scholarly journals The efficacy of two web-based and theory-based interventions with and without brief motivational interviewing over the phone in promoting Human Papillomavirus (HPV) vaccination among Chinese men who have sex with men: a randomized controlled trial (Preprint)

10.2196/21465 ◽  
2020 ◽  
Author(s):  
Zixin Wang ◽  
Joseph T.F. Lau ◽  
Tsun Kwan Mary Ip ◽  
Yebo Yu ◽  
Francois Fong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Human Papillomavirus ◽  
Motivational Interviewing ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Web Based ◽  
Chinese Men ◽  
Randomized Controlled ◽  
Sex With Men

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).

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

Effect of a cervical cancer survivor story on willingness and behavioral change for Human Papillomavirus Vaccination: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Yukio Suzuki ◽  
Akiko Sukegawa ◽  
Yutaka Ueda ◽  
Masayuki Sekine ◽  
Takayuki Enomoto ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Randomized Controlled Trial ◽  
Human Papillomavirus ◽  
Cancer Survivor ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Cervical Cancer Survivor

BACKGROUND Providing adequate information to parents who have children eligible for human papillomavirus (HPV) vaccination is essential to overcoming vaccine hesitancy in Japan, where the government recommendation has been suspended. However, prior trials assessing the effect of brief educational tools showed only limited effects on increasing the willingness of parents to vaccinate their daughters. OBJECTIVE The aim of this trial was to assess the effect of a cervical cancer survivor story on the willingness of parents to get HPV vaccination for their daughters. METHODS In this double-blinded, randomized controlled trial implemented online, we enrolled 2175 participants aged 30–59 years in March 2020 via a webpage and provided them with a questionnaire related to the following aspects: awareness regarding HPV infection and HPV vaccination, and willingness for HPV vaccination. Participants were randomly assigned (1:1) to see a short film of cervical cancer survivor story or nothing, stratified by sex (male vs. female) and willingness to HPV vaccination prior to randomization (Yes vs. No). The primary endpoint was the rate of parents who agreed to HPV vaccination for their daughters. The secondary endpoint was the rate of parents who agreed to HPV vaccination for their daughters and the HPV vaccination rate at 3 months. RESULTS Among 2175 participants, 1266 (58.2%) were men and 909 (41.8%) were women. A total of 191 (8.8%) participants were willing to consider HPV vaccination prior to randomization. Only 339 (15.6%) participants were aware of the benefits of HPV vaccination. In contrast, 562 (25.8%) patients were aware of the adverse events of HPV vaccination. Although only 476 (21.9%) of the respondents displayed a willingness to vaccinate their daughters for HPV, there were 7.5% more respondents in the intervention group with this willingness immediately after watching the short movie (odds ratio [OR] 1.55, 95% CI 1.27-1.91). In a sub-analysis, the willingness to vaccinate daughters for HPV was 10.9% higher in males in the intervention group (OR 1.75, 95% CI 1.36-2.25); however, such a difference was not observed among females (OR 1.25, 95% CI 0.86-1.81). Male participants were more likely to have willingness for HPV vaccination compared to female participants. In the follow-up survey at 3 months, 1807 (83.1%) participants responded. Of these, 149 (8.2%) responded that they had had their daughters receive vaccination during the 3 months, even though we could not see the effect of the intervention; 77 (7.9%) in the intervention group and 72 (8.7%) in the control group. CONCLUSIONS A cervical cancer survivor story increases immediate willingness to consider HPV vaccination, but the effect does not last for 3 months. Furthermore, this narrative approach to parents did not increase vaccination rates in children eligible for HPV vaccination. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000039273; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043714.

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