MAY 22, 2019 – In this issue, we highlight the opportunities for more meaningful engagement with adolescents, young women, and girls in HIV prevention research. We also cast some light on the clinical trials for a novel vaccine candidate recently launched by IAVI and hear from a former participant in a vaccine trial.
Every year on May 18, we commemorate the World HIV Vaccine Awareness Day (HVAD). This is an opportunity for us to recognize the efforts of volunteers, community members, health professionals, and scientists working together to find a safe and effective preventive HIV vaccine. It is also a time to educate communities about the importance of continued support for research and development towards finding an HIV vaccine.
This year as we observed #HVAD2019, we celebrated the growing consensus that an effective HIV vaccine is a more realistic prospect now than it was 10 years ago. In the past six months, two IAVI-sponsored HIV vaccine clinical trials have been initiated, one in the U.S. and the other in the U.S. and Africa. Additionally, IAVI clinical research center partners are involved in larger clinical trials to evaluate the efficacy of promising vaccine candidates. They include one in South Africa and the other spanning five southern African countries, namely South Africa, Zimbabwe, Mozambique, Malawi, and Zambia. Furthermore, an innovative combination efficacy study of two vaccine regimens with pre-exposure prophylaxis (PrEPVacc) is set to begin later this year. (Read IAVI Report for more on the science capacity in Africa.)
In this issue of VOICES, we shed more light on IAVI’s most recent vaccine trial that hopes to bring science closer to developing a fully protective HIV vaccine; hear an activist make the case for more meaningful engagement with communities at the HIVR4P 2020 Conference; learn about the challenges and opportunities of working with adolescents, girls, and young women in HIV prevention and sexual reproductive health research; and share the experience of a former participant in an HIV vaccine trial
Finally, if you know someone else who would benefit from reading the VOICES, please share it with them! We also encourage you to write to us and let us know how we can improve this newsletter.
Associate Director Advocacy, Policy, and Communications
The views and opinions expressed in this newsletter are those of the authors
and do not necessarily reflect the official policy or position of IAVI.
By Ethel Makila, Associate Director Advocacy Policy and Communications, IAVI
On March 27, 2019, IAVI and partners launched the clinical trial of a new HIV vaccine candidate. The clinical trial named IAVI W001 is at the first step in testing the experimental vaccine in humans (Phase I) and will enroll 60 healthy adult volunteers in Seattle, Boston, and Nairobi.
Over the next two years, the IAVI W001 trial will test the vaccine candidate called BG505 SOSIP.664gp140. The trial will answer questions on how safe the vaccine is and how well it can induce the human body to produce antibodies that can neutralize HIV. These are called neutralizing antibodies (NAbs). BG505 SOSIP.664gp140 belongs to a new generation of immunogens (molecules that are capable of causing an immune response in the body) called native-like trimers.
HIV is covered by an envelope protein (Env), which is shaped like a three-pronged spike. This spike, known as a trimer, is a target for antibodies produced by the human immune system after infection. Some of these antibodies can block viral replication by preventing entry into cells. Native-like trimers are molecules that are designed to look like the spikes on the outer surface of HIV and can induce the body to develop neutralizing antibodies.
In late 1999, researchers observed that a Kenyan baby born HIV positive was able to produce antibodies that could neutralize multiple strains of HIV, similar to some adults that had lived with the infection over a long period of time. While the NAbs were not able to eliminate infection, the concept of producing such a response in non-infected individuals to provide protection against HIV infection was conceived. The design of the BG505 SOSIP.664gp140 immunogen is based on hypotheses on the best approaches to producing targeted immune responses.
For decades, scientists have collaborated in research to engineer the HIV Env protein in its native-like configuration. IAVI W001 is one of the first clinical trials of a native-like Env trimer, and the first time that this particular trimer is being evaluated in humans. Previous vaccine trials involving Env proteins have tested the immunogenicity of only a portion of the Env structure or proteins that do not resemble the native structure. In animal testing, the BG505 SOSIP.664 gp140 vaccine candidate showed promising results by causing production of antibodies that neutralized an HIV-like virus. Investigators hope to see if a similar specific response is elicited in humans.
One of the goals of HIV vaccination is to produce a specific type of NAb known as a broadly neutralizing antibody (bNAb) capable of neutralizing a wide range of HIV strains. Scientists hope this study is one of the first steps in learning how to do this. It is hoped that this vaccine trial will allow researchers to better understand what is required to induce bNAb responses in humans and pave the way to developing a fully protective HIV vaccine.
By Shakira Namwanje, People in Need Agency and 2019 AVAC Fellow
As a young woman overcoming the trauma of being raped at eight years old and being infected with HIV, I began my journey as a community advocate by sharing my experience with survivors of rape and their families. I am a strong advocate for access to HIV prevention interventions, such as pre-exposure prophylaxis (PrEP), by women and girls who are at a higher risk of HIV infection. I am determined to be a voice that connects HIV prevention research to my community.
I attended the HIV Research for Prevention (HIVR4P) 2018 conference in Madrid, Spain, as part of the Young Women’s Leadership Initiative supported by ATHENA and AVAC. My goal was to represent young women back home at a conference where research about HIV prevention interventions relevant to their needs was being discussed. I wanted to make sure that the voices — issues, ideas, concerns, and complaints — that come up during my engagement with young women and girls get heard by researchers. I also wanted to ask researchers if, as they design new HIV prevention tools, they are thinking about how a young girl from a low-income setting in my village in Masaka in Central Uganda will access them.
I participated in a satellite session titled ‘Next Steps for the Dapivirine Ring’ and in my presentation, I made the case for providing choice by developing different types of prevention tools for young women. Young women are such a diverse population, and contrary to how researchers might want to approach product development, one size does not fit all. There are some women for whom an injection with a product that stays in the body longer would be ideal as it makes visits to the health centers less frequent. There are others whose low risk of HIV infection makes them not want chemicals inside their bodies all the time and prefer an on-the-go prevention approach.
I feel that overall, the sessions at HIVR4P were not designed to adequately address community concerns. I don’t see how researchers can talk about what young women do, what they are going through, or what they want, when the young women themselves are not present. This applies to conducting research for any other community group. For instance, I attended a session where there were discussions on a prevention intervention being developed as an implant. In my community, implants are associated with long-term birth control methods for women. If this intervention were successful, I wonder how acceptable it would be to men in my community!
Furthermore, the language used during the sessions was too difficult for non-scientists to understand. Advocates have the role of sharing information from such conferences with the community — we need to understand what the researchers are talking about. Perhaps there should be a pre-conference session between scientists and advocates to bring them up to speed on some of the key concepts in HIV prevention research.
In 2020, I would like to see some sessions dedicated to empowering community representatives, including the advocates, to understand the science. There should also be more sessions allowing community representatives to respond to the scientists. This will enable us to engage more meaningfully with them. The Young Women’s Leadership Initiative presentation on ‘What Women Want’ during the Dapivirine ring session was well received by researchers present who said that there should be more community voices at the conference.
Better engagement of communities with researchers could contribute to the acceleration of the research and development process. If we understand the research better, we are not only able to give insights on what we prefer but are also more likely to be receptive to interventions developed.
By Ireen Mosweu, Community Engagement Officer, The Aurum Institute Clinical Research Division in Rustenburg, South Africa
I work as a community engagement officer at an adolescent-friendly clinic at The Aurum Institute Clinical Research Division in Rustenburg, a city located in South Africa’s platinum-mining belt. I have worked for 14 years in community engagement, 11 of them with the Institute. My journey to working as a link between HIV prevention researchers and adolescents is a very personal one.
While still in school, I witnessed some of my relatives dying because of AIDS-related illnesses. It was a difficult time in the country: treatment was not easily accessible, and my relatives were afraid to go to the clinic because stigma and discrimination were widespread. I watched as they first developed signs and symptoms, opportunistic infections, and then suddenly passed on. The social and emotional impact of watching my relatives die made me realize that the life skills training available did not adequately address issues around HIV. That is why I decided to pursue a career in HIV Counseling and Testing. In 2009 when my friend was devastated by her HIV-positive diagnosis, I counseled her, and it makes me feel good to see her today, still living a healthy and productive life.
I now work with an Adolescents Community Advisory Group that meets at our adolescent-friendly clinic in Rustenburg. I am very passionate about my work as an engagement officer as well as giving motivational talks at forums to empower adolescents. When working with adolescents, I do my best to see things from their perspective. Music and roadshows are a big part of the young people’s lives, so these are features that I include in our engagement strategy. I am also considering the use of social media to share relevant HIV prevention information. The adolescent-friendly clinic has a warm and friendly atmosphere, a separate reception area, cable TV, and access to free WiFi during their visits. We also assist adolescents with their homework. We need to make the two hours they spend at the clinic during their visits enjoyable and memorable for them!
The Aurum Institute’s Clinical Research Site conducts clinical research involving adolescents, focused primarily on evaluating the feasibility of enrolling and retaining adolescents in clinical trials. Given the rate of new HIV infections, unwanted pregnancies, and low rates of consistent condom use among adolescents in South Africa, there is an urgent need for interventions targeting this vulnerable population. There is, however, limited involvement of adolescents in research studies or clinical trials, where enrollment and retention are compromised for various reasons. Although adolescents and parents/legal guardians are willing to participate in clinical trials, the fear of possible vaccine side effects, fear of getting tested for HIV, perception that an HIV vaccine is not necessary, limited knowledge on vaccine development and trials, and mistrust of the scientific community are potential barriers to HIV vaccine uptake. The institute aims to bridge this gap by offering adolescents and their caregivers the opportunity to enroll in the feasibility study.
Working with adolescents at this level requires close collaboration among the clinical research team at The Aurum Institute, government departments, adult stakeholders, and community members including religious representatives. Parental consent is also critical in the work that we do.
My dream is to have an HIV-free generation and I hope that through my work amongst adolescents, I am creating a cohort of ambassadors for HIV prevention.
By Miriam Nakitto, Medical Research Council (MRC Uganda)
I work as a study coordinator for the Zero Transmission of HIV among High Risk Adolescents (ZETRA) project being conducted at the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine, Uganda Research Unit (MRC/UVRI & LSHTM) in Kampala. The study is being conducted in collaboration with University of California, San Francisco; University of Connecticut; and the National Institute of Mental Health (NIMH).
The ZETRA study is assessing sexual and reproductive health behavior of young female sex workers in Kampala following interventions that address their knowledge of HIV and other sexually transmitted infections (STIs), their cognitive processes, and their contextual or environmental factors. We work with adolescent girls and young women aged 15 to 24 years old primarily looking at the outcomes of unprotected sex, which could be infections with STIs or HIV, or unplanned pregnancies. We are also assessing both the uptake and continued use of family planning and retention in care, which includes regular STI, HIV, and cervical cancer screening. Out of the 644 HIV-uninfected volunteers participating in the study, 322 are receiving the standard-of-care prevention counseling (the control group) while the other 322 are receiving health literacy and technical skills building in addition to the standard-of-care prevention counseling.
Challenges and opportunities in conducting research among adolescent sex workers
One of the structural challenges that we currently face is that the adolescent girls come to the same clinic as the adults. While we have created separate physical spaces for their clinic visits, the fact that they are seeing the same clinical staff as the adults means there is a chance that they will encounter their parent or guardians as they move around the clinic, so we still have to modify our set-up. One of the approaches we are considering is having sessions over the weekend for the 322 participants receiving the intervention package so that they are completely separated from the adults and have shorter clinic visit times. We are working towards having an adolescent-friendly clinic with ample private spaces for adolescents, clinical staff who only attend to adolescents, and entertainment like free WiFi, TV, and music that appeals to them.
Since the adolescents are interested in using computers and having access to smartphones, these technologies have been incorporated into the study. Many of our volunteers already use social media platforms so we have incorporated social media applications as a channel for health literacy. Discussions on various health issues take place on a closed Facebook group which is moderated by a counselor when necessary. We have also reserved two computers for those who want to drop in and use them. Audio computer-assisted self-interviewing (ACASI) in local languages is more popular among the younger volunteers who sometimes find it easier to answer very sensitive questions through this interface as opposed to doing face-to-face interviews. As some girls do not have numeracy and literacy skills, we incorporate illustrations and show-and-tell approaches to explain various concepts including how to keep clinic visit dates.
Many of our participants, like so many other sexually active adolescents, have a low negotiating power when it comes to whether to have unprotected sex. Older men sometimes prefer younger girls for transactional sex because they charge lower and have less negotiating power. The fact that they often use alcohol and other drugs to enable them to cope with the tough environment in which they work makes them more vulnerable and less able to negotiate for safe sex. Furthermore, unprotected sex is paid more highly than protected sex. Some of our sessions are aimed at giving them skills to negotiate condom use and to reduce — and eventually stop — substance abuse.
The high rate of mobility among the girls poses a great challenge to keeping them in the study. Often under the control of a “Queen Mother,” the girls are made to migrate from town to town depending on where there is money to be made. This makes it hard for them to honor their clinic visits. Additionally, they often live and work in groups, and sometimes conflicts within these groups cause the girls to change location abruptly. Despite these challenges, the study team works with the same groups and sometimes with bar owners to trace the volunteers.
The need for more sexual and reproductive health research among adolescents
One of my observations, having worked on this study, is the urgent need to tackle misinformation associated with sexual and reproductive health among young women and adolescent girls. More can and should be done to develop scalable interventions that will ensure this very vulnerable group has access to and uses available interventions for healthier lives.
To do this, we would need more comprehensive policy guidelines on working with and providing sexual and reproductive health services to adolescents in general. The adolescents we are working with are not under the control of their parents or guardians, so we use the Uganda National Council for Science and Technology (UNCST) guidelines on working with emancipated minors. However, these guidelines do not cover non-emancipated minors who may seek the same services.
By Frankie Rentas, Program Assistant, HIV Vaccine Trials Network (HVTN)
Moving to Seattle just over a decade ago opened my mind in ways I never thought possible. In college, I decided to go down the path of the fine arts, studying theater and English. Later, I was licensed as a public-school teacher and did that for a while. It wasn’t until my involvement in a vaccine trial, working at Fred Hutchinson Cancer Research Center, and ultimately landing at the HVTN, that I discovered a real passion for science, research, and HIV prevention.
Back then, a recruiter came into Madison Pub, a gay bar in Seattle’s Capitol Hill neighborhood, and handed out condoms and lube with a card that had information about HVTN trials. I was immediately intrigued and asked the recruiter questions about it. I had no idea HIV vaccines were even being researched! Shortly after that, I began dating someone who was in the process of enrolling in the HVTN 505 trial, which investigated the safety and efficacy of a vaccine regimen in men and trans women who have sex with men. When he told me about it, I decided right then and there that I would call the clinic and find out if I might be eligible for the trial as well.
During my first visit, when my eligibility was established, I decided immediately that I would enroll. The clinic staff was incredibly welcoming, friendly, and knowledgeable. They did a great job of explaining the trial and the science behind it. I was so excited at the thought of being a part of history, and the idea that there might be a real preventive vaccine in the future fueled my energy and desire to be in the trial.
Unfortunately, now that my immune system has reacted to a test product, they cannot include me in future studies. My vaccine-induced seropositivity makes it look like I have HIV on some tests, so I am always tested by the research site. However, I know for certain that if I had a chance to do things over again, I would still decide to enroll in an HVTN trial. I am proud to have participated in research that could have far-reaching impact in ending HIV for good.
Steven Wakefield – Director, External Relations, HIV Vaccine Trials Network
Dr. Morenike Ukpong-Folayan – Coordinator, New HIV Vaccine and Microbicide Advocacy Society
The views and opinions expressed in this newsletter are those of the authors
and do not necessarily reflect the official policy or position of IAVI.