What’s New on AVAC.org

We’ve posted several new resources on AVAC.org that you won’t want to miss.

1) The WHO’s recently released guidance on the use of hormonal contraceptives in women at risk of HIV has prompted a great deal of interest from advocates working in HIV prevention and women’s sexual and reproductive health and rights. We have several new resources that address this complex issue.

2) Advocates continue to work to understand the difference between the US CDC and WHO recommendations about the number of doses that new users of daily oral PrEP need to take to achieve reliable protection. In our webinar, Time to Protection for PrEP, pharmacologists take you through their data. Check out the recording as prelude to our upcoming webinar, Time to Protection Part 2, which follows up on this issue on Tuesday, April 4, 9am US ET / 3pm CET. Tune in to hear representatives from the CDC and WHO review current PrEP guidelines.

3) And on our blog, P-Values, don’t miss Micheal Ighodaro’s post, Building Solidarity Between African American Gay Men and African Gay Men Through PrEP.

Building Solidarity Between African American Gay Men and African Gay Men Through PrEP

Last month, I attended my third NAESM Conference (National African American MSM Leadership Conference) in Dallas, Texas. The conference happened at a period of significant change in America. It actually took place the same week as the Presidential Inauguration! Not surprisingly, many at that conference needed an avenue to express how they were feeling. NAESM also offered the opportunity for anyone who wanted to talk to a therapist about the election.

The conference was also a space for so much more than processing feelings about and reactions to the new President. This was the largest NAESM to date, with about 600 hundred black gay men and their allies from around the country—and a few, like myself, from Africa. We talked about many things, including a growing concern about HIV among black gay men in the US. This isn’t news. In the United States, gay, bisexual, and other men who have sex with men are disproportionately affected by HIV.

Gay and bisexual men, black/African American men, especially those who are younger, are the most disproportionately affected by HIV. A lot of times this is reported in the news, but by voices who are talking about affected groups. When men talk about how HIV affects their lives and communities, it sounds different. I heard people talk about their personal lives in ways that remind me of my own experience in Africa. In one group discussion, a gay man from Houston talked about how limited access to quality health care, lower income and less education place men like him at higher risk of HIV than some other races/ethnicities. This is true for gay men in Africa, who already face a greater risk of getting infected, mainly because of who they love or their socio-economic status.

Looking at ways for gay men in the US and those in Africa to build alliances is actually one of the things that brings me to the conference. Reflecting back just before the conference, I posted on my Facebook wall about the need to have a conversation with my African American friends/brothers about the complicated relationship between Africans and African Americans! A few hours a later I was getting tens of comments and messages from friends who also felt that there was a serious need for this conversation! I believe the time has never been so urgent for us to have this very needed conversation, and what better way to do it other than using something that everyone of us can relate to? PrEP for HIV prevention!

And that is why attending NAESM this year was so crucial for me. I came there to work with members of AVAC’s PxROAR program from the US and Africa—and with our board member and External Relations Director at the HVTN, Steve Wakefield—to have a discussion about PrEP in our respective worlds.

The panel was one of the first times that I can remember that a space was created for Africans and African Americans who identify as gay to look at what our differences are and what brings us together. It was the beginning of a conversation that we need to keep going and that the PxROAR program will hopefully catalyze through online forums, calls and informal relationships to hear each other’s voices and views.

Some of the key things that we talked about in Dallas are that PrEP is a key tool no matter where you came from or the color of your skin. We looked at the data and how they show that it has been proven to be an effective tool that could help prevent new HIV infections among both communities. Then we talked about how PrEP has been delivered in the US and in Africa. We found out that in most parts of Africa, PrEP is just starting to be discussed and there is nearly no public campaign for PrEP for gay men. Whereas in the US, campaigns like PrEP4Love are already making headways in the black gay community. So, we all have a lot to share with each other! And AVAC is excited for PxROAR to engage gay men as part of its program in the US and in Africa.

Now, more than ever, is the time that black people and people of color all over the world must hold up one another up in solidarity and love. As Africans, we must not stand by and assume that what we see going on in our American communities is just an African-American problem. As Martin Luther King Jr. once said, “Injustice anywhere is a threat to justice everywhere.”

Webinar: “Time to Protection” on PrEP

UPDATE: The audio and slides from the webinar are now available. Or watch the webinar on YouTube.

Daily oral PrEP using TDF/FTC provides high levels of protection against HIV in people who take the pill regularly. But this protection doesn’t happen overnight. Instead, a person needs to take a number of doses to build up protective levels of the drug in the blood.

Just how many doses?

Right now, the answer to this question is an educated guess—and the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) have different answers about “time to protection” in their respective guidelines for oral PrEP use.

Please join us for a webinar on the data behind “time to protection for PrEP” on Thursday, February 9, 11am–12:30pm US Eastern Time (visit www.timeanddate.com for the local time in your area) to learn more. This webinar will include pharmacologists who have studied drug levels in the blood and tissue of PrEP users, as well as representatives from the WHO who were involved in developing the guidance on this topic along with advocates and implementers.

Register here.

The primary difference between US CDC and WHO guidelines on time to protection relates to women. Specifically, US CDC guidelines recommend that women complete 20 doses of daily oral TDF/FTC to achieve protective levels of the drug in the vaginal tissue. WHO recommends seven days for men (penile and rectal exposure) and women (vaginal and rectal exposure).

Both of these recommendations are based on measurements of the amount of drug that accumulates in blood and/or tissue over a specific period of time. The studies of how drugs are taken into the body and how they leave the body is called “pharmacokinetics” and “pharmacodynamics” or “PK” and “PD” for short, as explained in our primer for advocates (www.avac.org/pharmacokinetics-and-pharmacodynamics). There isn’t a single PK measurement that is associated with PrEP protection—so both WHO and CDC guidelines are based on inference.

When indirect measures are used for direct conclusions, advocates need to understand the rationale. We hope this webinar will further the conversation. Please join us.

What’s New on AVAC.org

AVAC.org has a host of new resources providing concise updates, informed perspective and handy tools. Take a look at the highlights below and get up to speed on a range of strategic issues.

New Resources

  • AVAC, in partnership with the Clinton Health Access Initiative (CHAI), is taking on new work focused on supporting innovation in the prevention “market”—including the programs that deliver new products and the pipeline of products in trials. This two-page intro to the “HIV Prevention Market Manager” gives an overview of this new body of work.
  • To get a flavor of the work the Prevention Market Manager team is focused on, check out this new resource: End-User Research Landscape Mapping and Findings. The term “end user” is used by people who work on developing and marketing products. It refers to the individual who’s ultimately going to make the decision to seek out and use a given product or intervention. This resource gives a sense of the range of efforts trying to understand what is and isn’t known about one key set of “end users” for new prevention options—adolescent girls and young women in sub-Saharan Africa.

From the Infographics Gallery

  • Introduction to Long-Acting Injectables is an updated graphic to guide you through the basics of antiretrovirals that are being developed as long-acting injectables for both treatment and prevention.

Strong Voices in P-Values

  • Progress and justice for women and girls has come under attack by the new US administration via the reinstatement and proposed expansion of the Global Gag Rule. In Standing Together Against the Global Gag Rule the AVAC team reaffirms its commitment to the fight for bodily autonomy, for justice, for choice and voice for women and girls.
  • In New and Touted HIV bNAb: Big deal or news blip?, veteran science writer and HIV journalist Mark Mascolini delves into the nuances of vaccine research using broadly neutralizing antibodies. You will learn more than just what these are; Mascolini looks at the big promises and the small print.
  • Lindsay Roth, a long-time organizer and advocate for sex workers’ rights, gives any lay reader on the subject of sex work an opportunity to gain a deeper understanding of the issues at stake in Getting Set to Defend and Advance Sex Workers’ Rights in 2017 and Beyond. Roth’s reporting shows how HIV prevention, human rights and economic justice can only succeed together.

Px Wire January-March 2017, Vol. 10, No. 1

This issue of Px Wire, AVAC’s quarterly update on HIV prevention research, looks ahead at a host of issues we are watching in 2017. Are we confronting “Fast Track” goals with the sober analysis they demand? Will oral PrEP guidelines translate into programs and will programs meet people’s needs? What progress can we expect from studies on the dapivirine vaginal ring, various vaccine candidates or on broadly neutralizing antibodies, which are garnering so much press attention of late? Will global leaders embrace policies that ensure data gaps on key populations will finally be filled?

Px Wire’s Take on 2017: #Onwards #UntilTheEpidemicIsOver

2017 promises to be a year of big changes, but how the political winds will touch the field of HIV is still unknown. Amidst the uncertainty, long hard work advancing HIV prevention is pushing frontiers all over the world from the lab to the clinic to the household medicine cabinet.

This issue of Px Wire, AVAC’s quarterly update on HIV prevention research, looks ahead at a host of issues we are watching in 2017. Are we confronting “Fast Track” goals with the sober analysis they demand? Will oral PrEP guidelines translate into programs and will programs meet people’s needs? What progress can we expect from studies on the dapivirine vaginal ring, various vaccine candidates or on broadly neutralizing antibodies, which are garnering so much press attention of late? Will global leaders embrace policies that ensure data gaps on key populations will finally be filled?

Check out AVAC’s round-up of these and other questions that we think will define the state of HIV prevention in 2017. And this issue’s centerspread extends the story beyond 2017 with an infographic showing the status of large-scale prevention trials through 2020.

AVAC Introduction to Long-Acting Injectables

A strategy that uses long-acting injectables is being tested now for treatment and prevention. Injected antiretrovirals that are being developed to remain effective for weeks or months could potentially simplify adherence. Our infographic explains the research underway and reviews some of the major questions that research must address.

Introduction to Long-Acting Injectables

This infographic details the process for developing long-acting injectables for PrEP and Treatment U=U.

PrEP Won’t Protect if it’s Priced Out of Reach

Kenneth is a 2015 AVAC Advocacy Fellow, hosted by HEPS-Uganda. He works with both grassroots communities and national level stakeholders in promoting health and the rights of people living with HIV in Uganda by advocating for consumer friendly policies. He’s currently the head of HEPS-Uganda’s advocacy program, and coordinates the Uganda Coalition for Access to Essential Medicines.

The cost of providing new tools for preventing HIV infections like oral PrEP is concerning. I hear cries about the sky-high prices of these new prevention options all the time. Unfortunately, after the lament, there’s little conversation about reducing these high costs and enabling access. Access is defined by 4 A’s: Affordability, Acceptability, Accessibility and Availability. Lose any one of them and you lose access – and impact – altogether. For anything and everything you ever wanted to know about PrEP, including information about costs as it becomes available, checkout PrEPWatch.org.

Globally, we have 37 million people living with HIV, but only 50 percent of these are enrolled on treatment. That’s despite the landmark study, HPTN 052, that showed early initiation of antiretroviral treatment in people living with HIV with a CD4 count between 350 and 550, not only improved their health but also reduced HIV transmission to HIV-negative partners by 96 percent.

There is a lot of public taxpayer’s money invested in research and development of new tools for preventing, and managing HIV. No doubt, a lot of innovation and brain power goes into the development of these products and I salute that work. But let’s not forget the ultimate goal of an AIDS-free generation. This can only happen if people, irrespective of their location, gender, race, sexual and political orientation, have access to affordable commodities.

The irony is once these products are out, few can afford them.

The latest prevention option, oral PrEP, has been adopted in guidelines, or is in the process of being adopted, by several countries, both middle and low income, as a prevention option for people at substantial risk HIV infection. However, there are already concerns that the cost of PrEP may be a barrier to access, and that’s partly the reason officials are dragging their feet as they consider adding it to their package of prevention.

Pricing PrEP is still underway, but looking at cost for the delivery of antiretrovirals for treatment may give us an idea. A July 2016 analysis of three ART delivery models in Uganda, published in the Journal of the International AIDS Society, showed that it costs $257 (facility-based model), $332 (a combination of community distribution and facility-based model) and $404 (community distribution model) to deliver ART annually per person. Like ART, the expectation is that most people taking PrEP will receive it for free, and if PrEP delivery costs about the same as ART delivery, this could be a big barrier to its access, especially for low income countries and populations at risk. Someone, somewhere, will have to pay, and $257 to $404 per person per year is quite a high cost.

As we prepare to deliver PrEP, we need to mirror the solidarity and teamwork exhibited when these products were developed. A multi-disciplinary collaboration between potential PrEP users, healthcare providers, government and funders should characterize how we make PrEP accessible to everyone who needs it.

In October, I attended the 2016 HIV Research for Prevention (R4P) Conference in Chicago. Being the only conference focused solely on biomedical HIV prevention, I was really looking forward to hearing new ways to address the access issues I highlighted above. Unfortunately, even here there was too little conversation about protecting public health interests over private commercial interests, which hike prices for new HIV prevention tools. I’m excited by the potential of PrEP to drive new infections down, but I worry that if the high cost of its delivery isn’t checked, PrEP may not realize this potential, especially not in the developing countries where it’s needed most.

To Be PrEP-ared for the Future, We Must Learn from the Past

Simon K’Ondiek is a 2011 AVAC Advocacy Fellow, hosted by the Nyanza Reproductive Health Society in Kisumu, Kenya. He is an HIV prevention research advocate with vast experience in the mobilization of communities to effectively engage with HIV prevention research and educating these communities on clinical trials around them.

Five years ago, I was an AVAC Advocacy Fellow. At the time, voluntary medical male circumcision (VMMC) was just beginning to be rolled out in sub-Saharan Africa. Kenya, where I live, was out in front of many other countries but even then, there were problems and challenges—getting information out about what the intervention did and didn’t do, encouraging adult men to take up the procedure, fostering support from female partners, spreading the word, persuading traditional leaders to take it up—I spent my fellowship working on these things. The year culminated in a documentary photography series, exploring themes centered on the knowledge, attitudes, communication and behavioral intentions of young men and women as VMMC rolled out in Nyanza Province. I also built an advocacy task force to work in the province and monitor the rollout.

All of that work was triggered by a joint recommendation in 2007 from the World Health Organization (WHO) and UNAIDS. It called for the adoption of VMMC as an additional strategy for HIV prevention in priority countries. A subsequent document, Joint Strategic Action Framework to Accelerate the Scale-Up of Voluntary Medical Male Circumcision for HIV Prevention in Eastern and Southern Africa, identified key success factors for VMMC. These include leadership and governance. Steadfast political support, if sustained through the entire process of implementation, results in much greater uptake. Engaging national champions (such as Prime Minister Raila Odinga who became one of the key faces of VMMC in the region), developing national policy and operational plans, and designating a spokesperson for the national program helped bolster VMMC uptake in Kenya. I focused on community-level work and can say from first-hand experience that rollout without comprehensive community engagement beforehand almost brought VMMC to its knees. Few men showed up at clinics to be circumcised, and local leaders balked at the idea of circumcision, considering it a foreign intrusion. Something had to change to address these and other challenges. And when communities and traditional leaders were more meaningfully engaged, the pace of rollout intensified.

So much of what I did in that fellowship is applicable today—especially when it comes to PrEP. Here is what I wish everybody knew, and would carry forward as they plan for the kind of comprehensive engagement that made VMMC a reality in Kenya.

For PrEP to be effective community-wide, it will take strong leaders, resources, and the engagement of multiple stakeholders, including health service providers, clinic by clinic. Pre-exposure prophylaxis, or PrEP, for HIV prevention involves the use of antiretroviral medications, known as ARVs, to reduce the risk of infection in HIV negative people. Oral PrEP uses a two-in-one antiretroviral (ARV) pill, containing the ARVs tenofovir and emtricitabine under the brand name Truvada. These ARVs were originally developed to treat people who have already acquired the virus. As a pill taken as HIV prevention, several trials have found PrEP to be safe and effective if taken correctly.

PrEP implementation shares similarities with other sexual and reproductive health products being implemented across sub-Saharan Africa. Contraceptives, like PrEP, are also safe and very effective if used. Adherence in both cases is essential. PrEP is highly protective for both men and women. Similarly, a condom also protects both men and women from contracting sexually transmitted diseases (STIs) and prevents unintended pregnancies. Voluntary medical male circumcision (VMMC), PrEP, condom use and other safe sex practices represent a range of options that can be used in combination and tailored to individual needs.

Numerous demonstration projects aim to establish the benefit of PrEP in the real world, outside the controlled environment of a clinical trial. As access expands, oral PrEP will surely face several challenges.

One example, a lack of awareness of available options, and lack of access to services adversely impacts the health of women, and children too. For PrEP implementation to be effective, administrators must overcome a similar lack of awareness and create access for those most vulnerable to HIV. Key populations need to know it’s available and effective. These groups, including sex workers, adolescent girls and young women, men who have sex with men (MSM) and discordant couples, must be engaged.

Consider this: in places where family planning needs are great, common explanations given for not using family planning methods include health concerns, side effects, poor access to products and services, partner reluctance and prohibitive costs. In some place, family planning challenges have been overcome by integrating HIV treatment and maternal and child health (MCH) services, training healthcare workers, engaging male partners, and continually building awareness of the availability of family planning services through TV and radio to reach a wider community.

It’s also important to note two other factors shaping local context: poor attitudes among health care workers hold back the uptake of family planning services, especially for adolescents and young women. And the involvement of men in family planning plays an important role, as women in many developing countries are not empowered to take family planning decisions on their own.

Therefore, successful PrEP implementation at the community level depends upon engaging those most vulnerable to HIV, and address these real-world challenges. They need to be aware of the availability, the side effects, the benefits. Unforeseen obstacles must be addressed as they arise to ensure successful rollout and uptake.

At the national level, we must operationalize PrEP guidelines and work with politicians to secure political will for a sustained delivery model. Well-coordinated community education and literacy programs are needed at the outset to explain PrEP and identify challenges such as stigma and the under-use of reproductive health services.

Government campaigns on TV, radio and posters, with support from local NGOs and local opinion leaders, should be considered. Such campaigns increase knowledge of PrEP, and influence social and cultural attitudes. Health care workers must be trained and provided with materials on PrEP as prevention, and their training must be integrated with reproductive health services to reach women and speed the delivery of PrEP to everyone who needs it.

As Kenya again leads in HIV prevention, this time with PrEP, we cannot repeat the mistakes of the past, which seriously hampered the roll out of VMMC. The potential public health benefits are enormous. There must be a pragmatic approach of integrating existing HIV prevention efforts, especially PrEP, into broader sexual reproductive health services. Overall, increasing PrEP access and acceptance requires effort to make sure those most vulnerable to HIV—including adolescents, sex workers and MSM learn about PrEP and can get it in a safe, culturally sensitive and cost-effective manner.