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 ◽  
...  

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

2021 ◽  
Author(s):  
Ruanne Barnabas ◽  
Elizabeth Brown ◽  
Maricianah Onono ◽  
Elizabeth A. Bukusi ◽  
Betty W. Njoroge ◽  
...  

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 limits 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: NCT03675256


2019 ◽  
Author(s):  
Paul L. Reiter ◽  
Amy L. Gower ◽  
Dale E. Kiss ◽  
Molly A. Malone ◽  
Mira L. Katz ◽  
...  

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).


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 ◽  
...  

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


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Mingyu Si ◽  
Xiaoyou Su ◽  
Yu Jiang ◽  
Youlin Qiao ◽  
Yuanli Liu

Abstract Background While the HPV vaccines have been approved by the US FDA since 2006, in recent years an increasing number of women are living with cervical cancer globally. Among them, Chinese women have a higher cervical cancer incidence and mortality rate than the global average, with mortality rates being almost twice the global average. However, the current approach of HPV vaccination in China is not satisfactory given the high disease burden of cervical cancer. The current study is a randomized controlled trial designed to identify the barriers and facilitators of HPV vaccination among Chinese female students. This study will also test a health intervention measure via a popular form of new media in order to improve the HPV vaccine uptake under the framework of Information-Motivation-Behavioral skill Model (IMB). Methods This investigation is a multicenter, school-based, prospective, randomized, parallel group, double-blind, blank-controlled trial involving a 7-day education intervention with a further 6-month follow-up. We will enroll at least 3360 participants older than 18 years. The enrolled participants will be randomly divided into two groups (1:1 ratio). The intervention group will be offered a 7-day mobile health education, and participants in both groups will fill out 4 questionnaires at the baseline, 1 month, 3 months and 6 months after the intervention. The primary outcome is the difference in HPV vaccination or reservation for the HPV vaccine between the intervention and control groups. Secondary outcomes will include the comparison of (1) knowledge, attitudes, motivation, beliefs and behavioral skill about HPV and cervical cancer prevention, and (2) the willingness to uptake HPV vaccination. Discussion This study will examine the theory-based intervention in improving HPV vaccination among Chinese female college students. We will conduct the randomized controlled trial to provide scientific evidence on the potential effect of the IMB theory-based intervention. Findings from this study will contribute to a growing research field which assesses the effectiveness of mobile-based, school-targeted and theoretically guided interventions for promoting HPV vaccination in adolescents. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900025476; Registered on 27 August 2019.


2021 ◽  
Author(s):  
Ruanne V. Barnabas ◽  
Elizabeth R. Brown ◽  
Maricianah A. Onono ◽  
Elizabeth A. Bukusi ◽  
Betty Njoroge ◽  
...  

Abstract Background: Single-dose HPV vaccination, if efficacious, would be tremendously advantageous; simplifying implementation and decreasing costs.Methods: We performed a randomized, multi-center, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) or bivalent (HPV 16/18) HPV vaccination compared to meningococcal vaccination among Kenyan women aged 15-20 years. Enrollment and six monthly cervical swabs and a month three vaginal swab were tested for HPV DNA. Enrollment sera were tested for HPV antibodies. The modified intent-to-treat (mITT) cohort comprised participants who tested HPV antibody negative at enrollment and HPV DNA negative at enrollment and month three. The primary outcome was incident persistent vaccine-type HPV infection by month 18.Results: Between December 2018 and June 2021, 2,275 women were randomly assigned and followed; 758 received the nonavalent HPV vaccine, 760 the bivalent HPV vaccine, and 757 the meningococcal vaccine; retention was 98%. Thirty eight incident persistent infections were detected in the HPV 16/18 mITT cohort: one each among participants assigned to the bivalent and nonavalent groups and 36 among those assigned to the meningococcal group; nonavalent Vaccine Efficacy (VE) was 97.5% (95%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, p=<0.0001). Thirty-three incident persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: four in the nonavalent group and 29 in the meningococcal group; nonavalent VE for HPV 16/18/31/33/45/52/58 was 88.9% (95%CI 68.5-96.1%, p<0.0001). The rate of SAEs was 4.5-5.2% by group.Conclusions: Single-dose bivalent and nonavalent HPV vaccines were each highly effective in preventing incident persistent oncogenic HPV infection, similar to multidose regimens.


2021 ◽  
Author(s):  
Yukio Suzuki ◽  
Akiko Sukegawa ◽  
Yutaka Ueda ◽  
Masayuki Sekine ◽  
Takayuki Enomoto ◽  
...  

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.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039383
Author(s):  
Aaron MacCosham ◽  
Mariam El-Zein ◽  
Ann N Burchell ◽  
Pierre-Paul Tellier ◽  
François Coutlée ◽  
...  

IntroductionHuman papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.Methods and analysisThe TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention–intervention, intervention–placebo, placebo–intervention and the placebo–placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.Ethics and disseminationThe TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l’Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.Trial registration numberNCT01824537.


Author(s):  
Radhika M. ◽  
Sadiqunissa Sadiqunissa ◽  
Mehfooza Ahmed

Background: Cervical cancer is the most common malignancy amongst women in India. Identification and prevention of the pre-cancerous lesions helps to reduce the incidence of Carcinoma of cervix. The main aim of the study is to know the awareness and knowledge of HPV vaccine in prevention of cervical cancer among medical students.Methods: The study included 97 medical students (final year) studying in Yenepoya Medical College, Mangalore. It is a cross-sectional questionnaire-based study.Results: The results of awareness and knowledge about the HPV vaccine are interpreted in percentage. In this study, 76% of study subjects were aware that cancer cervix is preventable, 80% of the study subjects were aware about the association between the causation of cancer cervix by HPV. Majority of the study subjects about 72% ware about the vaccines for HPV but, awareness about the cost and efficacy of the vaccine was low only about 30% and 10% respectively. However, importantly students had a positive attitude to educate people regarding HPV vaccination and also to clear myths and misconceptions.Conclusions: Medical students should be educated regarding HPV infection, risk factors for causation of cervical cancer, screening methods which are available, HPV vaccines available in India and also about the efficacy and to motivate the society to have a positive attitude towards HPV vaccination by clearing the misconceptions regarding its information.


Author(s):  
Suchith Hoblidar ◽  
Suma S. Moni ◽  
Rathnamala M. Desai ◽  
Asha Neravi

Background: Cervical cancer is the second leading cause of death in india. it is also one of the few malignancies where an infectious etiological agent human papilloma virus (HPV) has been identified. With the advent of HPV vaccination, it is possible to reduce the morbidity and mortality associated with carcinoma cervix. But biggest hurdle to achieve this is the lack of awareness about the availability and use of HPV vaccine. This study was conducted to know knowledge and awareness of HPV infection and vaccination among medical and paramedical students. We also evaluated the acceptability and coverage of HPV vaccine among these students.Methods: This study was conducted among a total of 520 female students of the Sri Dharmasthala Manjunatheshwara University with the help of a questionnaire. The study group included 207 MBBS students, 167 BDS students, 89 nursing students and 57 physiotherapy students.Results: Most of the students were in 18-20 years’ age group. Nearly 40.57% of the students knew that HPV is sexually transmitted and 29.80% were aware that this infection can be prevented. Availability of HPV vaccine was known to 75% of the students and the main source of their information was through their college teachings. Nearly 43.75% of the students knew HPV vaccine protects against cervical cancer and 26.73% of the students were vaccinated. Overall knowledge and awareness were better among medical students.Conclusions: A lot of work needs to be done so as to make the target population accept HPV vaccine. There is a great difference between awareness of availability of the vaccine and its use. This emphasizes the need for health care professionals to take special interest in promoting this vaccine in the general population.


2006 ◽  
Vol 4 (3) ◽  
pp. 177-186 ◽  
Author(s):  
John Moraros ◽  
Yelena Bird ◽  
David D. Barney ◽  
Sasha C. King ◽  
Matthew Banegas ◽  
...  

The human papillomavirus (HPV) is one of the most common sexually transmitted infections (STI) in the world and it is associated with cervical cancer. The development of a prophylactic HPV vaccine has proven effective in clinical trials and it is now available to the public. The HPV vaccine represents a viable prevention strategy against cervical cancer. However, parental preferences, perceptions, and willingness to use the HPV vaccine are crucial, and if not assessed accurately, may threaten the successful implementation of a broad HPV vaccination program. This pilot study explored the views of 60 adult, Mexican women, all of who were mothers of female children between the ages of ten to 14 years old on the following four areas of interest: HPV knowledge; HPV vaccine knowledge and attitudes; barriers to HPV vaccine use; and potential uses and side effects of the HPV vaccine. Only 7% of respondents knew that HPV was a virus or STI. Eighty-six percent had not heard of the HPV vaccine, but 62% felt that the HPV vaccine would prevent HPV infection. However, 38% said the church would not approve of the HPV vaccine use for 10-14-year-old girls. Twenty-seven percent thought that promiscuous behavior would increase following HPV vaccination. Overall, respondents had very little knowledge of the HPV vaccine, were willing to be vaccinated themselves (83%), but were lesser willing to vaccinate their daughters (63%). Ultimately, understanding the beliefs about and identifying the barriers of HPV vaccine use will influence the effectiveness of the vaccine and its potential impact in reducing cervical cancer incidence rates worldwide.


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