@misc{103927,
  keywords = {Safety, Antimicrobial resistance, Azithromycin, Mass drug administration, Children, Nigeria, Clinical Protocols, Implementation science},
  author = {Salako A and Musa Z and Bamidele T and Idigbe I and Osuolale K and Adewale B and Fowora M and Chukwu E and Ajibaye O and Herbertson E and Akinsolu F and Oladele D and Odubela O and Tijani W and Hakizimana D and Wamyil-Mshelia T and Madaki S and Odubela O and Adekola H and Ayegbeso D and Abubakar A and Fashoto O and Onuoha M and Mmirikwe I and Osoteku D and Aidenagbon A and Oresanya O and Adewole A and Ononogbo I and Achu I and Omokore O and Mohanty R and Shehu A and Kenny A and Means A and Igbokwe U and Olamiju F and Kolawole M and Shuaibu J and Ezechi O and Salako B},
  title = {Safety, antimicrobial resistance and implementation of azithromycin mass drug administration among children aged 1–59 months in Nigeria: protocol for a hybrid type II effectiveness–implementation study},
  abstract = {<h4>Introduction</h4>

<p>Evidence is needed on how mass drug administration of azithromycin (MDA AZM) affects child health, antimicrobial resistance (AMR), and safety as countries weigh adopting it as part of child survival strategies in areas meeting WHO eligibility thresholds (infant mortality above 60 per 1,000 live births, or under-five mortality above 80 per 1,000).</p>

<h4>Methods and Analysis</h4>

<p>SARMAAN II is a hybrid type II effectiveness-implementation study built on the RE-AIM framework. Every six months, children aged 1–59&nbsp;months will receive azithromycin through existing community health platforms in eleven northern states: Adamawa, Bauchi, Gombe, Jigawa, Kaduna, Kano, Katsina, Kebbi, Sokoto, Yobe, and Zamfara. Coverage will be tracked via post-MDA surveys and survey-weighted estimates. To measure effectiveness, the study will look at under-five mortality and hospital-treated illness. Mortality data will come from DHS full pregnancy histories, using a stepped-wedge cluster randomized design across 24 LGAs in Kano and repeated cross-sectional surveys elsewhere, analyzed with mixed-effects models (Kano) and synthetic cohort estimates (other states). Illness trends will be captured through facility-based surveillance and interrupted time series analysis. AMR will be assessed via community carriage surveys, clinical sampling in select states, and reviews of non-MDA antibiotic use among households, pharmacies, and medicine vendors.</p>

<p>Safety monitoring will combine caregiver-reported reactions from coverage surveys with adverse event reports gathered during implementation. Implementation will be tracked prospectively and analyzed descriptively and through multilevel regression, while readiness for adoption and long-term sustainability will be explored through interviews and focus groups with community, state, and federal stakeholders.</p>
},
  year = {2026},
  pages = {1 - 23},
  month = {08/2026},
  publisher = {F1000 Research Ltd},
  url = {https://verixiv.org/articles/3-267},
  doi = {10.12688/verixiv.3608.1},
  language = {ENG},
}