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Table 5 Overview of the intervention delivery fidelity strategies and monitoring plan for HeLTI SA

From: A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa

Goal

NIH description

Strategies used in HeLTI SA

Fidelity monitoring tools for HeLTI SA

Control for provider differences

Monitor and control for participant perceptions of non-specific intervention effects across the intervention group

- Providers are selected for specific characteristics.

- Qualitative methods are used to assess participants’ perceptions of intervention delivery.

- Any participant complaints are reviewed by the researcher and project coordinator.

- Debrief sessions with health helpers.

Reduce differences within the intervention

Ensure that providers are delivering the same intervention

- The intervention manual developed for each phase is used.

- Rather than a script, session checklists on REDCap have been developed to encourage session standardization.

- Electronic activity logs and checklists will be monitored in REDCap by the project coordinator.

Ensure adherence to the intervention protocol

Ensure that the intervention is being delivered in the way in which it was conceived with regard to content and dose

- The intervention manual per phase outlines relevant content.

- Session checklists on REDCap guide the intervention content.

- Health helpers keep a contact and activity log per participant on REDCap.

- Electronic activity logs and checklists monitored for completion and adherence by the project coordinator.

- Monitoring of health assessment outcomes and actions taken on REDCap.

- Health helper’s debrief notes and recorded sessions are reviewed by the process evaluation team for non-specific intervention effects, omissions, and intervention delivery.

- External audit of standard operating procedures and trial documents.

- Quarterly quality assurance reports.

Minimize contamination between groups

Minimize contamination across intervention and control groups, especially when implemented

- HeLTI SA intervention materials and manuals are intervention-specific and not publicly available.

- Health helpers are specific to the intervention or control group.

- Observation and recording of sessions are part of the process evaluation.

  1. NIH National Institute of Health [19], HCS Healthy Conversation Skills