Table 3. Implementation barriers and bottlenecks identified through formative research, application of contextualized strategies and their impact on PSBI program implementation.

Level	Observation made during formative phase—Challenges identified	Action taken and impact on the program implementation
ASHAs (Accredited Social Health Activist) Performance	1. Pregnancy Tracking: House to house pregnancy survey was done by the research team in the 50 study villages. ASHAs did not share their records for five villages; in the remaining, ASHAs had missed 36% (857/2359) pregnancies in 45 villages.	• Block ASHA Coordinators and District Immunization Officer re-emphasized the quarterly door to door survey by ASHAs. However, no change occurred in the intensity of supervision and ASHAs continued to rely on their social network approach for pregnancy detection.
	2. Record maintenance: Almost half (49.4%: 2605/5270) of the ASHAs refused to share their home visitation records with the research team citing incompleteness and not having permissions from their superiors. Most ASHAs maintained rough records before copying these in the official forms. HBNC (Home-based newborn care) forms and ANC (Ante-natal Clinics) records were incomplete/ partially filled. ASHAs mentioned that they did not know how to fill in ANC and HBNC visit recording forms. 3. Post-Natal Home Visitation: Home visits were irregular, not as per schedule and ASHAs did not accomplish the tasks as expected. ASHAs did not emphasize the identification of danger signs to the mothers during the home visitations.	• Following administrative actions were taken: Twelve trainings and re-orientation sessions were conducted by ASHA supervisors and local ANMs with small batches of ASHAs (total-82; 5–9 ASHAs per batch) to reorient ASHAs on various HBNC and ANC indicators, filling reporting formats and counseling of mothers during home visitation, VHND (village health and nutrition day) and VHSNC (Village Health, Sanitation & Nutrition Committee) meetings. • Record maintenance did not show any improvement; the practice of having rough record-keeping persisted • The frequency and regularity of the home visitation did not improve (Table 4).
	4. Monitoring of Post-Natal home visitations: The monitoring of ASHA’s post-natal home visitation by ASHA Coordinators was practically absent.	• CMO convened a meeting of the ASHA coordinators in the second quarter of the study and thereafter were asked to report their supervisory tasks during monthly meetings. • We could not verify the frequency and quality of monitoring visits by ASHA coordinators.
	5. Supplies of HBNC forms to ASHAs: Availability was irregular during the formative phase	• On the direction of TSU, INCLEN ensured the availability of relevant stationery with all the ASHAs through the study period.
	6. Referral of Sick infants to PHCs (Primary Health Centers)/CHCs (Community Health Centers): ASHAs were reluctant to refer sick young infants to CHCs and PHCs because ‘doctors referred these infants without even assessing’.	• As the PHCs and CHCs became functional during the implementation research, ASHAs started referring sick young infants to these facilities. • 11% of the PSBI infants were identified by ASHAs and were referred to primary care facilities compared to none in the six months before the launch of the study.
Health Service providers (Primary care physicians in CHC/PHC, ANMs, Staff Nurses)	7. Operationalization of sub-centers and ANMs: Formative research revealed that ANMs did not consider themselves as care providers and did not have the confidence to assess and manage sick young infants. They looked up to physicians at PHCs and CHCs for guidance.	• As part of the research, joint training of ANMs, nurses and physicians was conducted, which gave the trainees opportunity to independently assess sick young infants and write simplified antibiotic prescriptions for them. • ANMs could not be made confident to assess and manage sick young infants independently in the sub-centres. Only one ANM identified and managed two PSBI patients at one of the CHCs under the supervision of the medical officer.
	8. Management of Sick Young Infants by Primary care physicians:  • PHC/CHC Doctors were reluctant to assess and treat sick young infants even after regular IMNCI / PSBI trainings. Sick infants were frequently referred by them without even preliminary assessment.  • Doctors were unwilling to fill up IMNCI recording forms  • Up to the co-implementation phase, doctors were hesitant to give injectable gentamicin	• As part of the study, the trainees were allowed to independently assess sick young infants and write simplified antibiotic prescriptions for them. • IMNCI trained research team members accompanied sick infants in the first two implementation quarters to support medical officers in the assessment and management of sick young infants at PHCs/CHCs. This practice was gradually reduced and stopped in the third implementation quarter as they had become confident to assess and manage and appropriately refer sick young infants if required. • TSU organized hand-holding visits by district paediatricians from the third implementation quarter onwards by rotation to the CHCs and PHCs. This was to re-affirm the appropriateness of the assessment and prescriptions for sick young infants by primary care physicians and enhance their confidence. Visiting paediatricians emphasized the rationality and effectiveness of prescribing simplified antibiotic therapy including injection gentamicin. • From the second implementation quarter onward, the PSBI performance review of PHCs/CHCs became the standing agenda item of the CMO’s quarterly review. • Impact: Primary physicians at PHCs/CHCs were able to manage almost 1/3rd of the PSBI cases in the first 2 quarters and thereafter ended the study with over 40% of PSBI cases being managed at primary care health facilities (Table 5). • Doctors continued to be reluctant to fill IMNCI case classification forms throughout the study • The prescription and administration of gentamicin improved as the study progressed
	9. Referral of sick young infants to higher facilities:  • The referral system was almost non-functional; doctors and other health staff from PHCs/CHCs referred sick young infants without referral notes and any written guidance about where to take the infant. None received any pre-referral treatment.  •PHC and CHC staff was usually not sure about the compliance by the families on suggested referral.  • Families faced difficulties due to little importance and priority accorded to the referral slips from the field, sub-centres or PHCs/CHCs at the district hospital and other higher-level facilities.  • The parents would many times decide to give up and return home without any treatment due to lack of clear guidance about the place of treatment for their sick infant, running from one facility to another or seeking care from private practitioners.	• On the advice of TSU, CMO office notified: (i) doctors at CHCs and PHCs were to inform paediatrician at the district hospital when referring any sick infants; (ii) referral note was made mandatory with a clear mention of the reason for referral and place of referral; and (iii) medical superintendent was apprised of the admission in SNCU and requested to conduct a monthly review of neonatal admissions. • District hospital administration made available round the clock transport arrangement to regional medical college Nuh (50 KMs) and another tertiary hospital in Delhi (65 KMs). • Despite these efforts, the referral system remained inadequate till the end of the research and could not be streamlined as desired.
	10. Governance and human resource management: During the implementation period there was a frequent change in leadership (4 CMOs changed) and a strike by health staffs (once by ANMs and other paramedical personnel for 3–4 weeks) and ASHAs (twice for a total period of 6–7 weeks)	• The achievements of the implementation research were with available staff and no effort was made to re-deploy the staff in the study area.
	Also, there was a deficiency of doctors 23% (8/34-including district pediatricians); 45% nurse (13/29) and 24% (13/55) ANMs. All ASHA positions were filled.
Mothers and community	1. Identification of Sick young Infants: Formative research showed that 1/3rd (33.8%; 51/151) of the mothers could not mention even a single danger sign for their infants. 2. Care-seeking behavior: The majority of mothers and families did not realize the sickness of their young infants; this led to delayed care-seeking. Also, they were not sure about the appropriate health facilities for the treatment of their sick young infants. 3. Perceptions of ASHA’s Home Visitation: Most families and mothers were neither aware of ASHA’s home visitation schedule nor about its purpose. Therefore many mothers and families did not value post-natal home visitation made by AHSA. 4. Opinion on Public Health Facilities: Family had trust issues in the public health facilities particularly for their young ones at PHCs/CHCs; and or had a previous bad experience.	• Initial interaction between the research team and the families indicated that mothers could quickly learn to recognize the danger signs and were ready for prompt and timely care-seeking once they realized the baby was sick. The response was encouraging within the first quarter of the study (co-implementation phase). • TSU advised implementing structured and multi-pronged, contextually relevant social mobilization activities, utilizing existing community platforms and institutions. Mobilization activities focused on four aspects. (a) Identification of danger signs by the families and mothers. (b) Awareness about ASHAs’ home visitation schedule and her expected duties during home visitation. (c) Awareness of the availability of treatment facilities for sick young in PHCs and CHCs. (d) Dissemination of case-studies of successful recovery from illness after availing treatment from public health facilities. Through the study period, 87.6% (324/370) PSBI infants were brought by the mothers and families to health facilities
		The strategy worked and 87% of the PSBI infants were brought by the mothers and families to health facilities.