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. Author manuscript; available in PMC: 2020 Nov 5.
Published in final edited form as: Int J Clin Trials. 2020 Apr-Jun;7(2):83–93. doi: 10.18203/2349-3259.ijct20201715

Table 4:

Implementation Strategy for intervention and control clusters.

Activity What Who When Where How

Intervention clusters

Case identification Detection of cases Community-level health worker (CLHW) Young infant is seen by the CLHW either at their place of work or during routine postnatal home visits Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment

Screening and enrolment Detection of eligible cases CLHW Young infant is seen by the CLHW either at their place of work or during routine postnatal home visits Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment, pulse oximetry and consent

Confirmation of cases Validation of eligible cases identified by CLHW Study Supervisor An eligible young infant is identified by a CLHW and supervisor is informed Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment, pulse oximetry and confirmation of CLHWs findings

Treatment provision Oral amoxicillin CLHW and parents/care givers After enrolment and consent First dose given at place of enrolment and remaining doses given at home Practical demonstration of giving the first dose in front of mother/caregiver

Follow up Follow up assessments of infants under intervention treatment CLHW On days 2,4 and 7 after enrolment Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment, pulse oximetry and checking treatment adherence

Supervision Sub-sample on follow-up days for quality assurance Study Supervisor Follow-up visits on days 2, 4, and 7 Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Conformational assessment

Outcome assessment Outcome assessment Independent Outcome Assessor Days 6, 14 and if patient deteriorated in between Patients household or a hospital if patient was admitted Clinical assessment and filling outcome assessment form

Control clusters

Case identification Detection of cases CLHW Young infant is seen by the CLHW either at their place of work or during routine postnatal home visits Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment

Screening and enrolment Detection of eligible cases CLHW Young infant is seen by the CLHW either at their place of work or during routine postnatal home visits Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment, and consent

Confirmation of cases Validation of eligible cases identified by CLHW Study Supervisor An eligible young infant is identified by a CLHW and supervisor is informed Community clinic in Bangladesh, Health Post in Ethiopia, Household in India and Malawi Clinical assessment, and confirmation of CLHWs findings, pulse oximetry

Treatment provision Refer to a referral facility CLHW After enrolment and consent First dose given at place of enrolment and refer to a referral facility Counselling for referral

Follow up NA NA NA NA NA

Supervision NA NA NA NA NA

Outcome assessment Outcome assessment Independent Outcome Assessor Days 6, 14 and if patient deteriorated in between Patients household or a hospital if patient was admitted Clinical assessment and filling outcome assessment form

NA: not applicable.