Dr Matovu supervised the research site that discovered that the vaginal ring can work
Last Monday, Uganda gave the world yet another breakthrough news of an HIV research results that a using a vaginal ring that contains an ARV called dapivirine, can help reduce your risk of contracting HIV from sex with an infected man.
New Vision tracked down Dr. Flavia Matovu Kiweewa, who was the principal investigations officer of the research to ask her more about this exciting news. The study was hosted by Makerere University - Johns Hopkins University Research Collaboration in Mulago
How do you feel being the principal investigator of a study that breaks such good news to the world?
It’s indeed exciting news. The research we conducted, ASPIRE, and a sister study called The Ring Study consistently found that using a vaginal ring containing an ARV called dapivirine was very safe and can help protect against HIV.
This is a great achievement, not only for researchers, but also for African women who are the hardest hit by the HIV epidemic. Despite great advances in preventing and treating HIV, women still face disproportionate risk, and a number of prevention options are not practical or usable by many women.
These are the first results ever in the world to show that African women are able to use a vaginal ring and that a ring providing sustained delivery of an ARV is safe and can help protect against HIV.
The dapivirine vaginal ring has great potential to make a difference in reducing the burden of HIV in women. It also sets the stage for the development of ring products for both HIV prevention and contraception.
But the 27% overall protection seems small! Is it worth the celebration?
There is every reason to jubilate the first results to show that a vaginal ring can protect HIV among women! This overall protection level of 27% means that if there were 100 women using the dapivirine ring, about 27 infections would be prevented.
This protection level goes up to 37% in a secondary analysis that we defined early in the study which excluded participants enrolled at the 2 sites with poor retention to study visits and adherence. In other words, the ring prevented about one-third of HIV infections!
About one in three women who would have been infected was not. Consider that about 400 people get HIV daily in Uganda.
Over 50% of these are women. If all the 200 women used the ring, at a protection of one in every three women, we would save about 66 women per day. In a year, these are over 24,000 women!
Research also found that the level of protection for women above 25 years of age was 61%. We would save 122 such women per day, which makes it 44,530 women a year! That is a recommendable product! Women should celebrate because they may not have control over certain HIV-prevention decisions like condom use or faithfulness.
The ring can be used privately with or without the partner’s consent.
How did you share it among the trial participants?
Participants are our greatest stakeholders in this achievement. Immediately, following release of the ASPIRE and The RING study results at the Conference for Retroviruses and Opportunistic Infections (CROI) in Boston on 22nd February, we called in our study participants and broke the great news, and thanked them for their participation.
The women felt very proud to be part of this successful story which stands to benefit generations to come.
So when shall we start getting the product?
Obtaining approval and licensure of a new product is a process that involves several steps. For the women who participated in the ASPIRE and The RING study, there are plans to have them access the ring before everyone else.
We anticipate submitting the first application for licensure by the end of 2016. The regulatory process is an important one that takes time. We are hopeful that the first approvals could be received by 2018 in some countries in Africa.
Why do you think girls below 21 years did not get much protection?
The ring worked better with participants who actually used it. We call it adherence. The rings prevented almost two-thirds of infections among women who were over 25 years old in ASPIRE who also demonstrated consistent ring use.
We are still teasing out how much non-adherence affected the protection levels for women below 21 years. A behavioural follow up study of a that group is planned to better understand why some women were not able to adhere to ring use.
Is this the first study site you are manning?
Yes, but I had served as a project coordinator on other studies like the VOICE study where we were testing the use of using pills or gels to see if they can prevent HIV infection (pre-exposure prophylaxis studies).
The experience I drew from this study led to my being the lead investigator for the ASPIRE study. My research interests also centre on HIV care for infected women.
I was recently awarded a grant from the US National Institutes of Health (NIH) worth $625,000. The grant targets international research in infectious diseases, including AIDS (R01).
An R01 is one of the most competitive sources of NIH funding, which includes direct support to independent investigators who wish to establish their research careers. Getting an R01 grant is an enormous step in any scientist’s professional development.
What usually stops women from volunteering?
In most African settings like Uganda, we still value opinions of family and peers. Many women will seek opinion of at least one person who, in most cases, will be a close family member.
Some women are discouraged at this level. The strict eligibility criteria which requires one to be HIV negative, between 18 to 35, not pregnant or breastfeeding also discourages others.
To get the 253 women at the MU-JHU Research Collaboration, we had to screen 406 women.
What are the advantages of volunteering?
Volunteering means agreeing to take on a task without expecting individual benefits. Our women volunteer because they wanted to make a contribution in ending the HIV infection among women.
However, we provided them free HIV counseling and testing monthly HIV, care, treatment for sexually transmitted infections and that is for their male partner(s) also.
Do you think we are winning in the war against HIV?
ASPIRE and The Ring Study have made important strides for women. This ring has potential to protect against a substantial fraction of new infections with high population coverage.
The door has also been opened to developing next-generation products that can simultaneously prevent HIV, pregnancy and other sexually transmitted infections.
Tell us about yourself
I am a medical doctor, married with three sons and a daughter to Dr Francis Kiweewa, the head of research for Makerere University –Walter Reed Project. I have worked with MU-JHU Research Collaboration since 2006.
I have risen through the ranks to the level of Study Principal Investigator of the ASPIRE study. Following an extremely competitive process and with my very first submission, I was awarded an R01 grant for new investigators by the US NIH to conduct research in the highly relevant but understudied area of bone health among HIV infected young women in resource limited settings.
Following this award, I have gained international reputation in HIV and women research as evidenced by invitations to serve on various scientific committees including the NIH funded 2016 inter-Center for AIDS Research (CFAR) Women and HIV Research Symposium planning committee, to be hosted by the University of Alabama at Birmingham in December 2016, the Women Health Task Force under The network - Towards Unity For Health, and the CFAR 2016 –Sub Saharan Africa meeting planned for July 2016 in Durban where she is co-leading the Treatment strategies subcommittee.
Given the insights drawn from the extensive experience in research, I joined Makerere University School of Public health as an honorary lecturer four years ago where I lecture, supervise and mentor students.
I am currently pursuing a PhD in public health with the University of Wits Waters rand in Johannesburg, South Africa. Together with my husband we do give back to the community by facilitating health talk shows every Tuesday on Family radio, 105.3 FM.
My overall vision is to build Africa’s scientific capacity through supporting other rising African researchers.
I believe this can be achieved through training and mentorship.