scholarly journals Chasing the storm: Recruiting non‐hospitalized patients for a multi‐site randomized controlled trial in the United States during the COVID‐19 pandemic

2021 ◽  
Author(s):  
Kelly Hu ◽  
Jean‐Claude Tardif ◽  
Melanie Huber ◽  
Maria Daly ◽  
Aisha T. Langford ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
The United States ◽  
Hospitalized Patients ◽  
Randomized Controlled

scholarly journals Dissemination of the Look AHEAD Intensive Lifestyle Intervention in the United States Military: A Randomized Controlled Trial

Obesity ◽  
2018 ◽  
Vol 26 (10) ◽  
pp. 1558-1565 ◽  
Author(s):  
Rebecca A. Krukowski ◽  
Marion E. Hare ◽  
Gerald W. Talcott ◽  
Leslie A. Gladney ◽  
Karen C. Johnson ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
The United States ◽  
United States Military ◽  
Randomized Controlled ◽  
Intensive Lifestyle Intervention ◽  
Look Ahead ◽  
The Look

scholarly journals Effects of Side-Effect Risk Framing Strategies on COVID-19 Vaccine Intentions in the United States and the United Kingdom: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nikkil Sudharsanan ◽  
Caterina Favaretti ◽  
Violetta Hachaturyan ◽  
Till Baernighausen ◽  
Alain Vandormael
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Side Effect ◽  
Motor Vehicle ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Percentage Points ◽  
Framing Strategies

Vaccination rates have stagnated in the United States and the United Kingdom leading to the continuing spread of COVID-19. Fear and concern over vaccine side-effects is one of the main drivers of hesitancy. Drawing from behavioral science and health communication theory, we conducted a randomized controlled trial among 8998 adults to determine whether the way COVID-19 vaccine side-effects are framed and presented to individuals can influence their willingness to take a vaccine. We presented participants information on a hypothetical future COVID-19 vaccine -- including information on its side-effect rate -- and then examined the effect of three side-effect framing strategies on individuals stated willingness to take this vaccine: adding a qualitative risk label next to the numerical risk, adding comparison risks, and for those presented with comparisons, framing the comparison in relative rather than absolute terms. Based on a pre-registered and published analysis plan, we found that adding a simple descriptive risk label (very low risk) next to the numerical side-effect increased participants' willingness to take the COVID-19 vaccine by 3.0 percentage points (p = 0.003). Providing a comparison to motor vehicle mortality increased COVID-19 vaccine willingness by 2.4 percentage points (p = 0.051). These effects were independent and additive: participants that received both a qualitative risk label and comparison to motor-vehicle mortality were 6.1 percentage points (p < 0.001) more likely to report willingness to take a vaccine compared to those who did not receive a label or comparison. Taken together, our results reveal that despite increasingly strong vaccination hesitancy and exposure to large amounts of vaccine misinformation, low-cost side-effect framing strategies can meaningfully affect vaccination intentions at a population level.

Advancing PrEP Delivery: A Randomized Controlled Trial for Use of ePrEP to Expand PrEP Access to Non-Urban Young Black MSM (Preprint)

2019 ◽  
Author(s):  
Aaron J Siegler ◽  
James B Brock ◽  
Christopher B Hurt ◽  
Lauren Ahlschlager ◽  
Karen Dominguez ◽  
...  
Keyword(s):  
United States ◽  
North Carolina ◽  
Randomized Controlled Trial ◽  
Interactive Video ◽  
Small Town ◽  
Positive Impact ◽  
Controlled Trial ◽  
Scale Up ◽  
The United States ◽  
Randomized Controlled

BACKGROUND Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons, who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored smartphone application (app), specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care. OBJECTIVE Our goal is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up. METHODS This two-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged 18-24 from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of Black or Latino MSM. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate). RESULTS Enrollment is anticipated to begin in March 2019, with study completion in 2022. CONCLUSIONS This trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small town areas of the United States. CLINICALTRIAL University of North Carolina Institutional Review Board (#18-0107); ClinicalTrials.gov NCT03729570

Neonatology Needs Help

PEDIATRICS ◽  
1992 ◽  
Vol 89 (1) ◽  
pp. 158-158
Author(s):  
Jerold F. Lucey
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Clinical Research ◽  
Controlled Trial ◽  
The United States ◽  
Bad News ◽  
Good News ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Prospective Randomized Controlled Trial

I just reviewed the April 1991 issue of Pediatric Research which contains the APS-SPR abstracts. You can't help but notice that neonatology is the most active area of clinical research. Of the 2257 manuscripts submitted, at least 1119 can be classified as neonatal. There are now more than 2500 board-certified neonatologists in the United States. We certainly get high marks for producing abstracts. That's the good news. The bad news, I think, is how trivial, repetitive, and fruitless some of these studies seem to be. I stopped counting when I reached 20 abstracts which ended with the phrase "but of course this study needs to be repeated on a larger number of patients in a prospective randomized controlled trial."

scholarly journals Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial

Drug Safety ◽  
2015 ◽  
Vol 39 (2) ◽  
pp. 171-184 ◽  
Author(s):  
Lauren McCormack ◽  
R. Craig Lefebvre ◽  
Carla Bann ◽  
Olivia Taylor ◽  
Paula Rausch
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Drug Safety ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled

scholarly journals Comparing Methods of Recruiting Spanish-Preferring Smokers in the United States: Findings from a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Patricia Medina-Ramirez ◽  
Patricia Calixte-Civil ◽  
Lauren R Meltzer ◽  
Karen O Brandon ◽  
Ursula Martinez ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
The United States ◽  
Recruitment Strategy ◽  
Lower Percentage ◽  
Foreign Born ◽  
Effective Strategies ◽  
Randomized Controlled

BACKGROUND There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials. OBJECTIVE Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost. METHODS Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307). RESULTS Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (<i>P</i>=.008) and had spent fewer years in the United States (<i>P</i>&lt;.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (<i>P</i>&lt;.001) and an annual income above US $10,000 (<i>P</i>&lt;.001). In addition, a greater percentage of individuals were employed (<i>P</i>&lt;.001) and foreign born (<i>P</i>=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (<i>P</i>&lt;.001) and a greater percentage of individuals were of Central American (<i>P</i>=.02), South American (<i>P</i>=.01), and Cuban (<i>P</i>&lt;.001) origin. CONCLUSIONS Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers.

Effectiveness of the Fun for Wellness Online Behavioral Intervention to Promote Well-Being Actions in Adults With Obesity or Overweight: A Randomized Controlled Trial

2020 ◽  
pp. 1-14
Author(s):  
Seungmin Lee ◽  
Adam McMahon ◽  
Isaac Prilleltensky ◽  
Nicholas D. Myers ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
The United States ◽  
Three Dimensions ◽  
Double Blind ◽  
Randomized Controlled ◽  
Parallel Group

The purpose of this study was to evaluate the effectiveness of the Fun For Wellness (FFW) online intervention to increase well-being actions in adults with obesity in the United States in relatively uncontrolled settings. The FFW intervention is guided by self-efficacy theory. The study design was a large-scale, prospective, double-blind, and parallel-group randomized controlled trial. Data collection occurred at baseline, 30 days after baseline, and 60 days after baseline. Participants (N = 667) who were assigned to the FFW group (nFFW = 331) were provided with 30 days of 24-hr access to FFW. Supportive evidence was provided for the effectiveness of FFW in real-world settings to promote, either directly or indirectly, three dimensions of well-being actions: community, occupational, and psychological. This study shows that theory-based intervention may be effective in promoting well-being actions in adults with obesity in the United States.

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