The research portfolio of RTI’s Women’s Global Health Imperative paints an optimistic picture for reproductive health. The group’s projects—novel female-initiated HIV prevention products, multi-purpose technologies, long-acting technologies for all genders, violence prevention and youth health, and more—provide hope that people around the world will soon have more choices about how to prevent HIV with a method that works for them, not because it is the only one available.
This work reached a milestone in July 2020, when the European Medicines Agency released a positive opinion on the monthly dapivirine vaginal ring for HIV prevention. WGHI has been studying the DPV ring’s effectiveness and acceptance among women in sub-Saharan Africa for several years.
This is the first long-acting, safe and effective, HIV prevention product of its kind for women. The decision further secures the DPV ring on a trajectory towards regulatory approval in multiple countries.
WGHI’s work in 2020 and beyond is set up to build on these findings and work toward more diverse methods of prevention that take into account end-users’ needs, desires, and preferences.
WGHI’s projects provide hope that women will have the option to use a combined product to prevent HIV and pregnancy in a safe, discreet way to help minimize violence and stigma from their communities. They provide hope that everyone, of all genders, will have the tools that they need to live an HIV-free life without having to be reminded about it every day.
WGHI’s diverse research portfolio today is a result of decades of hard work and commitment by staff and partner colleagues, led for the past 10 years by Dr. Ariane van der Straten. The path was not always straightforward, however. In the 1990’s, the field of biomedical HIV prevention, especially for prevention in women, was at a standstill.
“At the time,” van der Straten explains, “there wasn’t a good enough understanding of the biology of HIV transmission.”
Other aspects of HIV research were also in the formative stages. The extent of the epidemic on the continent of Africa was still emerging. Dr. Nancy Padian, the founder of WGHI, focused on heterosexual HIV transmission and prevention of HIV in women.
During that decade and the next, researchers evaluated the HIV prevention potential of a wide range of products. At WGHI specifically, Drs. Padian, van der Straten, and colleagues studied diaphragms, spermicides, acid-buffering gels, multiple varieties of condoms (male and female), and cervical caps. They assessed them separately and in combination. Nothing seemed to work.
Many years of underperforming or flat results from HIV prevention clinical studies frustrated researchers and practitioners. But persistence and determination are cardinal virtues in research. A theme that has driven Dr. van der Straten’s work since she took over the role of Director of WGHI in 2011, has been passion and excitement for women’s health research. Her goal has been to “make a difference, not knowledge for knowledge’s sake.” To do this, Dr. van der Straten has worked to cultivate a culture of learning from failures. This meant being willing to evolve and grow, drilling deeper to better understand the end-users’ perspectives when developing HIV prevention innovations.
Dr. van der Straten worked as a lab scientist for a decade after receiving her PhD in Zoology. During that time, she dreamed of working more directly with the people impacted by the pathogens she was studying. In the early 1990’s, she went back to graduate school to get a master’s degree in public health at Johns Hopkins University, developing an interest in qualitative and socio-behavioral research. One volunteer opportunity she participated in while in Baltimore matched her with a woman who was in the late stage of AIDS, and that relationship, along with her experience doing family planning research in Cameroon, helped Dr. van der Straten grasp the complexities of women’s social and reproductive lives and how they overlapped with women’s risk for HIV.
In 1994, Dr. van der Straten met Dr. Padian when she moved to California to complete a traineeship at the Center for AIDS Prevention Studies at UCSF. Dr. van der Straten was able to apply her interest in the socio-behavioral aspect of HIV prevention research with Dr. Padian’s epidemiological work on understanding the heterosexual transmission of HIV in women.
Qualitative research methods were not always fully appreciated in epidemiological or biomedial research. WGHI began including them as ancillary components in several prevention studies in the 1990s and early 2000s.
Their shining moment, and a pivotal shift in Dr. van der Straten’s career, came a decade later when the MTN-003/VOICE trial was unable to demonstrate effectiveness for any of the three daily antiretroviral products evaluated for prevention in women (Viread tablet, Truvada tablet and tenofovir gel). It turned out that most women had not used the products much, and certainly not sufficiently to gain protection from them, thus making effectiveness impossible to prove in VOICE. This unfortunate study outcome proved to perfectly epitomize the lesson of “embracing failure and learning from it” for Dr. van der Straten. Findings from VOICE-D, a qualitative ancillary study led by Dr. van der Straten that involved a subset of former VOICE trial participants, highlighted both the need to measure adherence objectively, and to understand the whole context of users’ lives to better support them and their product use, including during randomized trials.
The VOICE and VOICE-D results also highlighted the need for options that are “more discreet, user-friendly and that do not require action on a daily basis.” This led Dr. van der Straten to start an ongoing R&D program to develop user-informed implants for HIV prevention (or as dual prevention products for HIV and pregnancy) that can confer protection from months to years. Concurrently, In MTN-020/ASPIRE a phase 3 trial of the monthly dapivirine vaginal ring, the investigative team (including Dr. van der Straten) used both quantitative and qualitative methods throughout the trial. In 2016, the ASPIRE study found that the ring was safe and effective at reducing the risk of HIV acquisition, realizing its promise as the first long-acting HIV prevention product for women. Monitoring trial performance and exploring emerging issues during implementation, including through biomarkers of adherence and qualitative research, averted some of the pitfalls that led to futile results in VOICE.
As a first-generation, woman-specific product, “The dapivirine (DPV) ring is a great success, even though protection is not 100 percent,” van der Straten explains. “It demonstrates that a topical product that can be kept discreetly inside the vagina for a month does protect.”