Expert Panel on Prevention of Mother-to-Child Transmission of HIV

Beginning with the President's Mother and Child HIV Transmission Initiative in 2002, and then expanding with the launch of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) in 2003, prevention of mother-to-child transmission (PMTCT) has been a central focus of U.S. Government global HIV/AIDS efforts. Congress established the Expert Panel on Prevention of Mother-to-Child Transmission of HIV in Section 309 of H.R. 5501, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008. Its purposes are to provide an objective review of PEPFAR's PMTCT activities, and provide recommendations to the U.S. Global AIDS Coordinator and the appropriate Congressional committees for further scale-up of services to achieve the ambitious target of reaching 80 percent of pregnant women in countries most affected by HIV/AIDS in which the U.S. has HIV/AIDS programs.

The Expert Panel met on January 9, 2009. The meeting was convened by the Office of the U.S. Global AIDS Coordinator and hosted by Peace Corps. Topics for the January 9 meeting included the Global Status of PMTCT Program Implementation, Update on the Science of PMTCT, PEPFAR PMTCT Programs, Overcoming Barriers, and Collaboration with International and Multilateral Groups.

Presentations from each of the sessions are available below.

SESSION 1: Global Status of PMTCT Program Implementation
Presentation on global and country-specific coverage of PMTCT Programs

• Prevention of Mother-to-Child Transmission of HIV: Status of Implementation and Ways Forward, René E. Ekpini, UNICEF. Presentation includes an overview of global PMTCT goals and targets as well as distribution and trends of infection between different regions worldwide. Goals for PMTCT include reducing the proportion of infants infected with HIV and increasing the access of pregnant women to resources that help reduce the risk of mother-to-child HIV transmission. Ways forward include rapid scale-up towards universal access, increasing linkages with antiretroviral treatment (ART) and other health programs, strengthening evidence-based approach, and a shift from averting infection to maternal and child survival.

SESSION 2: Update on the Science of PMTCT
Presentations on recent findings from clinical trials and other research

• Update on the Science of Prevention of Mother-to-Child HIV Transmission Lynne Mofenson, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. Presentation points out that because of a cascade effect, significantly increasing the coverage of existing treatment delivery systems by ensuring that women who attend an antenatal clinic also receive HIV testing and antiretroviral treatment could be as, or more effective than use of better PMTCT regimens. Other data presented suggests that earlier initiation of treatment for pregnant women, and a CD4 threshold of <350 for initiation of treatment could provide benefits in PMTCT. Some maternal highly active antiretroviral therapy (HAART) and infant prophylaxis studies lack information that prevents effective cross-study analysis. Dr. Mofenson concluded with a list of pros and cons of ante-partum and post-partum treatment and an overview of ongoing and planned clinical trials.
   
• Comments on Status of Science of Prevention of Mother-to-Child Transmission, William Blattner, Institute for Human Virology, University of Maryland. William Blattner delivered comments on the Update on the Science of PMTCT. Studies on the effect of viral load on rates of transmission of HIV from mother-to-child suggest that even with a high viral load antiretroviral treatment can reduce transmission of the HIV virus, and the use of HAART can effectively prevent transmission. Dr. Blattner asked the panel to discuss if this data required further corroboration, or if the panel could use it as the basis for changing recommendations. Further data presented related to the appropriate CD4 level to initiate treatment for women, and how extended antiretroviral treatment has shown success in reducing postpartum transmission, primarily through breastfeeding. Dr. Blattner concluded with the suggestion that PEPFAR could incorporate high impact clinical trials into selected high volume PMTCT programs.

SESSION 3: PEPFAR PMTCT Programs
Presentations from PEPFAR's PMTCT interagency technical working group followed by a panel discussion of the effectiveness of programming

• PEPFAR PMTCT Update, Nathan Shaffer, Centers for Disease Control and Prevention (CDC); Maggie Brewinski, U.S. Agency for International Development (USAID); Co-Chairs, PEPFAR PMTCT/Pediatrics Technical Working Group. Presentation on the strengths, weaknesses, issues and recommendations for PEPFAR PMTCT Programs based on reporting and results. Currently, PMTCT lags behind other program goals and ART scale-up efforts. Few pregnant women currently receive HAART in PEPFAR programs, and creating a standard system of reporting is critical. Priorities should include better incorporation of PMTCT into other care programs, tracking the HIV status of mother and infant on health cards, and using routine opt-out testing. Partner country programs should support regional or district health systems, including PMTCT and other treatment and care linkages, and better systems for monitoring and reporting. New evidence shows efficacy of prophylaxis given to mother or child during breastfeeding can reduce risk of postpartum transmission. Other recommendations include prioritizing pregnant women for access to HAART, continuing PMTCT into post-natal and breastfeeding periods, strengthening the role of community-based services, and the establishment of clear goals for PMTCT programs.
   
• Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) PMTCT Programs, Laura Guay, EGPAF. Primary barriers to the scale-up of PMTCT are not related to scientific knowledge, but to implementation. Best practices of EGPAF include a decentralized approach to scale-up, routine opt-out testing practices, and integrating PMTCT into other care and treatment services, including routine maternal and child health (MCH) services. A decentralized/district level approach to scale-up leads to greater ownership and sustainability, and a better ability to integrate new PMTCT services into existing structures. To implement a district-level approach, programs need to be customized to the local setting, working closely with district administration and community leaders, and with district control over the budget. Evaluating the impact of PMTCT should be a priority, and consistent re-evaluation and strengthening of PMTCT programs should occur as programs become more complex.
   
• Reconceptualizing PMTCT: A Paradigm Shift, Robin Flam, Columbia University, International Center for AIDS Care and Treatment Programs (ICAP). Presentation on ICAP PEPFAR PMTCT Programs. Current limitations to PMTCT include separation from other aspects of chronic HIV care and treatment, limited attention to the relationship between maternal and child health, and a focus on process, rather than outcomes. A new model for treatment would lead to decreased morbidity and mortality in HIV-positive women and increased child survival. This would include identifying the HIV status of women and infants across all services, providing ART to pregnant women within MCH, follow-up treatment for all babies exposed to HIV with a "package of care," and more follow-up resources for all mothers after birth. [Note: Elaine Abrams is the PMTCT panel member representing ICAP.]
   
• Siripon Kanshana, Ministry of Public Health, Thailand, delivered the following comments regarding the Session 3 presentations: Do we have enough scientific information, how are we going to provide the intervention to the mothers and children, and how do we increase the coverage and quality, as well as sustainability, of the services? Whichever approach you use, we still need to address the three above questions. Social component is also integrally important. Health system strengthening is a way forward. How do we do it? This is something that needs to be addressed. We need leadership at all levels (global, district, etc.) to get on board and to commit (both in policy and with resources) to improving the health system strengthening with whichever model makes the most sense within the country context. We also need to monitor and evaluate by developing new indicators.
   
• Martha Rogers, Task Force for Child Survival, commented that she has been impressed with the progress so far since implementation of scale-up. Policy making, training and capacity building seem to be moving along. Health care workforce shortages must be addressed so that the PMTCT programs are sustainable when PEPFAR scales-down. There is a need for better models of care in rural areas - especially for those who lack transportation - and the model needs to include not only PMTCT services, but also treatment services. Operational research needs to be done at a rigorous level.

SESSION 4: Overcoming Barriers
Presentations on, and discussion of, approaches to increasing access to PMTCT, addressing stigma and its effects, and improving linkages between PMTCT services and care and treatment programs; key evaluation needs for overcoming barriers

• The PEARL Study: PMTCT Effectiveness in Africa: Research and Linkages to Care and Treatment, Jeffrey Stringer, CIDRZ Foundation, Zambia and University of Alabama. The purpose of the PEARL evaluation was to measure practical real-world effectiveness and how well PMTCT services are working. The study was conducted in South Africa (Free State and Western Cape) and Cameroon (English speaking areas) and sampled facilities and corresponding communities in each area. The study demonstrated where failures occur along the PMTCT cascade and the importance of coverage.
   
• Overcoming Barriers to Increasing access to PMTCT, Marie Marcelle Deschamps, GHESKIO, Haiti. GHESKIO offers free hospital delivery and pays women for transportation to the hospital. Barriers to PMTCT include logistics, low or no income, stigma, knowledge and beliefs, gender issues and cultural issues. Economic situations such as lack of access to food and education are also factors.
   
• Modern Quality Improvement and HIV/AIDS Care in Africa, James Heiby, U.S. Agency for International Development. James Heiby commented that issues need to be framed from the health systems perspective and methodologies to respond must be considered. PMTCT as health system has three fundamental aspects: inputs or resources that programs have including trained personnel, buildings, vehicles, drugs, scientific research, and protocols; with these assets, carry out complex range of processes in service delivery; these processes produce outcomes. With these outcomes we look at what we can change. The following questions were raised regarding process: What do staff in PMTCT programs actually do, and can these processes be improved? Can the programs have better design and implementation of complex series of processes? One set of these activities is based on science. The second set of activities is more local and context specific: to be designed by health systems workers themselves. The knowledge needed to improve in this area cannot be found in scientific research. The health system itself needs the capacity to improve. We have access to a well developed field with large-scale rapid improvement conducted and owned by regular providers themselves- aka "field of modern improvement"- not by professional researchers and investigators. This has been extensively developed in some countries. One recommendation is to draw on this field and apply it in a large-scale and rigorous way to PMTCT programs.
   
• Gloria Ncanywa, Mothers2Mothers (M2M), South Africa, commented that women need to know what medications they are taking, why they are taking them, and what they are for. M2M employs HIV-positive mothers to counsel other mothers. M2M also offers psychosocial support to newly diagnosed mothers by "mentor mothers" who also make follow-up appointments and explain treatment and the meaning of taking antiretroviral drugs. It is also important to ensure that babies are being tested. Medication alone cannot do anything; there must be support. The M2M program targets families and partners to disclose status and provides education and support to all. This helps to break down the stigma around HIV.

SESSION 5: Collaboration with International & Multilateral Groups
Presentations on other groups' efforts in PMTCT and discussion of opportunities for collaboration

• Children's Investment Fund Foundation's (CIFF) support for Prevention of Mother-to-Child Transmission, Peter McDermott, CIFF, UK. CIFF invests with four main objectives related to PMTCT: fund catalytic programs, strengthen the evidence base, actively advocate for change, and extend success beyond direct impact. As a new funder in PMTCT, some of the questions and challenges CIFF is facing include: 1.) absence of any cost data for these activities doesn't allow rational investment choices. How is it possible to make comparative choices about where to invest money? 2.) Considering the barriers and gaps, which are more important? Which ones will allow for most efficient scale-up? 3.) Given that we do know so much, what are the most pertinent operational research questions? 4.) How can there be rational discussion outside of formal meeting settings? Where is the intellectual driving force behind the PMTCT agenda outside of the more formal mechanisms, and is there a need to create more robust government, partner and donor funding to move forward on some of these agendas?
   
• UNICEF's Contribution to Scaling-up PMTCT and Links with PEPFAR and Other Implementing Partners, René E. Ekpini, UNICEF. This presentation focuses on UNICEF's contribution to scaling-up PMTCT including experience in procurement, child survival interventions, links with governments and the private sector and strong advocacy. The presentation also outlined areas for cooperation with PEPFAR and other implementing partners including global coordination through the Inter-Agency Task Team (IATT), resource leveraging, health systems strengthening and promotion of program innovation.
   
• Prevention of Mother-to-Child Transmission of HIV: Role of the World Health Organization (WHO), Kevin DeCock, WHO. Presentation focuses on the critical roles of WHO in PMTCT and more generally including: 1) Leadership and partnerships in health, 2) Defining, disseminating and translating knowledge and knowledge gaps, 3) Setting and promoting norms and standards (including upcoming PMTCT guideline revisions), 4) Developing policy options, 5) Technical support and capacity development and 6) Monitoring health trends. This presentation also addresses the public health approach to HIV in the context of maternal and child health including prevention and care for the whole family.
   
• RJ Simonds, Centers for Disease Control and Prevention (CDC), reflected on the area of partnership, stating that it is an achievement just to be discussing national level coverage. We have achieved this through research and feasible and targeted approaches to developing the program model to deliver these services in clinical settings. The challenge is that it requires many pieces to work together and there are also obligations to many other areas where you are working. When you figure out a delivery model at the program level, there is an additional layer of systems to coordinate. At the international level, there are people all over world to share knowledge and interactions. Inherently this requires partnership and we need to focus on what it takes to make a partnership work. It requires time to converse, to develop trust and good communications and relationships. We must figure out each person’s roles in partnerships and deal with conflicts. To reach scale, we need to spend some effort on this aspect of our work in addition to improving the science. He challenged the panel to make something of this and to determine how to work together and how to inform the PEPFAR program.