Monday, 29 March 2021
There are many complexities in developing MPTs that will be safe, effective, affordable, and used by women. One key aspect of this process is to study the desirability and acceptability of an MPT candidate during its development so that, when it reaches the market, women will actually use it.
To this end, it is essential for multidisciplinary experts—including those with expertise in HIV, other STIs, contraception, socio-behavioral and market research, drug development, and clinical research—to connect and collaborate to ensure that end-user research is integrated throughout different phases of the product development.
To help unpack issues related to the integration of end-user perspectives into MPT development, we brought together some of the MPT field’s leading experts. Here’s what we learned from our discussion.
Reflections from the Socio-behavioral Workshops
Travis Kent, PhD (Program Officer, National Institute of Child Health and Human Development) affirmed the NICHD's Contraceptive Research Branch (CRB) is prioritizing the integration of socio-behavioral research into MPT product development. To realize this goal, The CRB organized a multi-day workshop around discrete products from a wide variety of contraceptive needs (e.g., male, female, on-demand, long-acting, MPTs, etc.). These discussions explored how socio-behavioral data are used in development processes and promoted cross-sector engagement among multidisciplinary experts (e.g., product development, market research, social science, HIV, contraceptive, etc.). Dr. Kent shared several points that were brought up by many of the workshop participants:
MPTs in the Pipeline
Deborah Anderson, PhD (Professor of Obstetrics & Gynecology, Boston University School of Medicine) presented the advantages of utilizing monoclonal antibodies (mAbs) as a basis for new MPT products. Dr. Anderson spoke about several products that she and her colleagues have in the pipeline, including a vaginal film that incorporates natural human HIV and HSV antibodies (MB-66) and combining it with an anti-sperm antibody film (ZB-06) to create a next-generation MPT film that will provide protection against HIV, HSV, and unintended pregnancy. She notes this is promising because these natural products are anticipated to not cause side effects. Dr. Anderson and her colleagues also recently completed phase 1 clinical trials for their MB-66 vaginal film and noted that socio-behavioral data was collected and considered throughout prototype development for the products in their milestone tracker.
Next, Mary Weitzel, MBA (President/CEO, Yaso Therapeutics) presented on Yaso Gel, the polyphenylene carboxymethylene (PPCM) polymer-based gel, which has been extensively evaluated by several major laboratories and is a promising candidate for STI prevention and contraception. Ms. Weitzel discussed that the Yaso team has worked to develop PPCM to be an aqueous substance that dries to a non-tacky film and that they are optimistic about acquiring IND approval with hopes to be in phase 1 clinical trials in the first quarter of 2022. She highlighted that their team always had the end-users in mind. She also noted that, based on their SurveyMonkey research data, women in the US had trouble with the MPT concept in that they didn’t see themselves to be at risk for STIs as much as for pregnancy. She went on to say that, while Yaso Therapeutics is focused on marketing to high-income countries, they are working on offsetting product costs to make their product affordable for low- and middle-income countries as well.
You can learn about actively funded products in our MPT Product Development Database.
Opportunities and Challenges in Socio-behavioral Research
During the discussion, Elizabeth Tolley, PhD, MA (Senior Scientist, FHI 360) shared some opportunities, and Matthew Quaife, PhD (Assistant Professor, London School of Hygiene & Tropical Medicine) walked the participants through a series of challenges for consideration regarding the integration of socio-behavioral and market insight into product development.
Socio-behavioral methods are less often used in early product development. However, it is advantageous to explore potential end-user perspectives prior to a product entering clinical trial research. Participatory, qualitative, and structured quantitative methods can be used. For example:
Existing research shows that end-user preferences vary and change, but that, overall, there tends to be greater demand for longer-acting products with less frequent dosing and product delivery forms with which the user is already familiar. So, what challenges does this pose for different stakeholders, and what questions should they seek to address?
Perspectives from HIV Prevention Clinical Researchers
Khatija Ahmed, MD (CEO, Setshaba Research Centre), from her extensive experience conducting clinical research in South Africa, discussed that proper communication and education (video graphics, illustrations, etc.) within the community is important during participant recruitment, including addressing MPT end-user concerns and questions about potential product side effects. Reflecting upon the recent TRIO study in which she was involved, Dr. Ahmed also noted that when speaking with different populations, study recruiters must introduce new MPTs using proper explanations and truly listen to what end-users want, as it is not a “one size fits all.” You can check out this TRIO brief around end-user perspectives on long-acting injectables.
Joseph Murungu, MD (Senior Technical Advisor, Pangaea Zimbabwe AIDS Trust), from his HIV prevention and clinical research experiences in Zimbabwe, also spoke to the importance of addressing the needs and preferences of both healthcare providers and end-users. He emphasized that MPT products should be developed with these populations in mind as they look for delivery methods that would increase convenience and reduce costs, pain, and risk of infection. Healthcare providers are gatekeepers of health information, including about MPTs. As such, it’s important to provide healthcare providers with the resources that will help them properly communicate about these products and administer them safely. Doing so will help to ensure patients and other end-users are well-informed about MPT benefits and risks and help increase product acceptance and adherence. Furthermore, he stated that sociocultural norms should be considered when innovating new MPTs.
Our panelists shared so many valuable insights on their experiences in incorporating the MPT end-user perspective into product development. They also shared their reflections on how this process can be improved upon in the future. Some considerations are to:
Want to learn more? Go here to watch our entire discussion with the expert panelists and to access resources on socio-behavioral and market research for MPTs. You can also revisit our previous webinars around end-user research here and here.
The IMPT's “Let’s Talk MPTs” webinar learning series is aimed at addressing the latest identified MPT priorities and gaps, which you can learn more about here, here, and here. Through this series, we also stimulate global interest in the MPT field by exploring compelling topic areas for advancing the MPT field, including vaginal microbiome and more.
We also encourage you to join our IMPT mailing list and follow our social media (Facebook, Twitter, LinkedIn, and Instagram) for more information on future opportunities to engage within our global learning network.
IMPT Secretariat Staff, Monday, 29 March 2021
IMPT Secretariat Staff, Monday, 08 March 2021
IMPT Secretariat Staff, Wednesday, 23 December 2020
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