scholarly journals A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/16294 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e16294 ◽  
Author(s):  
Paul L Reiter ◽  
Amy L Gower ◽  
Dale E Kiss ◽  
Molly A Malone ◽  
Mira L Katz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hpv Vaccine ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Text Messages ◽  
Web Based ◽  
Randomized Controlled ◽  
Sex With Men ◽  
The Web

Background Gay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. Although the HPV vaccine is currently recommended for young adults, HPV vaccine coverage is modest among young gay, bisexual, and other men who have sex with men (YGBMSM). Objective We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually tailored, Web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (ie, mediation), and whether efficacy varies by participant characteristics (ie, moderation). Methods Outsmart HPV was previously developed and pilot-tested. This study is a 3-arm prospective RCT that will enroll a projected 1995 YGBMSM who are aged 18 to 25 years, live in the United States, and have not received any doses of the HPV vaccine. Participants will be recruited by means of paid advertisements on social media sites and randomized to receive (1) standard information on the Web about HPV vaccine (control group), (2) Outsmart HPV content on the Web with monthly unidirectional vaccination reminders sent via text messages, or (3) Outsmart HPV content on the Web with monthly interactive vaccination reminders sent via text messages. Participants will complete Web-based surveys at 4 time points during the study: baseline, immediately after engaging with Web-based content, 3 months after randomization, and 9 months after randomization. Primary outcomes will include both HPV vaccine initiation (ie, receipt of 1 or more doses of the HPV vaccine) and completion (receipt of all 3 doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators and demographic and health-related characteristics as potential moderators of intervention effects. Results The institutional review board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT began in fall 2019. Conclusions If shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. Trial Registration ClinicalTrials.gov NCT04032106; http://clinicaltrials.gov/show/NCT04032106 International Registered Report Identifier (IRRID) PRR1-10.2196/16294

scholarly journals Protocol for a Randomized Controlled Trial of a Web-Based HPV Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex with Men (Preprint)

2019 ◽  
Author(s):  
Paul L. Reiter ◽  
Amy L. Gower ◽  
Dale E. Kiss ◽  
Molly A. Malone ◽  
Mira L. Katz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hpv Vaccine ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Text Message ◽  
The United States ◽  
Hpv Infection ◽  
Web Based ◽  
Randomized Controlled ◽  
Sex With Men

BACKGROUND Gay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. HPV vaccine is currently recommended for young adults, yet HPV vaccine coverage is low among young gay, bisexual, and other men who have sex with men (YGBMSM). OBJECTIVE We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually-tailored web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (i.e., mediation), and whether efficacy varies by participant characteristics (i.e., moderation). METHODS Outsmart HPV was previously developed and pilot-tested. The current study is a three-arm prospective RCT that will enroll a projected 1995 YGBMSM who are ages 18-25, live in the United States, and have not received any doses of HPV vaccine. Participants will be recruited via paid advertisements on social media sites and randomized to receive either: (a) standard information online about HPV vaccine (control group); (b) Outsmart HPV content online with monthly unidirectional vaccination reminders sent via text message; or (c) Outsmart HPV content online with monthly interactive vaccination reminders sent via text message. Participants will complete online surveys at four time points during the study: baseline; immediately after engaging with online content; three months after randomization; and nine months after randomization. Primary outcomes will include both HPV vaccine initiation (i.e., receipt of one or more doses of HPV vaccine) and completion (receipt of all three doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators, and we will examine demographic and health-related characteristics as potential moderators of intervention effects. RESULTS The Institutional Review Board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT is scheduled to begin in Fall 2019. CONCLUSIONS If shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. CLINICALTRIAL The trial is registered at ClinicalTrials.gov: NCT04032106 (available at: https://clinicaltrials.gov/ct2/show/NCT04032106).

Physicians’ Choice in Using Internet and Fax for Patient Recruitment and Follow-up in a Randomized Controlled Trial

2004 ◽  
Vol 43 (03) ◽  
pp. 268-272 ◽  
Author(s):  
S. Morita ◽  
T. Fukui ◽  
J. Sakamoto ◽  
M. Rahman
Keyword(s):  
Randomized Controlled Trial ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Data Entry ◽  
Regression Analyses ◽  
Multivariate Logistic Regression ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web

Summary Objective: To examine the physicians’ preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. Methods: We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians’ choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. Results: A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. Conclusions: This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

scholarly journals Online HIV prevention intervention on condomless sex among men who have sex with men: a web-based randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Weibin Cheng ◽  
Huifang Xu ◽  
Weiming Tang ◽  
Fei Zhong ◽  
Gang Meng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Web Based ◽  
Prevention Intervention ◽  
Hiv Prevention Intervention ◽  
Condomless Sex ◽  
Randomized Controlled ◽  
Sex With Men

scholarly journals Traditional and Web-Based Technologies to Improve Partner Notification Following Syphilis Diagnosis Among Men Who Have Sex With Men in Lima, Peru: Pilot Randomized Controlled Trial

2018 ◽  
Vol 20 (7) ◽  
pp. e232 ◽  
Author(s):  
Jesse L Clark ◽  
Eddy R Segura ◽  
Catherine E Oldenburg ◽  
Hector J Salvatierra ◽  
Jessica Rios ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Partner Notification ◽  
Web Based ◽  
Randomized Controlled ◽  
Sex With Men ◽  
Pilot Randomized Controlled Trial

scholarly journals Go Play Outside! A web-based and in-person risk reframing intervention to influence mothers’ tolerance for, and parenting practices associated with, children’s outdoor risky play: Results of a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Mariana Brussoni ◽  
Christina S Han ◽  
Yingyi Lin ◽  
John Jacob ◽  
Ian Pike ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognitive Theory ◽  
Social Cognitive ◽  
Cognitive Theory ◽  
Controlled Trial ◽  
Post Intervention ◽  
Web Based ◽  
Randomized Controlled ◽  
Risky Play ◽  
The Web

BACKGROUND Outdoor risky play, such as climbing, racing and independent exploration, is an important part of childhood and is associated with various positive physical, mental and developmental outcomes for children. Parental attitudes and fears, particularly mothers’, are a major deterrent to children’s opportunities for outdoor risky play. OBJECTIVE To evaluate the efficacy of two versions of an intervention to reframe mothers’ perceptions of risk and change parenting behaviours: web-based intervention or an in-person workshop, compared to the control condition. METHODS The Go Play Outside! randomized controlled trial was conducted in Canada in 2017 to 2018. Participants were recruited through social media, snowball sampling, and community notices. Mothers of children aged 6-12 years were self-assessed through eligibility questions, and those eligible and consented to participate in the study were randomized into a fully automated web-based intervention, the in-person workshop or the control condition. The intervention was underpinned by social cognitive theory, incorporating behaviour change techniques. Participants progressed through a series of self-reflection exercises and developed a goal for change. Control participants received the Position Statement on Active Outdoor Play. The primary outcome was increase in tolerance of risky play and the secondary outcome was goal attainment. Data were collected online via REDCap at baseline, 1-week and 3-months post-intervention. Randomization was conducted using sealedenvelope.com. Allocations were concealed to researchers at assignment and data analysis. We conducted mediation analyses to examine whether the intervention influenced elements of social cognitive theory, as hypothesized. RESULTS A total of 451 mothers were randomized and completed baseline socio-demographic assessments: 150 in the web-based intervention, 153 in the in-person workshop, and 148 in the control condition; of which a total of 351 mothers completed the intervention. At 1-week post-intervention, 121, 85, and 135 mothers completed assessments for each condition, respectively, and at 3-months post-intervention, 105, 84 and 123 completed the assessments, respectively. Compared to mothers in the control condition, mothers in the web-based intervention had significantly higher tolerance of risky play at 1-week, and 3-months post-intervention; and mothers in the in-person workshop had significantly higher tolerance of risky play at 1-week post-intervention. No other significant outcomes were found. None of the potential mediators were found to significantly mediate the outcomes. CONCLUSIONS The trial demonstrates that the web-based intervention was effective in increasing mothers’ tolerance for risk in play. CLINICALTRIAL ClinicalTrials.gov, NCT03374683. Retrospectively registered on December 15, 2017. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-2552-4

Evaluation of the efficiency of the web-based epilepsy education program (WEEP) for youth with epilepsy and parents: A randomized controlled trial

2020 ◽  
Vol 111 ◽  
pp. 107142
Author(s):  
Şerife Tutar Güven ◽  
Ayşegül İşler Dalgiç ◽  
Özgür Duman
Keyword(s):  
Randomized Controlled Trial ◽  
Education Program ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web ◽  
Epilepsy Education

Next Generation of Self-Management Education: Web-based Bipolar Disorder Program

2007 ◽  
Vol 41 (11) ◽  
pp. 903-909 ◽  
Author(s):  
Judith Proudfoot ◽  
Gordon Parker ◽  
Matthew Hyett ◽  
Vijaya Manicavasagar ◽  
Meg Smith ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Randomized Controlled Trial ◽  
Education Program ◽  
Health Professionals ◽  
Controlled Trial ◽  
Management Training ◽  
Self Management ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web

Objective: Education and self-management training assist patients with bipolar disorder to take control of their condition and to reduce disability, but the timeliness and availability of the education are important. A free Web-based bipolar education program has been recently developed to provide accessible evidence-based information for patients, carers and health professionals. The present paper describes the nine-module program, reports usage data and user profiles, and overviews the aims and methodology of a randomized controlled trial to measure its impact. Methods: Customized Web reports were developed to measure usage of the Web-based program, and to profile its users on a month-by-month basis. Data on the percentage of completers of each module were also collected. A randomized controlled trial evaluating the program in people with newly diagnosed bipolar disorder was also commenced. Results: More than 8000 visitors used the online program in its first 6 months. Users were predominantly female, of a broad cross-section of ages, 43.5% with bipolar disorder, and with the remainder describing themselves as health professionals, carers/family/friends of a person with bipolar disorder or members of the general public. The majority (76%) completed the sessions they commenced. Conclusions: The Web-based education program is attracting a steady stream of users and is exhibiting good completion rates. This preliminary support for the program's utility requires validation from our randomized controlled trial before definite conclusions can be drawn.

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