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The Dapivirine Vaginal Ring: Gone far and far to go


Anna Miti
Wednesday, October 13, 2021

Anna Miti is a journalist, media trainer and advocate. She is the current chairperson of the Health Communicators Forum of Zimbabwe. She works with the Humanitarian Information Facilitation Centre to convene media science cafes in Zimbabwe.

In July 2021, The Health Times of Zimbabwe reported that the Medicines Control Authority of Zimbabwe approved the monthly Dapivirine Vaginal Ring for use as an HIV prevention tool, making Zimbabwe the first country to do so. This news is a milestone in a longer process of approvals and recommendations that was triggered when the ring received a positive scientific opinion from the European Medicines Agency in July 2020 for its use among women ages 18 and older in non-EU countries with a high disease burden. Next came WHO prequalification in November of 2020. Then, in January of 2021, WHO issued a recommendation for the ring as an additional prevention choice for women at substantial risk of HIV infection. Following these actions from the WHO, news of the approval of the ring in Zimbabwe generated a lot of excitement, locally and elsewhere, as this tool is one of the few HIV prevention methods that are solely within the control of women. The ring can be used covertly or overtly to reduce their chances of getting HIV.

I am excited too, but I’m not sitting down to rest with congratulations on my lips.

There is a popular song in Zimbabwe called Kure whose lyrics go “kwatinobva kure, kwatinoenda kure”—loosely translated to mean, “We have come a long way, but we still have a long way to go”. I’m singing that song as I consider the news of the approval of the Dapivirine Vaginal Ring in Zimbabwe. This journey has been really long. People have been struggling to push forward an option women control and can use discreetly for decades.

Over the years, some microbicide and PrEP studies showed promise, others ended with disappointing results (see box). But advocates, researchers, champions of women’s health, of women’s rights, of HIV prevention, we all pushed on. Researchers were exploring drugs such as tenofovir, using different delivery methods such as gels and films. It was not until 2016, when the results of two large-scale studies of the Dapivirine Vaginal Ring, ASPIRE and RING, that a woman-controlled option showed significant efficacy in HIV prevention. Five years later, the world has its first approval. Now, in the days, weeks and months to come, so much needs to be done. Women who need the ring must be able to find it when and where they look for HIV prevention, and they need to know about it, with every question answered, to feel empowered to choose it.

What is the Dapivirine Vaginal Ring?

The ring is made of a flexible silicone matrix polymer and contains the antiretroviral (ARV) dapivirine, which is slowly released over the course of a month. The ring delivers dapivirine directly at the site of potential infection, with a very low amount of drug ever absorbed into the body (known as systemic absorption). Women insert the flexible, long-acting ring themselves into the vagina and replace it every month. Two Phase III studies found that the ring reduced the risk of HIV and was well-tolerated with long-term use. The Ring Study, led by IPM, found that the ring reduced overall risk by 35 percent, and ASPIRE, conducted by the US National Institutes of Health-funded Microbicides Trials Network (MTN), found that the ring reduced overall risk by 27 percent. Open-label studies showed that, with higher adherence, the efficacy rates can be higher: the DREAM and HOPE open-label extension trials (OLEs), which enrolled former participants of The Ring Study and ASPIRE, showed increases in ring use compared to the earlier studies. Modelling of this data showed increased efficacy—by over 50 percent across both studies—compared to the earlier studies.

Furthermore, interim results from REACH show encouraging levels of adherence to both the Dapivirine Vaginal Ring and oral PrEP. (About 50 percent used the ring for the full month, another 45 percent used it at least some of the time. About 58 percent of oral PrEP takers took the pills four days or more per week, another 40 percent took the pills 1-3 days per week). The study assessed safety, adherence and acceptability of both products among adolescent girls and young women in Africa. Other studies include the DELIVER and B PROTECTED studies to assess the ring's safety among pregnant and breastfeeding women. The ring has potential for further development into longer-acting rings and into a multi-purpose prevention option which can potentially prevent both HIV and pregnancy.

The rollout of oral PrEP in Zimbabwe has taught us—advocates, researchers and other stakeholders—that this work to properly introduce a new product is essential. It took several years from approval and WHO recommendation to finally get oral PrEP into the hands of those who need it. Even then, there are still low levels of knowledge of PrEP among those who need it, young people especially. In addition, there are barriers to PrEP access such as negative health care workers attitudes towards AGYW who seek sexual and reproductive health services.

The idea of a woman-controlled HIV prevention method is an important one considering that women, especially young women, are more susceptible to both new HIV infections and gender-based violence and susceptibility represents a serious barrier to HIV prevention. The numbers tell the story. In sub-Saharan Africa, UNAIDS estimates that women and girls accounted for 63 percent of all new HIV infections in 2020; six in seven new HIV infections among adolescents aged 15–19 years are among girls; young women aged 15–24 years are twice as likely to be living with HIV as men; around 4200 adolescent girls and young women aged 15–24 years became infected with HIV every week in 2020; and around the world, more than one third (35 percent) of women have experienced physical and/or sexual violence by an intimate partner or sexual violence by a non-partner at some time in their lives.

In Zimbabwe the situation is not that different. The Zimbabwe Population-based HIV Impact Assessment Survey (ZIMPHIA 2020) showed that the rate of annual new HIV infections among adults in Zimbabwe is disproportionately high for women, in fact rates for women more than twice what they are for men: 0.54 percent among women and 0.20 percent among men. There are many reasons for this trend: patriarchal social dynamics and gender-based violence are chief among them. For example, UNAIDS says in some regions, women who have experienced physical or sexual intimate partner violence are 1.5 times more likely to acquire HIV than women who have not experienced such violence.

Currently there are a number of HIV prevention options available. The most commonly used in Zimbabwe is the male condom, available from both public (where they are free) and private facilities. There is also the female condom and daily oral PrEP. But clearly, women at risk need more than the existing options, as the number of new HIV infections among young women remains far too high. Achieving the UN targets to end AIDS by 2030 depends on it.

In Zimbabwe, as in other countries, approval is just one important step among many still to come. In talking with advocates whom I know and trust and who have been calling for options like the ring for years, I hear concrete actions that must happen now.

First, the ring must be incorporated into the HIV response by Ministries of Health and integrated into programs. For example, the Ministry of Health and Child Care, and the National AIDS Council as the coordinating body of the HIV/AIDS response in Zimbabwe, need to outline how the ring will be made available to those who need it. All stakeholders must be engaged in this exercise, including potential users themselves, advocates, researchers and implementers. Definate Nhamo, Senior Programs Manager at Pangaea Zimbabwe AIDS Trust, says “clear policy must guide efforts to bring the ring to potential users. These policy guidelines should be disseminated and they should address how to roll out and scale up access.”

Second, advocates highlight the need to train healthcare workers, deepening their skills to support women who need HIV prevention and who should have the ring as a choice.

Third, a big part of the next steps is demand creation. Previous experience with both the female condom and oral PrEP showed that even products with great potential may fail to deliver impact due to low uptake, if the potential end users do not have access or information. For example, some young women are more afraid of getting pregnant than HIV. Even so, the female condom, which prevents pregnancy, HIV and other STIs, has low uptake. Too little information on how to use the female condom, and even where to get it in some instances, is part of the problem. I see the same thing with oral PrEP. There has been just too little information about this intervention.

Fourth, ensure community groups are linked to programmes from the start. There has been a lot of work done by different stakeholders to assess how best to potentially market the ring. The International Partnership for Microbicides has been working with advocates across Africa in preparation for rolling out the ring, and this work is bringing a needed focus on marketing research. From my own work with communities, it’s clear the field will need to use different methods to get the word out. Mass communication campaigns are one way, involving celebrities and public service adverts. Zimbabwe saw success with such campaigns for voluntary medical male circumcision (VMMC) and the Protector Plus condom campaign. But other methods will be needed too, to support outreach at many levels from peer-to-peer to mass media and in between. These strategies must be funded, targeted, and well-researched, so that motivating messages reach those who need to hear them.

In my work as an advocate, I have come across robust, youth-led and youth-focused community and grassroots organisations. These groups are in touch and on the ground, understanding community attitudes and real-world conditions related to sexual and reproductive health and rights (SRHR). A crucial next step is working with these youth and community groups in the development of phased approaches to introducing the ring. Youth groups who are based in the community are key to success. They’re able to track the response to the ring, support uptake, and flag emerging issues. For example, in one community meeting, questions came up about how to dispose of the ring safely. Well-prepared and trusted community advocates were on hand to address this and other concerns that cannot always be anticipated.

As the field moves forward on all these fronts—getting the right policy in place, training providers to offer the ring, developing marketing and communications, investing in community groups to support women using the ring—there is another important step that applies to them all. We must all manage expectations, our own and everyone else’s, about how to measure success as we encounter challenges. Whilst the response to the ring is encouraging, real world settings are more complex and strategies for building awareness and demand must be responsive to this. For example, conditions vary greatly between urban and rural, and public and private settings. Also, the ring does not prevent pregnancy and STIs. Studies have proven that the higher the adherence to the ring, the higher the efficacy. As such, adherence support for the ring must be integrated with broader reproductive health that includes methods for family planning and STI prevention.

We have our work cut out for us, but all of it can and must be done, Kwatinobva kure, kwatinoenda kure/we have come a long way, but we still have a long way to go. The anxiety of a former participant of the REACH study (a study exploring how young women use the ring and their preferences) speaks for so many of us who understand the difference the ring could make. She said, “I really wish we could just get the ring as soon as tomorrow, I just want to know where”.

It’s up to us to answer.