2021
DOI: 10.1186/s13063-021-05400-8
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Responding to COVID-19 threats to trial conduct: lessons learned from a feasibility trial of a psychological intervention for South African adolescents

Abstract: The COVID-19 pandemic has posed challenges to the conduct of clinical trials. Strategies for overcoming common challenges to non-COVID-19 trial continuation have been reported, but this literature is limited to pharmacological intervention trials from high-income settings. The purpose of this paper is to expand the literature to include a low- and middle-income country perspective. We describe the challenges posed by COVID-19 for a randomised feasibility trial of a psychological intervention for adolescents in… Show more

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Cited by 10 publications
(13 citation statements)
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“…Recent work in low- and middle-income countries suggests that some groups may experience structural and cultural barriers to technology-based research, even when it is necessary [ 13 , 14 ]. Thus, it is important to explore means of inclusive research that enable diverse voices to be heard.…”
Section: Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…Recent work in low- and middle-income countries suggests that some groups may experience structural and cultural barriers to technology-based research, even when it is necessary [ 13 , 14 ]. Thus, it is important to explore means of inclusive research that enable diverse voices to be heard.…”
Section: Resultsmentioning
confidence: 99%
“…This includes a range of activities, such as teaching [ 6 ], and the provision of medical treatment, ranging from services for neurology [ 7 ] and psychology [ 8 , 9 ] to midwifery and occupational therapy [ 10 ], physiotherapy [ 11 ], and yoga classes [ 12 ]. Research has also been forced to move online so as not to lose momentum, but evidence is emerging that this presents new challenges, as switching to remote data collection is not always seamless and can be difficult for participants [ 13 , 14 ].…”
Section: Introductionmentioning
confidence: 99%
“…Providers described low rates of engagement in virtual services largely due to patients having limited access to mobile phones and privacy concerns. Other studies also noted privacy issues and inconsistent access to data, hardware and technology (often due to economic hardship) as barriers to young people (who use substances) engaging in telehealth services in this setting [25]. Arguably these factors may have contributed to the higher rates of disengagement from treatment observed by our participants during this time.…”
Section: Discussionmentioning
confidence: 70%
“…Over half of the respondents reported using the skills learned in class "at least a few times a week" to "daily." The word cloud generated from the responses of 16 participants to the open-ended question "Overall, what did you find most useful in the course?" identified 110 unique words.…”
Section: Resultsmentioning
confidence: 99%
“…Our study adds to the few existing resources [14][15][16][17] on adapting recruitment procedures, protocols for study implementation, and lessons learned for transitioning in-person RCTs to virtual delivery. Major changes from the transition to a virtual format included recruitment, modifications to the study procedures, and intervention delivery.…”
Section: Principal Findingsmentioning
confidence: 99%