On 11 August 2021 the Clinical Research Support Unit (CRSU) organised a meeting with the Blantyre District Health Management Team (DHMT), during which three MLW studies were presented. This is standard procedure for all research, requiring approval from the District Health Office (DHO) before work can commence.
During this meeting, MLW presented one new study Exploring Post-TB morbidity in urban Blantyre (Expo-TB), and an update on the progress (including planned modifications) of the PAVE Study (evaluating a PCV13 alternative schedule, 3+0 vs 2+1) and the IVAR Study (evaluating the impact of the alternative PCV13 vaccine schedule and the malaria vaccine in reducing the spread of antimicrobial resistance [AMR]). Head of CRSU Markus Gmeiner presented Expo-TB on behalf of Dr. Jamilah Meghji, while PAVE and IVAR were presented by the studies’ local Principal Investigators Dr. Akuzike Kalizang`oma, and Dr. Ana Ibarz, respectively.
The meeting was attended by over 20 members of DHMT, with all three presentations well received. The DHMT was highly appreciative of the CRSU’s initiative in ensuring MLW studies are presented for approval & authorization before commencement.
During the feedback session in-charge of the Zingwangwa Health Centre Dr. Atusaye Mughogho and Co-chair of the Blantyre DHO Research Committee made an appeal toMLW , requesting that MLW investigators follow the precedent of the PAVE Study in sharing study progress during study implementation. The team was happy to see PAVE sharing the progress after 5 months of project implementation.
As a result, the DHMT agreed to provide feedback to MLW through the CRSU, with guidelines for the expected timelines for the project progress updates, highlighting once again the strong bonds and collaboration between the DHO and the MLW.
In her remarks, Dr Mughogho informed the MLW team that the committee is creating a database capturing all studies they currently support. CRSU committed to reviewing the MLW component of that database, working to ensure all the information required is updated. This will further ensure the approval and update process is streamlined and simplified for MLW researchers.
A summary of the studies that were presented to the DHMT:
Expo-TB: This study will leverage the existing digital TB surveillance platform in Blantyre to collect surveillance data on residual morbidity amongst TB survivors in urban Blantyre. The study will use in-depth qualitative work with TB survivors and clinical providers to explore beliefs and health-seeking practices for residual and recurrent post-TB symptoms. The study aims will inform the development of an intervention to improve the diagnosis, management, and outcomes of symptomatic TB survivors in Blantyre.
IVAR: This is a cross-sectional study to be implemented by October 2021. In Blantyre District, leveraging the PAVE Study, IVAR will assess the impact of a PCV booster dose at 9 months of age in reducing the spread of AMR. Endpoints include AMR among Streptococcus pneumoniae (the bacterium targeted by the vaccine) carried in the nasopharynx and among Extended Spectrum Beta-Lactamase producing E. coli and Klebsiellae bacteria detected in fæces. In Mangochi District, the comparator will be the RTS,S/AS01 malaria vaccine, introduced in April 2019 as a pilot implementation project in selected geographic regions. IVAR will run in close coordination with the ongoing PAVE Study.
PAVE: The PAVE study is evaluating whether changing the current PCV schedule (from 6,10, and 14 weeks [3+0] to 6, 14 weeks, and 9 months [2+1] prolongs the protection against pneumococcal disease. This study will evaluate the carriage of vaccine-type pneumococci in vaccinated and unvaccinated (including age-ineligible children and HIV-infected adults) populations.
