title: Challenges in Implementation of the ANISA Protocol at the Matiari Site, Pakistan.
abstract: BACKGROUND
  The Aetiology of Neonatal Infection in South Asia (ANISA) study is a population-based study with sites in Bangladesh, India and Pakistan. It aims to determine community-acquired incidence, etiology and associated risk factors for neonatal infections. Matiari, a rural site in Pakistan, was chosen for the study due to its high neonatal mortality rate and the presence of an established pregnancy and birth surveillance system. This article summarizes various challenges, remedial measures taken and lessons learned during the implementation of the ANISA study protocol in the unique rural setting of Matiari where the majority of births take place at home and accessibility to health care is limited.
  
  
  CONCLUSIONS
  Achieving and maintaining project targets of early registration of birth and collection of biological specimens in households have been challenging in Matiari. Capturing births of study subjects that occur outside the catchment areas and those taking place during public holidays and acquiring parental consent for specimen collection from healthy controls require extensive community mobilization. Contamination and power outages that affect the laboratory equipment are 2 of the major logistic challenges faced. We keep track of pregnancy outcomes through mobile phones and reimburse the costs for birth notifications to the caller. We created separate dedicated mobile teams that visit newborns outside the catchment area and carry out possible serious bacterial infection assessments. We also formed mobile teams for specimen collection from residences of newborns as there is no facility for specimen collection at this site. Our study personnel work on holidays and weekends to improve the study's performance. We nurture strong community liaison by employing staff from within the community. We train the study physicians on communication and counseling skills required for overcoming refusal for referral and specimen collection. The contamination rate is controlled by repeated training and supervision and extensive monitoring of phlebotomy activities. The majority of phlebotomy procedures are recorded on video in the field to provide feedback to phlebotomists for improving their performance.
  
  
  CONCLUSIONS
  The contextual challenges faced in field implementation of the ANISA protocol in the rural setting of Matiari are unique. These challenges are being successfully addressed through hard work, strict monitoring and improvisation. This experience can be used for improving study performance in similar settings elsewhere.
authors.affiliation: From *The Aga Khan University, Karachi, Pakistan; and †Child Health Research Foundation, Dhaka, Bangladesh.
authors.forename: Sheraz
authors.initials: S
authors.lastname: Ahmed
authors.forename: Shabina
authors.initials: S
authors.lastname: Ariff
authors.forename: Sajid Bashir
authors.initials: SB
authors.lastname: Soofi
authors.forename: Amjad
authors.initials: A
authors.lastname: Hussain
authors.forename: Aneeta
authors.initials: A
authors.lastname: Hotwani
authors.forename: Muhammad
authors.initials: M
authors.lastname: Yaqoob
authors.forename: Shahida M
authors.initials: SM
authors.lastname: Qureshi
authors.forename: Imran
authors.initials: I
authors.lastname: Ahmed
authors.forename: Mohammad Shahidul
authors.initials: MS
authors.lastname: Islam
authors.forename: Samir K
authors.initials: SK
authors.lastname: Saha
authors.forename: Zulfiqar A
authors.initials: ZA
authors.lastname: Bhutta
mesh_terms: D003625:Data Collection; D062665:Epidemiological Monitoring; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D000071074:Neonatal Sepsis / Q000453:epidemiology / Q000209:etiology*; D010154:Pakistan / Q000453:epidemiology; D012307:Risk Factors; D012424:Rural Population; D013048:Specimen Handling