The PROMISE-EPI study is evaluating a novel strategy for identifying infants who, despite big drops in mother-to-child transmission, have still been infected with HIV.

Finding ‘hidden’ HIV-infected infants

WHO now recommends that all pregnant and breastfeeding women with HIV should be offered antiretroviral therapy and all infants at risk of contracting HIV should be given antiretrovirals for 6 weeks. This so-called option B+ strategy has been implemented across most of sub-Saharan Africa. However, significant numbers of infants are falling through the net – in 2015, residual transmission rates were still about 14% at one year, well above the WHO target of 5%.

The challenge

The PROMISE-EPI study is assessing whether a ‘rescue’ package can be integrated into routine immunisation services (generally known as the expanded programme on immunisation, EPI). Its goal is to identify and treat the hidden infant HIV cases, and to prevent transmission from previously undiagnosed HIV-infected mothers.

In countries such as Burkina Faso and Zambia, nearly all newborn babies receive vaccinations through the EPI at 4–6 weeks. The PROMISE-EPI study will assess whether it is possible to use the EPI platform to examine mothers’ experience of prevention services at birth; to detect missed HIV infections through point-of-care testing, so antiretroviral therapy can be started; and to measure virus levels in mothers, to identify infants at risk of infection, so mothers can be treated and preventive measures initiated.

The project

For more than a decade, the PROMISE consortium, set up with EDCTP funding, has developed a portfolio of studies addressing mother-to-child transmission of HIV in Africa. Having generated vital evidence on the importance of pre-emptively treating infants to prevent transmission of HIV, the latest study could identify a readily implementable strategy for reducing still further infant infection rates, and for identifying those who nonetheless have been infected.

Impact


crucial in

widening African

children’s access

to antiretrovirals

Bringing antiretroviral drugs to children

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

EDCTP portfolio: HIV & HIV-associated infections

The challenge

WHO now recommends that all pregnant and breastfeeding women with HIV should be offered antiretroviral therapy and all infants at risk of contracting HIV should be given antiretrovirals for 6 weeks. This so-called option B+ strategy has been implemented across most of sub-Saharan Africa. However, significant numbers of infants are falling through the net – in 2015, residual transmission rates were still about 14% at one year, well above the WHO target of 5%.

The PROMISE-EPI study is assessing whether a ‘rescue’ package can be integrated into routine immunisation services (generally known as the expanded programme on immunisation, EPI). Its goal is to identify and treat the hidden infant HIV cases, and to prevent transmission from previously undiagnosed HIV-infected mothers.

In countries such as Burkina Faso and Zambia, nearly all newborn babies receive vaccinations through the EPI at 4–6 weeks. The PROMISE-EPI study will assess whether it is possible to use the EPI platform to examine mothers’ experience of prevention services at birth; to detect missed HIV infections through point-of-care testing, so antiretroviral therapy can be started; and to measure virus levels in mothers, to identify infants at risk of infection, so mothers can be treated and preventive measures initiated.

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.

For more than a decade, the PROMISE consortium, set up with EDCTP funding, has developed a portfolio of studies addressing mother-to-child transmission of HIV in Africa. Having generated vital evidence on the importance of pre-emptively treating infants to prevent transmission of HIV, the latest study could identify a readily implementable strategy for reducing still further infant infection rates, and for identifying those who nonetheless have been infected.

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

Projects: CAPRISA 018 study

Project lead: Professor Salim Abdool Karim, Centre for the AIDS Programme of Research in South Africa, South Africa

Countries involvedFrance, The Netherlands, South Africa

Target population(s): Women

Year funded: 2017

EDCTP funding: €9.8 M

Total project funding: €11.4M plus donation of study drugs

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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