Identification of cases of PSBI.

During routine HBNC visits or additional visits, ASHA identifies sick young infants including those with PSBI signs. ASHAs advise parents of all such infants to visit the CHC/PHC/tertiary care hospitals for medical care. ASHA can consult the ANM, if she is available in the village on that particular day. When ANM confirms a case of PSBI, they are referred to a public hospital/ tertiary care facility after administration of pre-referral dose of injection gentamicin and oral amoxicillin (see S2 Table). The exception is for only fast breathing (> 60 breaths per minute) in 7–59 days old infants who are given 7 days of oral amoxicillin without referral. Similar process is carried out by attending physician for young infants with PSBI signs who present at a PHC/CHC. If referral is not accepted, then the sick infant is categorized into critical illness (convulsions, no movement on stimulation, not feeding at all) or clinical severe infection (less than normal movements or movement only on stimulation, not feeding well, severe chest indrawing, temperature of > = 38°Cor <35.5°C) or severe pneumonia (fast breathing 0–6 days). WHO recommended simplified treatment is offered for clinical severe infection and severe pneumonia and referral is reinforced in those with critical illness as they are unable to take oral antibiotics [15].

Simplified treatment.

Oral amoxicillin twice a day (40–50 mg/dose) plus intramuscular injection gentamicin once a day (7 mg/Kg) for 7 days was administered to those with clinical severe infection or severe pneumonia [14]. Parents either brought the case daily to the health facility to receive injectable gentamicin or ANM visited home of the case daily for administering it. Parents gave the first dose of oral amoxicillin under medical supervision and then subsequent doses at home. ASHA visited such cases almost daily to ensure adherence to treatment. Young infants aged 7–59 days with only fast breathing were given only oral amoxicillin twice a day for 7 days [14]. Cases were categorized as “treatment success” when the care providers perceived that the infant was cured or better on day 8 of follow up and as “treatment failure” when condition worsened or there were persistent signs on day 8 or the patient died.

Policy dialogue.

For informing policy makers and for their approval for implementation research work, national as well as state level meetings were held prior to initiation of the project as the implementation research was done by the state government and health care functionaries. There was a continuous communication of the investigators with the implementers and the policy makers.

National level meeting.

There were two meetings held at national level. First meeting was held in October 2016. It was attended by National advisors to government, representatives from Central Ministry of Health and family welfare, investigators of the four participating states, the World Health Organization representatives and expert advisors from Save the Children. Outcome of the meeting was adaptation of guidelines for PSBI management in young infants where hospitalization is not feasible [14]. The second meeting was held with all the stakeholders who were present in the first meeting in New Delhi in July 2017. During this meeting, plans of all the four research sites were reviewed and discussed. Suggestions and recommendations to and from the government were incorporated customized to every research site.

State level meeting.

A meeting of investigators with the Director, managing director and general manager Child health of Uttar Pradesh-National Health Mission was held in January 2017. They were briefed about the implementation research. All the officials appreciated and supported it and assured the availability of Sick newborn care unit and Kangaroo Mother Care units in four implementation blocks for management of the referred sick young infants. The director proposed incentives of INR 100 to the ASHA workers on successful referral of cases of PSBI to public health facility. He also recommended a brief re-training, especially for ASHA workers on management of PSBI. A technical advisory group (TAG) was formed to support and guide the research. Its members were representatives of state government and multilateral agencies working in child health such as UNICEF and Save the Children. Functions of the TAG was to review program implementation once in 6 months and provide inputs. At the end of the implementation phase, a state level dissemination meeting was also held where members of TAG were invited.

Role of Technical Support Unit (TSU).

A TSU was established at KGMU which had the investigators and research staff trained by the investigators for supportive supervision of ASHAs and ANMs; effective implementation of HBNC program and simplified treatment for PSBI when referral was not feasible; necessary data collection from health care providers’ records for continuous evaluation; and provide feedback to the program for quality improvement and for assessing effectiveness of the implementation research.

Role of district health staff.

Government doctors conducted trainings for strengthening home based newborn care program and giving simplified treatment, logistic support and ensured supplies as well as continued their routine monitoring and supervisions. ASHA and ANMs conducted their routine activities which now included identification and management of cases of PSBI by simplified treatment where referral was refused.

Establishment phase (June 2017 to Feb 2018).

The activities during this phase were:

1. Training: Initial training of master trainers for PSBI was conducted centrally in New Delhi (November 2016) by the WHO facilitators using pre-validated materials [15, 27]. The master trainers trained pediatricians and some medical officers in the state public health system for them to become the trainers for medical officers, nurses, ANMs, ASHAs and ASHA “Sangini”. The training emphasized on the acquisition of necessary skills on identification and management of PSBI or neonatal sepsis in young infants (S3 Table). The research staff hired were trained by project investigators on HBNC and PSBI over three days, using the modules provided by the WHO which were used for the training for trainers. In addition, they were taken to the neonatal intensive care unit and sick newborn care unit of King George’s Medical University and shown all signs of PSBI at least twice over a period of one week by the project investigator. There were multiple transfers of doctors and ANMs during the project. One to one training of new doctors and ANMs with refresher training of those trained earlier was conducted by TSU staff at their place of posting, which mandated by the government that they must remain in their places of duty all day. Newly inducted ASHA were also trained at CHCs (S3 Table).
2. Baseline survey: This survey was conducted in 120 villages of four implementation rural blocks of Lucknow using the thirty cluster sampling technique. In each block, 30 villages were included based on the population enumerated in census 2011 [1]. The villages were selected on the basis of size as small villages (<200 households), medium sized villages (200–400 households) and large sized villages (>400 households) in the ratio of 4:3:1 respectively. Mothers of infants 0–59 days was the unit if this survey. Mothers of all the young infants (0–59 days’ age) registered with the ASHA in selected villages were visited and interviewed after taking informed written consent. Using a predesigned, structured questionnaire they were asked about the number of HBNC visits done for their young infant and what the ASHA did on each visit. ASHAs of selected villages were interviewed using a predesigned, structured questionnaire and in addition one ASHA who was doing HBNC on the day of survey was interviewed and observed as she conducted the procedures laid down in HBNC. All the ASHA were interviewed to assess training given to them and their knowledge about HBNC and the functional status of HBNC kit given to them was evaluated. A predesigned, structured interview questionnaire was used.
   During this survey, to assess the knowledge of HBNC, recognition and management of PSBI, in-depth qualitative interview of a few mothers, ANMs and doctors was also done by purposive sampling. Baseline audit of health facilities was done to check for availability of oral amoxicillin, injectable gentamicin, 1 ml syringes and gentian violet lotion.
3. Data Collection for process indicators: From the records maintained by the district health staff, data was abstracted by TSU on numbers of pregnant women and deliveries per village, number of times HBNC visit was done for each infant with findings of each visit like weight, respiratory rate, temperature and presence of any danger signs or signs of PSBI. In about 15% of such visits the TSU staff observed the practice of ASHA workers and identified areas which needed strengthening either with support of the ASHA-“sangini” or through re-training. The district health continued usual independent monitoring and evaluation of the HBNC program.
   The TSU staff also collected information about cases of PSBI with, their presenting symptoms from the records maintained by the district health staff. Each PSBI case was visited by the research staff to validate findings abstracted as well as collect information on place of treatment, type of treatment specifically simplified treatment when referral was not accepted, response to administered treatment on days 4 and 8. Data on cases of PSBI on simplified treatment was collected by the research staff but in cases where parents took their child to a private provider or accepted referral to a district hospital, follow-up at home could not be done.
4. Refresher training and support: Members of TSU attended routine monthly cluster meetings of ASHAs and ANMs in their respective blocks. During this time, they scheduled refresher training on HBNC and PSBI program for ASHA with medical officers or ASHA “sangini” and observed them. During such trainings, skills which were found to be deficient like respiratory rate counting, physical examination to identify signs of infection and counselling for referral were re-enforced. ANMs were motivated by medical officers to administer pre-referral dose and in providing treatment at home/SC. Experiences on successful case identification and/or referral were also shared to encourage others. Medical officers appreciated ASHA who identified infants with danger signs and referred them for management. These meetings were also utilized for dialogue and fostering linkages between ASHA and their respective ANMs (See S4 Table).
5. Management Information System (MIS): Common case report forms were developed and customized in India for all the sites for research data collection. It included five forms: 1) Pregnancy identification and listing form, 2) Postnatal Home visit record, 3) Sick Young infant assessment form, 4) Facility Follow-up form (for record of Simplified Treatment given), 5) Home follow up and outcome. Information collected was entered in the secure web based application, Research Electronic Data Capture “RED Cap” [28]. Information collected from the field was checked and verified before entry into the database. Data analysis was done using MS excel and SPSS version 18.0 [29]. Univariate distribution of variables was done and presented as proportion with 95% confidence interval where required. Since it was an implementation research no inferential statistical analysis was done.

The establishment phase took around 9 months to stabilize and deliver optimal performance with reference to number of cases of sick infants identified and administering of pre-referral dose and/or simplified treatment.

Implementation phase (Mar 2018 to Feb 2019).

After the establishment phase, the intervention activities continued in the implementation mode, performing same activities as done in the establishment phase. The only new activity done during this phase was midline survey.

1. Midline Survey: One year after baseline survey, another survey was done using the same methodology as baseline survey. Same villages were visited as done in baseline survey however, mothers having infants 0–59 days were new. If there was no mother in the village selected earlier, adjoining village of the same size was visited. During this survey, interview of mothers was done to evaluate the change in knowledge level. ASHA interview and observation was also done to evaluate the change in her skills. Interview of medical officers and ANMs was done to evaluate the change in their knowledge for treatment of young infants and also to have a feedback for the simplified treatment of PSBI.

Baseline survey.

Baseline survey had both qualitative as well as a quantitative component and was conducted in 120 selected villages of four implementation blocks from February 2017 to May 2017. As a part of qualitative data collection, in-depth interviews (IDIs) were conducted with mothers of infants aged 0–59 days, ANMs and doctors. Twenty eligible mothers (five per block) were purposively selected for IDIs and interviewed for knowledge of HBNC program and danger signs of illness in young infants. Mean age of mothers who participated was 25.17±3.52 years.

During IDIs, it was found that most of the mothers did not know the detailed schedule of visit of ASHAs during HBNC program. However, they informed that the ASHA visited the home 3–4 times within 42 days of the birth of a neonate. Almost all mothers reported that ASHAs did not tell them about signs of sickness in young infants. She usually gave instructions for breast-feeding, vaccinations and maintaining temperature of the child. Most of the mothers were not aware of all the danger signs of sickness. Some recalled fever, loose motions and fast breathing as signs of sickness. One of the respondent said “Whenever ASHA visits, she asks about the health of the infant, washes and air-dries her hands, weighs and measures the temperature of the infant” [Block–Kakori]

IDIs were also conducted with 24 ANMs (6 per block and one per SC) at their respective SC. Purpose of conducting IDI was to obtain information on their training on HBNC, knowledge of danger signs of illness in young infants and its management. During IDIs, the ANMs informed that all of them were trained in HBNC program at the time of appointment by the government. HBNC training had a larger knowledge component and relatively small skills development component. There was no in-service reinforcement of training. None of them recalled having seen any sick young infant with “danger signs” in the last one month. Most of them said that fast breathing, loose motions, fever, skin infections and jaundice were danger signs. They referred such cases to a doctor to a CHC, which often had a pediatrician. They were not aware about giving pre-referral anti-biotics or any other advice at the time of transportation. When they were asked that whether they were comfortable in giving injectable anti-biotic treatment, most of the ANMs were apprehensive that if an infant died or disease progressed the family members would blame them.

IDIs were conducted of four medical doctors (one per block), who were not pediatricians, at their respective CHC. Respondent was purposively selected to assess their knowledge about symptoms of PSBI and its management. During IDIs, medical doctors informed that at CHC/PHC that was without pediatricians, only some of the doctors gave treatment to sick young infants. Most enumerated fever, diarrhoea, skin infections, fast breathing, lethargy, inability to feed and jaundice as danger signs and referred sick neonates to higher centers without any pre-referral dose. They also informed that most of the families did not accept referral to higher government hospitals and went to private hospital for treatment.

Baseline health facility audit showed that there was shortage of oral amoxicillin suspension in most facilities and amoxicillin dispersible tablets were not available. Vials of gentamicin injections were available in the pharmacy of all health facilities but not issued to the ANMs for use in the field for management of sick young infants. One ml injections with 26 gauze syringes were not present in the government supply.

Quantitative structured interviews were conducted with mothers who did not participate in the qualitative interview. All 416 eligible mothers were interviewed from 120 villages. Socio-demographic characteristics of these mothers are given in Table 1.

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Table 1. Socio-demographic characteristics of the parents during baseline and midline surveys.

https://doi.org/10.1371/journal.pone.0234212.t001

In addition to interview of 416 mothers, 118 ASHAs were also interviewed using a structured questionnaire. Knowledge of the mothers and ASHAs elucidated about danger signs during baseline survey is also shown in Table 2.

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Table 2. Change of knowledge of mothers and ASHA about danger signs between baseline and midline’s survey.

https://doi.org/10.1371/journal.pone.0234212.t002

Midline survey.

Midline survey was conducted in 120 villages of four implementation block from June 2018 to July 2018. While 51.6% (62/120) villages were the same as in baseline survey.48.3% (58/120) were new since there was no young infant in the corresponding number of villages at the time of midline survey. Structured interviews of 266 eligible mothers and 120 ASHAs were done to assess the change in their knowledge about danger signs. The sociodemographic characteristics of these mothers are shown in Table 1. Change in knowledge of mother and ASHAs about individual danger signs is given in Table 2. There was statistically significant improvement in knowledge as compared to baseline interview.

IDIs were conducted with 16 ANMs (04 ANMs per CHC) to understand the experiences in the implementation research, also to receive their suggestions for strengthening management of PSBI. Most of the ANMs had identified a sick young infant and more than half of them had administered either pre-referral dose or simplified treatment to cases of PSBI. Most of the ANMs appreciated the availability of treatment at SC/PHC/CHC. They said that it was easy to deliver simplified treatment and most of the ANMs had developed confidence in giving the gentamycin injection in the field setting. Villagers now held them in esteem as they perceived that their treatment had saved lives of sick young infants. Most of the ANMs requested for retraining sessions of ASHA and ANMs. One of the ANM, sharing her experience of implementation research that “The revision training on PSBI identification and its management should continue and the availability of medicines should be ensured” [Block-Mall]

In-depth interviews of 24 non-paediatreic doctors at CHC/PHC was taken to assess feasibility of continuing simplified treatment at SC/PHC/CHC to cases of PSBI after implementation program was over. Most of the non-paediatric doctors acknowledged the improvement in their knowledge and skills to effectively treat sick young infants with danger signs. They also said that they were able to give treatment of PSBI case at CHC/PHC and referred only those with critical illness to higher centres.

The medical doctors acknowledged that there was improvement in skills of ASHAs and ANMs in identifying and referring sick young infants with PSBI. Most of them said that simplified treatment to cases of PSBI would be integrated in routine practice and continue beyond the implementation research period. However, periodic refresher training would be beneficial.

One of the non-pediatric doctor shared his experience of implementation research as follows “We would continue the simplified treatment as this is very simple, safe and easily administrable at CHC/PHC/SC level” [Block- Sarojini Nagar]