In this issue, we highlight community perspectives on the AIDS 2018 conference and the need for greater community involvement in tackling the HIV epidemic.
As the dust settled on the 22nd International AIDS Conference, which took place in Amsterdam from July 23-27, 2018, it was evident that the global war against the HIV/AIDS epidemic is not progressing as anticipated. A report from UNAIDS revealed that 50 countries experienced a rise in new HIV infections in 2017, and AIDS-related deaths are not falling fast enough. It was evident from conversations framed by the conference theme, “Breaking Barriers, Building Bridges,” that the goal of ending AIDS as a public health threat by 2030 faces cultural, religious, economic, political, educational, legal, and scientific barriers.
In this issue of VOICES, we highlight community perspectives on the AIDS 2018 conference and the need for greater community involvement in tackling the HIV epidemic; an activist’s view on what Africa should do to prevent a resurgence of the HIV/AIDS epidemic and accelerate progress towards ending AIDS as a public health threat on the continent; the importance of involving adolescents in HIV prevention biomedical research; understanding HIV clinical trials; and strategies to encourage women’s participation in clinical trials.
Lastly, we would appreciate your help in improving this newsletter to better meet the needs of readers like you. Be sure to take the short, five-question survey at the end!
Associate Director Advocacy, Policy, and Communications
International AIDS Vaccine Initiative (IAVI)
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 Brian Kanyemba, Key Populations Technical Advisor, Desmond Tutu HIV Centre
The Global Village: AIDS 2018 was a huge success for me. Its ability to engage the broader community through the global village was exemplary. This, I think, has and will enable people at the grassroots level, not just experts in the field of HIV and AIDS, to remain really engaged in addressing the global HIV epidemic. The conversations at the global village were rich, trans-cultural in nature, engaging, and educational. People held in-depth discussions with scientists, researchers, and policymakers. Giant names you otherwise would not have an opportunity to engage with were asked pertinent questions that could inform future organizational activities, individual activism, and advocacy work. I can only hope that those stakeholders will allow the dialogues they had with grassroots people to shape their work in ways that are more people-centered. All in all, there was a lot to be learnt about cure research that was relevant to me – as one involved in engaging communities – through the sessions at the global village.
PrEP access: In the main conference space, my interest was focused on HIV prevention. Key highlights were the updates and information on what was new in pre-exposure prophylaxis (PrEP). I observed that the way researchers communicate about PrEP differed from the way communities perceive PrEP. For example, in science we say things like, “We are offering PrEP to the community,” “PrEP is not for all,” and “PrEP can be used daily or based on sexual activities.” This, in my view, sounds like we wield the power to offer or not to offer PrEP. It implies that the decision to use PrEP is not made in collaboration with those who need it.
This may actually be part of the reason why uptake of PrEP has been slow. For example, in South Africa, where PrEP was made available to approximately 30,000 sex workers, only 2,000 came forward to access it. This begs the question: did the health care workers simply put PrEP on the table as something sex workers could use, or was there a discussion between the providers and sex workers to help them understand how useful PrEP can be to them given their high exposure to HIV? If we truly want to get PrEP into the hands of the large number of HIV-negative clients with high HIV risk behaviors, we need to promote client discussion that results in acknowledgement of the personal need for PrEP. Such a dialogue could also help health care providers identify the structural challenges that may make alternative HIV prevention tools a better choice for the client. It cannot be a blanket prescriptive procedure.
I attended a presentation by Velephi Okello, deputy director clinical services at the Ministry of Health in Eswatini (formerly Swaziland), on a government-led program offering PrEP, which clearly demonstrated the value of meaningful stakeholder conversations. Despite the criminalization of same-sex relationships in this country, the government is actively engaging the end users and the community on designing and implementing PrEP access for all.
Transwomen: One key group visibly missing in the narratives around HIV prevention and treatment was transwomen. There were lots of discussions on the use of hormones when transitioning from male to female, and the use of antiretrovirals by the general population. But discussions on the intersection of the hormone treatment, behavior, and introduction of antiretrovirals in transwomen still remain largely untouched. Since the last AIDS conference in 2016, there has been a shift in the South African conversation about transwomen, which now includes access to antiretrovirals for HIV prevention and treatment. The community is not homogenous – there are transwomen who are sex workers, thus considered more at risk and in need of PrEP. For transwomen, issues like gender identity – do I identify as a female sex worker, or do I identify as MSM (men who have sex with men) to be able to get treatment – are real dilemmas that are not yet being adequately addressed.
People who inject drugs: I felt that during the AIDS 2018 conference, PrEP was discussed outside of the context of the realities of the lives of people who inject drugs. They also have sex and have HIV sex-related risks. The focus of discussion for this population was on harm reduction, such as needle exchange programs, as the preferred HIV prevention program. I think our focus should be enhancing the ability of all people who perceive themselves at risk of HIV to be able to do something to reduce that risk. The silos of people defining our risks for us and labeling access is a problem we face in Africa, including in South Africa. How do we ensure we get HIV prevention services as a combination of interventions, prioritized and accessible to all persons at risk?
Messaging around dolutegravir: This may all seem very clear to you and me as educated advocates, but it is not for the majority of people on the ground. The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) is rolling out dolutegravir as the preferred HIV treatment because it has lesser side effects than the current antiretroviral therapy. However, we recently learnt there are neural tube birth defects associated with its use by pregnant women, so the World Health Organization (WHO) is developing guidelines to avail it to men and women who are not of childbearing age or those who don’t expect to be pregnant very soon. For the women who are on dolutegravir and want to get pregnant, they will be taken off the drug, and then after they finish breastfeeding, it will be available to them again. Do you see the confusion — I am HIV positive, you give me drugs, you remove them, you give me another one? Where is the context of the individual in this decision of on-off-on medication? PEPFAR and WHO have made the decision on what we should have as treatment.
Where is the respect for the client’s decision-making in all this? In my view, a client-centered HIV treatment program will educate, discuss, and make a decision on treatment regimen based on what individuals find appropriate. The message I got from the conference and generally is that the approach to HIV care is very paternalistic – we forget that people can make decisions for themselves and we need to respect that. The reality is that while countries have to make specific decisions about the use of dolutegravir, these countries often have no choice as they are asked to implement treatment regimens by those who make the regimens available. There is need to open up the space for more discussions.
Empower community to make decisions about their HIV risk reduction: The bottom line is about empowering people to make decisions. With the loads of information from evolving research, the need to empower individuals to make autonomous decisions about their health is critical. I saw a glaring need to demonstrate meaningful community engagement that promotes research literacy, which in turn helps to create informed community members. For example, how informed are the communities in Botswana about the results of the study on dolutegravir? How well are community members in Nigeria informed about ongoing PrEP access programs? With plans for injectable PrEP, have we started the needed community dialogues around this? Community education needs to start before the intervention is out – when we start to conceptualize the research, through its design and implementation, prior to its roll out. Sadly, this strategic action is often opposed. Just to demonstrate the lack of autonomy in health care decisions, I will share a story I heard of a 50-year-old man who was taken off PrEP by his doctors because of the anticipated challenges with his liver function. Six months down the line, he contracted HIV infection and now has to access antiretrovirals for life, which is costly for the individual or the government if the government is paying for it. Apparently, the doctors did not discuss his social context with him, or realistically assess the risk and jointly make a decision with him on preferable HIV prevention approaches. Equally important is the input from a research-literate community in the design of studies and products.
I would have liked to hear researchers tell us more about strategies to provide enough education to enable people to make informed decisions. If we are to learn from history, it is critical to support research literacy efforts that are independent of the research towards the product development. Research literacy efforts have to be funded in their own rights. Local competency to conduct local research literacy in places conducting and not conducting trials is essential. Product use will happen everywhere, and so research literacy needs to go on everywhere.
Expectations for AIDS 2020: In 2020, I would like to see a lot more evidence of community engagement and its impact on HIV prevention. There should be evidence of a large number of research-literate community members, and a lot more young people making presentations at the conference. We should see a lot more evidence of researchers tackling the social dimension of the HIV epidemic and evidence of social acceptability of interventions being developed. A second issue is the hosting of AIDS 2020 in the U.S., as U.S. travel restrictions make it impossible for sex workers and people who use drugs to attend the conference. Is this the right country to host an AIDS conference? Sex workers were so visible in Amsterdam. I think this kind of visibility highlights different HIV prevention and treatment issues that need funding. At the AIDS 2018 conference, the Dutch government committed 10 million euros to make HIV prevention and treatment more accessible to key populations. What do we expect in the U.S. with its gag rules? Will we have that same level of representation in the U.S. that we saw in Amsterdam? I don’t think so!
Conversations at the recently concluded International AIDS Conference (AIDS 2018) in Amsterdam sounded the alarm on a growing crisis of new infections and the high health burden of HIV on millions of people – especially young women and key populations in lower middle-income countries – despite major global advances that have been made in HIV testing, treatment, and prevention in the last decade.
A report released by the Joint United Nations Programme on HIV/AIDS (UNAIDS) shows that vulnerable and most-at-risk populations account for 47 percent of new HIV infections globally. While several interventions have been implemented to ensure access to health services and HIV prevention tools for these key populations – including harm reduction, pre-exposure prophylaxis (PrEP), social care, and condoms – the investment in such interventions in many countries is still not adequate enough to overcome the barriers that deny people their rights.
In this five-minute video, Vuyiseka Dubula-Majola – director at Stellenbosch University’s Africa Centre for HIV/AIDS, who is well recognized for her activism to ensure affordable access to health services for people living with HIV – gives her perspective on what it will take for Africa to put up a notable fight against what is being termed by experts as a looming resurgence of the HIV/AIDS epidemic.
Located in Cape Town, South Africa, the Desmond Tutu HIV Foundation (DTHF) is one of IAVI’s African clinical research center (CRC) partners. Among DTHF’s flagship programs is the Adolescent Center of Excellence, based in Masiphumelele Township in the Western Cape Province. This program is home to a youth center where adolescents and young adults aged 12 to 25 can get access to reproductive health care as well HIV prevention interventions that include biomedical, social, and structural approaches.
A partnership between IAVI and the DTHF enables early career investigators from across Africa to benefit from DTHF’s expertise through adolescent health research fellowships. This strengthens Africa’s capacity to conduct research amongst adolescents, a key population group that continues to be disproportionately affected by HIV.
When asked about the importance of involving adolescents in HIV biomedical prevention research, DTHF staff gave their perspectives on the urgent need for policy changes and community engagement strategies to allow youth to more fully engage in research.
Adolescents are not mini adults
Dr. Sheetal Kassim, medical officer
While other vaccine trials typically use data gathered from adults to develop vaccines for adolescents and children, the search for an HIV vaccine presents an additional challenge in that for any intervention to be effective, it would have to be closely linked to what different groups of people need in their lives. HIV study results generally show that the epidemic affects different groups in different ways. It follows that our response needs to be as specific as the disease is in any given group.
Adolescents are at a transition period in their lives. There is a lot going on with their bodies – biologically, psychologically, hormonally – and we need to be sensitive to the changes they are going through. We need to know how adolescents work and then develop prevention options that work for them; give them a real choice. For example, do we know if a vaginal ring is as acceptable among adolescent girls as a pill? How about a multipurpose prevention injection product that would provide contraception and sexually transmitted infection and HIV prevention in one? We cannot take what works for adults and assume adolescents will adopt it – they are not mini adults!
Research should be as adaptive as the adolescents are
Lauren Fynn, socio-behavioral scientist
The majority of new HIV infections in sub-Saharan Africa are among young adolescent girls. In South Africa, young women are four times more likely to be infected with HIV than men their age. In 2016, 37 percent of new infections in South Africa occurred among young women between the ages of 15 and 24. The age at which adolescents are having their first sexual experience is becoming younger, with ever-younger individuals engaging in experimental sex – this alone should give researchers a sense of the urgent need to ensure that this population is well represented in HIV prevention research.
The idea that adolescents are incapable of making informed decisions about their health and their participation in research is misleading. In South Africa, the rates of child-headed households, with no parents or adult guardians to make decisions, is rising. We already have many adolescents making adult-like decisions. Our research should be as adaptive as these adolescents, who are learning and growing in different ways. Why can’t clinic services, and research processes and policies, be as adaptive as adolescents have learnt to be?
We need to build stronger alliances with adolescents and their communities
Dr. Precious Garnett, principal investigator for an adolescent HIV prevention study/investigator in adolescent treatment studies
We need to have more conversations taking place within the community about sex, reproduction, and HIV. I think, as researchers and service providers, we may have focused too much on having these discussions with adolescents, but have forgotten to bring their parents, guardians, and communities up to speed.
While the default position of adults or guardians is to assume adolescents are not sexually active, or that sex only happens between adults, constant engagement with communities might help adults realize that culture is fluid. The definition of adolescence has evolved such that today, an 11-year-old is counted among this age group, which wasn’t the case 10 years ago.
We work very hard to protect our adolescents and give them the choices they deserve, and we sometimes do so in a manner that doesn’t recognize that they are a part of a bigger community that plays a critical role in enabling their participation in HIV prevention interventions. We might be more successful in introducing prevention interventions to a community if we create a more open and engaging environment.
The research design process is interactive – adolescents tell us what they want and need through youth community advisory boards. But there are no adolescents on research ethics committees. How can we be certain that these committees are truly representing the adolescents’ needs? Adolescents have the best insights to their lives. We need to engage them more in research design and implementation processes and stop assuming that we know best!
More social-behavioral research could drive evidence-based policy changes
Elzette Rousseau-Jemwa, socio-behavioral scientist
With HIV prevention, it’s not just about the product. If that were the case, it would be easy to just prescribe everyone to take a specific product and we would have an AIDS-free generation. We have biomedical products such as PrEP that work. Efficacy of a product is not the biggest issue when it comes to HIV prevention and treatment. What is equally important to product efficacy are the issues surrounding decision-making and the ability to access, adhere to and implement the treatment or prevention plan.
There is still stigma connected to how HIV infection is acquired, and it is not common for adolescents to discuss sex, HIV, and HIV prevention with adults. In HIV prevention studies with adolescent girls, we have had participants drop out of studies because they didn’t have the physical space or social capacity to make and keep their commitments. They had nowhere to privately store the PrEP pills that they were using. When the pills were discovered by their family members, they jumped to the conclusion that the girls were on antiretroviral drugs, concealing an HIV positive status. Young girls often have difficulty explaining their whereabouts when it comes to clinical and research visits.
We need a strong evidence-based advocacy component in research with adolescents to ensure that our science is going in the direction where adolescents need it to go. I believe it would be useful to undertake research that unwraps some of the realities facing adolescents with the goal of getting the community to understand and support research among adolescents. We need to do more participatory research within communities and obtain data that reflects actual perspectives of what is or is not acceptable. If we do that, the community can then help us advocate for policy changes in the interest of adolescents. They can begin to guide decisions made by ethics committees on conducting research amongst adolescents in order to better serve them. The community’s primary interest is its children. As those researching and providing interventions that promote the well-being of those children, it is our responsibility to ensure fewer barriers and more bridges between research and communities.
By Barbara Kawoozo, Clinician, Uganda Virus Research Institute-IAVI HIV Vaccine Program
I have worked on two studies testing the efficacy of HIV vaccine candidates among healthy populations in Central Uganda. My role in these studies has largely been coordination. As a study coordinator, I often have one-on-one conversations with volunteers, following up with those who are unable to come for scheduled visits and finding out what their needs, challenges, and preferences are. While the contact with volunteers is sometimes demanding, I am very passionate about it as it helps me better understand them. This close contact also contributes to the research team’s strategies to make it easier for the volunteers to participate fully in the research.
In both of the vaccine trials that I have been involved in implementing – the APPROACH study sponsored by Janssen, and EV07 sponsored by the EuroVacc Foundation – I have observed that there is a marked difference in male and female participation, even though recruitment for both studies targets participants from both sexes.
I believe it is critical to include women in HIV vaccine development studies, and in other HIV biomedical prevention interventions, because we need to work with populations that represent the people that will use the interventions being developed. Working with a non-representative sample could create the assumption that a particular intervention only works well in one population group, and not the other. This could make the community in which the study takes place less confident in study results, and less receptive to outputs of such a study.
There are many factors that contribute to women not participating as actively as men in HIV prevention studies, but I think the greatest hurdle in Uganda is cultural practices. Women in relationships rarely take part because despite their own interest in prevention studies, they feel they must seek permission from male partners/husbands. I remember a case where a participant chose not to inform her husband that she was part of a study. She was able to take advantage of the fact her husband worked in a different town and was away from home for extended periods of time. Our team at the clinic worked with her to schedule her visits around her husband’s absence, and we would sometimes have to see her very close to the last day of the visit window (the timeframe within which every visit should occur).
The fact that the trials, which typically run for up to two years, emphasize the need for contraception makes it harder for females to participate. We are recruiting women from a reproductive age group and asking them not to have children for two to three years. While the woman herself may not have an issue with such a requirement, after a while, many who join studies feel pressure to conceive from their male partners and husbands. We have had two participants get pregnant after the last vaccination, before the completion of the study. Some women become elusive and begin to play hide and seek with the clinic staff – I can only imagine that they are feeling pressure from home to leave the study.
One of the challenges that we are trying to address is the frequency and duration of the visits, particularly for women with young children. After a vaccination visit, a participant may need to return three days later; then seven days; then two weeks later – this is part of the study design, but it can be a challenge. For mothers with young children needing care, the visits can be very hectic. We provide meals for the babies, but the participants often have to carry their children throughout the visit, with support from the nurses and clinic staff. I think for upcoming studies, it would be good to think of how to better accommodate the children and make their visit comfortable. Having visited a clinical research center in Johannesburg, I saw that with just a few toys and a bit of a comfortable space, we can easily have a baby center – it doesn’t have to be a big thing. Another thing I imagine would be an incentive to women with children would be providing basic medical attention to the babies. That would make the women always look forward to their visits.
All in all, we are trying to get the community to support greater participation by women in HIV prevention and vaccine trials. Through engagement, we are sensitizing the community to the importance of the vaccine and other HIV prevention clinical trials. At community seminars, we encourage both females and males to attend research literacy sessions. We continuously encourage females to attend these forums with their partners, and once they are enrolled, we encourage them to bring their partners along for clinic visits once in a while. I am optimistic we will have more women participating in these clinical trials in the future.
By Aziel Gangerdine, Communication Director, HIV Vaccine Trials Network (HVTN)
The HIV Vaccine Trials Network (HVTN) 100 Phase I/II clinical trial served an important function: testing the safety of a vaccine regimen in human study participants and documenting if any side effects occurred. The scientific evidence from the Phase I/II trial equipped researchers with the information needed to make a decision to start a Phase III clinical trial, another big step closer to finding an effective HIV vaccine.
On June 10, 2018 the official findings of one of the most important HIV vaccine clinical trials of the modern era were published. An early phase clinical trial by HVTN, the world’s largest publicly funded collaboration on a quest to find an effective HIV vaccine, reported that the immune responses produced from an HIV vaccine regimen appeared to be stronger than those observed in a landmark 2009 study (RV144). The 2009 findings had given the first evidence that a vaccine can protect people from HIV infection. The world is “edging” closer to the discovery of a much-needed vaccine to curb one of humankind’s most formidable foes. The results of the Phase I/II HVTN 100 study, which enrolled 252 study participants, suggested that the potential for higher levels of protection is possible.
Bridging the journey toward evidence-based results
The term “research” designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge.1 The goal of Phase I clinical trials is to use science to test a drug or treatment in a small group of people for the first time in order to learn about its safety and identify side effects. Phase II trials confirm the safety of the same dose that was found to be safe in the previous phase, in several hundred participants. Phase III clinical trials enroll a large number of study participants to confirm the effectiveness of a drug and to monitor its side effects, compare it with standard or similar treatments, and collect information that will allow the new drug to be used safely.
“There was a pre-specified set of immune-response criteria to signal whether the regimen should move forward into advanced phase testing or not – the results from the HVTN 100 study met them. This is why we are currently conducting a Phase III clinical trial titled HVTN 702 to understand if the vaccines can prevent HIV infection in human beings,” explained Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Centre and HVTN 100 Protocol chair.
It takes involvement and a community to find resolve for a global epidemic
Involving communities and key stakeholders in the design, implementation, and management of clinical trials ensures sound ethics, scientific quality, relevance, and acceptability of the proposed research in an affected community.2, 3 The HVTN clinical trials are evidence of the selfless and enormous commitment by a global community of scientific experts, funders, and philanthropists, and the political will of countries, community leaders, and inspiring study participants who are all on a quest to find a safe, effective HIV vaccine that can be accessible and affordable to millions of people who need it in low- and middle-income countries. This degree of involvement and ownership of the scientific process is what defines clinical trials as an invaluable effort of care to rid our future of the present-day statistics of an estimated 5,000 new daily HIV infections globally.
“Community engagement is a cornerstone for the successful conduct of HIV prevention research,” said Larry Corey, M.D., principal investigator of the HVTN, virologist, and faculty member at the Fred Hutchinson Cancer Research Center. “Community advisory boards and advocacy groups are our partners in building the bridge for the development of ways to prevent HIV in our communities. This approach ensures that our communities join the scientific community in the journey to find an effective HIV vaccine.”
Ethics and caring enough to do the right thing
Research teams such as the HVTN have an ethical responsibility to enroll study participants who enter voluntarily and with adequate information. Study participants must be afforded an opportunity to understand the purpose and duration of the study, what their role and responsibility in the study will be, how their results and safety will be monitored, what the risks and benefits are, and also how the study can affect their daily lives. Through this conduct, researchers ensure study participants’ right to respect, beneficence, and justice.
Lastly, an important ethical responsibility and obligation is that researchers must honor the commitment embedded in the informed consent process to report all study findings to the individuals without whom the research would not have been possible: the study participants and their communities. This act of placing study participants at the heart of information sharing nurtures existing community relationships and builds new stakeholder relations by demonstrating transparency to foster trust.
1 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. [Bethesda, Md.]: The Commission, 1979.
2 UNAIDS Guidance Document: Ethical considerations in HIV preventive vaccine research. 2000.
3 Okpokoro E, Osawe S, Datong P, Yakubu A, Ukpong M, Orhii P, et al. Preparing for HIV vaccine trials in Nigeria: building the capacity of the community and national coordinating, regulatory and ethical bodies. J AIDS Clin Res. 2013;4(12):260.
As we share with you the last issue of the VOICES Newsletter in 2018, we would appreciate your feedback on how we can improve this newsletter. Please click the button below to take a short, five-question survey and help us to better meet the needs of readers like you.
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.