Research Academy for HIV cure investigators

Are you an early to mid-career HIV investigator or clinical scientist, affiliated with or working in collaboration with an institution or university in a resource-limited country? IAS invites you to apply for a fellowship to attend an interactive three-day workshop in South Africa on state-of-the-art HIV cure research, led by Nobel Laureate Françoise Barré-Sinoussi. The IAS Academy will award fellowships to 25-30 outstanding applicants to attend this workshop, with full travel support to participate. Applications deadline: 9 April 2017.

Community Perspectives Survey

Treatment Action Group (TAG) is conducting a survey of community perspectives on provision of Truvada for PrEP in clinical trials of biomedical HIV prevention interventions. We would be very grateful if you would consider completing the survey, which will be anonymous and is online at: http://www.treatmentactiongroup.org/content/community-survey-prep-and-biomedical-prevention-clinical-trials. Deadline: Monday, 20 March 2017, 5:00PM EST.

WHO Updates Guidance on Hormonal Contraception and HIV

Update: AVAC hosted a webinar discussing this topic in further depth. Click here to listen.

Today the World Health Organization issued an updated guidance statement on its recommendations for the use of hormonal contraception by women at high risk of HIV. The update changes the WHO classification of long-acting injectable contraceptives like DMPA (also known as Depo) and NET-EN. WHO states “there continues to be evidence of a possible increased risk of HIV among progestogen-only injectable users.” Based on this possibility and women’s right to informed choice, the WHO has changed the grade for both methods from “use without restriction” to “benefits outweigh theoretical or proven risks”. Click here for a plain language explanation of these grades and to register for a March 10 webinar on this topic. (Update: Recording now available.)

The new guidance is clear that the recommendations are based on women’s right to informed choice in health and that women should have information about this possibility as well as full access to the method of their choice, regardless of their HIV risk.

Here are links to key resources:

What happened?

Since 1996, the WHO has used a grading system for contraceptive methods. This system is called the Medical Eligibility Criteria or MEC. (AVAC has developed a background guide to “grades” and the MEC available here.) The MEC are used to make sure that family planning programs around the world use methods in the same way. Part of the MEC is a grading system that shows how safe each method is and who can use it. Today WHO changed the grade for DMPA and NET-EN.

Both methods are now in the category for which “the benefits outweigh the theoretical or actual risks.” Simply put, this means this method works well and women should feel free to use it, but they should also know about possible risks. In this case, the specific possible risk is that DMPA or NET-EN might increase risk of acquiring HIV. This risk isn’t proven yet and this classification makes it clear that DMPA and NET-EN should be freely available to all women, regardless of HIV risk.

The technical term for the category is MEC 2. A method that can be used without restriction is in the MEC 1 category. Previously DMPA had been classified a MEC 1*. This meant that it could be used safely by anyone but that there were key things for women and health care workers to think about. The MEC 1* classification for DMPA stated that women at high risk of HIV should be told about the uncertainty about this method and HIV risk, and counseled to use condoms.

For the past several years, advocates for women’s sexual and reproductive health and rights have urged action to ensure that all women receive clear information about possible risks and benefits of all contraceptive methods. In many settings, the 1* classification did not change counseling messages about DMPA. Today’s change to a 2 could help ensure that the right to information is fulfilled. As advocates have made clear, this must be in the context of free choice among a range of contraceptive and HIV prevention methods. (Background on this issue is available here.)

Why the change?

The change was recommended by an Expert Review Group convened by the WHO in December. The group looked at available data on the possible connection between the use of hormonal contraceptives and HIV risk in HIV-negative women. This group also looked at information on women’s values and preferences and discussed the ways that the MEC 1* classification had affected what women were told about DMPA and HIV risk. Based on this and other information, the ERG recommended a change to a “2.” The available information suggest a potential increased risk of risk of getting HIV among users of DMPA. The guidance notes that it is not clear whether this risk is real, but also signals that women should know about theoretical risks in their decision making. An independent WHO committee subsequently reviewed and approved the recommendation.

What does it mean?

The change is a strong affirmation of the sexual and reproductive health and rights of women and girls, including the right to information and informed choice. The guidance statement affirms that these rights were “at the core” of the process. It is a positive signal that all women should receive complete information about all of their family planning options. ICW Eastern Africa and other Africa-based civil society groups have documented that the MEC 1* classification did not substantively change the information most women received about Depo.

Women and adolescents need more choices for contraception and HIV prevention at the same clinic. The call for expanded “method mix” (having more contraceptive choices for women) and integration of HIV and sexual and reproductive health programs is not new. But this updated guidance must catalyze action in these key areas. Some women may not want to use DMPA or NET-EN after being counseled. Others may be motivated to take additional HIV prevention steps. Expanded access to a range of long-acting, discrete contraceptive methods is urgently needed, as is expanded access to male and female condoms and oral PrEP at family planning clinics.

Use of DMPA and NET-EN should not be restricted in any way. Any woman who wants to use DMPA or NET-EN should be able to do so, regardless of her HIV risk. Women are fully capable of weighing risks and benefits when given full information. Every woman should have the option she needs and wants and have access to the method as well as comprehensive information about the options.

This guidance affects specific contraceptives and is most relevant for specific parts of the world where injectable use and rates of HIV are both high. There are limited data on many contraceptives and their impact on HIV risk. The ongoing ECHO trial which is a randomized clinical trial designed to assess the impact of DMPA, the Jadelle implant and the copper intrauterine device on HIV risk, as well as pregnancy, side-effects, and long-term acceptability, will provide more information.

In response to the WHO’s revised guidance, ECHO is updating materials and counselling messages for the trial’s participants. ECHO leadership issued a statement reiterating their commitment to fill information gaps on contraceptive and HIV risk in the service of expanding women’s rights.

AVAC will be working with partners in the weeks and months to come to ensure the guidance is operationalized in ways that uphold women’s right to informed choice and access to a wider range of contraception and HIV prevention. We will also continue to work with other stakeholders in the field to understand how the change impacts ongoing research, including the ECHO trial. Please join us for the webinar next Friday, March 10 to learn more and discuss these issues with colleagues. (Recording now available.)

Please let us know your thoughts, questions and information needs and please join us on next week’s call.

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.”

Refining the NIH research enterprise

Every 7 years, NIH competitively renews its funding of the HIV clinical research networks operating in the United States and internationally….By establishing a forward-looking agenda to guide this process, NIH will determine the focus and priorities through 2027. Learn more with resources available on this site, and to join the conversation, go to: https://www.niaid.nih.gov/research/HIV-Research-Enterprise.

What to Expect for CROI 2017

The annual Conference on Retroviruses and Opportunistic Infections (CROI) kicks off next week in Seattle. This year’s program covers a range of topics of interest to advocates including new data on basic science, a look at clinical trial design, planning to end the epidemic in New York, applying good participatory practices in research, understanding HIV and substance use and more.

Whether you’re en route to Seattle for the four-day meeting or following the proceedings from your favorite wifi-enabled device, this update is for you. Read on to learn more!

A few events are at the top of our list.

On Sunday, AIDS Treatment Activists Coalition, AVAC, DefeatHIV,European AIDS Treatment Group, Project Inform and Treatment Action Group are sponsoring a day-long community cure workshop. The workshop brings together educators and advocates interested in learning about HIV cure research. Attendees spend half of the day hearing from leading researchers about developments in the HIV cure field followed by a strategy session dedicated to developing and increasing advocacy around those topics. The community event is open to all but is nearing capacity. Please be in touch if you are interested in attending.

Monday’s agenda includes the Martin Delaney Presentation (12:15pm in Room 6AB), held in honor of the late HIV activist Martin Delaney. This year’s lecture will focus on Good Participatory Practice Guidelines (GPP) and include presentations from AVAC staff and partners. Through a series of discussions, presentations and feedback from participants, this panel will provide global highlights of GPP and build awareness around their significance in the research process. Please be sure to add it to your Seattle agenda!

And please join fellow advocates and activists on Wednesday night for a community reception, 6-9pm at Tap House. Download the flyer for more information.

Real-time Coverage

CROI also offers excellent webcast coverage, including live reports of the press conferences (press conference schedule available here), as well as taped playbacks. Electronic posters will be available a week after the conference and webcasts of the sessions will be archived online. Visit their electronics materials page for more.

As in years past, Medscape and aidsmap will be covering the conference with their excellent in-depth reporting across a range of research areas, including HIV prevention. And you can follow all the latest on Twitter at #CROI2017 where AVAC and others will be tweeting the latest data in 140 characters or less.

As always, please be in touch with any questions, and we look forward to seeing some of you in Seattle—and working with all of you post-CROI to plot what’s next!

NIH/NIAID/DAIDS Council-approved FY 2018 Concepts

https://www.niaid.nih.gov/grants-contracts/opportunities

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.

Beta version of ClinicalTrials.gov available for testing

A new beta version of ClinicalTrials.gov is available for user testing. The test site can be accessed from a link on the homepage or directly at https://clinicaltrials.gov/beta/, and will be available for at least one month to obtain feedback from the public. The new version [provides] new features to support searching for clinical studies.

Announcing the 2017 AVAC Advocacy Fellows

AVAC is delighted to announce the 2017 AVAC Advocacy Fellows—the eighth class of Fellows selected from a pool of over 100 applicants from 20 countries in Africa, Asia and the Caribbean. Please join us in congratulating these seven talented advocates:

The 2017ers will plan their projects in a busy and exciting time for HIV prevention. As we described in our recent Px Wire, there are many issues to rally around. Will more countries be able to roll out PrEP, will PrEP affect the standard of prevention of new trials? Will prevention initiatives for the growing number of young women be innovative and address their needs? Will we be able to accelerate progress towards meeting the Fast Track goals? And, where resources for sexual and reproductive health and rights may be challenged, can we work to ensure that the voices of those who have most at stake are heard?

The 2017 Fellows have bold ideas to address many of these opportunities and challenges in their Fellowship year, beginning on April 1, and we hope you’ll find ways to collaborate with them. With this incoming class, the AVAC Fellows family has grown to fifty-seven, with Advocacy Fellow Alumni from ten sub-Saharan African countries and China. Please visit the Advocacy Fellows page and follow the P-Values blog to learn more about the new Fellows’ planned work for the year and to learn about the Alumni Fellows’ ongoing work.

We thank all of the applicants and their proposed host organizations for the time and effort put into this process. We’re also grateful to the independent review committee of advocates, scientists and former Fellows and Hosts who guided the decision-making process.

A Call for Applications for the 2018 Fellows Program will be announced this June with an application deadline in August. If you would like to be notified of the 2018 Call for Applications or have any questions, please email us at [email protected].