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

Lesson Study to Scale Up Research-Based Knowledge: A Randomized, Controlled Trial of Fractions Learning

2017 ◽  
Vol 48 (3) ◽  
pp. 261-299 ◽  
Author(s):  
Catherine Lewis ◽  
Rebecca Perry
Keyword(s):  
Randomized Controlled Trial ◽  
Elementary Teachers ◽  
Teacher Leadership ◽  
Lesson Study ◽  
Controlled Trial ◽  
Scale Up ◽  
Linear Representation ◽  
The United States ◽  
New Approach ◽  
Randomized Controlled

An understanding of fractions eludes many U.S. students, and research-based knowledge about fractions, such as the utility of linear representation, has not broadly influenced instruction. This randomized trial of lesson study supported by mathematical resources assigned 39 educator teams across the United States to locally managed lesson study supported by a fractions lesson study resource kit or to 1 of 2 control conditions. Educators (87% of whom were elementary teachers) self-managed learning over a 3-month period. HLM analyses indicated significantly greater improvement of educators' and students' fractions knowledge for teams randomly assigned to lesson study with resource kits. Results suggest that integrating researchbased resources into lesson study offers a new approach to the problem of “scale-up” by combining the strengths of teacher leadership and research-based knowledge.

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.

scholarly journals A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Laura Whiteley ◽  
Elizabeth Olsen ◽  
Leandro Mena ◽  
Kayla Haubrick ◽  
Lacey Craker ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Positive Impact ◽  
Controlled Trial ◽  
The United States ◽  
Developmental Phase ◽  
Randomized Controlled ◽  
Research Activities ◽  
Young Msm ◽  
Exposure Prophylaxis ◽  
Gaming Intervention

BACKGROUND In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP’s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. OBJECTIVE The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. METHODS This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). RESULTS Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. CONCLUSIONS This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. CLINICALTRIAL ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18640

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 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.

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