The social drivers of HIV: In conversation with Charles Stephens Part 3

Original content from our Mapping Pathways blog team

"I'd like to see us...reflecting on our successes. It has been proven that testing someone for HIV and, if positive, linking them to services and care as soon as possible has very positive health outcomes."

In the final part of this three-part series, Charles Stephens of AIDS United, a Mapping Pathways partner organisation, speaks about the successes in the HIV prevention landscape and some of the challenges faced by people in rural areas. Read part one here and part two here.

MP: What are the things being done well in the HIV prevention landscape?

CS: Models like the Mapping Pathways project excite me. The process of collecting data from a variety of different experts and stakeholders on the field and using that data to make a strong case is an excellent model. Other interesting models are AVAC’s HIV prevention research advocacy working group, which I’m a part of, and the community education and research advocacy work of the Black AIDS Institute. Most importantly, stakeholders and leaders within communities are trained and supported to go back to their communities with new biomedical HIV prevention information to disseminate it within their communities.

One of the things I’d like to see more of is reflecting on our successes and planning how to build on the victories we’ve seen over the last few years. It has been proven that testing someone for HIV and, if positive, linking them to services and care as soon as possible has very positive health outcomes. Also from the community perspective we have achieved certain successes like reducing stigma, mobilising communities and providing support networks and services. I’m extremely interested in finding out how we can build on these successes.

MP: What are some of the challenges individuals and communities face in rural areas?

CS: Capacity is one of the main challenges in rural areas. I find that the doctors on the ground are often very knowledgeable, passionate and committed, but the problem that is there just aren’t enough doctors and medical resources. 

Transportation is another huge barrier in rural areas. People have a hard time getting to their doctors, as the transportation infrastructure isn’t always in place. Some people have to travel three or four hours to get to their physicians.

Addressing these barriers has been a challenge, but there have been some innovations like telemedicine, where doctors can remotely provide medical information and check in with their clients from a different location.

MP:  Are there any trial results that came out recently that you have followed closely? Are there any upcoming trials you are interested in?

CS: The HPTN 061 study, which looked at 1553 black, American MSM, shared initial results at AIDS 2012 that reinforced what a lot of us had been seeing on the field. One of the most startling projections of the study was that unless improvements are seen, more than half of all young black gay men who are gay or bisexual will be infected by HIV within the next decade.

Other upcoming trials I will be following with interest are the HPTN 073 study which looks at ways to optimise PrEP adherence in black MSM and the HPTN 069 study, also called NEXT PrEP, which seeks to assess the efficacy of four ARV drug regimens used as PrEP to prevent transmission of HIV in a population of at-risk MSM.

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Sustainable HIV prevention possibilities present choices, challenges

via Science Speaks, by Antigone Barton

When he looks at what biomedical science can do in the next decade to prevent HIV transmission, Jim Turpin of the National Institutes of Health said, he thinks of the lyrics of a Timbuk3 song: “The future’s so bright I gotta wear shades.”

By, which, actually, he means — don’t get blinded by the light; the search for answers will require focus.
“The challenge is not the lack of options,” he said, “but prioritizing the best options.”

Turpin, program officer and branch chief in the Prevention Sciences Program in the Division of AIDS at NIH”s  National Institute of Allergy and Infection Disease spoke this morning in webinar titled “The HIV Prevention Pipeline: A Future of Possibilities.” The webinar was sponsored by the International Rectal Microbicide Advocates (IRMA) and AVAC Global Advocacy for HIV Prevention.

After a series of disappointments in the quest for a vaccine or microbicide to prevent HIV transmission, the last two years offered hope, in strategies using antiretroviral medicine to prevent acquiring HIV, organizers point out. But, with a diversity of prevention needs and challenges among women and men worldwide still demanding answers, is that all there is?

Or, as Turpin put it, “Do we currently have what it takes to create a sustainable prevention pipeline?”

Read the rest.


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AVAC Updates: Newest Issue of Px Wire and M2012 Road Map are Now Available!

via AVAC.org

This update provides a summary of and link to download the newest issue of Px Wire, as well as a roadmap for advocacy and communications-related sessions at the upcoming International Microbicides Conference (M2012).

Px Wire

Download the current issue of Px Wire (Volume 5, Issue 2), a quarterly update on biomedical HIV prevention research worldwide.

In this issue of Px Wire, we are excited to showcase a new ARV-based prevention timeline graphic, just in time for M2012. The timeline shows estimated efficacy trial end-dates, related confirmatory studies and dates of possible regulatory submission for a range of prevention options including oral PrEP with TDF, oral PrEP with TDF/FTC, vaginal and rectal formulations of tenofovir gel and the dapivirine-containing vaginal ring.

We also hope you enjoy reading the feature story in Px Wire where we describe the ongoing work of advocates who are working to influence PEPFAR Country Operating Plans.

Other highlights in this issue of Px Wire include:

• Information on how advocates can contribute their voices to the US FDA’s May 10 public meeting on Gilead Science’s submission for TDF/FTC (Truvada) as PrEP for HIV-negative adults

• Summaries of new AVAC resources: PrEP Using Daily Oral TDF/FTC or TDF in Women (and Men) — What the science tells us in March 2012, and new advocacy resources for voluntary medical male circumcision

• Upcoming events

2012 International Microbicides Conference (M2012)

Next week advocates, policy makers, researchers and funders will meet at the 2012 International Microbicides Conference taking place April 15-18 in Sydney, Australia. Building on past conferences, M2012 is a platform to discuss the latest in microbicides, PrEP and other ARV-based prevention research, as well as the basic science, structural, social and community issues that affect research and eventual rollout of these new tools. M2012 will feature several sessions that focus on advocacy and the role community advocacy and communication plays in the field. Our online conference “roadmap” highlights a number of these sessions. If you will be attending the conference, we invite you to join us at these events. Please visit the AVAC M2012 page for updates on these activities.

If you are not able to participate in M2012 in Sydney, please watch out for information on special AVAC post-M2012 webinars covering critical issues that emerge at the conference. For key updates during the conference visit NAM/AIDSMAP.

As always, if you have any questions please contact us at avac@avac.org.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

AVAC Launches Research Literacy Database!

via AVAC

AVAC is pleased today to launch the Research Literacy Database at www.avac.org/researchliteracy, an important new resource for the biomedical HIV prevention field.

The Research Literacy Database is the first central portal for educational resources on biomedical HIV prevention including:

• Global and country-specific materials;

• Resources specific to given prevention interventions including AIDS vaccines, ARV-based prevention and
voluntary medical male circumcision; and

• General information on clinical trials and the research process.

The tools featured in the database were developed by a range of stakeholders worldwide to meet specific needs. We will continue to expand the database and encourage our users to share their favorite materials on an ongoing basis. The database focuses on materials that won’t necessarily change substantially over time; for trial updates, timelines, recent results and their implications and current issues, please see other areas of the AVAC website.

Using an innovative design, the database allows users to search for what they need based on key criteria. For example, a journalist in South Africa who wants to learn more about the basics of microbicide research can use the database to find relevant fact sheets, e-learning courses and other helpful tools. Research organization staff members who need tools for training and outreach to wider audiences can use the database to get a tailored toolkit according to location, audience and specific content.

We all know that the science behind HIV prevention research is challenging. AVAC believes that building
basic research literacy among key stakeholders is fundamental to effective advocacy, to moving research forward as quickly and ethically as possible, and ultimately to getting new prevention options to people who need them. Whether you are a researcher, advocate, journalist, policy maker or someone interested in learning more about clinical trials and new ways to prevent HIV, we hope this database will make learning and outreach efforts easier and more effective.

The database is an iterative tool, and will be constantly updated with new materials and other user input. We need your help in ensuring that useful materials are available and used! Please contact us at researchliteracy@avac.org with any and all feedback you have as you use the database—and we are especially keen to receive additional relevant resources to be shared with the field.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Open Letter to FDA Urging Immediate Review of PrEP

via AIDS Foundation of Chicago

This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation's protest of the FDA regarding this review. To read the PDF of the letter, with footnotes, click here.

Dear Commissioner Hamburg:

We write as a coalition of 25 leading HIV/AIDS and health organizations to request that FDA grant priority review of a supplemental New Drug Application1 (sNDA) for the approval of emtricitabine/tenofovir disoproxil fumarate (Truvada®) fixed dose combination for preexposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults as part of a comprehensive prevention package including risk reduction counseling and condoms. The rigorous priority review process applicable to efficacy supplements is the best means to promote public health by recognizing the potential of PrEP to offer a major advance in HIV prevention and deserving this priority “where no adequate alternate therapy exists or as a significant improvement compared to marketed products … including nondrug products or therapies.”

Our organizations understand that granting priority review is not tantamount to a final approval. Nevertheless, we are hopeful that the full dossier of data on emtricitabine/tenofovir disoproxil fumarate fixed dose combination of PrEP from multiple clinical trials in different populations
can lead to a responsible regulatory and marketing plan that allows safe use in the populations that may benefit from this innovative development.

The need for significantly improved safe and effective HIV prevention tools is clear. Despite many years of efforts to reduce HIV incidence using available counseling methods, some 50,000 new infections occur annually. Disparities persist so that incidence continues to concentrate among African Americans and Latinos, men who have sex with men (including transgender individuals), and the poor. These grim and stubborn facts led to the creation of the White House directed National HIV/AIDS Strategy for the United States (NHAS), which lists enhanced prevention efforts as a primary objective.3 If emtricitabine/tenofovir disoproxil fumarate for
PrEP satisfies FDA approval criteria, health programs and individuals will have improved choices to address a domestic priority and save lives.

The PrEP sNDA for Truvada® meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.

HIV advocacy organizations made it possible to launch such regulatory procedures for the benefit of all patient disease groups when those tools were not yet available. We are not aware of any legitimate reason to thwart the faster introduction of medicines FDA determines to be safe and effective to stop HIV, nor should anyone turn back the pages of history and act against the interests of patients to do so now. Unfortunately, recent actions by the AIDS Healthcare Foundation regarding PrEP would introduce unwarranted roadblocks in the FDA process of making responsible decisions about potentially useful medicines and public health. Those actions also foster misunderstandings of the careful balancing of risk and benefits that informs a mature marketing permission based on all available data. Those actions would also set an unhelpful precedent as PrEP research evolves in the future and the FDA is asked to review nontenofovir- based regimens (e.g. maraviroc), microbicide gels, and intermittent PrEP. We urge that FDA continue its public health promotion goals now in the service of the critical need to prevent, as well as treat, HIV and grant this priority review.

We would be happy to discuss the priority review process as applied to HIV prevention further at your convenience. Mitchell Warren, Executive Director of AVAC, acts as the contact person for the organizations signing this letter (tel: 1-212-796-6423 or email: Mitchell@avac.org).

Sincerely,
AIDS Foundation of Chicago
AIDS Legal Referral Panel
AIDS Resource Center Ohio
AIDS Research Consortium of Atlanta
AIDS United
amfAR, The Foundation for AIDS Research
Asian & Pacific Islander Wellness Center
AVAC: Global Advocacy for HIV Prevention
Black AIDS Institute
Caracole, Inc.
Chicago Black Gay Men’s Caucus
Fenway Health
HIV Prevention Justice Alliance
International Rectal Microbicide Advocates
Justice Resource Institute
LA Gay and Lesbian Center
Multicultural AIDS Coalition
National Alliance of State and Territorial
AIDS Directors
National Black Gay Men's Advocacy
Coalition
National Latino AIDS Action Network
National Minority AIDS Council
Ohio AIDS Coalition
Project Inform
San Francisco AIDS Foundation
SisterLove, Inc.
Ursuline Sisters of Youngstown HIV/AIDS Ministry
Us Helping Us

Read the PDF version of the article (with footnotes) here.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

To End AIDS, We Need a Plan!

via Huffington Post, by Mitchell Warren

Last Thursday (December 1), on World AIDS Day, President Obama threw the full weight of the U.S. government behind a vision that would have seemed outlandish until now: The end of the global AIDS epidemic.

Over the past few years, a string of HIV prevention research breakthroughs has put that ambitious goal within sight for the first time. Voluntary medical male circumcision is the most powerful, under-utilized biomedical HIV prevention strategy available: with a single surgical procedure, men's risk of HIV from female partners is reduced by more than 60 percent. Treatment for HIV positive individuals is also potent prevention -- reducing risk of transmission by up to 96 percent.

These two strategies are the cornerstone of a new era of HIV prevention, and it is critical that the president continue to be a supporter and leader of the chorus of advocates, health and political leaders who are saying "Yes, we can end AIDS."

Now the question is: How will we achieve this goal? What are the priority actions to take today, tomorrow, and years from now?

First and foremost, the resource commitments need to match the strength of the scientific data. Funds are needed to ensure that the most effective prevention is put in place for the people who need it, in programs that meet their needs, with rigorous evaluation of impact so that no dollars are wasted.

President Obama's commitment to expand access to HIV treatment for two million more people by 2013 is a wonderful first step. But his call to the leaders of the world to match the US commitment must be heeded.

Last week, the Global Fund to Fight AIDS, Tuberculosis and Malaria - which supports HIV treatment programs in resource-poor countries along with PEPFAR - announced that it has been forced to curtail new grant-making until2014. The Fund pointed to a drop-off in contributions from governments in the face of the global economic crisis.

There's no question that economies are hurting. But global AIDS programs are among the smartest investments in history: they've saved countless lives and have shifted the course of the epidemic so that annual HIV infections are on a slow but steady decline. In most cases, these efforts represent a tiny share of donor countries' national budgets - for the U.S., it's well under one percent. It is precisely at this moment, when the potential dividends are greatest, that the world's modest AIDS investments should be sustained.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

AVAC Realeases Its 2011 Report: "The End?"

via AVAC

This AVAC report presents a three-part agenda for ending the AIDS epidemic. It is intended as a vision and a challenge to the field, and a first step in holding all of us—civil society, researchers, governments, and funders—accountable for progress.

Each of the major priorities below demands action now—but the dividends will come in the short, medium, and long terms.

1. DELIVER today’s proven strategies at scale for immediate impact

• Model combination prevention programs to identify the parameters that are essential for scale-up to have a major impact on infections
• Mobilize demand for new tools among people who could benefit, through social marketing and other efforts
• Reprogram existing resources when evidence shows they could be used to greater effect
• Fund evidence-based scale-up today—and save money in the future—through substantial increases in commitments from U.S., European and developing country funders.

2. DEMONSTRATE and roll out newly available HIV prevention tools, including PrEP and microbicides, for even greater impact in 5 to 10 years

• Plan for the introduction of PrEP and microbicides in the next several years, and for follow-on research needed to address questions that remain unresolved in trials to date
• Pilot these interventions through demonstration projects that help define their optimal use and real-world impact
• Prioritize the use of these interventions in populations, and in combinations, where the potential benefits are greatest

3. DEVELOP long-term solutions—including an effective vaccine and a cure—that will enable us to close the door on AIDS

• Sustain funding for research, to capitalize on recent scientific insights that have begun to revitalize the search for a vaccine, while pursuing new leads that may eventually result in a functional cure for HIV infection.

Read the full report here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Contraceptive injections and HIV transmission risk - what happens now?

via aidsmap, by Roger Pebody

With new data suggesting that injectable contraceptives may double the risk both of acquiring and passing on HIV, how will this affect women’s contraceptive choices? What are the implications for family planning policy in countries with a high burden of HIV?

Panellists on a teleconference on the topic, organised by AVAC last week, agreed that the data do not yet provide definitive answers and that healthcare providers need to avoid frightening women away from contraceptive methods they know and trust.

Experts are mindful that the HIV-related risks need to be balanced with contraception’s benefits for maternal and child health. Family planning helps to prevent unintended pregnancies and the number of unsafely performed abortions, thereby reducing maternal deaths, disabilities and infertility. It can prevent high-risk pregnancies among adolescents, older women, women in poor health and women who have had many births or births spaced too closely together. Because it helps women to space births, child mortality rates are lower; mothers have more time to breastfeed, improving infant health; and women have more time to recover physically and nutritionally between births.

Moreover, preventing unwanted pregnancies in women with HIV is also one component of strategies to reduce mother-to-child HIV transmission.

At the International AIDS Society’s conference in Rome in July, Dr Renee Heffron of the University of Washington presented results from an analysis of data from the Partners in Prevention cohort in seven African countries. The results, reported on Aidsmap at the time, showed that HIV-negative women who were in a relationship with an HIV-positive man had twice the risk of acquiring HIV if they used hormonal contraception. Furthermore, HIV-positive women had twice the risk of transmitting HIV to their male partners if they used hormonal contraception.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

FDA, Gilead And HIV Prevention-In-A-Pill?

via Pharmalot, by Ed Silverman


The debate over whether the FDA should approve an existing AIDS medication for preventing the spread of HIV has ratcheted up as more than a dozen advocacy groups are urging the agency to accelerate its review process and not wait for data about heterosexuals. The move comes just one month after one prominent advocacy group urged the FDA not to approve Truvada, which is sold by Gilead Sciences, for prevention, or as pre-exposure prophylaxis, for any group.

In a letter to the FDA and Gilead, the groups say that approval is needed as soon as possible in order to provide protection to gay and bisexual men and transgender women. And they cited data from a study released last November that found that men and transgender women who have sex with men and received a daily dose of Truvada, along with condoms and safe sex counseling, had an average of 42 percent fewer HIV infections than those who received only condoms and counseling (read here).

In fact, three PrEP trials have shown evidence that using Truvada or Gilead’s Viread, which is a component of Truvada, reduced the risk of infections. The other trials examined use by heterosexual men and women, and a so-called partners trial that looked at couples in which one partner is HIV-negative and the other is HIV-positive.But the advoacy groups complain that before results of the heterosexual study were released, the FDA and Gilead were believed to be ready to proceed with a review of PrEP for men who have sex with men, or MSM. And to them, delay means more infections.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Whatever Happened to the AIDS Vaccine?

via The Huffington Post, by Michael Warren

"Now is exactly the time to maintain commitment. Now is exactly the time to hold a steady course in funding for basic science, clinical trials and product development. It's good business sense: Our investments are paying off -- and the dividend, in the form of an effective vaccine, would have value beyond our wildest dreams."

Recent news about HIV/AIDS has focused on the good -- promising trial results that prove the antiretroviral (ARV) drugs used to treat HIV can also prevent HIV infections -- and the bad -- retreats in donor commitment that imperil the substantial gains that have been made in treating global AIDS, at the precise moment that treatment has been recognized as a powerful prevention strategy. In discussions about whether AIDS treatment can be used to end the AIDS epidemic, scant attention is paid to the search for an AIDS vaccine.

When AIDS vaccines do get mentioned, it is often in the context of questions about whether a vaccine is still needed, or whether the search for an AIDS vaccine is affordable in today's economic climate.
Researchers and advocates who gathered Sept. 12-15 in Bangkok, Thailand, for the AIDS Vaccine 2011 conference have clear answers: Yes, we still need a vaccine, and yes, we need to continue to invest in AIDS vaccine research.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

From 'what if' to 'what now': implementing the new prevention technologies

Via AIDSMap, by Gus Cairns.

 

Two consecutive sessions at the sixth International AIDS Society conference in Rome yesterday were devoted, now we have convincing scientific data on the benefits of treatment as prevention and PrEP, to putting these new prevention methods into practice.

“We have moved from ‘What if?’ to ‘What now?’” was the comment of Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC), on what else we need to know, what barriers need to be addressed , and what resources might be required, to maximise the promise of antiretroviral-based prevention.

Anthony Fauci, Director of the US National Institute of Allergies and Infectious Diseases (NIAID), said: “We now have a solid scientific foundation to say that even in the absence of a vaccine we have the capacity to end the epidemic. I can’t go to the US President and say: 'We can cure HIV.’ But I can say ‘Ending the epidemic is scientifically doable’.”

Earlier, however, Nancy Padian from the Office of the US Global AIDS Coordinator had outlined formidable challenges still to be answered if antiretroviral treatment could bring about this goal.

She said that questions still needing answers include whether antiretroviral drugs (ARVs) really are a durable and reliable means of viral load suppression over a period of years and whether increasing the proportion of people on treatment would lead to increased levels of resistance. The biggest practical question, however, was whether treatment as prevention would work in situations where a high proportion of transmissions came from people with acute, recent HIV infections.

The biggest barriers to treatment as prevention, however, are stigma and lack of resources. Implementing ARV-based prevention would not only be expensive in terms of drugs; it would require added human resources and increased training and task-shifting for prevention counsellors so they can deal with biomedical data. There would also be added costs in terms of tests and monitoring.

The other big barrier will be the stigma of being tested, she said, particularly for at-risk populations in societies where injecting drug use, male-male sex, or sex work were criminalised and stigmatised. Treatment as prevention would require people not simply to test and then go to more supportive community organisations for prevention advice; it required a much closer relationship with medical personnel who might be prejudiced or feared to be so.

Mitchell Warren issued a call to action to implement the new strategies, but his presentation was tempered by realism. “We have evidence, we have data, and we now need to make decisions,” he said.

Read the rest here

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]