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

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 Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ruanne V. Barnabas ◽  
Elizabeth R. Brown ◽  
Maricianah Onono ◽  
Elizabeth A. Bukusi ◽  
Betty Njoroge ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Immune Response ◽  
Single Dose ◽  
Hpv Vaccine ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Vaccine Group ◽  
Meningococcal Vaccine ◽  
Randomized Controlled

Abstract Background HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule. Methods We are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15–20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models. Discussion This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery. Trial registration ClinicalTrials.gov NCT03675256. Registered on September 18, 2018

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 POP4Teens: Results of a randomized controlled trial to evaluate the effectiveness of a web-based program to prevent adolescent prescription opioid misuse (Preprint)

2020 ◽  
Author(s):  
Lisa A. Marsch ◽  
Sarah K. Moore ◽  
Michael Grabinski ◽  
Sarah E. Bessen ◽  
Jacob Borodovsky ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Risk ◽  
Risk Perceptions ◽  
Controlled Trial ◽  
The United States ◽  
Prescription Opioid ◽  
Dissemination And Implementation ◽  
Opioid Use ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND Prescription opioid use is not uncommon among adolescents in the United States. Despite recent declines from unprecedented peaks in adolescent prescription opioid (PO) use, there is seemingly paradoxical evidence that prescription opioid-related consequences (e.g., opioid use disorder and overdoses) are increasing. These trends and their possible consequences emphasize the importance of prevention efforts targeting PO misuse. To our knowledge, we have developed the first interactive, web-based program focused specifically on prevention of PO misuse among adolescents. OBJECTIVE Evaluate the effectiveness of a web-based program designed to prevent adolescent prescription opioid (PO) misuse, Pop4Teens (P4T) compared to an active control website, Just Think Twice (JTT) on impacting PO-related attitudes, knowledge, risk perception and intentions to use. METHODS We conducted an online, randomized controlled trial in 2018. A total of 406 adolescents (aged 12-17) were randomly assigned to P4T or JTT. The outcome variables were attitudes, knowledge, and risk perceptions associated with PO misuse, intentions to use POs, and program feedback. Data were collected at baseline, 1-, 3-, and 6-months. RESULTS Both programs produced significant and sustained improvements on intentions to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills. P4T produced significantly greater increases in PO-related knowledge compared to JTT and was reportedly easier to use and more liked. Baseline scores for youth reporting past-year medical use of POs, friends who engage in non-medical use of prescription opioids, and/or poor mental health underscored their at-risk status compared to youth who were not in those groups. CONCLUSIONS P4T positively impacted all study variables consistent with preventing PO misuse among teens. P4Ts online nature simplifies dissemination and implementation of this novel tool designed to help meet the challenges of the evolving national opioid crisis. CLINICALTRIAL ClinicalTrials.gov NCT02737696; https://clinicaltrials.gov/ct2/show/NCT02737696?term=marsch&rank=6

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

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