A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial

Marhefka, Stephanie L.; Lockhart, Elizabeth; Chen, Henian; Meng, Hongdao; Ortiz, Miguel Reina; Powell, Brittani; Shuter, Jonathan

doi:10.1016/j.cct.2021.106475

Cited by 3 publications

(1 citation statement)

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“…A promising approach to overcoming these barriers is the integration of technology such as telehealth visits, digital consent, and application of remote patient monitoring devices into clinical trial design [3,[7][8][9]. In addition, for some studies, research participants collect their own samples at home and mail them to a lab for analysis [10,11]. Conducting research visits via telehealth mitigates travel-related time and expenses, can reduce wait times and missed appointments, and allows for greater scheduling flexibility [12].…”

Section: Introductionmentioning

confidence: 99%

Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach

Daudelin

Brewer

Cabrera

et al. 2022

J. Clin. Trans. Sci.

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Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens. Methods: A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery. Results: Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology. Conclusions: The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.

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