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

Table 2 Overview of the study fidelity monitoring plan

Monitoring tools	Areas of fidelity addressed
Monitoring tools	Study design: theoretical framework, intended dose, and intended content	Provider training: standardize training and maintain provider skills	Delivery: intervention delivered as specified	Receipt: participant’s understanding and ability to use the skills during the session	Enactment: participants’ ability to use and apply skills in real life
Observation or recording of intervention sessions and accompanying criteria (Additional file 1: Figs. S1 and S2) (1–2 sessions per month per health helper)	X	X	X	X	X
(Review of) electronic workflow (activity/contact logs and weekly electronic data dashboards)	X		X	X	X
Individual session checklist		X	X
External audit of trial standard operating procedures and trial materials			X
Qualitative evaluation methods (including focus groups and in-depth interviews with intervention participants, health helpers, and control group staff)		X	X		X
Health helpers review and monitor progress, understanding, and ability of skills during each session		X		X	X
Health helpers reflect on their own use of HCS per session	X		X
Health helpers debrief notes from sessions			X	X
Weekly team debriefs with health helpers		X	X
Quarterly quality assurance reports	X		X
Evaluation following training of each new health helper and maintenance training		X
Participant complaints (as these arise)		X	X
Record of health helper attrition	X	X

ISSN: 1745-6215