Engaging End-Users in the Implant Product Development Pipeline

For people at risk of HIV infection, reliable preventive medication can be life-changing. In recent years, biomedical researchers have worked to create implantable devices that provide the user with HIV protection and contraception. These devices are discreet and long-acting, helping solve some of the barriers to their use, especially among vulnerable populations. For the devices to make a major impact on the spread of HIV, however, the user experience should be as seamless as possible.

RTI has been involved in the development of long-acting implants for HIV prevention, treatment, or combined HIV prevention with contraception since 2013. Over the course of our work, we have learned that end-user research is key to the success of these innovative devices. End-user research means learning from the people who will eventually use our implants, either for themselves or as health-care workers. By considering the end users’ perspectives, preferences, and recommendations, we can unlock the full potential of implants to improve reproductive health around the world.

How End-User Research Works

End-users are individuals, communities, or organizations external to researcher personnel that will directly use or directly benefit from the output, outcome, or results of such research. End-user input is essential, as efforts to create biomedical products that lack this feedback risk not being easily integrated into users’ lives. The use of sexual and reproductive health products can easily be hindered by key design features of the products themselves, such as discreetness, comfort, and duration. Medical mistrust and stigma also prevent people from using these products. Having end-user input early in the process is critical to informing development of a product that will be acceptable and desirable to priority populations.

Our end-user research has taught us to consider crucial potential barriers to use of prevention products, such as rumors, fears, misunderstandings, health care access, communication channels, and more. The product development process at RTI has been designed so that there are multiple timepoints during which we can modify the product design to increase responsiveness to end-user recommendations. Designing a prevention product that is acceptable – and hopefully appealing – to potential users will be important during clinical trials and eventual product roll-out. Given the advantage of end-user perspectives in research, the implant development team at RTI has consistently incorporated end-user considerations in the product development process.

The end-user research team relies on our expertise in surveys and behavioral economics. We have combined qualitative and quantitative methods, including discrete choice experiments, based on the scope, stage, and research questions being asked. At all stages, the team included strategies to allow for rapid feedback loops between end-users and the product development team. For example, with qualitative methods, brief reports written by interviewers after each focus group discussion and in-depth interview were synthesized into a rapid analysis table to share key findings on a regular basis with the product design team. Collection of quantitative data on tablet computers allowed the RTI team to have instant access to data and complete analysis promptly once data collection was complete. For both quantitative and qualitative data collection activities, the team utilized a variety of tools to enhance the quality and specificity of end-user feedback. Such tools included implant prototypes, models to mimic feeling the implant under skin, visuals to describe the biodegradation process, comparisons of existing implants such as Jadelle and Nexplanon as points of reference, as well as human body outlines to describe different insertion locations.

Over the course of eight years of development work at RTI, the implant has evolved through multiple iterations in response to technical advances and feedback from end-users, health care providers, and key stakeholders. Each new generation of the implant incorporated updates to the design to increase acceptability among end-users in response to their feedback, specifically related to the product appearance, duration, and delivery method. Some of the alterations to the implant design that we made based on our findings include:

• Ensuring a minimum duration of six months
• Optimizing the implant for the fewest clinic visits possible
• Maximizing discreetness
• Ensuring compatibility with existing implant insertion systems
• Avoiding an appearance that could be misconstrued as unhealthy plastic or illicit drugs
• Designing an MPT implant for HIV and pregnancy prevention with independent retrievability of each component to allow for easy return to fertility

These changes and others resulted in an implant that meets its users’ needs and preferences—simply by engaging them early in the design process.

Improving Implants and Realizing the Advantages of End-User Research

Integrating end-user research closely into the implant development process has informed critical design decisions. It also improves future end-user research. The RTI team looks forward to future engagement with product developers working on novel HIV and MPT products to offer a unique skill set of tailored end-user research based on product considerations and populations of interest. The RTI team strives to collaborate with funders, product development partners, and research implementing partners to ensure that novel biomedical products for HIV prevention and MPTs in the pipeline be fully vetted by end-users to ensure efficiency of resources allotted for product development and to maximize uptake and use of products.