survey and interview guide development, and help to develop and facilitate the recruitment strategies. They will review and provide feedback of summaries of analysis and results, advise on next steps, and help disseminate findings.
This mixed-methods feasibility study will explore the views of gbMSM and donor centre staff regarding source plasma donation and eligibility criteria to better understand the modifiable barriers and enablers to implementing revised eligibility criteria. We will use qualitative interviews and an online anonymous survey to identify the barriers and enablers to source plasma donation that may emerge with the implementation of revised screening criteria for source plasma donation by gbMSM. Qualitative interviews will be used to elicit potential barriers and enablers to implementing revised eligibility from the perspectives of donor centre staff.
This study will be conducted in London (Ontario) and Calgary (Alberta). Canadian Blood Services operate two dedicated source plasma donation centres that are located in London (Ontario) and Calgary (Alberta). These centres are potential locations for a first implementation of a gbMSM source plasma donation programme if approved by Health Canada. The study was first developed in London (Ontario) due to operational feasibility and strong relationships with the local gbMSM community. The research team sought additional funding to expand the project to Calgary (Alberta).
Many factors may emerge as barriers and enablers to source plasma donation by gbMSM or to donor centre staff’s implementation of revised eligibility criteria. Solutions and strategies for encouraging and supporting donation should be tailored to address these barriers to ensure that the supports developed are fit for purpose . Theories of behaviour provide a useful set of factors to consider when investigating barriers and enablers. By providing an understanding of which modifiable factors may be associated to implementing revised criteria, such theories provide a source of factors that could then be directly targeted to develop strategies and materials to support donation. There are many different theories that could be used as a basis for identifying such factors in a systematic way. A group of researchers sought to synthesise key content across 33 predominant theories and the 128 constructs within them. They developed the Theoretical Domains Framework (TDF) [29, 30], which summarises key factors from theory that are known to be associated with behaviour and behaviour change and is well suited to explore the full breadth of factors that are relevant in this behaviour and population. The TDF identifies 14 different modifiable factors, as follows: knowledge, skills, beliefs about capabilities, optimism, beliefs about consequences, intention, goals, professional/social role and identity, social influences, reinforcement, behavioural regulation, emotion, memory/attention/decision processes, and environmental context and resources. Clear guidance has been developed to use the TDF for developing qualitative interview guides  and quantitative surveys . The TDF has been used broadly as a basis for understanding barriers and enablers in the healthcare setting and with the public [32,33,34,35]. Once identified, this approach specifically suggests particular strategies and behaviour change techniques that best suit addressing the barriers and enablers identified based on expert review and the evidence base .
Participants and recruitment
We will use a combination of purposive and snowball sampling to recruit adult (18+) gbMSM in London (Ontario) and Calgary (Alberta) as well as in surrounding communities for interviews. Purposive sampling will be used to recruit gbMSM who represent a breadth of age, cultural backgrounds and geographic locations (rural/urban). We will work with our local advisory groups, local organisations and social groups that provide services to gbMSM to help identify potential participants. In 2020, many countries, including Canada, were practicing social distancing to reduce the spread of COVID-19. In light of this, we will advertise on social media platforms with assistance from organisations that provide services to gbMSM. We recognise that this method of sampling may not reach those who are not active on social media and, as such, we will supplement this strategy with snowball sampling methods by inviting participants to recommend others for participation. Snowball sampling is well suited for the recruitment of traditionally underserved groups and those who experience stigmatisation, including gbMSM.
We will conduct up to two semi-structured interviews per participant, by phone, scheduled over a period of 2–6 weeks. Informed consent will be obtained prior to the interview. Interviews will be approximately 60 min in length and audio-recorded for verbatim transcription. The use of a multiple interview format will promote the development of rapport over time, facilitating the discussion of sensitive and personal topics while allowing time for reflection and elaboration . We will offer the option of one longer interview if participants prefer, to take a participant-centred approach to data collection. Field notes will be captured after each interview to assist with analysis and reflection on the impact of the interviewer’s positionality on the data generated. Interview participants will receive a CAD$ 20 gift card at each interview session to thank them for their time, to a maximum of CAD$ 40 per person. Participants that opt for one longer interview will receive a CAD$ 40 gift card.
Interview guide development
The first interview will explore the context of how source plasma donation is perceived by gbMSM using a semi-structured approach to interviewing. Key interview questions will be used to help define the areas to be explored but the interview style will remain flexible to allow for the discovery and discussion of topics of importance to the participant [38, 39] that may not have otherwise been thought of as pertinent by the research team . The topic guide includes questions regarding experiences of donation, deferral or exclusion, views on current gbMSM donor deferral criteria, and the acceptability of the three behavioural screening questions suggested for inclusion in revised eligibility criteria.
The second interview will build on the first to elaborate on emerging themes and explore participants’ views regarding the implementation of revised eligibility criteria, potential impacts of revised eligibility criteria on donation practices, and possible barriers and enablers to source plasma donation. The topic guide for the second interview draws on existing literature  and previously developed guides  to assess if and how the identified barriers align with TDF domains. Interview guides will be reviewed by the study’s local advisory groups in each city and piloted prior to broad enrolment. At the end of the interviews, participants will be asked about the interview experience and this feedback will be considered and incorporated as appropriate.
Our sample size will be determined by the available number of interviewees. We aim to recruit 15–20 men from each region to complete a series of two interviews. This sample size estimate is informed by the scope of the study, the nature of the topic and the use of a multiple interview format . Given that data collection and analysis are concurrent, informational and thematic redundancy [42, 43] will be assessed on an ongoing basis and the number of interviews will largely be driven by the quality and richness of data . Drawing on the literature, saturation is often reached within 15–20 TDF interviews [33, 34].
Interviews will be audio recorded, transcribed verbatim and de-identified prior to analysis. As an additional step, we will send each participant their written transcript to review for completeness and resonance. We will use NVivo12 to facilitate analysis. Data collection and analysis will be concurrent to generate emerging understanding of the research questions, which will inform both the sampling and the questions being asked . We will conduct two phases of qualitative descriptive analysis—inductive thematic analysis  to identify, analyse and report patterns within the data, and theory-driven, directed content analysis to code barriers and enablers expressed by gbMSM to specific TDF domains . Throughout, reflexive journaling will be used to capture the analytic process and any developing insights about the patterns in the data. Data from each region will be analysed separately as each context may have unique cultural, societal and political forces that shape the views of gbMSM regarding source plasma donation. We will contrast findings between cities to inform city-specific modifications for implementation.
During thematic analysis, we will follow the six analytic steps proposed by Braun and Clark : becoming familiar with the data, generating initial codes, searching for themes, reviewing themes, defining and naming themes, and producing the report. We will then re-visit the data during directed content analysis and use guidance from the literature  to code barriers and enablers to source plasma donation expressed by gbMSM to specific TDF domains . We will develop a code book to enhance the reliability of coding. To enhance the trustworthiness of our findings, we will use a combination of duplicate coding by two researchers trained in both inductive analysis and the use of the TDF, peer debriefing activities and consensus-building measures.
We will invite adult gbMSM (aged 18+) living in London (Ontario) and Calgary (Alberta) to complete an anonymous questionnaire regarding their views about current and potential future barriers and enablers to donating source plasma. Questionnaire items will enable the assessment of respondents’ eligibility to donate according to the revised criteria but will not exclude participants to the survey on the basis of these criteria.
Recruitment and procedure
Our local advisory groups of gbMSM will facilitate recruitment by providing access to the venues and organisations through which a link to the online survey can be circulated as well as by advising on additional non-traditional venues for recruiting participants. We will offer the opportunity to enter a draw for one of ten pre-paid Visa gift cards valued at CAD$ 125 each.
The questionnaire will be designed for completion by adult gbMSM and will include screening questions to ensure that we involve our targeted respondents. We will use items from a TDF questionnaire previously assessed for its discriminant content validity  to assess barriers and enablers to donating source plasma if they were eligible under revised eligibility criteria. Appropriate language and response options will be informed by the interviews; thus, certain questions may be unique to each city. The questionnaire will be piloted by gbMSM prior to launching.
Our analytical approach is modelled on an approach used by Presseau et al. . We will conduct descriptive analyses to identify mean scores and standard deviations on each of the 14 TDF domains. As donation represents a hypothetical behaviour for respondents at the moment, we will assess intention to donate as a proxy for actual donation (consistent with other donation studies) . We will assess bi-variate associations between intention to donate source plasma with socio-demographic factors, including self-identified gender, eligibility to donate (based on revised criteria) and responses to each TDF domain. Informed by behavioural theory [33, 48], we will then conduct multiple regression analysis to investigate which variables are associated with gbMSM’s intention to donate source plasma. We will investigate whether these associations are moderated by their eligibility as determined by the revised criteria. If the surveys end up very similar between sites, we will analyse the combined sample and investigate whether the associations differ by location. We are powered to conduct independent analyses in each region if needed.
For analysis of our survey data, for a regression model comprised of data covering 20 independent variables [i.e. 13 TDF domains (not including intention), as well age, self-identified gender, rural/urban, sex with new partner in last 12 months (yes/no), sex with more than one partner in last 3 months (yes/no), in a monogamous relationship (yes/no), married (yes/no)], we will require a total sample size of 314 participants (157 participants in each region) to detect a medium effect size (R2 = 0.15). We will aim to continue to recruit until this sample is exceeded or the recruitment period is completed (6 months).
Participants and recruitment
We will interview English-speaking donor centre staff involved in applying current eligibility criteria or discussing eligibility with potential donors at the London donor centre. Recruitment will be facilitated by our stakeholder contacts at the donor centre. Nurses and donor care associates will be invited to participate in a one-on-one semi-structured telephone interview lasting 30–45 min. Interviews will focus on the barriers and enablers to using each of the proposed revised screening criteria.
Our approach to interview guide development, data analysis and sample size is rooted in the TDF framework and will follow the methods outlined for the interviews with gbMSM.
The findings of the study may be of interest to diverse audiences and require a multi-pronged dissemination strategy. A key advantage of an IKT approach is that stakeholders are members of the research team and provide real-time guidance on the type of dissemination that is needed at different stages of the project. Our first priority is to work with our stakeholders to ensure they have the findings in an appropriate format and to develop a dissemination plan for their respective communities. We will collaborate with our local advisory groups of gbMSM to disseminate among their local communities and beyond, which may involve a website and online events or articles in gbMSM-focused venues. We will also work with our blood operator stakeholders to disseminate appropriately through their organisations and international networks. Beyond our stakeholders, dissemination of this work is likely relevant to stakeholders outside the traditional scientific audience and, thus, we will aim to publish in open-access journals or repositories and share these via social media to reach a broader audience.
Source plasma donation by sexually active gbMSM is not currently permitted. The data generated in this study is based on a hypothetical change in policy. The barriers and enablers will be elicited by asking respondents to answer to a hypothetical scenario, which may be different from their responses to real-life scenarios . If revised eligibility is approved, ongoing investigation is needed alongside any initial implementation.
This protocol is based on a grant funded by Health Canada, administered by Canadian Blood Services, and peer-reviewed by experts external to the funder and blood operator. The study has been reviewed and received ethics approval from the Ottawa Health Science Network Research Ethics Board (ID # 20190287-01H and 20200255-01H). The Canadian Blood Services Ethics Board has also reviewed and approved the parts of the study involving donor centre staff (ID 2019.020). At the time of submission, recruitment and data collection had begun with donor centre staff and gbMSM.