Statement on Gilead’s Announcement of PrEP Donation

Mitchell Warren is the Executive Director of AVAC.

Gilead’s donation is an acknowledgment that there is a huge issue with PrEP access in America, as in many parts of the world. We welcome this indication that the company grasps the gravity of the situation. However, we urgently need a lower price for all. It’s disappointing that even this small step has taken so long.

At nine years post demonstrated safety and efficacy of oral PrEP and seven years post-FDA approval, Gilead is making this announcement quite late in the process of trying to scale PrEP to achieve public health impact. And it is nowhere near enough. The donation offers PrEP to only 200,000 individuals, while the CDC estimates that 1.1 million Americans overall are at substantial risk for HIV and should be offered PrEP. Based on what we know about the generic costs of Truvada (FTC/TDF), this donation offers a mere $10 million per year in drug supplies—irrespective of the list price for the drug.

It’s important to remember that PrEP is not a pill—it’s a program that has to include regular HIV and STD testing, support to take the pills as prescribed, training providers in culturally competent care, and strategic demand creation effort. The availability of more pills, while welcome, is not enough to move PrEP to the public health intervention that is needed for it to have a real impact for individuals and communities.

Gilead’s offer—and the announcement from Secretary of Health and Human Services Alex Azar—leave many open and important questions. How will the CDC distribute this additional oral PrEP? And how will they ensure it does not replace current PrEP access, but rather is additive? Who will pay for these distribution costs, as “free donations” often come with costs? Will Gilead continue its Truvada for PrEP Medication Assistance Program (MAP)? Will CDC and NIH—which, along with the Bill & Melinda Gates Foundation, funded the trials that demonstrated PrEP is safe and effective—still act on their intellectual property rights to Truvada for PrEP and reinvest any profits that could be realized into PrEP programs that work?

The bottom line is that the price of Truvada (FTC/TDF)—and Gilead’s new, additional PrEP pill, Descovy (FTC/TAF)—is still too high. We need sustainable price cuts, and clear strategic programs, that will support long-term access to and use of the medicines needed for PrEP. We cannot afford to lose any more time, or money, in translating PrEP’s promise into public health impact.

Young People Need More Contraceptive Options — and More Room at the Discussion Table

Cleopatra Shiella Makura is a 2019 AVAC Advocacy Fellow. This post first appeared CHANGE’s blog.

When I hear the phrase “reproductive health,” I find myself having a flashback to each time I was at a clinic either by myself or with someone else. From that I try to understand how and why I get scared about the whole topic, and to my surprise, sometimes I can’t even understand why I get scared. I ask myself this question: Is it worth it to go to the clinic or hospital to get reproductive health services?

Reproductive health is defined as a state of complete physical, mental, and social well-being in all matters relating to the reproductive system. It implies that people can have a satisfying and safe sex life, the capability to reproduce, and the freedom to decide if, when, and how often to do so.

Sixty-two percent of Zimbabwe’s population is young people below the age of 25. Growing up talking about sex was taboo, and one could only get sex-related information from friends and the theoretical information one gets from school is either too scientific or half-baked. Sex education is mostly delivered by tutors and teachers who are almost your parents’ age and the culture clearly defines every adult taking the parental role in society, and schools and colleges are part of society.

Most young people are aware of basic sexual education, however they lack the realities. It is very difficult for young women and girls to decide when they have sex and how. Zimbabwe’s 2012 Violence Against Children Survey found that seven out of 10 girls did not plan their first sexual encounter. Because our culture hands the decision and initiation of sex to men, young girls and women do not decide when and how to have sex. Usually when we are talking about sex education, it’s that moment of flashback and realising the mistakes which would have already been made.

Nowadays, most young people are afraid of getting pregnant rather than contracting HIV. The first thing on a young girl’s mind after unprotected sex is how to prevent pregnancy rather than HIV and other sexually transmitted infections. This can contribute to young women and girls in Zimbabwe at the age of 15 to 17 having an HIV prevalence of 2.7 percent, a figure that sharply rises to 13.9 percent in the 23 to 24 age range, according to 2017 data. Adolescents in Zimbabwe face challenges such as teenage pregnancy, sexually transmitted infections including HIV, unsafe abortions, child marriage, and lack of access to sexual and reproductive health information services.

The golden question is: Why are young people not accessing services? The main barrier to accessing reproductive health services is a lack of youth-friendly services. It’s very interesting that most health workers are trained on how to treat adolescents by people who are far older than adolescents, and who really do not understand the feelings and thoughts of adolescents. Most meetings and youth-friendly packages are based on speculations about how young people want to be treated. There is little to no involvement of young people on matters that affect them.

It is vital to include young people when designing programs which affect them. However, involvement has been tailored to mean showcasing a young person in a room. What we need is a whole group of young people in the room. Young people have different needs and a one-size-fits-all approach does not work. On top of that, we need young people’s voices to be documented. We are sick and tired of attending meetings and contributing our needs, but when information is documented, our voices are not included. Again, nothing for us without us.

Cultural beliefs heighten the risks and worsen the vulnerabilities of young people. Adolescent girls are often already at a disadvantage due to gender discrimination. Young women and girls must overcome not only the crisis of culture itself, but also potential abuse, violence, and exploitation, which can compromise their development and violate their rights. Because of these vulnerabilities, young women need different HIV prevention options.

As a young woman walks her journey of life, abstinence can work at one moment but then there comes a point when abstinence cannot work, and condoms can protect her instead. However, there may be a point when condoms cannot work due to negotiation issues, and pre-exposure prophylaxis can work. But taking a pill every day when you are not sick can be tiresome, and one might prefer the dapivirine ring as it gives a woman power and control. And still others would prefer an implant or an injection.

There is a need for different HIV prevention methods for young people to use. Because if we acknowledge everyone’s needs together, we can end the HIV epidemic.

Two Themes and Two Webinars for this Year’s HVAD

[UPDATE: Slides and recordings from both webinars are now available at www.avac.org/hvad.]

The field is on the brink of yet another HIV Vaccine Awareness Day – next Saturday, May 18. To mark the day, we hope you will join us for webinars on May 16 and on May 23 to explore the two themes at the top of our minds here at AVAC this HVAD.

First, of course, we’re excited by the momentum and promise in HIV vaccine research. Three HIV vaccine efficacy trial programs are now underway, including, for the first time in our field, a potential path to licensure of a vaccine.

On the other hand, we’re alarmed and disheartened by a global rise in what is sometimes called vaccine hesitancy, marked by measles outbreaks and a comeback of a disease almost eradicated through a vaccine.

On Thursday, May 16, 9am ET, Mary Marovich, the Director of the Vaccine Research Program at the Division of AIDS at the National Institute of Allergy and Infectious Diseases, and long-time HIV vaccine research advocate and community leader, Mark Hubbard, will provide their perspectives on the current vaccine landscape, the advocacy priorities and what should be on all of our minds as this exciting science progresses. Register here.

On Thursday, May 23, 9am ET, Heidi Larson, the Director of The Vaccine Confidence Project at the London School of Tropical Medicine and Hygiene will discuss vaccine hesitancy and its implications across global health. We’ll also be joined by colleagues at Bhekisisa, the health journalism center of the Mail & Guardian newspaper in South Africa, who will share perspectives on broader vaccine issues, especially as they play out in the media and affect the AIDS response. Register here.

Finally, watch this space! In the coming days, AVAC will provide you with our annual HVAD Toolkit of up-to-date materials and infographics to help translate HIV vaccine research in 2019 – and prepare for the future. If you need any of these ahead of time, please reach out!

Good Participatory Practice Online Training Course Now Accepting Applications!

AVAC is pleased to announce the next offering of its global Good Participatory Practice Online Training Course! This course offering will run May 29 through August 2, 2019.

Click here to apply. Completed applications are due by May 24th.

The Good Participatory Practice (GPP) Online Course is designed for research implementers, specifically those individuals directly responsible for community engagement in a research or implementation context. (To learn more about GPP, click here.) Learners develop practical GPP plans for their context and those who complete the course receive a GPP Implementer Certificate.

For this upcoming course offering, applicants are encouraged to enroll in pairs as team members who have complementary research and implementation expertise, since clinical trials and rollout of new products have a natural relationship with regard to community outreach and stakeholder engagement. An ideal partnership would include someone from the public health or service delivery arm of an institution and someone currently or about to be working on a clinical trial, but all partnerships will be considered.

The pairing is not required for participation but encouraged. We won’t match those who do not have partners but will try to balance the cohort with a mix of those working on clinical trials and those on service delivery and/or public health projects. Over the years of implementing the GPP Online Course, AVAC has learned that the participants who have worked in teams have enhanced their learning experience by having a thought partner to with whom to brainstorm and advocate for tangible changes that can be made at the institution level.

To date, over 150 learners have been certified through AVAC’s GPP Online Course, and nearly all of them have ranked their learning experience as “excellent” or “very good”. The majority report significant gains in their ability to “develop measurable objectives” and “self-efficacy to identify stakeholders”. These metrics indicate learners are better equipped to measure engagement and identify stakeholders in the community who can help advance engagement goals.

Today, a robust pipeline of products are moving through testing, not only for HIV prevention, but for tuberculosis, emerging pathogens, and other disease areas where GPP is being applied. As products progress through trial phases and beyond, important lessons are being learned about translating research into rollout. GPP can play an important role, not only in preparing communities for results and future implementation, but also in incorporating lessons from rollout back into the clinical trials process. By enrolling the pairs as described, we hope that this course can start to add to that body of knowledge.

Join these learners to strengthen your GPP implementation and to add to this growing global community of practice!

For more information about the program, please contact Jessica Salzwedel ([email protected]).

May 21 Webinar: Understanding and improving HIV prevention for young women

Please join us on May 21, 9-10:30am EDT for a webinar, Breaking the Cycle of Transmission: Increasing uptake and effective use of HIV prevention among high-risk adolescent girls and young women in South Africa—quantitative findings & segmentation.

This webinar is the second in a series presenting the work of the HIV Prevention Market Manager’s project researching what encourages or discourages the effective use of HIV prevention among adolescent girls and young women. Check out part one for the qualitative results.

Click here to register.

This webinar will review the findings from quantitative research on the needs, desires, and structural elements that impact the effective use of HIV prevention products by adolescent girls and young women (AGYW) in places where they are at high risk of exposure to HIV. Join to learn about the results from a survey of 2,000 girls and women and some of the major drivers they contend with as they make decisions about their sexual and reproductive health.

This research initiative of the HIV Prevention Market Manager (PMM) is conducted in partnership with the behavioral research firm Final Mile, user-centered design firm Upstream Innovation and the market research group Ask AfriKa, with the Surgo Foundation providing strategic guidance. The work is funded by the Bill & Melinda Gates Foundation.

PMM applies behavioral research and human-centered design to generate product-agnostic information that will inform the development of HIV prevention interventions that are the most likely to succeed.

The webinar will be recorded and a link posted—and if you have any questions ahead of time, please let us know!

COMPASS Reverse Congressional Delegation Advocates: Impress, inspire, inform and invigorate

This post originally published by the Center for Health and Gender Equity (CHANGE).

“We’re the generation to make conversations about HIV prevention with adolescents and youth normal among African families.”

These were the words of young women’s health advocates Maria Kapira, Cleopatra Sheilla Makura, Thandie Msukuma, Dr. Lilian Benjamin Mwakyosi and Hilda Zenda during a COMPASS Africa reverse congressional delegation CHANGE hosted on HIV prevention last week.

Maria, Cleopatra, Thandie, Lilian and Hilda traveled from Malawi, Tanzania and Zimbabwe to Washington, DC as our partners in COMPASS Africa and spent one week exchanging their expertise on sexual and reproductive health and rights (SRHR) in US-funded HIV prevention programs for adolescent girls and young women with policymakers, the media and fellow SRHR experts.

COMPASS Africa stands for Coalition to build Momentum, Power, Activism, Strategy and Solidarity in Africa, and aims to provide a comprehensive, integrated HIV response supported by a robust advocacy system that is Africa-centered, addresses non-HIV issues and is high impact and data-driven. CHANGE’s role in the program, which is an initiative led by AVAC, is to hold the US government accountable to its commitments to HIV and AIDS prevention for adolescent girls and young women in the three countries, and to be a resource to in-country partners on integrating sexual and reproductive health and rights in HIV and AIDS prevention programs.

Visiting Congress

As part of the COMPASS Africa reverse congressional delegation — or reverse co-del — Maria, Cleopatra, Thandie, Lilian and Hilda participated in CHANGE’s signature advocacy tool. We flip the traditional structure of congressional delegations because policymakers need to hear from sources outside of the US government even within the halls of Congress. As such, we bring advocates from countries receiving US global health assistance to the United States to speak truth to power.

The advocates met with Representative Joaquin Castro and Nita Lowey’s staff to discuss HIV prevention programs in US global health assistance. Maria, Cleopatra, Thandie, Lilian and Hilda also met with new members of Congress, including Representatives Andy Levin and Ilhan Omar to educate them on the importance of comprehensive SRHR programs as they onboard in their new roles. They shared compelling stories with policymakers and their staff to provide critical perspectives that are too often missing from the decision making process in Washington.

visiting planned parenthood

Maria, Cleopatra, Thandie, Lilian and Hilda also met with staff from Planned Parenthood of Metropolitan Washington to discuss comprehensive sexual and reproductive health care and Whitman-Walker Health to learn about the comprehensive sexual and reproductive health services they provide to the LGBTQ+ community and people living with HIV and AIDS.

Visiting Whitman-Walker Health

The advocates led a media briefing with top-tier media outlets, including Reuters and PBS. To further share their stories, they recorded a podcast episode on the importance of comprehensive HIV prevention in US global health assistance with RePROS Fight Back, a podcast hosted by Jennie Wetter from the Population Institute that features reproductive rights and justice advocates about issues under attack and provides listeners with way to fight back.

Recording the podcast as RePROS

We had an exhilarating week exchanging expertise on SRHR, brainstorming solutions for strengthening US global health assistance, and listening to the advocates’ powerful stories. The advocates left us feeling impressed, inspired, informed and invigorated.

As the advocates mentioned during the media briefing last week, we need to work together to change cultural norms so we can have a positive influence on future generations. Our pursuit of SRHR for all the generations to come has never been more critical — and after last week, watching these fierce advocates in Washington, DC, it feels like it might be possible.

On Capitol Hill

In Memoriam: Manasseh Phiri

Mitchell Warren is Executive Director at AVAC.

It is with an incredibly heavy heart that I share the news that Manasseh Phiri passed away earlier today in Lusaka.

Manasseh was a dear friend and partner: a doctor, writer and radio journalist, activist, advocate, mentor and farmer! Such a long list of roles, each which he managed with passion, courage, wisdom, intelligence and humor.

Many AVACers and partners had the chance to learn from him, enjoy time with him, and be challenged by him at various meetings, workshops and Partners’ Forums. He was also a leading voice in the establishment of AfNHi.

Even when he was diagnosed with prostate cancer and went through many rounds of treatment, he continued to be a passionate AIDS advocate – while also establishing the Prostate Cancer Foundation of Zambia so that he could channel his public health, person-centered commitment to HIV/AIDS and to prostate cancer.

He will be sorely missed on so many levels.

Manasseh Phiri

The New Px Pulse is Up — Check out “The Science of Choice”

Now up on our Px Pulse page, and available on your favorite podcast platform, is our latest episode of Px Pulse: “The Science of Choice — The future of HIV prevention research”.

This episode features unmissable conversations about some of the challenges associated with today’s HIV prevention options, and analysis about what should be in the research pipeline of the future.

The field of HIV prevention has been buzzing about the US Government’s National Institutes of Health’s (NIH) Funding Opportunity Announcement (FOA) since it was published in January 2019. The FOA is the latest development once again bringing the topic of choice to the lips of advocates, researchers, funders and community members—and hear why in this episode of Px Pulse.

NIH’s Division of AIDS (DAIDS) leader Carl Dieffenbach and his colleague, Director Sheryl Zwerski—speaking at a January meeting of the AIDS Research Advisory Committee meeting—address the portfolio of prevention strategies that sets the stage for this episode. Linda-Gail Bekker, former President of the International AIDS Society and a leader at the Desmond Tutu HIV Foundation, shares her agenda for the “science of choice”. And AVAC’s Manju Chatani-Gada talks to two young women advocates from Zimbabwe, Maximina Jokonya of Africaid, and Audrey Nosenga of Young Positives. These young women explain the limits of prevention today and why more choices will mean greater empowerment.

For the full podcast episode, highlights and resources, visit avac.org/px-pulse. And subscribe on iTunes to catch every episode!

PrEPWatch Redesign!

A redesigned PrEPWatch.org is now at your fingertips! The search engine is more powerful, the site navigation is cleaner and simpler, and you will continue to find the rich selection of resources that inform PrEP introduction around the world. Since 2006, PrEPWatch.org has been home to information on PrEP research, data, cost, access, implementation and advocacy around the world.

As the PrEP field evolves, so does PrEPWatch. Don’t miss these new and trusted tools and resources:

For a quick orientation to the site’s new look and feel, check out the short 5-minute video below. It provides a tour of the main navigation and dives a little deeper into a few of the powerful tools found on PrEPWatch.org.

Activists on the Frontlines of the PEPFAR Planning Process: Week 2

Emily Bass is AVAC’s Director of Strategy & Content.

The three-week PEPFAR Regional Planning Meetings (RPM) wrapped up last week. Each week two included a fresh group of countries, some familiar patterns and some new ideas. You can check out a write-up of the first week here. One of the most important takeaways to consider is the need for ongoing attention to this work. It can’t be contained within these few weeks—PEPFAR engagement is a 365-day effort, and the wins at the RPM are sometimes fragile. Just one week removed from their COP review, Tanzanian activists went into action after language in the government’s circular on forced anal exams didn’t have a clear prohibition, as promised at the RPM, of the practice. And in Malawi, once activists, government and PEPFAR got home, conversations about seemingly settled issues continued. This isn’t a problem—it’s how the process works, and it’s why the work continues after the RPMs. Here are some additional areas to celebrate and watch with vigilance.

A View from the Zimbabwe Room: Preserving primary prevention, speeding TLD transition

Going into the RPM, Zimbabwe’s lean US$145 million program – as compared to, say, Kenya’s US$350 million program – wasn’t facing any cuts, but its funds were largely consumed by antiretroviral treatment and programming for orphans and vulnerable children (OVC). Growth seemed off the table, and by the end of the week both DREAMS and voluntary medical male circumcision (VMMC) – both key prevention strategies for AGYW and men respectively – faced US$2 million cuts. Zimbabwean civil society, represented by Diana Mailosi of Advocacy Core Team (ACT) and Walter Chikanya of Zimbabwe Community Health Intervention Research (ZiCHIRe) presented priorities developed via in-country consultations—many previously shared with PEPFAR. [The ACT is a key Zimbabwean partner in the Coalition to build Momentum, Power, Activism, Strategy and Solidarity (COMPASS Africa)—learn more about this work here]. These priorities included expanding the coverage of viral load testing; protecting and expanding VMMC; differentiated service delivery and accelerated transition to dolutegravir for treatment, also known as TLD transition. Advocates also pushed for the cuts to DREAMS and VMMC to be rescinded, and those dollars were restored to the programs.

After a week of public negotiation in the Zimbabwe room and in side-discussions, civil society also ensured a commitment to include screening for intimate partner violence (IPV) in all index-testing programs, a PEPFAR intervention to increase identification of people living with HIV. IPV screening is a key step to protect individuals who are asked to disclose their sexual contacts, biological children and needle-sharing partners as part of index testing.

In these meetings, other stakeholders make commitments, too, in response to advocates calling out gaps. This year, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) stepped in with approximately US$5.5 million for viral load reagents. This became a priority as it became clear that without such a commitment, viral load testing would cover only 60 percent of those eligible. Activists also helped to win accelerated TLD transition, now set to occur in nine months rather than one year, and the Ministry of Health representative from Zimbabwe outlined an approach that centers on women’s choice—so that women of childbearing age who wanted to opt for DTG can do so whether on contraception or not. These are big wins and require ongoing vigilance from in-country advocates to ensure that providers, women and all PLHIV have robust treatment literacy and that the shelves carry the options for contraceptives and antiretrovirals needed to make informed choice a reality.

A Return to Treatment Literacy: It’s about time

The discussion of the Zambia program looked at many issues—including struggles with retention in treatment among certain age groups, persistently low rates of HIV testing within key population programs, and the need for programs to deliver condoms, lubricant, oral PrEP and more while protecting human rights, safety and security. For many in the room—which included Enock from Friends of Rainka and Fred from Network of Zambian People Living with HIV—one key win was the strong commitment to expand treatment literacy at antiretroviral treatment (ART) sites and in the community, led by and for people living with HIV. So many of today’s programmatic interventions, from index testing to TLD transition to PrEP uptake are best delivered with the support of peers who can provide correct, comprehensive information. This “treatment literacy” was once a mainstay of AIDS treatment—but funding for it fell by the wayside as ART clinics got medicalized, and it seemed a matter of just prescriptions and refills. It was never this simple; and today, countries and programs are finally returning to a fundamental element of truly effective public health programs: information from, by and for the people who are the true experts.

What’s Next

COMPASS coalitions in Malawi and Zimbabwe are following up and nailing down the fine points; in Uganda, HEPS, a longtime AVAC collaborator, is finishing up a report on how civil society can participate in PEPFAR’s site-level monitoring work, known as “SIMS”—a critical way to keep tabs on what is actually happening on the ground. Look for that report in the coming months. We’ll announce it on the P-Values blog, and you’ll be able to find it on avac.org/high-impact-prevention.

We’ll also be closely following developments in so-called “reboot” countries, where the Office of the Global AIDS Coordinator (OGAC) is demanding wholesale overhauls of the programs before any money gets spent. Mozambique, South Africa and Tanzania are all in this category; likewise, the transition to “indigenous” partners—local organizations versus international NGOS—will be something to track to ensure that resources go to groups with ground-level expertise, proven track records and the ability to deliver.

We’ll be watching—will you?