Kaduna state, Federal Republic of Nigeria
The ShORRT initiative, a collaboration between TDR, the WHO Global Tuberculosis Programme and partners, is now involving and supporting 25 countries worldwide. Below, we highlight how Nigeria is adapting the operational research package to support implementation of treatments to tackle drug-resistant TB.
In the latest World Health Organization (WHO) guidelines on drug-resistant tuberculosis (DR-TB) treatment, modifications to the recommended all-oral treatments for multidrug- and rifampicin-resistant (MDR/RR) TB and novel regimens for patients with extensively drug-resistant TB are encouraged under operational research conditions.
TDR, in collaboration with the WHO Global Tuberculosis Programme and technical partners, has developed an operational research package (dubbed ShORRT for Short all-Oral Regimens for Rifampicin-resistant Tuberculosis) to support the implementation of such drug regimens.
Since its official launch in Hyderabad, India, in November 2019, the ShORRT initiative is now involving and supporting 25 countries worldwide,
working alongside WHO regional and country offices, academia, technical partners such as KNCV Tuberculosis Foundation, the Union and Damien Foundation,
and funding agencies such as the United States Agency for International Development (USAID) and The Global Fund to Fight AIDS, Tuberculosis and Malaria.
Countries involved in the ShORRT initiative (blue) and countries involved in the initiative led by the WHO Regional Office for Europe (red). Data collection methods are consistent across the ShORRT and EURO initiative;
more information on the EURO initiative is available here.
Nigeria: a pathfinder country develops BESTREAM
Nigeria, which has the highest burden of TB in Africa, is one of the pathfinder countries conducting operational research on modified shorter all-oral regimens for MDR/RR-TB patients, in line with the latest WHO guidelines and national guidance on drug-resistant TB treatment.
he National Tuberculosis and Leprosy Control Programme (NTBLCP) adapted the ShORRT research package and developed the “Bedaquiline-based all-oral Shorter Treatment regime for DR-TB patients- a Modified approach” operational research project (dubbed BESTREAM).
The study, which will involve 400 patients across eight states of Nigeria, aims to evaluate the effectiveness and safety of a modified Bedaquiline-containing regimen (comprised of six months of bedaquiline, and nine to 11 months of linezolid, levofloxacin and clofazimine), as well as its impact on the health-related quality of life of patients.
Training of the research assistants in Oyo state, Federal Republic of Nigeria
NTLCP Nigeria
Despite the challenges posed by the current COVID-19 pandemic, the study has been swiftly established through a mix of in-person and virtual preparatory activities. These include the readiness assessment of the laboratory network and of the study sites, the customization and piloting of the generic ShORRT data collection platform using the REDCap software, as well as training of data collectors and stakeholders on the study procedures.
The first patients were enrolled in the study in late October as BESTREAM is being sequentially rolled out in four “intervention” states (where patients will receive the novel all-oral shorter regimen) and four “control”
states (where patients will receive the standard of care). Patients enrolment will be ongoing for six months, and preliminary findings are expected at the end of 2021. |
|
| BESTREAM, funded by USAID and conducted in close collaboration with Damien Foundation and WHO’s Nigeria Country Office, has also paved the way for the implementation of a parallel study in a further four states investigating the
BPaL regimen (comprised of bedaquiline, pretomanid, and linezolid) supported by KNCV Tuberculosis Foundation. |
Operational research is proving to be a tremendous tool for guiding our efforts to manage TB in Nigeria, especially in the context of COVID-19.
- Dr Babawale Adekunle Victor, Programmatic Management of Drug Resistant Tuberculosis Unit, National Tuberculosis and Leprosy Control Programme, Nigeria
As the COVID-19 pandemic unfolds, the rapid roll-out of measures that reduce the need for daily encounters between TB patients and health care staff becomes more critical. These include the development and adoption of more effective and
easier to implement treatment options for people living with TB and DR-TB, such as all-oral shorter drug regimens.
TDR and partners can conduct its work thanks to the commitment and support from a variety of funders. These include our long-term core contributors from national governments and international institutions, as well as designated funding for specific projects within our current priorities. A full list of TDR donors is available on our website at https://www.tdr.who.int/about-us/our-donors
USAID has contributed designated funding for the development and implementation of the ShORRT initiative and therefore the BESTREAM project in Nigeria.
For more information, please contact Dr Corinne Merle, TDR.