“
test the safety and efficacy of this new formulation in young children

”

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

Sex and gender can have an important influence on the risk of disease and on the appropriateness and effectiveness of treatments. Influences may relate to biological differences between sexes, or sociocultural factors related to sex, gender or gender identity.

In particular, women may be disadvantaged within certain societies, or have particular interests that need to be considered in the design of clinical research studies. It is important that ethics review bodies routinely and systematically consider the specific interests of female participants in research, and more broadly take account of the potential impact of sex, gender and sexual identity.   

Through the BCA-WA-ETHICS project, an international consortium is mainstreaming a gender perspective into the activities of Senegal’s national research ethics committee (CNERS). It further aims to disseminate good gender-related practice in ethics review more widely across West Africa.

The project will build the capacity of CNERS committee members to systematically consider gender issues in its assessment of clinical research proposals, and whether such proposals have adequately considered and addressed gender issues. Existing tools focused on assessing a gender perspective in protocol evaluation and project monitoring will also be adapted for use in local context.

The project is beginning by mapping the full range of sex- and gender-related issues that need to be considered in Senegal and West Africa more generally. This landscaping activity will be used to inform the development of training plans for CNERS committee members and other key stakeholders.

A subset of trainees will also have the opportunity of internships in Spain to observe how gender-related issues are addressed by Spanish ethics committees. The project will also explore ways to further advance the professional development of individuals involved in initial training. In addition, it will liaise with other EDCTP-funded projects involving the CNERS (such as the SEN-ETHICS project) to promote consideration of gender-related issues.

The project will also build wider networks across West Africa to promote gender mainstreaming in national research ethics committees. The landscaping report will be widely shared, events organised to facilitate discussion and sharing of experience, and a virtual community of practice established to promote networking across stakeholders in West Africa.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The BCA-WA-ETHICS project will better enable members of national research ethics committees to consider the gender perspective. Through networking and development of a white paper, the project will also facilitate the development and harmonisation of gender-sensitive policies and practice in ethical review across West Africa more generally. It will also explore barriers to the participation of female scientists in health research and on research ethics committees in West Africa.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact