Navigating the trials of a trial: lessons from ProRIDE on recruitment, retention, and follow-up in rural Africa

TL;DR

This paper shares lessons from a successful clinical trial in rural Africa, focusing on infant recruitment, retention, and community collaboration.

Contribution

The study highlights practical strategies for conducting clinical trials in low-income rural settings with high follow-up success.

Findings

Successfully enrolled 2,000 infants in 11 months with a 97% follow-up rate at six months.

Home visits and community involvement were key to adherence and retention in the trial.

Collaboration between international and local teams improved infrastructure and training for the study.

Abstract

The ProRIDE randomized clinical trial (RCT) started participant recruitment in February 2022, successfully enrolling 2,000 infants within an 11-month period and achieving a follow-up rate of 97% at six months of age. This narrative article describes critical components of the research protocol, the composition of the research team, community sensitization efforts, and the local performance of the study. The research initiative was conceptualized by a collaborative group of scientists from both high- and low-income countries, and its successful implementation was contingent upon the active involvement and participation of a rural, low-income community. Based on previous study findings in Tanzania, which consistently indicated a high prevalence of severe infections related to multidrug-resistant bacteria, the research team recognized the urgent need for preventive strategies aimed at reducing the incidence of sepsis and severe bacterial infections. Given the scarcity of data from rural areas and the imperative for inclusivity, the rationale for conducting this RCT in a rural context was compelling. We believe that a key factor in the successful completion of this trial was the intentional design of a simple, straightforward, and practical intervention, and study framework. Caregivers administered the study medication at home, thereby mirroring real-world therapeutic practices and enhancing the generalizability of the findings. To ensure adherence to the one-month intervention regimen, the research team conducted a day-seven home visit to confirm proper administration of the investigational product and address any associated early challenges. During this interaction, the field workers reiterated the instructions for the proper application of the product, thereby serving as a reminder to the caretaker regarding its correct usage. Additionally, a thorough planning phase was undertaken prior to the study's commencement, involving extensive collaboration between the researchers from Norway, Muhimbili University of Health and Allied Sciences, Tanzania, and the leadership at Haydom Lutheran Hospital. Through a series of meetings and discussions, the research team in Norway and Tanzania identified specific areas requiring enhancement, particularly in laboratory infrastructure and the training of personnel in blood culture techniques and antimicrobial susceptibility testing. Despite facing numerous challenges both prior to and during the trial, this RCT successfully recruited 2,000 participants within 11 months. This accomplishment can be attributed to the strong collaboration and teamwork exhibited throughout the process. The insights gained from this study may be of particular interest to researchers and scientists aiming to conduct investigations involving infants and children in low-income settings.

Trial registrations This trial is registered with ClinicalTrials.gov, NCT04172012. November 21, 2019.

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