Finding balance between rigor and relevance: Implementing adaptations to a pragmatic randomized controlled trial (pRCT) of a two-way texting study for voluntary medical male circumcision in South Africa using the Framework for Reporting Adaptations and Modifications in Evidence-based Implementation Strategies (FRAME-IS)

Abstract

Abstract Background One of the major debates in implementation research is around fidelity and adaptation. The growing interest in obtaining evidence on the relative benefits and harms of interventions in real-world settings led to the use of pragmatic randomised controlled trials (pRCTs). While pRCTs must be implemented with fidelity, adaptation challenges the basic assumption that its core components must be implemented with fidelity. Objective To document adaptations that were made to the implementation strategy, the fit and effectiveness of the Two-Way Texting (2wT) intervention in South Africa and to provide a nuanced and generalizable difference between adaptations and fidelity. Methods We conducted a qualitative study using the Framework for Reporting Adaptations and Modifications in Evidence-based Implementation Strategies (FRAME-IS) to document adaptations to the 2wT intervention. Using the FRAME-IS as a codebook, adaptations were described and categorized. We documented adaptations to the 2wT intervention using two-steps: (1) used the Google doc to identify, categorize and describe adaptations made; (2) qualitatively assessed the impact of adaptations on project goals, and outcomes. We conducted ten (10) periodic reflections with VMMC implementers, and observations of real-time adaptation. For the fit, we reviewed participant engagement with the 2wT system, tracked the database containing daily RCT notes and bugs, and reminder emails about adaptations to research team and partners. For effectiveness, we used field notes, meeting minutes, did informal check-in with partners and member-checking for missing adaptations. Results Between June 2021 and February 2022, 13 adaptations were identified in the 2wT pRCT; 6 to the implementation strategy, 2 to improve the fit and 5 to strengthen the effectiveness of the 2wT system. Adaptations to the strategy were to conduct weekend camps to recruit and perform MCs at the same time, using mobile outreach services in the rural site, addition of two urban sites to increase recruitment, use of weekly WhatsApp calls for updates with all implementing teams, use of virtual meetings to implement the 2wT strategy remotely during COVID-19 restrictions, and allocating one clinician to be available to communicate with clients after normal working hours. Adaptations to the fit included adding two local language translations in the usability survey for 2wT men, and the contribution of a portion towards the salary of the implementing staff by the research partner. Adaptations to effectiveness were the exclusion of two rural clinics as recruitment sites because of constant phone network disruptions, adding another layer of data quality checks to ensure validity of the data, training non-clinical counsellors to help with enrolling clients and capturing them on the system, retraining of staff in the rural site with high staff turnover, and enabling the 2wT system to accommodate enrolment of at-risk VMMC clients using both primary and alternative phone numbers. Conclusions This study made adaptations to the 2wT pRCT without compromising the fidelity of the study. The 2wT pRCT provided a balance between rigor (fidelity) and relevance (adaptation). Adaptations should not be confined by rigor but should also not go unchallenged or unverified. We conclude that fidelity should not be the enemy of adaptation in closing the gap between research in the laboratory and in practice. Trial Registration: This trial from which this study was conducted, “Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision (VMMC) Participants in the Republic of South Africa,” was registered at ClinicalTrials.gov (ID: NCT04327271) on March 31, 2020.