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

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

10.2196/18640 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e18640
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. Trial Registration ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr International Registered Report Identifier (IRRID) DERR1-10.2196/18640

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

scholarly journals A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Elliot Marrow ◽  
Matthew J Mimiaga ◽  
Patrick Sullivan ◽  
Lisa Hightow-Weidman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
Pilot Rct ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Beta Testing ◽  
Pilot Randomized Controlled Trial

BACKGROUND HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. OBJECTIVE The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. METHODS This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. RESULTS App refinement is underway. Enrollment for the pilot RCT began in October 2018. CONCLUSIONS MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10694

scholarly journals A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Christina Psaros ◽  
Douglas S Krakower ◽  
Elliot Marrow ◽  
Steven A Safren ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Young Men ◽  
The United States ◽  
Hiv Incidence ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Pilot Randomized Controlled Trial

BACKGROUND New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. OBJECTIVE This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). METHODS This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. RESULTS Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. CONCLUSIONS Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM’s PrEP uptake and adherence to decrease the HIV incidence. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10661

scholarly journals Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection

2021 ◽  
Author(s):  
Shmuel Shoham ◽  
Evan M Bloch ◽  
Arturo Casadevall ◽  
Daniel Hanley ◽  
Bryan Lau ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Close Contact ◽  
High Titer ◽  
Controlled Trial ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Randomized Controlled ◽  
Contact Exposure ◽  
Exposure Prophylaxis

BACKGROUND: The efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. We hypothesized that CCP might prevent infection when administered before symptoms or laboratory evidence of infection. METHODS: This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was development of SARS-CoV-2 infection. RESULTS: 180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for SARS-CoV-2 RT-PCR positivity at screening. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. There were 28 adverse events in CCP and 58 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days; p=0.49) and COVID-19 (26.3 vs. 25.9 days; p=0.35) were similar for both groups. CONCLUSION: In this trial, which enrolled persons with recent exposure to a person with confirmed COVID-19, high titer CCP as post-exposure prophylaxis appeared safe, but did not prevent SARS-CoV-2 infection. Trial Registration: Clinicaltrial.gov number NCT04323800.

A Randomized Controlled Trial of Professional Development for Interdisciplinary Civic Education: Impacts on Humanities Teachers and Their Students

2015 ◽  
Vol 117 (2) ◽  
pp. 1-52
Author(s):  
Dennis J. Barr ◽  
Beth Boulay ◽  
Robert L. Selman ◽  
Rachel Mccormick ◽  
Ethan Lowenstein ◽  
...  
Keyword(s):  
Professional Development ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
The United States ◽  
Performance Measure ◽  
Civic Learning ◽  
Randomized Controlled ◽  
10Th Grade ◽  
The Impact

Background/Context Billions of dollars are spent annually on professional development (PD) for educators, yet few randomized controlled trials (RCT) have demonstrated the ultimate impact PD has on student learning. Further, while policymakers and others speak to the role schools should play in developing students’ civic awareness, RCTs of PD designed to foster civic learning are rare. This randomized controlled trial contributes to the knowledge base on the effectiveness of PD designed to integrate civic learning, ethical reflection, and historical thinking skills into high school humanities courses. Focus of Study The study examined the impact of a PD intervention in two areas: (a) teacher self-efficacy, burnout, and professional engagement and satisfaction; and (b) the academic, civic, social, and ethical competencies of 9th and 10th grade students in the teachers’ classes. Population/Participants/Subjects The study involved 113 teachers and 1,371 9th and 10th grade students in 60 high schools from eight metropolitan regions in the United States. Intervention/Program/Practice The intervention, Facing History and Ourselves, provides PD through a five-day seminar, curricular materials, and follow-up coaching and workshops to help teachers develop their capacities to implement an interdisciplinary historical case study unit using student-centered pedagogy. Research Design The study used a school-level, randomized, experimental design to investigate impacts of the intervention for teachers and their 9th and 10th grade students. Findings/Results Intervention teachers showed significantly greater self-efficacy in all eight assessed domains, more positive perceptions of professional support, satisfaction and growth, and greater personal accomplishment. Intervention students demonstrated stronger skills for analyzing evidence, agency, and cause and effect on a historical understanding performance measure; greater self-reported civic efficacy and tolerance for others with different views; and more positive perceptions of the classroom climate and the opportunities afforded for engaging with civic matters. Fidelity analysis found these causal effects despite the fact that roughly half of the intervention teachers did not fully implement the program. Conclusions/Recommendations Educators need evidence-based approaches for teaching complex social, civic, and political issues enabling students of diverse mindsets and backgrounds to engage constructively with one another while obtaining necessary skills and knowledge. These findings provide empirical support for a professional development approach that engages teachers in fostering academic and civic competencies critical to both participation in a democracy and success in college and career.

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.

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