Demographics:
59 people participated in this study, out of whom, 12 were HCWs, and 47 were guardians. Of the 12 health workers were interviewed, of which 2 were female, and 10 were male. While for the parents, all 47 were female. The average age of HCWs was 38 while for the guardians it was 29. All the 12 HCWs had completed a minimum of secondary education. While for the guardians, 35 had completed primary school, 11 had completed secondary education, and one had tertiary education. Additionally, 38 of the guardians were able to read and write, and nine could not do so. The average years of experience for the HCWs was 16. Additionally, 4 out of the 12 HWCs were senior HSAs. While for the guardians, 26 of them were housewives, 20 of them were self-employed (business), and one was formally employment.
Adherence to the malaria vaccine implementation protocol
This section illustrates the findings that determine the implementation protocol's adherence and uptake with respect to the implementation framework. The tenets of the framework include commitment, dosage, quality of delivery, participant responsiveness, and program differentiation.
i. Knowledge and Adherence
It was noted that there was some adherence to the protocols but to a lesser extent. The reasons varied from programmatic challenges to personnel. Training and orientations were not extensive; the HSAs had only one orientation session in which they were required to understand the entire protocol. This led to some parts of the protocol being adhered to, while others crucial to the study missed out by the implementers on the ground. Some of the features of the protocols that were not adhered to were during the pre-vaccination phase, where guardians were not allowed to ask questions about the vaccine; during the vaccination phase, the vaccination points didn’t have first aid kits for management of side effects. In some instances, guardians were not informed of the management of post-vaccine side effects and the supervision of vaccine providers was not done by supervisors. Health care workers during the interviews expressed knowing the study protocol. However further discussions and responses showed that they did not fully understand the protocols.
Almost all respondents, both HWCs and parents/guardians were able to describe what the vaccine is and the aims of the vaccines. Parents/guardians in the FGDs from both well performing and struggling facilities expressed satisfaction in the effectiveness of the vaccine in preventing malaria. Parents/guardians also said that they did not experience any problems with the vaccine. Most of the HCWs, especially from the well performing facility, in agreement also expressed satisfaction in malaria case reduction at the facility. This is what some HCWs and guardians had to say:
“We are seeing the number of children with malaria reduced if we compare to before. The reason is maybe the malaria vaccine” -(HCW, 53, Male, Facility 1).
“I have children, and previously all used to have regular malaria as if it was contagious. But now after the malaria vaccine program it seems as if this has changed” - (Parent/Guardian, 18, Single, Female, Primary, facility 2)
ii. Acceptance and Uptake
All the HCWs expressed that there was a positive vaccine uptake by parents/guardians. HCWs attributed high uptake to the hope that parents have had for a malaria free generation of their children. Some HCWs expressed that the positive uptake is also a result of decent counselling they provide to the guardians/parents.
“The vaccine is being received well. Parents of children are happy to bring their children to get the vaccines” -(HCW, 35, Male, Facility 2).
“I’m just grateful that with the malaria disease that has been problematic, those of us in this vaccination program can see some change with it…...” (Parent/Guardian, 27, Married, Female, Primary, Facility 2)
On actual uptake, not all HCWs were impressed. Some HCWs argued that just like many health care interventions, there were crucial challenges on uptake in the malaria vaccine program, particularly attributed to low literacy levels and misinformation by the public.
“One problem I would think of is probably the low literacy level of the population here in Mangochi. We can counsel women regularly and use appropriate routes through chiefs to reach out to them but comes of a surprise to us that some people claim to not know anything about the vaccine, this shows that some have a problem with understanding this program” -(HCW, 29, Male, Facility 2)
One HCW, in agreement, attributed the struggle in uptake to the rollout of the program. The HCW argued that the rollout should have considered counter-information that may affect the uptake of the vaccine. He argued that the inability to deal with these incidents right from the outset resulted in challenges.
iii. Coverage, Dosage and Vaccine Administration
Study participants were also interviewed on eligibility, dosage, and vaccine administration. All parents/guardians from both the facilities could describe the prerequisites. Their understanding was as outlined in the study guidelines. Additionally, all HCWs were also equally able to describe the guidelines, including the procedures for enrolling a child who presents late to the facility for their first dose.
The high level of knowledge observed in the HCWs from the well performing facility was reflected in the FGDs with parents/guardians, this however was not the case with FGD participants from the struggling facility. All parents/guardians from the well performing facilities were able to describe why their children were enrolled into the vaccine program. HCWs from underperforming facility attributed this low level of knowledge among parents/guardians to low literacy levels.
From the observations, it was noted that although, the parents and guardians are further informed and encouraged to use ITNs and other standard preventive measures of malaria along with the vaccine. Parents and guardians were not given an opportunity to ask questions or seek clarifications for issues they had regarding the vaccine. When prompted, some parents/guardians argued that the vaccines are offered in group set-up that does not allow one to express themselves fully. An element of inferiority complex was also noted among clients from rural villages towards HCWs precipitating the lack of meaningful participation.
From observations, during vaccine administration, poor adherence to the protocol was reflected. Neither of the centers had a first aid kit available. The ages of the children were however verified prior to administration of the vaccine, yet crucial information such as adverse reactions to previous vaccines was not obtained. The well performing facility had ruled out contraindications to the administration of the vaccine by asking mothers if their children had ever reacted to any medicine before. However, in contrast, at facility 2, the contraindications were not ruled out.
When prompted on coverage, HCWs revealed that the district was unable to meet the set target. HCWs agreed that the low performance observed in the national aggregations were genuine however were quick to dispute that it was not entirely HCWs fault. Some HCWs argued that amongst those reached at the facility, the uptake was good, but in general there was still a problem in having the wider community accept the vaccine. Superstition and poor program implementation were the factors highlighted repeatedly by HCWs.
iv. Storage, Transport and Cold Chain
The study observed that the guidelines for vaccine storage were well adhered to. The temperature was within the recommended range of 2 to 8 Degree Celsius and vials stored away from all cold air vents. There were no other food items in the fridge. Vaccines were placed in plastic trays within the racks. During transportation, vials were placed in cold boxes with adequate ice packs. Prior to the start of the clinic, vaccine expiry dates were checked, and the vaccine vial monitor was checked to ensure viability of the vaccine. The diluent and antigen were reconstituted appropriately and used well within 6 hours of reconstitution with dedicated syringes. Almost all HCWs were able to explain in detail the processes and detailing out the technical aspects of reconstitution and transportation.
v. Management of Side Effects
Further deficiencies were observed at both sites, reflecting poor knowledge on side effects as seen in both parents/guardians and HCWs. Parents and guardians were not informed of the signs and symptoms of adverse reactions to look out for. In an observed session, the HCWs did not explain about side effects. The HCWs were just quick to say if the child falls sick, the parents/guardians should rush with the child to a health facility.
vi. Data Management
From the observations, it was noted that the immunization tally sheet, which counts the number of doses provided, is not completed following the clinic. However, the HCWs would complete it another day, usually more than two days later, which may have led to errors in documentation. This can perhaps be attributed to lack of consistent supervision noted in the study period. When asked, some HCWs argued that in some cases they run out of tally sheets while in the field, as such it was hard to document.
Assess the magnitude of the moderators of the implementation with reference to the implementation fidelity framework
i. Strategies and Feedback Mechanisms
All HCWs reported that the program had no official feedback structures. The HCWs do know their supervisors but have never been visited by them. They relied on the knowledge they had received during their training or had to ask other HSAs for clarification when uncertain. This was more prevalent in the underperforming facility, perhaps due to the location and increased distance to the district hospital. HCWs argued that in some instances their superiors have not been a part of the team during program briefings hindering with proper supervision. HCWs from the well performing facilities cited that in cases of doubt they had human resources nearby to seek guidance from.
In addition to HCW feedback and reporting mechanism, all HCWs reported that they had no feedback mechanisms with parents/guardians. They said that the only opportune time they had with parents/guardians was during a vaccination meeting. Most of them took the initiative to ask parents/guardians if they had noted side effects or other challenges with the vaccine. Some of the HCWs from the underperforming facilities argued that they believed that for parents/guardians who are shy to ask for clarification and stay further from the facility, seeking further help when they experience side-effects and problems was low. They argued that this would negatively affect adherence to the vaccine in cases where the side effects were severe.
ii. Increased workload and no incentives
Health care workers expressed that increased workload was a challenge. They argued that although the program was incorporated into the standard EPI programs, the work in the vaccine program was demanding, which made their overall work tiresome. This was heavily tied to the lack of incentives for HCW participation in the program. All HCWs argued that allowances during the vaccine period would motivate most of them as compensation for their increased workload. These sentiments were shared by HCWs from both facilities, with HCWs from the underperforming facility being vocal and emotional on the topic.
This is a key lesson that highlights the fact that the health workers did not fully understand that administering the malaria vaccine was part of their daily routine tasks. Therefore, clarification at the beginning of the program would have addressed the expectations of the HCWs to not perceive it as an additional responsibility. Unfortunately, the perception of administering the vaccine as an additional task requiring incentives may have had an impact on fidelity as HCWs could have cut corners because it is an additional responsibility of which they are not being compensated for.
iii. Stock out of resources and supplies
Stock-outs of resources to be used in the program were also frequently mentioned by the HCWs. Materials like syringes would often run short during their vaccination campaigns. Stock-outs were discouraged parents/guardians who were adherent and those who travelled long distances, these groups were also not likely to return on the following suggested date.
From observations, stockouts were mainly due to poor planning. This was more common in the poor performing facility. HCWs argued that they depended on supplies from the district hospital, which were staggeringly replenished. In the program, tally sheets were introduced for planning purposes, and with an improper use, HCWs struggled to prepare for the next vaccination activity.
Furthermore, the deficiency in required additional IEC materials (flyers, pamphlets) also raised several red flags from the observations. Neither of the sites had the IEC materials available, nor did they have furniture to operate from. However, they did have a provision of water and soap and a safe disposal box. Each facility had a vaccine register and child health profile with inadequate malaria vaccine stickers and no calendar. From the observation notes, we noted that child health passports were available in both centers, however, neither of the centers had any of the following: under 2-year-old registers; vaccine tally sheets; guidebooks for HSAs; reference manuals; nor a vaccine vial monitoring poster.
iv. Erratic power supply
Supply of electricity, a common problem countrywide, was also frequently mentioned. HCWs argued that frequent blackouts affect their effectiveness. This remains a major challenge if the malaria vaccine study was expanded before mitigating the power shortages.
v. Lack of proper training and refresher training
Lack of extensive knowledge on the vaccine that is compounded with absence of refresher courses for HCWs was also a challenge. Training period for all HSAs was scheduled for 8 weeks, but an individual HSA would only be trained within 2 days. Most HCWs agreed that the training period was short and that there was supposed to be additional training or updated SOP shared to ensure consistency in work for all HSAs. Such an approach will equip the HSAs on how to deal with challenges from the field like traditional beliefs.
vi. Lack of sensitization and support from stakeholders
Another challenge mentioned by HCWs was lack of proper sensitization, specifically, lack of support from chiefs. HCWs argued that unlike many vaccine campaigns where chiefs were trained and tasked to sensitize locals, the vaccine program excluded chief’s involvement. Due to hierarchal traditions, it is a colossal challenge to convince parents/guardians without chiefs’ approval.