Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

Research Bronchoscopies in Critically Ill Research Participants: An Official American Thoracic Society Workshop Report.

Bronchoscopy for research purposes is a valuable tool to understand lung-specific biology in human participants. Despite published reports and active research protocols using this procedure in critically ill patients, no recent document encapsulates the important safety considerations and downstream applications of this procedure in this setting. The objectives were to identify safe practices for patient selection and protection of hospital staff, provide recommendations for sample procurement to standardize studies, and give guidance on sample preparation for novel research technologies. Seventeen international experts in the management of critically ill patients, bronchoscopy in clinical and research settings, and experience in patient-oriented clinical or translational research convened for a workshop. Review of relevant literature, expert presentations, and discussion generated the findings presented herein. The committee concludes that research bronchoscopy with bronchoalveolar lavage in critically ill patients on mechanical ventilation is valuable and safe in appropriately selected patients. This report includes recommendations on standardization of this procedure and prioritizes the reporting of sample management to produce more reproducible results between laboratories. This document serves as a resource to the community of researchers who endeavor to include bronchoscopy as part of their research protocols and highlights key considerations for the inclusion and safety of research participants.

Using a multicultural and multilingual awareness-raising strategy to enhance enrollment of racially underrepresented minoritized communities - the PassITON trial.

Racially and ethnically minoritized populations have been historically excluded and underrepresented in research. This paper will describe best practices in multicultural and multilingual awareness-raising strategies used by the Recruitment Innovation Center to increase minoritized enrollment into clinical trials. The Passive Immunity Trial for Our Nation will be used as a primary example to highlight real-world application of these methods to raise awareness, engage community partners, and recruit diverse study participants.

Youth Knowledge and Perspectives on Expedited Partner Therapy.

PURPOSE: Expedited partner therapy (EPT) is an effective sexually transmitted infection (STI) treatment and prevention practice that allows clinicians to provide treatment to the sexual partner(s) of individuals diagnosed with chlamydia and/or gonorrhea infections without a clinical evaluation. Due to the high incidence of STIs among youth, we sought to understand youth awareness and beliefs about EPT use. METHODS: MyVoice, a national text message survey of youth aged 14-24 years, posed 5 questions on EPT knowledge and perceptions to 1,115 youth in August 2018. Responses were reviewed to identify themes and iteratively develop a codebook. Two reviewers independently coded each question, and a third reviewer resolved discrepancies. Summary statistics were calculated for demographic and thematic analysis. RESULTS: A total of 835 participants responded to at least 1 question (74.9% response rate). Majority of youth (91.9%, n = 730/794) felt that it would be important to help their partners get treatment if they tested positive for chlamydia or gonorrhea. Although most participants were unaware of EPT (86.4%, n = 657/760), 81.3% (n = 624/768) supported the policy stating that it is "pretty darn convenient." Youth also noted they would be interested in asking their provider for EPT. Participants opposing EPT (6.9%, n = 53/768) noted that "they [sexual partner] are responsible for their own health" and preferred to "tell my partner to go to [their] doctor." CONCLUSIONS: Most youth in the MyVoice cohort felt that EPT was a good way to get treatment for their partners, even though the majority were not aware that EPT was available as an STI treatment option.

The future of STI screening and treatment for youth: a National Survey of youth perspectives and intentions.

BACKGROUND: Sexually transmitted infection (STI) rates continue to rise in the U.S., with disproportionately high rates among those aged 15-24 years. Effective programs and policies are necessary to address this growing public health problem. The purpose of this study is to assess the perspectives of a national sample of youth on access to STI care and behaviors regarding STIs. METHODS: MyVoice, a national text message survey of youth, was used to pose four open-ended questions on STI screening and treatment to 1115 youth aged 14-24 in August 2018. A mixed-methods strategy was employed for the study. Qualitative data was analyzed using a modified grounded theory approach. Summary statistics were calculated for demographic data and prevalence of themes. RESULTS: Of the 800 participants who responded to at least one question (72% response rate), mean age was 19 years (SD = 3.1), 55% identified as female, 61% identified as non-Hispanic white, and 33% qualified for free/reduced lunch. A majority felt it would be easy to get screened (69%) or treated (68%) for an STI. Nearly all respondents (95%) stated they would share an STI diagnosis with their sexual partners. CONCLUSIONS: Despite high rates of STIs among youth, most respondents reported that STI screening and treatment is accessible, and they would share an STI diagnosis with their partner.