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

Abstract

Introduction Despite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating complex, adaptable/pragmatic interventions in resource-strapped settings with systemic issues, unique challenges to intervention adherence and monitoring are introduced, increasing the importance of a fidelity protocol. We aim to describe the intervention fidelity and monitoring protocol for the Healthy Life Trajectories Initiative (HeLTI) South Africa, a complex four-phase intervention set in urban Soweto, starting preconceptionally and continuing through to pregnancy, infancy, and early childhood to improve the health of young women and reduce the intergenerational risk of obesity. Methods The HeLTI SA fidelity protocol was based on the NIH Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. Context-specific fidelity challenges were identified. The intervention fidelity components and associated monitoring strategies were developed to align with HeLTI SA. Strategies for fidelity monitoring include, amongst others, qualitative process evaluation methods, reviewing observed and recorded intervention sessions, monitoring of activity logs, standardized training, and intervention session checklists. Possible challenges to fidelity and fidelity monitoring include high provider turnover, lack of qualification amongst providers, difficulty tracing participants for follow-up sessions, participant health literacy levels, and the need to prioritize participants’ non-health-related challenges. Solutions proposed include adapting intervention delivery methods, recruitment methods, and provider training methods. Discussion The NIH BCC Treatment Fidelity Framework provided a solid foundation for reporting intervention fidelity across settings to improve intervention validity, ability to assess intervention effectiveness, and transparency. However, context-specific challenges to fidelity (monitoring) were identified, and transparency around such challenges and possible solutions in low- and middle-income settings could help foster solutions to improve adherence, reporting, and monitoring of intervention fidelity in this setting. Trial registration Pan African Clinical Trials Registry PACTR201903750173871. Registered on 27 March 2019

A qualitative analysis of community health worker perspectives on the implementation of the preconception and pregnancy phases of the Bukhali randomised controlled trial

“…Examples from this analysis include switching between languages, finding creative ways to explain the resources across levels of education, and helping participants find individualised solutions to socioeconomic barriers to participation. Although this kind of adaptability can have implications for fidelity to the study protocol, an adaptable, pragmatic approach to a CHW-delivered intervention improves the applicability and feasibility of the implementation [ 19 , 42 ]. For Bukhali , our results highlighted the importance of ongoing training of the HHs, with emphasis on how to adapt sessions and explanations in multiple ways, using pictures, drawings, and different languages and avoiding adverse tactics such as using exaggerated claims to scare participants into action.…”

A qualitative analysis of community health worker perspectives on the implementation of the preconception and pregnancy phases of theBukhalirandomised controlled trial

“…Examples from this analysis include switching between languages, finding creative ways to explain the resources across levels of education, and helping participants find individualised solutions to socioeconomic barriers to participation. Although this kind of adaptability can have implications for fidelity to the study protocol, an adaptable, pragmatic approach to a CHW-delivered intervention improves the applicability and feasibility of the implementation (10,32). For Bukhali , our results highlighted the importance of ongoing training of the HHs, with emphasis on how to adapt sessions and explanations in multiple ways, using pictures, drawings, and different languages and avoiding adverse tactics such as ‘scaring participants into action‘.…”

“You go an extra mile”: a qualitative study of community health worker perspectives in a health promotion intervention in urban South Africa

“…The Bukhali process evaluation has thus far explored trial implementation (32)(33)(34)(35), as well as participants' perceptions and experiences (36-39); however, HHs' perspectives have not been fully explored. The aim of this article is therefore to explore and describe their perspectives and experiences as CHWs of delivering the Bukhali intervention, in the context of living in Soweto.…”