Kit use was summarised again from the 3-month survey alongside acceptability variables pertaining to instructions, simplicity of test performance and overall experience. A qualitative study was undertaken with 10 cis-gender MSM participants during the pilot in order to examine intervention acceptability in greater depth. Sampling aimed to be diverse with regard to testing history: whether an individual had tested in the 12 months before joining SELPHI; not tested in the preceding 12 months; or never previously tested for HIV.
Efforts were made to ensure sample diversity with regard to demographic features, especially education. A semi-structured interview topic guide was developed to explore questions from formative research [ 11 , 34 ], including issues related to capability, HIVST potential, anticipated responses and acceptability and mapped onto COM-B. All interviews were audio recorded and transcribed.
A thematic framework was developed for analysis, fusing the approaches described by Braun and Clarke [ 36 ] and Richie and Spencer [ 37 ]. This inductive process involved familiarisation with the transcripts and drawing out emerging themes. These themes were arranged into groups, with higher-level themes emerging from sub-themes, both organised hierarchically, and again mapped onto COM-B to better elucidate how acceptability of intervention components related to the behaviour change domains.
The framework was piloted on two transcripts, refined, and applied to all remaining transcripts. We draw data from across this framework and report themes by COM-B domain for simplicity of interpretation. All RCT participants provided online written consent. Qualitative sub-study participants provided verbal recorded consent at the time of interview.
Costs were stable through this phase, with no evidence in the pilot of diminishing returns. The recruitment strategy engaged a range of MSM, but less so trans women. Median age was As anticipated, Growlr recruited older participants whereas Facebook recruited younger ones. Free advertising targeted towards trans people was most effective for reaching trans participants, although numbers were small.
All participants were cis-MSM. When discussing their motivations for joining SELPHI, participants described three predominant motivations: i to access HIV testing; ii desire to use a novel technology; and iii altruism. This was especially true for those who had never tested, and those who had not tested within the preceding twelve months. Opportunity barriers e. Altruistic motivations were reported by just over half of participants with a range of testing histories.
These were predominantly secondary motivations, helping support the decision to join a trial. Motivations were related to notions of good citizenship, desire to contribute to the gay community and to science more broadly. This indicates that although a significant minority delayed kit use, most did use the test kit by three months. All qualitative interview participants had used their kits to test themselves. Below we describe intervention acceptability as it relates to the main domains of COM-B: capability, opportunity and motivation.
Themes around physical capability tended to concern the instructions and using the lancet to take a blood sample. The inclusion of the two-week follow-up processes was a valued intervention element addressing psychological capability. The instructions were generally felt to be easy to understand and interpret, although one participant felt they did not cater to a sufficiently diverse range of skills. The testing process was described as simple and the result was easy to interpret:. Very clear and it was quite obvious as well what goes where and how to do it. It was clear.
The descriptions and the pictures were easy to follow 29 year-old man, undisclosed sexual orientation, tested in last 5 years. Blood collection via the included lancet was a barrier for some. Those who had no previous experience of drawing blood with a lancet reported concerns about their capability to collect their own sample, although all felt with experience this would no longer be an issue. Capability psychological also emerged when discussing the support components of the intervention. Participants generally felt that the supporting information provided was adequate and did not diminish acceptability of the intervention.
What I think relieved me of most of the anxiety was actually the kit included a card saying, at the end, if you are diagnosed with HIV then not to worry, here's what you can do. A, B, C. And if you're not, great. And I think the steps on that card saying, if you are, step one, step two, step three, it helped to relieve some of the uncertainty of what might happen if the test came out positive. Themes related to acceptability of the entire intervention package were primarily related to opportunity physical and social. For participants located in areas underserved by HIV testing opportunities, the kit ameliorated geographic barriers.
Individuals who faced psychosocial barriers to testing felt HIVST gave them increased privacy around testing, enhancing the acceptability of the intervention. Despite high acceptability related to the follow-up provided, HIVST as a concept was perceived to be associated with increased anxiety relative to other testing opportunities.
The 15 min interval between conducting the test and reading the result was described as an exceptionally anxious time, especially for those who had tested due to risk. I was feeling nervous actually because I was thinking what about if it does come back positive. All participants described significant relief when reading a negative non-reactive result. A minority, who had more experience of HIV testing, felt that HIVST was associated with less anxiety than testing methods relying on laboratory-run tests due to the relative immediacy of results.
Advertising performance varied according to platform by click and registration conversions and, crucially, cost. The pilot sample was predominantly white, well-educated, gay identified cis-MSM who reported CAI in the 3-months preceding and who had tested for HIV in the preceding months. The pilot struggled to recruit significant numbers of trans people, particularly trans women. Our recruitment did however, reach a range of participants across demographic groups.
Platforms recruited participants of a similar demographic and behavioural profile except when considering age and gender identity. The kit was considered usable and the intervention was acceptable across the three dimensions interrogated ease of use of instructions, test simple to perform and overall experience. Qualitative data provides nuance, with some participants reporting difficulty using the lancet.
The relationship between HIVST and anxiety was ambiguous; individuals thought it could increase or ameliorate anxiety depending on previous HIV testing experience. This is a key group with clear HIV prevention needs who should be a primary target for new testing interventions. The sample recruited in the pilot was comparable to previous convenience samples of MSM, as well as the ethnic make-up of the UK [ 38 , 39 ]. This indicates that this type of recruitment strategy is capable of reaching a group broadly representative of UK MSM in terms of ethnicity.
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A group which is underrepresented when compared to national statistics is MSM of Asian ethnicity [ 39 ]. This could be due to specific privacy barriers to a postal delivery HIVST service experienced by this group, outlined in formative work [ 11 ]. Acceptability and ease of use was very high, and indeed higher than in many other studies with MSM [ 8 ].
This is not without precedent, with similar levels of acceptability and reported ease of use observed in other settings [ 13 , 40 , 41 ]. These studies however provided oral fluid HIVSTs, which may have benefits in terms of simplicity though have lower sensitivity and specificity over kits which require self-collection of a whole blood sample [ 8 , 42 ].
Qualitative accounts of acceptability focused on COM-B domains related to capability more than opportunity or motivation [ 20 ].
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This could signify that when engaging with this novel testing technology, individuals are often doing so with questions about their own skills and capacity. Indeed, using the lancet was described as difficult for many, although they managed to use it successfully despite this, and all expected this would improve with experience. An additional focus of enquiry for future study is the experience of those who have reactive tests both confirmed as positive and subsequently confirmed negative to better understand their experiences, support needs and any potential harms arising.
A number of changes to the trial design were made as a result of this pilot. For the main roll-out of the RCT the language in the email linking the two surveys was made more motivational, specifically highlighting altruism. In addition, all messages used in the roll-out were designed to more clearly emphasise trans eligibility. In response to the increased costs generated by attrition and to take advantage of advertising efficiencies at larger scales, national rather than regional advertising campaigns were prioritised to increase recruitment volumes. Advertisement messages were also altered, with increasing use of motivational elements.
In efforts to increase survey completion rates, the number of reminders was increased from 2 to 3, and delivery times were staggered at different times of the day to account for a variety of employment patterns. A strength of this pilot is that the design perfectly mimics the full trial. Nevertheless, some limitations are noted. Recruited costs per participant should be treated with some caution.
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In addition, recruitment costs in this pilot phase did not show evidence of diminishing returns per participant randomised, meaning that overall cost per participant could become much higher when recruiting larger numbers. Test kit usability and intervention acceptability were extremely high when compared to other recent studies [ 8 ].
A possible explanation is the informed consent procedures in place provided a great deal of information about what a participant could expect from the study and the kit itself in a level of detail that a service might not include. This pilot struggled to recruit large numbers of trans people compared with cis gender MSM. In addition, sexual practice among MSM is diverse. This issue may be an especially pronounced for trans MSM and may have contributed to the low numbers of trans people recruited in this pilot phase.
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Finally, while the qualitative data is illuminative, interview were conducted with a small group of participants. The data presented here should be understood as highlighting the diversity of facets of kit usability and intervention acceptability. Recruiting to this online HIVST pilot RCT was feasible, the intervention was acceptable to participants, and the kit distributed had high reported usability. This pilot led to a number of changes to the implementation of the RCT, including national advertising and enhancing efforts to boost trial retention.
Further research investigating the experiences of trans people is necessary in order to optimise future intervention approaches for this group. All authors have read and approved this manuscript.
The funding bodies had no input in the design of the study and collection, analysis, and interpretation of data or in writing the manuscript. All participants provided informed consent ahead of their involvement with the RCT and qualitative sub-study. Due to the remote nature of these studies, RCT consent was online written consent; sub-study consent was verbally recorded at the beginning of each interview. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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