New Episode of Px Pulse: Getting Rollout Right for Ring and Injectable PrEP

At AVAC, we’ve been calling for coordinated planning to introduce and rollout new prevention products, while expanding access to existing options. We’ve said that these efforts must move much faster than they have in the past, and learn from the lessons of rolling out oral PrEP. So what matters right now for rolling out the Dapivirine Vaginal Ring and injectable cabotegravir as additional PrEP options? Find out in our latest episode of Px Pulse!

Until now, daily oral PrEP, first approved in 2012, has been the only drug-based strategy for HIV prevention. So now it’s time to take the next steps to deliver these new options.

In this episode of Px Pulse, Linda-Gail Bekker from South Africa’s Desmond Tutu Health Foundation and Lillian Mworeko from the International Community of Women Living with HIV East Africa (ICWEA) join host Jeanne Baron and AVAC’s Executive Director Mitchell Warren to discuss innovative models for scale-up and delivery. Taking the right steps now could mean HIV prevention options fulfill their life-saving, epidemic-ending potential, and to do so requires working faster and more efficiently than ever before. We dive into what lessons the field has learned, what’s still off-track, and the steps advocates, policy makers, drug makers and funders should each take right now to turn efficacious options into effective choices.

For the full podcast episode, highlights, and the archive of previous episodes, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

Reading, Resources and Webinars

At AVAC, we are seeing remarkable new developments and opportunities to engage in HIV and COVID research, development and advocacy. Here is a round-up of what’s been happening, essential reading and resources to help in your advocacy efforts, and some upcoming webinars to join.

In PrEP

Dapivirine Vaginal Ring Approved in South Africa

The South African Health Products Regulatory Authority (SAHPRA) approved the monthly dapivirine vaginal ring for use by women to reduce their HIV risk. South Africa joins Zimbabwe as the first countries to announce approval of the ring, which is already recommended by the World Health Organization as an additional prevention option. The ring’s developer, the International Partnership for Microbicides, has also submitted additional applications for review by several other Eastern and Southern African countries, and advocates are actively engaged in making the ring accessible, including the fabulous new EmpoweRing campaign from our colleagues at ICWEA. AVAC’s Nandi Luthuli told Herald Live, “we know that the most effective intervention is the one someone picks for themselves among an array of effective choices.”

Updates on Injectable Cabotegravir for PrEP

Following US FDA approval of injectable cabotegravir for PrEP in December, there has been a cascade of activities—and a huge need for advocacy! Multiple additional regulatory agencies are reviewing the application; WHO convened their Guidelines Review Group meeting earlier this month, and guidelines are expected mid-year; and Unitaid announced funding for the first two implementation science projects to introduce injectable PrEP, in Brazil and South Africa. A key lesson from oral PrEP over the past decade has been the essential role of civil society; and advocates released a number of important statements—AfroCAB released two sign-on statements: Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs and ViiV continues to not meet our demands to ensure CAB-LA is accessible for our communities, and a leading group Southern African women’s health advocates released a statement by Southern African Women Advocates in Advance of ViiV Convening. Stay tuned for our updated call to action and roadmap to ensure injectable PrEP and the ring get introduced faster and more strategically.

In Vaccines

New HIV Vaccine Study Using mRNA Platform Launched

The NIH also announced a new study to test three mRNA-based HIV vaccine candidates. This study follows an announcement in January from IAVI about another mRNA-based HIV vaccine study. AVAC is preparing a suite of materials on the latest in HIV vaccine research, development and advocacy for HIV Vaccine Awareness Day in May, so stay tuned. In the meantime, check out this snapshot that compares the two studies.

In COVID

New Resources for Journalists

The COVID-19 pandemic spawned an infodemic inside the onslaught of COVID-related information. Journalists struggle to identify reliable information in the everchanging pandemic landscape. With support from the Rockefeller Foundation, AVAC is expanding our partnership with Internews and our Media Cafe program conveners to support journalists covering HIV prevention science to include reporting on COVID. Check out the curated resources to help journalists find high-quality, understandable information.

WEBINAR: COVID-19 GPP Resources, 6 April at 9am ET/3pm SAST

While there are some resources that address stakeholder engagement in COVID-19 research, they may not adequately reflect the needs of advocates. Join AVAC and partners for a conversation to discuss advocates’ needs and shape the development of future resources. Register here.

WEBINAR: New COVID-19 Vaccines Trials in Sub-Saharan Africa, 6 April at 1oam ET/4pm SAST

Join us 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.

In Cure

WEBINAR: Breaking Down the Latest in HIV Cure Research, 5 April at 11am ET/5pm SAST

At CROI 2022, a number of exciting updates on HIV cure research were announced, including the most recent case of HIV remission after a stem cell transplant. Join a conversation with researchers as they break down the recent case of HIV cure, which is the first such cure in a woman. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV. Register here.

In Integration of Sexual Reproductive Health and HIV

WEBINAR: Consultation on the Dual Prevention Pill, 12 April at 8:30am ET/2:30pm SAST
Join FP2030 and AVAC for a conversation about The Dual Prevention Pill (DPP), a daily oral pill that is currently being developed for the simultaneous prevention of unintended pregnancy and HIV acquisition. This consultative webinar will highlight unique perspectives from stakeholder in the fields of family planning and sexual & reproductive health. Register here.

Just Published: Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment

We’re excited to announce this new publication – Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment – in the Global Health Action journal. This publication builds on the partnership between our HIV Prevention Market Manager project, ministry of health officials in Kenya, Malawi and Zimbabwe, and Georgetown University’s Center for Innovation in Global Health, and is a call to catalyze actions by development partners in support of national strategies to integrate HIV and SRH information and services.

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

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.