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Table 4 Overview the conceptual framework to assess acceptability, fidelity implementation, and type of data collection for each dimension

From: Implementation fidelity and acceptability of an intervention to improve vaccination uptake and child health in rural India: a mixed methods evaluation of a pilot cluster randomized controlled trial

Definition Purpose of the information Type of data
Fidelity components
 Content
Defined as an attempt to establish the “active ingredients” of the intervention, for example, in a theory of change or logic model, and assess whether they have been delivered as planned
Number of components implemented as planned
Community mobilization strategy
# community meetings
mHealth strategy
#“pushed” edutainment capsules
#“pushed” vaccination reminder messages
Quantitative a
 Coverage
Refers to the degree to which all persons who met study inclusion criteria received the intervention
Community mobilization strategy
# and characteristics of individuals (general population and target group) attending the different scheduled sessions
mHealth strategy
# and characteristics of individuals using the IVR platform by content type (edutainment (general population and target group), vaccination reminders (target group only))
 
 Frequency
Refers to whether the intervention was delivered with the regularity or frequency planned by its designers.
Number of activities delivered defined in time and frequency according to the scheduled calendar:
Community mobilization strategy
# community meetings
mHealth strategy
# “pushed” edutainment capsules
# “pushed” vaccination reminder messages
‟On-demand” to content through the IVR portal
 
 Duration
Establishes whether the intervention was delivered with the duration planned by its designers
Moderating factors
 Comprehensiveness of intervention description
Factors such as the degree of intervention complexity, and whether the intervention description is complete or incomplete, vague or clear, may influence the degree of implementation fidelity
To evaluate the implementers' understanding of:
-the theory of intervention
-the activities and resources allocated to the different components of the intervention
-the role in the intervention
This dimension is evaluated in three moments: (i) before beginning the data collection from intervention records, (ii) at the end of the implementation based on discussion groups and interviews with the intervention implementers and (iii) through feedback meetings with program designers
Qualitative b
 Strategies to facilitate implementation
Several support strategies may be used to optimize and to standardize implementation fidelity
According to the perspective of the implementers:
What were the strategies that facilitated the implementation?
What were the facilitating elements and the challenges encountered during the implementation phase?
 
 Quality of delivery
Concerns whether an intervention is delivered in a way that increases the likelihood of achieving the desires health outcomes
According to the perspective of the implementers:
To assess the quality of the material used, the delivery of the content of the intervention and the participation of the participant
 
 Participant responsiveness
Intervention uptake depends on its acceptance by and acceptability to those receiving it. Low participant involvement or responsiveness may negatively impact intervention fidelity
To know the acceptability and usefulness of the activities and the different key messages delivered and according to the perspective the
-Frontline workers
-General public and primary caregivers and families of children 0 to 12 months of age
To understand the reasons for non-participation of member of the target group in the proposed activities:
-Community mobilization (face-to-face) activities
-Messages via mobile phone (mHealth) activities
 
 Recruitment*
Refers to procedures that were used to attract potential program participants.
According to the perspective of the implementers:
To assess recruitment process, recruitment strategies and challenges to attract participants in each group (to compare the level of fidelity achieved in each village).
 
 Context*
Refers to surrounding social systems, such as structures and cultures of organizations and groups, and historical and concurrent activities and events.
-Reasons for any deviation from the planned activities according to the point of view of the implementers
-To assess which contextual factors influence the fidelity obtained in the different components of the intervention
-Information on context factors regarding the delivery and receipt of the intervention in the different villages
-The actions of the Government of India to provide primary health care in rural areas
 
 Control group
Monitoring of events in the control group
-Components of the intervention that took place in the control group during the intervention period.
-Strategies adopted to prevent contamination in the control group.
 
  1. Adapted from Carrol et al. [11] and these components* added by Hasson [16]
  2. a Research methods: structured observation with checklist, survey records and data from the interactive voice response (IVR) system and household surveys. Data source: implementers, administrative records of the intervention Tika Vaani, and the mobile platform IVR
  3. b Research methods: semi-structured interviews, discussion groups, documentary review and field observation. Data source implementers, frontline workers, general public and primary caregivers and families of children 0 to 12 months of age, records of the intervention Tika Vaani, and the mobile platform IVR, and journal of the main author