New COVID-19 Vaccines Trials in Sub-Saharan Africa

Join us on March 16, 2022 10am ET for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant.

Register here.

Announcing the 2022 AVAC Advocacy Fellows

AVAC is delighted to announce the 2022 AVAC Advocacy Fellows, marking the 12th class of the flagship Fellows Program. This group of eight advocates will participate in an 18-month program that supports their advocacy efforts, invests in the further development of their skills, shapes the agenda for HIV prevention research, and influences how quickly new interventions move into policy and programs in their communities and countries.

In response to the success of the program in its first decade and a comprehensive evaluation to expand and improve on that foundation, the program will now run for 18 months, enabling extended support to Fellows’ advocacy priorities. In addition, the program will strengthen the role of the alumni network in the program and strengthen the linkages between organizational partners.

Incoming Advocacy Fellows montage

The 2022 Fellows were selected from a pool of 140 applicants from 12 countries. The 2022 Advocacy Fellows and their host organizations include:

Please visit the Advocacy Fellows page to learn more about their planned work for the year. We hope you’ll find ways to collaborate with them in 2022 and beyond.

We are also extremely proud of the important achievements of the recently graduated Fellows of 2020/21. Their evidence-based advocacy focused on critical areas and marked significant progress to help accelerate ethical research and equitable access to HIV prevention options. Advocacy like this overcomes historic barriers to HIV prevention and represents a foundation the field must continue to invest in to finally end the epidemic. Keep watching this space to learn how the 2022 Fellows and the alumni Fellows carry this vital work forward.

Thank you to all of the applicants and their proposed host organizations for the time and effort put into the application process, and to the independent review committee of advocates, scientists and former Fellows and hosts who guided our decision-making.

2020/21 Fellows Update

The AVAC Advocacy Fellows Program, launched in 2009, fosters a network of deeply-informed, skilled and confident advocates to strengthen and expand advocacy for HIV prevention locally, regionally and globally. In the decade since its launch, 83 advocates from 14 countries in Africa and Asia have been through this program and have gone on to use their evidence-based advocacy to help accelerate ethical research and equitable access to HIV prevention options.

AVAC is tremendously proud of its 2020/2021 class of Fellows whose tenure in the program began during a time of great uncertainty in HIV prevention and in global health. Their tenacity, passion and unwavering commitment to bringing HIV prevention and sexual and reproductive health options and choices that their communities want and need are central tenants to recalibrating global health equity.

Read on for more on their achievements and accomplishments as AVAC Fellows.

Josephine Aseme, Heartland Alliance, Nigeria
Josephine’s advocacy for PrEP rollout in key populations is exemplary; her accomplishments speak to her drive and grit. As an oral PrEP-taking sex worker and founder of Greater Women Initiative for Health and Rights, she has taken the helm, steering Nigeria’s key populations (KP) community to accelerate access to HIV prevention. She trained almost 300 KP champions across select districts in peer-to-peer PrEP education and charted an increase of 23,000+ PrEP referrals as a result.

She successfully worked with the Ministry of Health and her host Heartland Alliance to secure PrEP inclusion in the National Consolidated Service Delivery Guidelines on HIV and STIs for Key Populations, in Nigeria’s National HIV/AIDS Prevention Plan, and in Heartland Alliance’s Peer Educators’ Manual, a nationally recognized compendium. And, as a KP representative to PEPFAR’s country planning, she convinced her peers as well as implementers to add language on the Dapivirine Vaginal Ring and cabotegravir injectables to Nigeria’s country operating plan in 2021.

Chisomo Chaweza, MANERELA+, Malawi
As a KP ally, Chisomo strategically selected MANERELA+, a network of religious leaders, to host him through his Fellow project. This reflects Chisomo’s big-tent approach to advocacy, tapping into all the key sectors to push for accelerated PrEP rollout in key populations. Specifically, he rallied demand for the release of the long-overdue PrEP Guidelines—finally launched in September, 2021.

And when the MOH was not forthcoming with where to find PrEP dispensing sites, Chisomo rallied pressure on PEPFAR to reveal this information. He handled the media as an advocacy tool from both sides—engaging them to consistently and accurately cover HIV prevention and also developing his own blog, Liberty, and writing opinion pieces. He drafted a policy brief Making up for Lost Time: Increasing Access to PrEP and HIV Self-testing for Key Populations in Malawi, which continues to be employed as an advocacy tool today by others such as the incoming 2022 Fellow.

Mandisa Dukashe, Wits RHI, South Africa
During her Fellow’s project, Mandisa became a renowned face of U=U, after launching South Africa’s first treatment as prevention campaign in the Eastern Cape. And she’s well on her way to leading regional advocacy to popularize and formalize the uptake of U=U to promote treatment, adherence and viral load suppression as a way to destigmatize and sexually disinhibit people living with HIV.

Mandisa established alliances with UNAIDS, prominent political leaders and South Africa’s National AIDS Council and collaborated closely with the Southern African HIV Clinicians Society and Prevention Access Campaign to promote U=U. Her work culminated in the organizing of a U=U Satellite session at the SA AIDS Conference and in the formation of the U=U Africa Forum she co-founded with AVAC Fellow Alumni Kennedy Mupeli from Botswana. They continue to advocate for ministries of health to officially implement U=U.

Winifred Ikilai, The National Forum of People Living with HIV/AIDS Networks in Uganda
Wini was the first AVAC Fellow to integrate COVID into her advocacy targets and the pay-off was huge. She successfully engaged social media in spearheading a campaign to secure ARVs, food, hygiene packs and other services and supplies for 2,700 households in 115 districts under lockdown. Her advocacy earned her the 2021 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy while also garnering opportunities to collaborate with IAVI, aidsmap, Aljazeera and others.

What’s more, Wini won big gains for improved HIV treatment literacy and counseling through her creation of the Beyond My Pill Campaign. As part of her advocacy for improved treatment services, she organized a national level dialogue on test and treat, revitalizing the voices of PLHV networks and mobilizing for further PEPFAR spending. She won both recognition and funding to enhance treatment programs, reflected in Uganda’s National HIV and AIDS Strategic Plan 2021/21–2024/25.

Joyce Ouma, National Empowerment Network of People Living with HIV/AIDS in Kenya
Joyce methodically threaded her way through all relevant power centers to influence large-scale integration of SRH and HIV. First, she built a cadre of young women champions who contributed to her successful campaign to win Machakos county-level budget for SRH/HIV integration, and to win further national commitment from PEPFAR COP 21 and Global Fund 2021–2024.

She sat on Kenya’s national HIV/SRH integration working group where they spearheaded the one-stop-shop piloting in five counties. In the midst of Joyce’s Fellow project, the WHO green lighted the Dapivirine Vaginal Ring, so, naturally, Joyce co-convened a civil society taskforce to fast track its introduction. All the while, she penned two opinion pieces in Kenya’s national daily Star speaking of the continued need for a robust HIV prevention pipeline.

Esnart Sikazindu, Community Based TB/HIV AIDS Organisation (CBTO), Zambia
Esnart’s advocacy for differentiated PrEP services played out through social and traditional media. As Zambia moved PrEP out of ART clinics into more youth-friendly spaces, she saw an unfulfilled need to let young women know about PrEP and where to find it. Thus, she spread the word and built demand via social media.

She also took to the airwaves and print to let the general public know about PrEP as well as forthcoming HIV prevention like the PrEP ring and injectable. And not least, Esnart drafted a policy brief Too Little for Far Too Long: A Gap Analysis for Adolescent Girls and Young Women, which continues to be employed as an advocacy tool today.

AVAC Applauds South Africa Approval of Dapivirine Vaginal Ring as HIV Prevention Option for Women

AVAC enthusiastically welcomes the South African Health Products Regulatory Authority’s (SAHPRA) approval of the monthly Dapivirine Vaginal Ring for use by women ages 18 and older to reduce their HIV risk. The Dapivirine Vaginal Ring is a much-needed addition to a proven HIV prevention method mix that also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and injectable cabotegravir (CAB) in some countries. South Africa joins Zimbabwe as the first countries to approve the ring, which is also under review in several other Eastern and Southern African countries, and is recommended by the World Health Organization as an additional prevention option.

“This is a critical step forward in providing a new prevention option that many South African women need and can use,” said Mitchell Warren, AVAC executive director. “It will be important for South Africa to ensure that the Ring is integrated into HIV prevention guidelines and made available to women as quickly as possible. Regulatory approval of the Ring must be accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the women most in need of HIV prevention.”

“We know that the most effective intervention is the one someone picks for themselves among an array of effective choices,” said Nandi Luthuli, AVAC’s Regional Stakeholder Engagement Manager, based in South Africa. “It’s very exciting that South African women will soon have a broader choice in HIV prevention options. More choices can mean more HIV infections averted, which will help South Africa control the HIV epidemic.”

“The SAHPRA approval is a critical step in translating scientific research into public health impact,” said Manju Chatani-Gada, AVAC’s Director of Partnerships and Capacity Strengthening. “We hope that other countries currently reviewing the Ring will follow the examples of South Africa and Zimbabwe and take the necessary steps to provide this important HIV prevention option to women. At the same time, we hope countries reviewing injectable cabotegravir as a new prevention option will move quickly to add yet another proven effective and much needed HIV prevention option to the toolbox.”

“We thank the thousands of women who participated in the trials that provided the evidence that the Ring works as well as dozens of advocates and community members in South Africa and across the globe who have tirelessly advocated for this important new prevention option for women,” Chatani-Gada added.

Developed by the International Partnership for Microbicides (IPM), the monthly Dapivirine Vaginal Ring is a longer-acting HIV prevention product that women can control and use discreetly to reduce the risk of HIV transmission during vaginal sex. Women insert the product themselves and replace it every month. Made of flexible silicone, the ring slowly releases the antiretroviral (ARV) drug dapivirine directly in the vagina at the site of potential infection, with minimal exposure elsewhere in the body. The Ring was proven effective in two Phase III studies, received a positive opinion from the European Medicines Agency (EMA) and is recommended by the World Health Organization (WHO) as a prevention option for women.

Recent data from the REACH Study showed that nearly all of the adolescent girls and young women aged 16-21 in the study accepted the Ring and daily oral PrEP as prevention options and that when young women had access to and experience with two biomedical prevention options, almost all of them chose to continue using one of them – and most of them actually chose to use the dapivirine vaginal ring.

“SAHPRA’s approval for women over 18 is great news, but we hope that soon the ring can also be made available to adolescent girls as young as 16,” said Maureen Luba, AVAC’s Senior Policy and Advocacy Manager and a member of the IPM Board of Directors. “We know that in South Africa and other Eastern and Southern African countries the HIV infection rates among girls and young women are very high in many communities. The Ring could also be an important option to help empower adolescent girls to protect themselves.”

AVAC looks forward to working closely with civil society partners, the South African National Department of Health, IPM, the USAID-funded MOSAIC and CASPR Projects, and many other partners to ensure this regulatory milestone can be rapidly translated into public health impact.

Essential Reading and Resources

AVAC and our partners have been busy the first couple of months of 2022. Here is a round-up of essential reading and new and updated resources including HIV treatment studies, PrEP, stakeholder engagement, research fundamentals and more.

Highlights From CROI

Our coverage of week one at CROI featured updates on data related to the Dapivirine Vaginal Ring, injectable cabotegravir (CAB) as PrEP, vaccine science and cure research. And our week two summary looked at symposia that explored how to reach key populations, the critical role of choice in effective HIV prevention, and the status of research on preventing sexually transmitted infections (STIs).

HIV Treatment Studies During COVID-19

A February commentary in JIAS, coauthored by AVACer Maureen Luba with a host of other experts on the topic, offered recommendations for the ethical continuation of treatment research among people living with HIV in the context of COVID-19: Mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.

Transgender Voices: Call to action

The Lancet’s February publication included a public letter from leading voices in the transgender community working in HIV research and public health. Titled, Research on transgender people must benefit transgender people, it called out exploitation in academic research and “called in” researchers to pursue priorities that offer direct benefit to transgender communities and to rely on resources such as No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities.

Stakeholder Engagement Must Overcome Tokenism and More

The ethics review process is a critical opportunity for stakeholder engagement. AVACer Jessica Salzwedel, CASPR partner Cathy Slack and other co-authors explore three themes that can make or break effective engagement in a new article in the Journal of Empirical Research on Human Research Ethics: “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?

South Africa Is Talking About Injectable CAB As PrEP and Getting Rollout Right

Leading South African publication on public interest health journalism, Spotlight, reported on the excitement among advocates – and the need to plan now – to add injectable CAB as PrEP to the HIV prevention options currently available. Check out two new stories: Start planning HIV prevention injection rollout, experts say and Prioritise HIV prevention injection, activists say.

Many Angles On PrEP And Resources For Advocacy

For context on injectable CAB as PrEP, resources to support the rollout of the ring, and a look at the research and development pipeline of next generation PrEP, check out PrEP and more PrEP: An update and important resources.

Research Fundamentals

What is an endpoint in clinical research and why does it matter? POZ magazine’s February issue featured a transcript of AVAC’s Px Pulse podcast on this question. Hear the original nine-minute podcast here. And you can find the Px Pulse archive here.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.

A Round Up From CROI 2022

The 2022 Conference on Retroviruses and Opportunistic Infections (CROI) concluded last week with dynamic sessions that put a spotlight on where and how HIV prevention must do better. It’s no surprise to many advocates that the answers involve a comprehensive commitment to informed choice, comprehensive & integrated responses, and the central importance of community-led interventions. These themes could be found throughout sessions from both weeks of CROI. Check out our highlights from week one for updates on the Dapivirine Vaginal Ring (DVR), injectable cabotegravir (CAB) for PrEP, vaccine science, cure research and more. And read on for highlights from the second week of CROI and from the Margarita Breakfast Club (check out the full MBC program and recordings here).

Week two of CROI covered key topics such as pioneering research on prevention of sexually transmitted infections, strategies to reach key populations, and the all important priority of choice at this historic juncture when two new HIV prevention options have been approved, the ring and injectable CAB.

CHOICE CHOICE CHOICE

The symposium, Bringing Choice in HIV Prevention, looked closely at how investing in healthcare systems, enhancing trust in providers, and offering an array of effective choices could meaningfully overcome some of the most significant barriers to delivering HIV prevention at scale.

Hyman Scott from the San Francisco Department of Public Health pointed to 2021 data from the US, where oral PrEP use is among the highest in the world, showing that only 25 percent of the population eligible for PrEP is using it. Those numbers plummet for women (10 percent), and for people who are Black (9 percent) or Latino (16 percent). Hyman said providers play a pivotal role as people seek an affirming, non-judgemental encounter with providers and look for them to “open the door to improve their engagement around their sexual health needs.” If those providers then connect people to real choices, it’ll lead to major advances in HIV prevention. Hyman also discussed data from a two decade study on contraception use, showing that each new option was associated with 4-8 percent increase in uptake. Data from the REACH Study, referenced in Scott’s presentation and in our round up from the first week of CROI, showed that people will act on diverse preferences for different forms of HIV prevention if given the opportunity.

Dominika Seidman from the University of California San Francisco offered another model from the field of contraception, a history lesson, and a warning. As long-acting contraceptives became available, a protocol referred to as “tiered effectiveness” instructed providers to emphasize efficacy above all else. Seidman reported that this method fueled mistrust as women experienced providers pushing one method over another. “The family planning world has been playing catch up ever since.”

Seidman offered three models for provider counseling, and flagged a clear favorite. “Method promotion” prioritizes one product based on its characteristics. “Informed choice” offers a menu of options with no guidance on how to choose among them. Seidman laid out the advantages of a third model for provider counseling, “shared decision-making”. Seidman said under this approach, providers offer information, elicit user preferences, facilitate decision-making, leave the door open for changes in plans and priorities, and foster trust in the relationship and in the broader health-care system. “Effectiveness is not the only variable people care about, in some cases it’s not even the primary one,” said Seidman.

The presentation by Kenyon Farrow of PrEP4All echoed the role of choice and the urgent need to establish trust between the users of HIV prevention and providers. “We have a trust problem and it’s getting worse,” said Farrow pointing to US data on the loss of public trust in health authorities since 2009. “We need to invest in this as much as in research and development.” Farrow called for research on practices that combat misinformation, more comprehensive efforts to demystify clinical research, greater support in navigating health systems, innovative public health campaigns, expanded community advisory bodies, and deep investment to improve the relationship between people and their providers.

STIs Are Part Of The Picture, Too

CROI 2022 put renewed attention on the six-year trend of increased sexually transmitted infections seen in the US and other countries. At the symposia, Sexually Transmitted Infections: Reversing the Tide, presenters explored the intersection with HIV prevention and provided updates on research in STI vaccines and drug-based prevention.

Leandro Mena of the US Centers for Disease Control and Prevention shared recent US data, where surveillance is strong, showing, for example, gonorrhea is up 10 percent since 2019 and 44 percent since 2016. And syphilis is up 3 percent since 2019 and 52 percent since 2016.

Sinead Delany-Moretlwe of Wits RHI in South Africa, in a presentation on the case for STI vaccines, said one million cases a day of curable STIs burden people, communities and governments. HIV and other STIs are tied to the same risk factors. An STI, in and of itself, increases the likelihood of HIV infection. But even more compelling, obtaining prevention or treatment for an STI is a critical opportunity for someone to be connected with HIV services for prevention or treatment.

The message from the session moderator, Connie Celum of the University of Washington: attention to better STI prevention is long overdue. What’s needed are better diagnostics, continued commitment to research on vaccines and anti-microbial prevention strategies, and access to affordable and integrated services in non-traditional settings. To be effective, interventions must go beyond past approaches, develop a paradigm where overall health and well-being are at the center of the response. “That’s the key to turning around the increase in STIs” said Mena.

The US launched its first STI national strategic plan in 2020, and its emphasis on raising awareness and making screening and treatment more accessible are a step on this path, more tools and advocacy for a community-led response remain urgent. Among those needed tools are vaccines. Delany-Moretlwe provided an update on the STI vaccine pipeline.

Lessons from a three dose vaccine for human papillomavirus (HPV) first approved in 2006 offered important context. Though highly effective, fewer than 5 percent of countries have succeeded in reaching target numbers of people at risk with the three dose vaccine, with delivery challenges hampering uptake. Delany-Moretlwe said research is moving in the right direction with several studies showing efficacy with a single dose HPV option, expected to be simpler to deliver. WHO is reviewing that data now. In addition, a host of studies are looking at therapeutic HPV vaccines. But effectiveness will not be decided by the efficacy seen in the data. Product attributes, such as the dosing schedule, will be critical considerations for any product to reach those who need it.

Delany-Moretlwe also described a proof-of-concept study for a gonorrhea vaccine that was developed after researchers saw a protective signal for gonorrhea from a meningitis vaccine. Further studies are underway. When it comes to herpes (HSV), a trial that reported findings in 2012 on a preventive vaccine showed no protection against disease. Since then, investors have shown more interest in the potential of therapeutic vaccines for HSV. Vaccines for other STIs, such as chlamydia and syphilis are not as far along, struggling with funding and questions of trial design.

Research on drug-based prevention for STIs is also underway. Elizabeth Bukusi from the Kenya Medical Research Institute discussed the potential of doxycycline as an STI PrEP or PEP, which is under investigation in several studies. Key questions remain including: the impact on HIV risk, the effect of doxycycline on people living with HIV, the drug’s impact on the vaginal and gut microbiome, and the risk of antimicrobial resistance. In answer to these important concerns, Bukusi said, “We need data on all these questions. We have to do the work to find out what will work and for whom. We have to find the answers. And then we have to implement, at scale.”

Paving The Road To HIV Prevention For Key Pops

The barriers to HIV prevention for sex workers, transgender people and people who use drugs remain overwhelming. A sample of HIV prevalence statistics tell the story: for transwomen the global average is 19 percent; for female sex workers in Zimbabwe it’s 52 percent by age 24. People who inject drugs have a global HIV prevalence of approximately 13 percent. The presentations in the symposium HIV Prevention in Special Populations showed a fundamental need for more data to answer a range of essential questions to finally reach these key populations with HIV prevention. For example, most health surveillance systems do not collect sex and gender data, the population size of trans communities is poorly documented, literature is just emerging on how people who inject drugs are engaging with PrEP, and little is known about how the life stage of a person engaging in sex work affects their relationship to prevention services.

A few key issues stood out: Sari Reisner, from Brigham and Women’s Hospital, highlighted the cross-cutting impact of gender affirming care as a central component to effectively offering HIV prevention services to transgender people. For more on this and other priorities for a transgender research agenda check out No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities, written by by trans and gender-diverse global activists, with support and solidarity from AVAC. Reisner said gender affirmation demands a personalized approach that can encompass social, medical, legal and psychological factors that will be different for each individual.

Frances Cowan, from the Liverpool School of Tropical Medicine, reported on growing evidence that stigma, food insecurity and discrimination isolate sex workers who remain poorly engaged with HIV prevention and care services. But here again, the transformative and essential role of peer-led community based approaches was evident. A meta analysis of community based interventions, reported by Cowan, showed they not only improve the lives of sex workers, but improve their engagement with care. However the data is sparse on long-term outcomes. Cowan’s presentation also included the successful example of Ashodaya Samithi PrEP demonstration project, a sex worker-led initiative in Mysaore India. Self-reported PrEP adherence, confirmed by blood tests, was 80 percent or better.

Cowan’s final remarks addressed what has worked in Zimbabwe’s effort to bring PrEP to sex workers, and they reinforced the priorities AVAC has been calling for as loud as we can. What worked: Peer leadership, diverse places to access PrEP including home delivery and community drop-in centers, multi-month dispensing, and integration with STI and sexual and reproductive health services. And the final component we hope is just around the corner: adding to these peer-led community-based services, an array of proven options from which one can choose.

Looking forward to working with you all to help make this happen.

Virtual CROI 2022 Roundup for Advocates: It’s all about choice

Welcome to Virtual CROI week two!

Here’s a roundup of the exciting science heard last week across the spectrum of HIV prevention, and on cure research (more on this further down) with a groundbreaking new case of HIV remission. We also want to be sure you are all aware of the CROI Margarita Breakfast Club dialogues—both last week and this week. Superb discussions last week and three more this week are not to be missed—recordings from last week’s conversations and registrations for this week are here.

The overarching message coming from CROI last week was clear: no one biomedical strategy will do the job, the world needs multiple options and real choices. In this round up, the importance of choice leads our coverage. (And listen to Carlos del Rio from Emory University put it all in context in a terrific US National Public Radio interview here.)

Choice and the Ring

New data from the REACH study, which incorporated informed choice into its design, made this point unmistakable. Almost all (98 percent) of the 247 adolescent girls and young women in this study where both daily oral PrEP and the Dapivirine Vaginal Ring were offered, chose one of the products over none at all. All participants tried each product for 6 months, followed by 6 months where they could choose their preferred method. Kenneth Ngure, presenting on the REACH Study, said about ⅔ of the participants chose the ring. But most of the women who had very high adherence to the daily oral pill preferred the daily pills to the ring. Ngure said overall adherence in the REACH trial surpassed levels seen in previous studies. More findings on factors driving adherence is under analysis. “REACH is just a small example of what the potential impact could be in the real world of HIV prevention, simply by allowing young women and girls the ability to choose,” said Ngure.

Choice and Injectable PrEP

HPTN 083, evaluating injectable cabotegravir as PrEP among gay men, transgender women and other men who have sex with men (MSM), presented updated data that evaluated new infections that have occurred since the trial unblinded in May 2020. Raphy Landovitz, from UCLA and HPTN 083 protocol chair, reported that adherence went down during this phase of the trial, but break-through infections among those receiving on-time injections remained rare. (He reported a total of 7 such cases in the life of the study that covers 4,660-person years.) The data continue to confirm both the safety and efficacy of cabotegravir for PrEP. Reflecting on the significance of the drop in adherence to both daily oral PrEP and injectable cabotegravir during the unblinded phase, Landovitz said complex barriers to adherence make it clear that “no one biomedical prevention option will address all issues in HIV prevention”.

Additional data from Susan Eshleman of John Hopkins University School of Medicine and the HPTN 083 team deepened the discussion on effective and feasible testing. Detecting HIV is a crucial part of prevention strategies that rely on antiretrovirals (ARVs). Exposure to a single ARV, which is the protocol for PrEP (in contrast to combination ARV used in treatment), can lead to resistant HIV. Eshleman reported on data showing that using a highly sensitive RNA-based HIV test to confirm a person is HIV negative could reduce the risk of someone with undetected HIV developing resistance to first line treatment. But she said access to these tests should not limit access to this highly effective intervention, “In the context of proven high efficacy, CAB-LA should be considered for HIV PrEP in settings where HIV RNA screening is not readily available.”

Choice and Vaccines

IAVI’s Mark Feinberg summarized the state of vaccine science. One the one hand, two recent large-scale trials showed no efficacy (Uhambo and Imbokodo). On the other hand, Feinberg said cutting edge approaches offer “a strong and vibrant source of promise” for HIV vaccine development, particularly the development of broadly neutralizing antibodies (bNAbs). Looking ahead, Feinberg predicted the next major priority to make a large-scale trial a possibility will be validating a “correlate of protection”, a mark or sign in the immune system that can be linked to preventing HIV acquisition.

As this research evolves, the need for many options that deliver real choices remains clear. In a later session on immune responses, South Africa Medical Research Council and HVTN leader Glenda Gray said the high rate of HIV in hard-hit places (as high as 4 percent) will mean effective prevention may well require a combination of strategies. “We will likely need a combination of PrEP with vaccines to combat high rates—4 percent incidence rate is just too much for a vaccine alone to overcome.”

Another Step in the Journey Toward a Cure

A fourth person was reported to achieve HIV remission, the first case among women, according to data from Yvonne Bryson from the David Geffen School of Medicine at University of California. The New York woman has no detectable HIV since she stopped treatment 14 months ago. Her treatment interruption followed a stem cell transplant from a donor with an HIV resistant mutation. As in the other three cases, the stem cell transplant was an urgent intervention to treat advanced cancer. This stem cell transplant pioneered an innovation where a family donor provided stem cells in combination with stem cells from umbilical cord blood that had the needed mutation. One possible implication for cure research is confirmation of the role of a critical receptor on white blood cells known as CCR5. HIV relies on CCR5 to enter and infect the cells. Mutations to CCR5 have once again led to a case of remission, and two of these cases have endured long enough to be confirmed as a cure. Want to learn more? One of last week’s Margarita Breakfast Club discussion was River Deep, Mountain High: Pathways Toward a Cure for HIV, with a wonderful discussion about these findings.

There’s more CROI coverage coming and please continue to follow along with us this week, www.avac.org/croi-2022, and check out great summaries from our friends at aidsmap.

Virtual CROI 2022

This year’s annual Conference on Retroviruses and Opportunistic Infections (CROI), February 12-24, begins this weekend and will once again, be virtual! This forum offers the latest from research on HIV, tuberculosis (TB) and hepatitis (HEP) and now also features findings from COVID-19 studies. The opening session begins Sunday Feb. 13. Plenaries and oral abstract sessions run from Monday, Feb. 14 through Wednesday, Feb. 16. Symposia are offered Tuesday Feb. 22 through Thursday Feb. 24. You must be registered to access the sessions during the virtual meeting, however, this email shares other ways to follow along and join in the discussion and debate. Note that all sessions will be available (without registration) 30 days after the conference ends.

Follow Along

Conference coverage is available via aidsmap, AVAC on Twitter: @hivpxresearch and the conference hashtag: #CROI2022.

Preview CROI

CROI’s Community Liaison Subcommittee (CLS), AVAC and EATG hosted a preview of CROI for global advocates to explore some of the key research on the program, get tips for how to get the most out of the conference, and learn where and how to stay connected. Here is a link to the recording.

Participate in Daily Research Updates at the Margarita Breakfast Club (CROI registration not required)

7:15–8:15 am MT (time converter) Feb 14-24
The Margarita Breakfast Clubs (MBCs) are one-hour Zooms that provide an intimate setting for dialogue between researchers and community advocates on the hottest #CROI2022 science being presented this year. These sessions are open to anyone and are made possible through a collaboration including the CROI Community Liaison Subcommittee, AVAC, EATG and other groups.

  • Topic: From Long to Longer – How New ARVs are Rewriting the Script for HIV Prevention and Treatment
    Date: Monday, February 14

    Speaker: Dr. Chloe Orkin
    Moderators: Ntando Yola and Jim Pickett
    Watch the recording.
  • Topic: River Deep, Mountain High: Pathways Toward a Cure for HIV
    Date: Wednesday, February 16

    Speakers: Dr. Katharine Bar and Moses Supercharger
    Moderators: Danielle Campbell and Michael Louella
    Watch the recording.
  • Topic: Aging with HIV – Frailty, Comorbidities and a Call to Action
    Date: Tuesday, February 22

    Speakers: Dr. Kristine Erlandson and Jules Levin
    Moderator: Jeff Taylor
    Watch the recording.
  • Topic: Rings and Injectable Things: Moving from options to choices for HIV prevention in cisgender women
    Date: Wednesday, February 23

    Speakers: Drs. Sinead Delany-Moretlwe and Kenneth Ngure
    Moderator: Danielle Campbell and Breanne Lesnar
    Watch the recording.
  • Topic: Long COVID – What We Know, What We Need to Know, and What We Need to Do
    Date: Thursday February 24

    Speakers: Dr. Steve Deeks and JD Davids
    Moderator: Michael Louella
    Watch the recording.

CROI 2022 Conference Materials

Check out the conference agenda and FAQs.

Looking forward to seeing you at the daily updates!

PrEP and more PrEP: An update and important resources

2022 is a critical year for the evolving role of PrEP, anti-retroviral drugs (ARVS) used to prevent HIV. Currently, two types of daily pills (FTC/TDF and F/TAF), injectable cabotegravir administered every two months (CAB-LA) and a monthly Dapivirine Vaginal Ring (DVR) are approved in some countries for at least some populations. But each face challenges that must be overcome for these proven interventions to effectively reach people who need and want them.

In addition, the pipeline of next-generation PrEP products in research and development is intensely dynamic. But if advocacy, global coordination, funding, and community-centered responses come together now, PrEP programs can be scaled, and these biomedical options can be translated into actual choices. This work is essential for the world to hit 2030 targets for ending the epidemic.

AVAC is tracking all things PrEP. Here are some resources to keep you up to date and to help frame key issues for your advocacy.

Global PrEP Tracker

Check out global trends in oral PrEP initiations with AVAC’s just updated PrEP Tracker, found on PrEPWatch.org. 2021 saw marked increases in global PrEP uptake, up 50 percent from 2020. Five countries in sub-Saharan Africa are driving this growth with expanding programs: Kenya, Nigeria, South Africa, Uganda and Zambia. Get details on the data here.

Overview of the Pipeline

These trends can be put into context with the Biomedical HIV Prevention Research in 2022 and Beyond which provides a concise update on the full landscape of biomedical interventions, including: PrEP products in the market, next-gen products in the pipeline, including multipurpose products (MPTs) and vaccines and broadly neutralizing antibodies. And check our handy cheat-sheet on Evolving Designs for HIV Prevention Trials.

Primer on Injectable Cabotegravir for PrEP

With the recent US FDA approval of CAB for PrEP, we’ve updated our advocates’ primer to outline what’s known and what’s next for this new prevention option.

Two Training Packages for Peer-led Product Introduction

The HIV Prevention Ambassador Training Package for adolescent girls and young women (AGYW) supports them to play a meaningful role in the rollout of PrEP products in their communities. Developed by the PROMISE & CHOICE consortiums, it includes a training manual on essential topics and session instructions, and a toolkit. This version of the Ambassador Training Package is intended for all priority populations, including men who have sex with men, people who inject drugs, serodiscordant couples, pregnant and breastfeeding people, sex workers, transgender people as well as adolescent girls and young women.

A Strategy for the Future of PrEP, From Research to Rollout

The Biomedical Prevention Implementation Collaborative (BioPIC) is developing a model for a comprehensive and coordinated global platform for the introduction of new biomedical products for HIV prevention. The BioPIC Adaptable Framework incorporates stakeholders from all stages of product development and delivery, from research to rollout. And watch this space for the upcoming launch of BioPIC’s online dashboard that will be tracking efforts to introduce CAB for PrEP.

Learning Lessons from Oral PrEP – and Implications for the Future

AVAC’s six-year HIV Prevention Market Manager program produced a wealth of insights on how to get rollout right. Learning the lessons from oral PrEP introduction is essential, and this series of issue briefs distills the priorities for advocates, implementers, funders, product developers and ministries of health. And in case you missed it, check out the recent webinar recording and summary.

Resources to Support the Introduction of the Dapivirine Vaginal Ring

This package of resources supporting the introduction of the Dapivirine Vaginal Ring includes: advocacy messages, an introductory slide deck, FAQ’s and more.

Are We PrEPared This Time?

Just last week, the AIDS Foundation Chicago, AVAC and partners hosted a webinar, Are we PrEPared this time? Ensuring a Swift Translation of Research into Community Impact, featuring presentations and debate on what must happen for positive research results to effectively reach communities without delay. A link to the recording is here.

The PrEP field is moving at an historic pace, but significant obstacles threaten to derail the potential PrEP holds for contributing to the end of the epidemic by 2030. Our joint work will confront these challenges. Keep watching this space for the information, resources, analysis and convening opportunities to keep this work on track.

3 Weeks, 3 Webinars: An agenda for 2022

So much is happening (and not) in HIV prevention and the larger world of global health equity. AVAC is tracking it all, bringing together different perspectives and hosting global dialogues to help inform and set a powerful agenda for 2022.

In the first three weeks of January, AVAC hosted three important conversations for the year ahead. Global health leaders and stalwart advocates provide critical perspectives and compass points on the issues that will make and break advances in HIV prevention and global health equity this year. (And read to the end for info about the first webinar in February.)

We’ve synthesized the key messages of each of the three, and posted the recordings and slides:

Understanding—And Improving—COVID-19 Vaccine Uptake
Jan 10, 2022
Recording | Summary

In collaboration with the COVID Advocates Advisory Board (CAAB) and the Coalition to Accelerate and Support Prevention Research (CASPR), this webinar, moderated by WACI Health’s Rosemary Mburu, looked closely at how global health leaders are tackling public resistance to COVID-19 vaccines, and lessons for the HIV field. Speakers included: John Nkengasong, current director of the Africa Centres for Disease Control and Prevention; Heidi Larson, founding director of the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine; and Kate Hopkins, Director of Research, Vaccine Acceptance & Demand at the Sabin Vaccine Institute.

Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022
Jan 13, 2022
Recording | Summary

This webinar reviewed the latest advances, opportunities and disappointments in HIV prevention and provided an opportunity to address key questions including: where we are with the introduction of injectable cabotegravir and the Dapivirine Vaginal Ring; the development status (including setbacks) of promising new PrEP agents; and how to ensure HIV prevention and equitable access to innovation do not fall further behind; and much more. This webinar featured the perspectives of Linda-Gail Bekker from South Africa’s Desmond Tutu Health Foundation (and AVAC’s board); Grace Kumwenda of Pakachere Institute of Health and Development Communication in Malawi and Kenneth Mwehonge, the new executive director of Coalition for Health Promotion and Social Development (HEPS-Uganda) — both former AVAC Fellows — and Rachel Baggaley from the World Health Organization.

Oral PrEP Implementation and Implications for Next Generation PrEP
Jan 19, 2022
Recording | Summary

This webinar discussed insights from oral PrEP programs and how these experiences can inform faster, smarter and more affordable rollout of next-generation HIV prevention products. It featured Saiqa Mullick of Wits RHI in South Africa, Joseph Murungu of Pangaea Zimbabwe AIDS Trust (PZAT), and Daniel Were of Jhpiego in Kenya.

And the conversations continue!

Join the AIDS Foundation Chicago, AVAC and partners February 3 at 1:00pm ET/12:00pm CT for: Are we PrEPared this time? Ensuring a Swift Translation of Research into Community Impact. This webinar will feature presentations and debate on what must happen for positive research results to effectively reach communities without delay. Register here.

We hope you’ll look at the summaries of these important conversations and/or listen to the recordings and share with your colleagues, partners and friends. With this round-up of webinars setting the stage for 2022, we at AVAC are preparing for a year of deep collaboration and action with you.