03683nas a2200697   4500000000100000008004100001260003200042653001100074653002900085653001700114653002900131653001300160653001200173653002300185653002700208100001300235700001100248700001500259700001300274700001500287700001400302700001300316700001300329700001400342700001700356700001500373700001400388700001400402700001300416700001700429700002100446700001300467700001400480700001400494700001500508700001500523700001400538700001300552700001500565700001400580700001700594700001500611700001400626700001500640700001100655700001400666700001400680700001200694700001200706700001200718700001400730700001400744700001500758700001400773700001300787700001300800245021000813856003901023300001101062520191201073       2026                            d  c08/2026bF1000 Research Ltd10aSafety10aAntimicrobial resistance10aAzithromycin10aMass drug administration10aChildren10aNigeria10aClinical Protocols10aImplementation science1 aSalako A1 aMusa Z1 aBamidele T1 aIdigbe I1 aOsuolale K1 aAdewale B1 aFowora M1 aChukwu E1 aAjibaye O1 aHerbertson E1 aAkinsolu F1 aOladele D1 aOdubela O1 aTijani W1 aHakizimana D1 aWamyil-Mshelia T1 aMadaki S1 aOdubela O1 aAdekola H1 aAyegbeso D1 aAbubakar A1 aFashoto O1 aOnuoha M1 aMmirikwe I1 aOsoteku D1 aAidenagbon A1 aOresanya O1 aAdewole A1 aOnonogbo I1 aAchu I1 aOmokore O1 aMohanty R1 aShehu A1 aKenny A1 aMeans A1 aIgbokwe U1 aOlamiju F1 aKolawole M1 aShuaibu J1 aEzechi O1 aSalako B00aSafety, 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  uhttps://verixiv.org/articles/3-267  a1 - 233 a<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>