Publications

Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

The LIFE study is assessing whether use of new rapid diagnostic tests for HIV leads to quicker and better treatment of infants with HIV.

Speeding up HIV treatment in infants

Less than half of infants exposed to HIV are tested for HIV, less than half of those tested receive early infant diagnostic test results, and less than half of those found to be infected receive antiretroviral therapy. The need to send samples away to central facilities for testing is a key barrier to timely diagnosis and initiation of therapy.

There are hopes that a new generation of easy-to-use rapid diagnostic tests could overcome these hurdles, so more infants receive an early diagnosis and start to receive antiretroviral therapy. Point-of-care testing has been recommended by WHO, but implementation presents practical challenges and is likely to have significant financial implications.

The challenge

Members of the LIFE consortium carried out a pilot trial in Mozambique, evaluating point-of-care testing administered by nurses. Compared with usual practices, point-of-care testing led to nearly all infants receiving results within 60 days, compared to 12% in the control group, and 90% of HIV-infected babies were put on antiretroviral therapy within 60 days, compared to 13% in the control group.

Following up these encouraging results, the LIFE consortium has begun a larger trial spanning 24 sites in two countries. The trial will follow infants for 18 months to assess initial antiretroviral therapy initiation rates as well as longer-term impacts on child mortality and illness. The team will also measure virus levels in mothers at delivery, as a way of identifying infants at high risk of mother-to-child transmission.

The project

The LIFE study will fill important gaps in the evidence base. It will reveal whether use of rapid point-of-care HIV diagnostics at birth increases antiretroviral therapy coverage and benefits infant survival; whether measurement of virus levels in mothers at delivery leads to the adoption of special measures to prevent mother-to-child transmission; and what the financial and practical implications are of rapid diagnostic use. The study will therefore provide key data for decision-makers on the cost-effectiveness and practicalities of implementing the new technology and new models of care.

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

Less than half of infants exposed to HIV are tested for HIV, less than half of those tested receive early infant diagnostic test results, and less than half of those found to be infected receive antiretroviral therapy. The need to send samples away to central facilities for testing is a key barrier to timely diagnosis and initiation of therapy.

There are hopes that a new generation of easy-to-use rapid diagnostic tests could overcome these hurdles, so more infants receive an early diagnosis and start to receive antiretroviral therapy. Point-of-care testing has been recommended by WHO, but implementation presents practical challenges and is likely to have significant financial implications.

Members of the LIFE consortium carried out a pilot trial in Mozambique, evaluating point-of-care testing administered by nurses. Compared with usual practices, point-of-care testing led to nearly all infants receiving results within 60 days, compared to 12% in the control group, and 90% of HIV-infected babies were put on antiretroviral therapy within 60 days, compared to 13% in the control group.

Following up these encouraging results, the LIFE consortium has begun a larger trial spanning 24 sites in two countries. The trial will follow infants for 18 months to assess initial antiretroviral therapy initiation rates as well as longer-term impacts on child mortality and illness. The team will also measure virus levels in mothers at delivery, as a way of identifying infants at high risk of mother-to-child transmission.

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 LIFE study will fill important gaps in the evidence base. It will reveal whether use of rapid point-of-care HIV diagnostics at birth increases antiretroviral therapy coverage and benefits infant survival; whether measurement of virus levels in mothers at delivery leads to the adoption of special measures to prevent mother-to-child transmission; and what the financial and practical implications are of rapid diagnostic use. The study will therefore provide key data for decision-makers on the cost-effectiveness and practicalities of implementing the new technology and new models of care.

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