International Women’s Day 2011: EDCTP hails the contribution of women to its clinical trial projects

08 March 2011

The European and Developing Countries Clinical Trials Partnership (EDCTP) celebrates the 100th International Women’s Day by honouring the contribution of women, in all capacities in the fight against HIV/AIDS, tuberculosis and malaria. Many projects funded by EDCTP are of immediate relevance to the struggle for equal opportunities for women and to the improvement of the health of women and children. Women play crucial roles in all EDCTP activities as policy makers, scientific project managers, research scientists, healthcare professionals, field workers, patients and healthy volunteers.

Women professionals in EDCTP projects
This year’s observance of International Women’s Day focuses on equal access to education, training and science and technology. The EDCTP is proud to fund the scientific and medical work of so many women in its projects. Gender balance is one of the concerns in evaluating applications for the funding of projects. Projects often provide for extensive professional training for women health care workers.

In total, 43 out of 160 EDCTP-funded projects (approximately 30%) are led by female scientists as Project Coordinators:

  • 15 of 58 integrated clinical trial projects
  • 7 of 37 Career Development and Senior Fellowship projects
  • 5 of 12 directly funded PhD and MSc training awards
  • 9 of 39 projects to establish or enhance the capacity to conduct medical research in conformity to the professional ethical standards
  • One of the 4 projects concerned with furthering collaboration in regional Networks of Excellence
  • 6 of 10 Networking grants.

Prevention of mother-to-child transmission of HIV
In developing countries, breastfeeding is crucial for child health. Unfortunately in low-resource countries, formula feeding of infants is neither feasible nor safe, due to lack in sanitation and scarcity of clean water to mix the formula. Additionally, many families cannot afford infant formula. Therefore, often mothers with HIV have been advised to breastfeed their babies even at the risk of thus transmitting the virus to their child had it escaped infection during childbirth.

The Kesho Bora study – ‘A better future’ in Swahilli – offers a new hope for preventing HIV infection and death among infants in low-resource settings where many mothers with the virus breastfeed. From June 2005 to August 2008, 882 women were enrolled, 824 of whom gave birth to 805 live born infants. The results published in Lancet Infectious Diseases on 14 January 2011, show that providing a combination of a triple antiretroviral combination to pregnant and breastfeeding mothers is a safe and effective way to reduce HIV transmission to infants. The findings of the Kesho Bora study have strongly influenced the revised WHO guidelines on prevention of mother-to-child transmission of HIV, and infant feeding.

Malaria in pregnancy
Pregnant women are at high risk for contracting malaria in areas where the disease is endemic. Every year, approximately twenty-five million pregnant women are exposed to malaria in sub-Saharan Africa, and pregnancy-associated malaria (PAM) is a serious public health concern. In areas where malaria transmission is intense, the disease leads to low birth weight for the baby and severe anemia for the mother.

One project, led by Professor Clara Menéndez, aims to contribute to the development of new clinical interventions to fight malaria by the evaluation of different antimalarial drug alternatives as intermittent preventive treatment in pregnancy in the context of insecticide treated nets. It will compare the safety and efficacy of the currently recommended drug with those of mefloquine. The study includes HIV-infected pregnant women to provide a better understanding of the interactions between antimalarial and HIV treatments. Another EDCTP- project aims to optimise the existing dose and regimen of intermittent preventive treatment in pregnant women with sulfadoxine-pyrimethamine.

Microbicides against HIV
The need to develop additional HIV prevention tools, especially those that women can use, is urgent. Women are often limited in their ability to abstain from sex, or convince their male partners to adopt safer sex behaviors, due to social, cultural and economic gender inequalities. Furthermore, the importance of having children is a major obstacle to condom use for many women and couples. Microbicides are being developed for application inside the vagina to prevent infection with HIV and possibly other sexually transmitted infections.

Remarkable progress has been made in the microbicides field in recent years. Funding for the field increased significantly, and the global movement for microbicides continues to grow, uniting women’s health and AIDS advocates, researchers, governments, and institutions.

Products used in some of the microbicide trials with early generation microbicides turned up unexpected results in terms of safety. Recent research with anti-retroviral (ARV) based microbicides however has shown promise in offering women protection against HIV. There is still  a need to increase our knowledge on  reliable biomarkers during the phase I and II safety trials. The EDCTP-funded project lead by Dr Kishor Mandaliya will sample a variety of study populations in four African settings to try and refine both clinical and laboratory methods and findings in search of more reliable safety biomarkers.

About EDCTP

The European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership between 14 European Union member states plus Norway and Switzerland with 47 sub-Saharan African countries. The aim of the programme is to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis through promoting the integration of national programmes of EDCTP European Member States and development of a genuine partnership with African counterparts.