Lassa fever (LF) is an acute febrile illness caused by Lassa virus (LASV) and associated with bleeding, organ failure, and shock. Each year, over 900,000 people are infected with the Lassa fever virus in Benin, Guinea, Liberia, Nigeria, Sierra Leone and Togo. Nigeria is the country by far most affected by LF in the world with about 80% of global cases.
Transmitted from contact with certain rats or from person to person through infected body fluids, LF virus acts with devastating speed, killing people within 10 days of their first symptoms if not correctly treated.
The current standard of care for LF is ribavirin but is associated with important toxicity and a recent reanalysis of historical data casts doubt on its clinical efficacy and potential for toxicity. Despite treatment, 12% of patients hospitalised for LF die. Overall, the absence of state-of-the-art intensive care, the questionable effectiveness and important toxicity of ribavirin, its high cost and the significant burden of LF in West Africa call for novel drug therapies.
The INTEGRATE consortium builds on a more than 15 years lasting highly successful collaboration between leading European and West African research and health care institutions focusing on the joint priority to better understand, manage, and combat LF in West Africa.
In this context, the general objective of the INTEGRATE project is to establish a platform clinical trial in West Africa to assess the efficacy, safety, tolerability and pharmacokinetics of repurposed and novel drug candidates for the treatment of LF. To address this overall objective, the project will target 3 specific objectives (SO):
- Objective 1: to develop and implement an adaptive randomised controlled phase II-III clinical platform trial in West Africa evaluating repurposed and novel antiviral drugs with proven preclinical activity against LF.
- Objective 2: to build capacity for sustainable and independently conducted clinical research in West Africa.
- Objective 3: to engage communities with the proposed work plan and to assess acceptability of the trial.
INTEGRATE brings together social science researchers, Lassa fever medical experts, operational experts, and community-based partners to work with local communities to promote support for and participation in the clinical trial. Getting people with LF to participate in the INTEGRATE clinical trial is essential for its success. However, several barriers can limit participation and addressing these challenges is critical. However, to date, no studies have explored these issues in the context of Lassa fever trials in Nigeria. The use of exploratory qualitative research, plays a crucial role in ensuring the success of the INTEGRATE project by addressing sociocultural and psychological factors affecting participation.
