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PrEP, Possibility, Pregnancy and Breastfeeding

The US Women and PrEP working group discussed PrEP, pregnancy and breastfeeding on October 5. A recording of the webinar can be found here.

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WHO Guidelines on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV

WHO recently issued an “Early Release Guideline” on when to start antiretroviral therapy and on pre-exposure prophylaxis (PrEP) for HIV. This document recommends 1) initiation of ART in adults living with HIV, regardless of CD4 cell count, and 2) offer of PrEP as a prevention option to all people at substantial risk of acquiring HIV. (The release is “early” relative to a comprehensive update of its consolidated ARV guidelines, slated to come out at the end of the year.) If implemented, these sweeping recommendations have the potential to change the world by simplifying ART for people living with HIV and revolutionizing prevention for people at risk.

In this webinar, Meg Doherty and Bob Grant from the Department of HIV/AIDS at WHO, spoke about the guideline and took questions. Links to the full presentation, slides and audio are below.

And for more background, Meg Doherty gave a presentation at IAS 2015 in Vancouver. Download the slides or view the presentation.

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The Next Generation of Global Health: Harnessing innovation to ensure healthy lives for all

US leadership in global health innovation has played a critical role in achieving landmark progress in global health over the past fifteen years. As the global community embarks on the next era of development, the Sustainable Development Goals (SDGs) challenge us to reach for zero and eliminate poverty, infectious disease outbreaks, and preventable maternal and child deaths.

The end of HIV/AIDs, malaria, tuberculosis, neglected tropical diseases and preventable deaths during childbirth are only within reach if we continue to invest in the research and development for new vaccines, drugs and devices that move us beyond current health interventions.

The Global Health Technologies Coalition had an interactive panel discussion on how global health innovation is key to tackling the world’s most pressing health issues and meeting the challenge of the Sustainable Development Goals. The panel highlighted the importance of partnerships, especially the role of the private sector, nonprofits and US Government in global health innovation.

A panel discussion with:

  • Kaitlin Christenson, PATH
  • Gary Cohen, Becton, Dickinson and Company
  • Dean Jamison, Lancet Commission on Investing in Health
  • Tony Pipa, US Department of State
  • Moderated by Lisa Cohen, Washington Global Health Alliance

In Collaboration with:

  • Senator Roger Wicker and Senator Chris Coons, co-chairs of the Senate Caucus on Malaria and Neglected Tropical Diseases
  • Congressman Ander Crenshaw and Congressman Gregory Meeks, co-chairs of the Congressional Malaria and Neglected Tropical Diseases Caucus

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EATG 2015 webinar 2: Treatment for all: prevention and community implications

Following the recent announcement of new guidelines by WHO, this webinar looked at the implications of treatment for all for HIV prevention programmes.

Speakers included Professor Jens Lundgren, one of the principal investigators of the START study; Dr Meg Doherty, Coordinator of Treatment and Care in the Department of HIV/AIDS at WHO, and Giulio Maria Corbelli, Chair of the European Community Advisory Board (ECAB).

The webinar was chaired by Gus Cairns of EATG.

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Strategies and Best Practices for Recruitment and Retention of Cisgender & Transgender Women in HIV Clinical Trials

The Centers for Disease Control reports nearly one in four people living with HIV in the United States is female. Federal funding has been allocated to increase awareness and inclusion of women in clinical trials, yet female participants are often underrepresented in HIV research.

Transgender women also encounter a high prevalence of HIV infection, but have not sufficiently been included in clinical trials. The National HIV AIDS Strategy states that although progress has been made in recent years the Federal government “must remain vigilant in increasing knowledge and appropriate support and interventions” for transgender communities.

The webinar featured:

  • Annet Davis, RN, MSW, CCRC, Project Director, at University of Pennsylvania’s HIV Prevention Research Division. She will speak to her success in engaging women with transgender experiences for HVTN 505, a Phase 2b HIV vaccine trial.
  • Rondalya DeShields, RN, MSN, Program Manager for the Infectious Disease Practice at Rutgers, New Jersey Medical School. She will speak on recruiting high risk women for HPTN 069, also known as NEXT-PrEP, a Phase 2 trial of maraviroc as PrEP.

These studies demonstrate some of the unique considerations that are necessary for successfully engaging cisgender and transgender women in HIV research.

The Women’s HIV Research Collaborative (WHRC), a working group of the Legacy Project, provides culturally appropriate leadership in development, implementation and dissemination of information about HIV research addressing the needs of women and girls in the United States. The WHRC works to raise the visibility of issues related to HIV in women in the US and promotes awareness of scientific research to women in disproportionately impacted communities.

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The Combine! Study: Protocol for a Pragmatic Clinical Trial on PEP, PrEP and Combination HIV Prevention Methods in Public Clinics in Brazil

The Network for Multidisciplinary Studies on ARV-Based HIV Prevention (NEMUS) webinar was presented by Dr. Eliana Miura Zucchi on:

The Combine! Study: Protocol for a Pragmatic Clinical Trial on PEP, PrEP and Combination HIV Prevention Methods in Public Clinics in Brazil

Dr. Eliana Miura Zucchi is a psychologist with masters (2008) and doctoral (2014) degrees in public health from the University of Sao Paulo. Currently she teaches at the Graduate Program in Collective Health at the Catholic University of Santos, and is a member of NEPAIDS – the Center for HIV Prevention Studies at the University of Sao Paulo. She is part of the Research Team of the Combine! Study.

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Demanding Clarity on PrEP: Understanding recent data on oral PrEP

This webinar featured Jean-Michel Molina of the French research agency ANRS and Sheena McCormack of the UK Medical Research Council discussing the data from the IPERGAY and PROUD studies, respectively. Both trials evaluated oral TDF/FTC (brand name Truvada) as PrEP in gay men and other men who have sex with men, and both reported high levels of protection against HIV acquisition. PROUD prescribed a daily pill regimen; IPERGAY asked trial participants to follow an “event driven” regimen that involved a sequence of doses before and after sex. IPERGAY participants took an average of four doses per week—comparable to the estimated protective dose required in trials of daily oral PrEP.

Prepare for the webinar with these talks from CROI and excerpts from AVAC Report 2014/15:

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Follow the Money: Knowns and unknowns when it comes to cash transfers and financial incentives to improve health in people living with and/or at risk of HIV

This webinar featured Wafaa El-Sadr, principal investigator of HPTN 065, which evaluated the use of cash incentives in improving outcomes for people living with HIV in the United States.

These were useful talks from CROI and excerpts from AVAC Report 2014/15 as preparation for our webinar:

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After FACTS: What’s next for HIV prevention in women?

This webinar featured Helen Rees, principal investigator of the FACTS 001 microbicide trial of vaginal 1% tenofovir gel, and Jared Baeten, co-chair of Partners PrEP.

FACTS 001, which released data at CROI, found no evidence of protection overall associated with the vaginal gel. Partners Demonstration Project, which reported data at the same meeting, found that serodiscordant couples using oral PrEP and/or ART had very low levels of HIV transmission. We discussed what these and other data meant for women, including young and adolescent girls.

Download slides and audio from the webinar.

In advance of the webinar, we suggested the following talks from CROI and excerpts from AVAC Report 2014/15 as background:

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Moving forward with development of GSK1265744 (cabotegravir) for long-acting injectable PrEP in men and women

In this webinar, Raphael Landovitz, Protocol Chair, presented on HPTN 077—a Phase IIa safety, tolerability and acceptability study of an investigational injectable HIV integrase inhibitor, GSK1265744, for PrEP in HIV uninfected men and women. It is currently enrolling HIV uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65.