“I felt like a TRIO champion”: end-user perspectives on their role as co-designers of multi-purpose technologies

Introduction

In sub-Saharan Africa, adolescents and young people aged 15–24 years make up only 10% of the population yet accounted for 32% of new HIV infections in 2019 (UNAIDS, 2020). Adolescent girls and young women in the sub-continent are more disproportionately affected, accounting for 62.5% of the new infections among adolescents and young people (UNAIDS, 2020) and acquiring HIV 5 to 7 years earlier than their male counterparts (Dellar et al., 2015). Despite the increased vulnerability of adolescent girls and young women to HIV in sub-Saharan Africa, their uptake, retention, and adherence to HIV prevention interventions that work (notably pre-exposure prophylaxis), have been sub-optimal both during trials and rollout (Celum et al., 2019; Koss et al., 2020; Were et al., 2020). It is hypothesized that, when new products are discussed with future end-users before development and their opinions are considered at the design stage, uptake and adherence are likely to improve (Guthrie et al., 2018; Shah & Robinson, 2007; Swain et al., 2019). Therefore, end-user input is increasingly considered essential for product development to ensure their attributes and usage preferences help guide the development process (Brady & Tolley, 2014; Guthrie et al., 2018; Thilo et al., 2017).

Most end-user studies focus on bringing together potential users and researchers/programmers to co-design strategies for roll-out after the intervention/product has been developed (Slater et al., 2017). At this point it may be too late or too expensive to consider modifying product attributes that may be unacceptable to end-users. The likelihood that research results will be relevant to and valued by end-users and their communities is enhanced when the perspectives of the “researchers” and the “researched” jointly inform the design of the intervention products (Montgomery et al., 2017). It is therefore prudent to bring end-users on board earlier in the product design stage to partner with developers and researchers in designing products that would be more acceptable — and adhered to when put on the market (Krogstad et al., 2018; Montgomery et al., 2017). The co-designer concept, in which the three key players (developers, researchers, and end-users) collaborate, encourages end-users to take an equal role in the design of healthcare interventions (Bate & Robert, 2006).

We conducted a study to assess the acceptability of and preferences for the attributes and routes of administration of three placebo-only multi-purpose technology (MPT) products (tablets, ring, and injections) for prevention of HIV and unintended pregnancy among young women in Kenya and South Africa (van der Straten et al., 2018). As part of joining the study, participants were invited to engage as co-designers so that their feedback could help researchers and product developers improve the products they would receive and use. The purpose of the sub-analysis informing this paper was to assess whether, and if so how, the young women who participated in the study perceived themselves as co-designers in the development of the three MPT products being investigated.

Methods

Tablets, Ring, Injections as Options (TRIO) was a 5-month clinical study conducted at the Impact Research and Development Organization (IRDO) in Kisumu, Kenya and Setshaba Research Centre (SRC) in Soshanguve, South Africa. Study enrollment occurred between December 2015 and June 2016, with follow-up visits completed in December 2016 and dissemination of results in May/June 2017. Details of the methods have been presented elsewhere (Minnis et al., 2018; van der Straten et al., 2018). Briefly, women were eligible to participate if they were aged 18 to 30 years, sexually active, not pregnant, HIV negative, and had no prior participation in HIV prevention product trials or demonstration studies. The three placebo-only MPTs that the women used and assessed were daily oral tablets, a monthly silicone vaginal ring, and two 2 mL monthly saline injections. This analysis focuses on findings from the qualitative data collected throughout the study, including during dissemination of results, to explore participants’ perceptions of being invited to engage as co-designers in the development of the MPTs.

Strategies for engaging TRIO participants started during recruitment and continued through to the end of the study (Table 1). Pre-enrollment workshops were held to introduce interested community members to the study and the placebo products being evaluated and to answer any questions. Once enrolled in the study, women received telephone check-ins between their monthly visits. Participants received a certificate at their month 5 visit with stars for each time they gave a pledge to provide honest responses about what they really thought of the products during monthly interviews. Additionally, suggestion boxes were available at the clinic for those wanting to provide anonymous feedback about their study experiences, and “Chill sessions” (where participants came to the study site to simply hang out) were conducted (at SRC site only) so that participants could receive more education about the study and to facilitate an atmosphere of trust, openness, and partnership among participants and the research team.

The qualitative data sources (Table 2) used for this analysis include 55 in-depth interviews (IDIs), six focus group discussions (FGDs), and five dissemination workshops, all conducted at the research sites. IDIs were conducted with randomly selected participants following their month 3 visit in TRIO, or with a purposive sample of women based on their decision to switch products during the usage period. The 37 women who participated in the six FGDs at study exit were purposively selected and stratified according to the product selected during the usage period. Detailed methods related to the IDI and FGD component are previously reported elsewhere (Shapley-Quinn et al., 2019).

Approximately 6 months after the study ended, we conducted dissemination workshops at each site with a total of 117 former study participants to share the key findings and solicit the women’s feedback about those findings; the results have been presented elsewhere (Agot et al., 2019). The workshops also explored how participants viewed their role as co-designers during their participation in TRIO and heard their recommendations to enhance a co-designer relationship between researchers and participants in future studies (see extended data for slide (Wagner & Shapley-Quinn, 2020)).

All qualitative data collection was conducted by trained interviewers and facilitators in local languages. IDIs and FGDs were conducted using semi-structured guides (see extended data (Wagner & Shapley-Quinn, 2020)), audio-recorded, transcribed, and translated into English when needed. The dissemination workshops were conducted using a structured guide. Dissemination workshops at SRC were audio-recorded, transcribed, and translated into English where necessary. A secure File Transfer Protocol site was used to transmit all audio recordings. Audio recordings were stored securely as protected health data until analyses were completed and audio recordings destroyed. At IRDO, three note-takers attended each workshop because the site did not apply for ethics approval to audio-record the workshop proceedings. Once the workshops were complete, the note-takers compared and triangulated their notes to develop full text.

Results

Across the two TRIO sites 165 women participated in at least one qualitative activity. Over half of the women were ages 18–24 and had completed secondary school (see Table 3). Among those who joined one or more qualitative activities, four key themes emerged from the data about what resulted in the women feeling like co-designers; these included altruism, respect, agency, and reciprocity.

Discussion

Although the main purpose of the TRIO Study was to obtain end-user perspectives into the development of three potential MPT products—tablets, ring and injections, the objective of this analysis is to present how participants perceived their role as co-designers of the three products being evaluated. Trying out each product and sharing their views on the attributes they liked or did not like, then making suggestions on aspects that could be modified made participants view themselves as more than a mere source of information for researchers; they felt like co-creators of the products. Even though the products are already designed and at different stages of clinical development as HIV prevention methods, none existed yet as MPTs or dual prevention products for pregnancy and HIV prevention. Furthermore, participants’ co-designer ideas truly contributed to identifying barriers to each of the product forms as well as potential solutions. As reported in another paper from the TRIO Study (Minnis et al., Under review), participants came with suggestions for improved product dosage and delivery modalities currently being evaluated by developers. These included a weekly pill (Kirtane et al., 2018), a transdermal patch (Puri et al., 2019; Vogler et al., 2010), and longer acting bi-monthly injections (Kerrigan et al., 2020). Thus, involving end-users early in product development can inform product attributes before form factors are locked in (Krogstad et al., 2018; van Velsen et al., 2018).

In a systematic review of 49 studies addressing the development of supportive technologies for persons with dementia, Suijkerbuijk et al. (2019) explored the level of engagement with end-users as co-designers, driving the process into four phases: pre-design (exploring people’s lived experiences that would make a product necessary), generative (exploring ideas of the product design), evaluation (iterative development and testing of the product in different formats with representative end-users), and post-design (actual use of the product while also monitoring acceptability). The authors reported that only 7 of 49 studies included people with dementia in multiple phases of development and iteratively consulted them across all the four co-designer phases while, similar to our study, the majority engaged end-users in the development (38/49) and generative (25/49) phases only. Importantly though, 38 (77.6%) of the studies reported explicitly that the recommendations by the end-users resulted in one or more changes in the design of the final product (11 studies did not report on this).

It was important for us to find out whether, in taking part in the study, participants were aware that they were co-designers of these products and that their opinions would be considered by product developers in designing new biomedical interventions. This is important in two ways: one, participants would appreciate the important role they play in determining how the products would look like when released into the market for use and two, in knowing and appreciating their co-designer role they would better understand the importance of providing their honest views.

As experts of their own lives, end-users should be offered an opportunity to influence the design processes of products being development for them (Giroux et al., 2019; Hussey et al., 2019), and working collaboratively can optimize the eventual acceptability of the interventions. Results from our study indicate that the women appreciated the respect accorded to them and the recognition that they as end-users and researchers must work hand in hand for the successful development of prevention products. Latkin and colleagues (Latkin et al., 2016) noted that a key to overcoming social desirability within research is to treat participants with respect, a factor also considered important by our participants. Participants were clearly aware of their role in determining what the end-users would and would not prefer. For some, volunteering to participate in the research to help other women made them feel like heroes. In joining the TRIO Study to share their experiences and preferences of the three dual-use products, participants made the statement that they were volunteering for the benefit of others. Joining a study for altruistic reasons has been expressed by participants in other studies, including one that examined acceptability of vaginal ring for HIV prevention (Montgomery et al., 2017).

Altruism alone is not enough to maintain a co-designer relationship. In co-designing health products, future end-users are empowered through being engaged as experts of their experiences (Cottam & Leadbeater, 2004; Taffe, 2015; Wetter-Edman, 2012). True to a participatory approach to the research process, the TRIO Study provided the women with new information on a topic of concern to them, worked with the women to increase the resources available to their community, delivered the study findings back to them and asked for their perceptions on those results, and translated what was learned from the women into strategies that will hopefully meet their HIV and unintended pregnancy prevention needs. Ideas from potential end-users better match the needs of the actual end-user than the ideas generated by professional developers or researchers (Kristensson & Magnusson, 2010). By engaging local knowledge, the quality and validity of the research is improved (Hussey et al., 2019). Thus, it is important to recognize the symbiotic relationship between product developers who understand what is technologically feasible and end-users who experience the product and therefore know what is best for them.

This study has several limitations to consider. The women who participated in IDIs, FGDs, and/or dissemination workshops may not represent the larger sample of women who participated in the TRIO Study. The qualitative sample participants were not selected based on perceptions of being co-designers. It is also worth considering whether women who felt more engaged with the study and who felt respected by the research team were more likely to participate in the qualitative components. Additionally, the study sought views from end-users after two of the products were approved or in late clinical stages for HIV prevention, although none had progressed very far yet for a dual or MPT indication.

Our study has demonstrated that when study participants are engaged to give opinions on the design of health products before they are developed and released into the market, they embrace their role as co-designers if they are treated well by study staff, given a chance to make choices during the study period, are recognized as equal partners of the researchers, and are motivated by a desire to help themselves and others. Studies are needed to engage end-users of multi-purpose technologies as co-designers across the different product development phases.

Data availability