Category Archives: Research

Statement from EGPAF and m2m on WHO’s Option B+ Approach to Protect the Health of HIV-Positive Mothers and Their Babies

WASHINGTON, D.C. – July 27, 2012 – At the XIX International AIDS Conference in Washington, D.C., there has been growing global momentum around optimal approaches to prevent transmission of HIV from mother to child and to keep HIV-positive mothers alive and healthy.

The World Health Organization (WHO) recently encouraged countries to consider accelerating the adoption of one of two options for preventing mother-to-child transmission of HIV (PMTCT) that both include added benefits for and emphasis on the health of mothers. Option B includes the use of triple-drug therapy for the mother during pregnancy and breastfeeding, and Option B+ continues that drug regimen for the mother’s lifetime.

The WHO’s three options – Options A, B, and B+ – all afford similar protection against mother-to-child transmission of HIV, but Option B+ has the greatest potential for health benefits for infected women, and can confer protection against transmission of HIV to an uninfected partner.

There is growing consensus that Option B+ represents an evolving best standard for protecting both mother and child from the effects of HIV. The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) and mothers2mothers (m2m) support the development and implementation of revised WHO technical and operational guidelines, and will assist the implementation of whichever option is chosen by national governments.

Adoption of Option B+ will require careful study of new and existing operational issues. EGPAF is prepared to use its considerable country presence, technical capacity, and research ability to investigate the operational issues that need to be addressed and understood for optimal implementation of this regimen. Issues that should be studied through operations research include acceptability, adherence, drug resistance, retention, safety, and funding. EGPAF has been an instrumental partner in assisting the WHO and individual countries to implement past guidelines, and will continue to assist as new guidelines are updated.

m2m will support country efforts to implement Option B+ by using its simple and effective Mentor Mother model to promote enrollment and retention in care. Because m2m’s Mentor Mothers provide additional human resources – educating and supporting mothers as they learn to understand, accept, and adhere to lifelong treatment regimens – they can further ease the pressure this new protocol might cause already strained health systems. m2m is prepared to use its trusted presence in communities to ensure that all women, especially those not currently accessing care, are able to benefit from Option B+.

As organizations working to implement the Global Plan towards the Elimination of New HIV Infections among Children by 2015 and Keeping their Mothers Alive, we are committed to overcoming any obstacle that prevents us from reaching our goal of ending HIV/AIDS in children and mothers.

There are still large numbers of HIV-positive, pregnant women who cannot access any effective PMTCT services, and so we must ensure that countries are able to accelerate efforts toward universal coverage.

We must also adequately address implementation barriers, such as weak health systems – especially in more rural settings – lack of human resources for health, and a need for significant education and community-based support to promote adherence to lifetime therapy and long-term retention in the health system.

We look forward to supporting countries to overcome these issues as they work toward achieving an AIDS-free generation.

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 About the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF):  The Foundation is a global leader in the fight against pediatric HIV/AIDS, reaching more than 14 million women with services to prevent transmission of HIV to their babies. It currently works at more than 5,400 sites and in 15 countries to implement prevention, care, and treatment services; to advance innovative research; and to execute global advocacy activities in order to bring dramatic change to the lives of millions of women, children, and families worldwide. For more information, visit www.pedaids.org. For live updates and resources from EGPAF at the XIX International AIDS Conference, visit www.EGPAF-IAS.org, and follow us @EGPAF.

About mothers2mothers (m2m):  mothers2mothers (m2m) is eliminating transmission of HIV from mothers to babies and sustaining the health of women and children with its proven Mentor Mother model. Since its inception, m2m has reached more than one million mothers in nine countries. Founded in Cape Town in 2001, m2m is a partner in the United Nations’ Global Plan towards the Elimination of New HIV Infections among Children by 2015 and Keeping their Mothers Alive. Learn more at m2m.org or follow mothers2mothers @m2mtweets.

Contacts:

Michelle Milford Morse, mothers2mothers; Phone: 323-969-0445; us@m2m.org

Robert Yule, Elizabeth Glaser Pediatric AIDS Foundation; Mobile: 202-390-9540; ryule@pedaids.org

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Filed under Community, EGPAF, Global Plan, IAC 2012, Implementation, Pediatric Treatment, PMTCT, Research

Late-breaking EGPAF-Funded Study on the Effects of TB Vaccine on HIV-Exposed, Breastfeeding Infants

By Robert Yule

Today, Dr. Heather Jaspan – a recipient of an EGPAF Pediatric HIV Vaccine Program Grant – released late-breaking results from her study at the International AIDS Conference.

The study investigated whether early administration of the Bacille Calmette-Guerín (BCG) vaccine for tuberculosis could be associated with an increased risk of HIV infection for HIV-exposed, breastfed infants in South Africa.

Dr. Heather Jaspan presenting her late-breaker study results.

Dr. Jaspan presents the results of her study and their implications below:

Bacille Calmette-Guerín (BCG) vaccine is given to infants at birth in high Tuberculosis (TB) burdened areas such as Southern Africa to protect them from severe forms of TB.

BCG given to monkeys causes immune cells to be active and replicate faster. HIV preferably infects cells that are actively replicating and have the HIV receptors CD4 and CCR5 on their surface. People who are frequently exposed to HIV yet remain negative have lower numbers of these HIV target cells in their blood.

We hypothesized that the routine immunization of neonates with BCG contributes to generalized immune activation in HIV-exposed infants, resulting in increased HIV target cells and increased risk for HIV transmission via breastfeeding.

We randomly assigned HIV-exposed and uninfected newborns to BCG vaccination at birth versus at 8 weeks of age. We determined the proportion of HIV target cells (activated CD4+CCR5+ cells).

Babies in the early BCG group had significantly higher HIV target cells in their blood than those in the delayed arm. This difference persisted at 8 weeks, despite immune stimulation from routine immunizations at 6 weeks in all babies.

No other cells were activated and no other markers of inflammation increased, suggesting the effect of BCG is isolated to CD4 T cells. Therefore BCG vaccination may increase the risk of HIV infection for HIV-exposed, breastfed infants.

However, other results not presented today show that infants with higher target cell activation had better responses to tetanus vaccine given at 6 weeks of age. This suggests that, in addition to protection against severe TB, BCG may have other benefits for HIV-exposed infants.

Therefore, the potential risks and benefits of BCG need further evaluation and investigation.

Our results can inform policy for the optimal timing of BCG vaccination for HIV-exposed infants, and have implications for the use of related vaccines – such as live, weakened bacterial vaccines – as potential future HIV vaccine strategies for newborns.

Dr. Heather Jaspan is a Senior Lecturer at the University of Cape Town and a Senior Scientist at Seattle BioMedical Research Institute.

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Filed under Advocacy, EGPAF, IAC 2012, Pediatric Treatment, PMTCT, Research, South Africa

Canadian International Development Agency and EGPAF Partner to Increase Uptake of MCH Services

By Robert Yule

This week the Canadian International Development Agency (CIDA) and EGPAF announced a new partnership to promote increased use of services for maternal and child health (MCH) and prevention of mother-to-child transmission of HIV (PMTCT).

On Monday, EGPAF gave a presentation at the IAC’s Canada Booth introducing our work to support national PMTCT programs, and the types of interventions that will be used through the ACCLAIM project with CIDA.

Read below for a joint press release from CIDA and EGPAF about this partnership:  

 

New ACCLAIM Program Will Help Expand MCH/PMTCT Services in Swaziland, Uganda, and Zimbabwe

Washington, D.C. – At the XIX International AIDS Conference, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) today announced a new partnership to improve progress toward elimination of pediatric HIV/AIDS. The project, Advancing Community-Level Action for Improving MCH/PMTCT (ACCLAIM), seeks to increase demand and retention in maternal and child health and prevention of mother-to-child transmission of HIV (MCH/PMTCT) services. The project is supported by the Canadian International Development Agency (CIDA), which has pledged CAD $10 million over a four-year period to fund the partnership.

The ACCLAIM Project will focus on changing community norms and attitudes about key health behaviors related to HIV, maternal and child health, and gender through targeted community-based interventions. The project will also use research to assess the behavioral and operational outcomes of selected community-based interventions and their relative effectiveness.

The program will help expand services in Swaziland, Uganda, and Zimbabwe, and will focus on three key interventions:

  • Engagement of Community Leaders: Training and capacity-building to generate increased demand for MCH/PMTCT services through development of Community Action Plans
  • Community Days: Semi-annual days of information, communication, and activities to generate awareness
  • Peer Support Groups: Men’s groups and MCH classes to increase and improve MCH/PMTCT behaviors.

CIDA’s contribution is part of the Canadian HIV Vaccine Initiative, a collaboration with other Canadian federal departments and the Bill and Melinda Gates Foundation. As work towards the development of a safe, effective, affordable, and globally-accessible vaccine continues, HIV prevention efforts must also continue, and CIDA is focusing efforts on the prevention of mother-to-child transmission of HIV.

This work will emphasize the need to scale up prevention of mother-to-child transmission programs and reach more HIV-positive pregnant women with simple and highly-effective – yet underutilized – interventions. It will also support operations research to analyze and overcome existing barriers to delivering prevention of mother-to-child transmission services.

“The Canadian International Development Agency has demonstrated a strong commitment to improving the welfare of women, children, and communities affected by HIV and AIDS,” said Charles Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. “We are proud to work with CIDA on this partnership, which will ensure that more mothers and children have access to essential prevention of mother-to-child transmission services by strengthening community support for those living with HIV and AIDS.”

“Canada is taking action that is saving the lives of women and their children,” stated Minister of International Cooperation, Julian Fantino. “Through our partnership with the Elizabeth Glaser Pediatric AIDS Foundation, we are working to protect women and children from HIV and prevent the transmission of HIV from mothers to their infants.”

While virtual elimination of pediatric HIV/AIDS has been achieved in high-income countries like the United States and Canada, much more needs to be done to protect women and children from HIV in the developing world. Each day, 900 children are needlessly infected with HIV, primarily in sub-Saharan Africa. With the proper medicines and PMTCT services, the risk that a mother with HIV will transmit the virus to her baby can be reduced to virtually zero.

It is critical to link vital facility-based PMTCT services with communities, many of which are rural and far from even the closest clinics. The EGPAF/CIDA partnership will address the need for community-level engagement and support for women, children, and families affected by HIV/AIDS.

The global impacts from this project will be:

  • An evidence base for packaged interventions to improve demand, access, retention, and participation in PMTCT programs at the community level;
  • Documentation of challenges and lessons learned from community-focused PMTCT-MCH interventions;
  • The opportunity to implement community interventions across different contexts, with greater involvement of men in PMTCT programs; and
  • The opportunity to contribute to literature on the effects of capacity building of local leaders on HIV/PMTCT outcomes.

Bringing interventions to communities will help ensure uptake and retention in life-saving PMTCT and MCH services, and the healthy survival of mothers, children, and families.

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About The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF):

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is a global leader in the fight against pediatric HIV and AIDS, and has reached more than 14 million women with services to prevent transmission of HIV to their babies. The Foundation currently works in more than 5,400 sites and in 15 countries to implement prevention, care, and treatment services; to further advance innovative research; and to execute global advocacy activities in order to bring dramatic change to the lives of millions of women, children, and families worldwide. For more information, visit www.pedaids.org and www.amothersfight.org.

About the Canadian International Development Agency (CIDA):

The Canadian International Development Agency (CIDA) is Canada’s lead agency for development assistance. CIDA’s aim is to manage Canada’s support and resources effectively and accountably to achieve meaningful, sustainable results. It also engages in policy development in Canada and internationally, enabling Canada’s effort to realize its development objectives.

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Filed under EGPAF, IAC 2012, Implementation, MCH, Pediatric Treatment, PMTCT, Public-Private Partnerships, Research, Swaziland, Uganda, Zimbabwe

New Public-Private Partnership for Pediatric HIV/AIDS Treatment

By Jane Coaston

Since our foundation began, our focus has been on the needs of infants and children living with HIV/AIDS. Currently 3.4 million children worldwide are living with HIV. Without early testing and immediate treatment, half of these children won’t survive to their second birthday.

Despite this urgent need, only 28% of children are receiving antiretroviral therapy (ART) – and there are not enough treatment options that are safe and effective for children, or easy for them to take.

On Friday, the Drugs for Neglected Diseases initiative (DNDi), a non-profit research and development organization, announced a new collaboration with Indian drug manufacturer Cipla to create a 4-in-1 pediatric antiretroviral therapy for infants and toddlers living with HIV/AIDS.

Current HIV medication options for small children are often not appropriate for certain conditions. Some are not intended for infants with high levels of the HIV virus in their bloodstreams, others are too expensive and too difficult to use effectively.

This collaboration between DNDi and Cipla represents not only a breakthrough in drug development, but also a step forward for pharmaceutical research into pediatric HIV treatments.

As Elizabeth Glaser herself noted, children living with HIV are often forgotten during the research process - but ending pediatric AIDS and keeping children alive and healthy requires effective medications.

As AIDS 2012 opens, we look forward to a continued focus on the treatment needs of children living with HIV.

For more information on this important announcement, click here. And for more on the Foundation’s research efforts, click here.

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Filed under Elizabeth Glaser, India, Pediatric Treatment, Research

A Focus on Children before AIDS 2012 Begins

By Robert Yule

In recent years, before International AIDS Society (IAS) conferences even begin, there are two events that place a special focus on the effects of HIV/AIDS on children:

The symposium, Children and HIV: Closing the Gap – Ending Vertical Transmission through Community Action, opened today at the Georgetown University Conference Center, with a keynote address from U.S. Congresswoman Barbara Lee. The symposium brings together service providers, donors, researchers, advocates, and policy leaders – all to share data and discuss best pratices for children and families.

EGPAF, a member of CCABA, is presenting throughout the symposium, including talks by staff from the     U.S., Switzerland, Tanzania, and Zimbabwe. EGPAF topics on preventing mother-to-child transmission of  HIV (PMTCT) include:

  • Country-level efforts to scale up and integrate community support with medical services
  • Improving the continuum of care by promoting male involvement
  • Mobilizing community engagement through capacity building of media practitioners
  • Strengthening district capacity for rapid PMTCT scale up in Zimbabwe using the District Focal Person Approach

CCABA has produced a  great roadmap on pediatric and PMTCT-related sessions at AIDS 2012, and will be hosting their own session on Wed, July 25 on community involvement that EGPAF will be participating in.

EGPAF also has a strong presence at the 4th Annual International Workshop on HIV Pediatrics. The abstract-driven workshop shares the latest scientific data and discusses how to implement advances in PMTCT and pediatric treatment in the field.

Both the symposium and the workshop conclude on Sat, July 21, but will help drive the discussion of HIV and children and families throughout AIDS 2012.

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Filed under Community, Implementation, Pediatric Treatment, PMTCT, Research, Switzerland, Tanzania, U.S., Zimbabwe

CDC’s Kevin De Cock on U.S. Leadership Fighting Pediatric AIDS

In advance of AIDS 2012, EGPAF hosted the following guest blog by Dr. Kevin M. De Cock – the U.S. CDC’s Director of the Center for Global Health - about U.S. leadership in preventing mother-to-child transmission of HIV globally:

Dr. Kevin De Cock, U.S. CDC

By Kevin M. De Cock MD, FRCP (UK), DTM&H

From July 22 to 27, Washington, D.C. will host the XIX International AIDS Conference, welcoming more than 20,000 attendees from around the world, representing hundreds of HIV/AIDS organizations and diverse backgrounds.  

 The U.S. Centers for Disease Control and Prevention (CDC) and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) partner with many of these organizations combatting HIV/AIDS through PEPFAR, the U.S. President’s Emergency Plan for AIDS Relief
 
PEPFAR is the largest public health program ever mounted for an individual disease, and is celebrating almost a decade since it was established. Now more than 7 million people worldwide are receiving antiretroviral therapy (ART) for HIV. The conference offers opportunity to assess progress in the fight against HIV/AIDS, review research advances and priorities, and recommit to meeting HIV/AIDS specific targets that we have collectively endorsed.
 
It was in the late 1980s that research in the U.S. and other countries such as the Democratic Republic of Congo laid the foundation for our understanding of mother-to-child transmission of HIV. Approximately one-quarter of children born to HIV-infected mothers acquired the infection themselves, with other research subsequently showing that prolonged breastfeeding contributed an additional 14% transmission risk.
 
Overall, up to 40% of children born to and breastfed by mothers living with HIV would become infected. And yet, alternatives to breastfeeding were not realistic options for most African mothers for reasons of poverty, stigma, and the fact that lack of breastfeeding exposed infants to higher risk of malnutrition and other lethal infectious diseases. 
 
The history of research on mother-to-child transmission of HIV and its prevention offers the clearest example of how domestic and global HIV/AIDS work have interacted and benefited from integration, and how research has led to specific program implementation. Communicating this relationship is an overarching contribution of International AIDS Conferences. 
 
In the early 1990s, the groundbreaking ACTG 076 trial showed that prophylactic zidovudine given to the mother during

Photo: EGPAF/James Pursey

pregnancy and labor and delivery, and postnatally to the infant, prevented HIV transmission by two-thirds. The trial initiated an avalanche of research on prevention of mother-to-child transmission in and tailored to low-income settings, the benefits of which we are reaping today. 

Opinion is growing that the World Health Organization’s “Option B+” – under which HIV-infected women start combination ART on detection of pregnancy and stay on it for life – will be an important tool to meet our ambitious goal of virtual elimination of mother-to-child transmission of HIV by 2015.
 
In 2010, 35% (42% in sub-Saharan Africa) of pregnant women in low- and middle-income countries received HIV testing and counseling, and the estimated coverage of antiretroviral drugs for prevention of mother-to-child transmission of HIV among pregnant women was 48%.  In 2011, 57% of pregnant women living with HIV in low- and middle-income countries received effective antiretroviral drugs to prevent transmission to the child.
 
Despite this progress, much remains to be done. Only 28% of exposed infants worldwide received an appropriate test for HIV infection in the first two months of life in 2010, with 22% coverage of ART for infected children. In 2011, treatment coverage for ART in infected children rose to 28%, yet treatment coverage among children is still substantially lower than the estimated 57% coverage among adults living with HIV.
 
The U.S. Administration’s Global Health Initiative has refocused attention on the health of women and children. Now we have unrivalled opportunity for synergy and integration – harmonizing programs for maternal and child health, HIV/AIDS, and family planning for the greater good of women and children’s well-being. 
 

Photo: EGPAF/Jon Hrusa

Re-commitment to the worthy goals of an AIDS-free generation would be a good outcome of the XIX International AIDS Conference. The targets are to reduce the number of children newly infected with HIV by 90% by 2015, reduce mother-to-child transmission of HIV to below 5% everywhere, and reduce maternal mortality related to HIV by 50%. 

 
Looking back to the dark days – when AIDS was a death sentence, life expectancy was declining in southern Africa, under-five mortality was rising because of AIDS, and hopelessness prevailed – the 2012 International AIDS Conference should be an occasion of pride, re-engagement, and forceful determination to achieve what was once thought impossible: an AIDS-free generation
 
To learn more about EGPAF’s collaboration with the CDC on global HIV treatment and PMTCT programs, click here.

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Filed under Countries, Democratic Republic of Congo, IAC 2012, Implementation, Pediatric Treatment, PEPFAR, PMTCT, Research, U.S.