記住我
Cervical cancer, a serious infectious disease mostly caused by high-risk human papillomavirus (HPV) types, is the fourth most common reason worldwide for tumor-related hospital admission in women [,]. In 2018, in China, cervical cancer resulted in 48,000 deaths and 106,000 cases []. Previous studies found that young women were at higher risk of HPV infection, and showed elevated HPV infection problems owing to their age and the sexually transmitted nature of the virus [-]. Female college students, most of whom were ready for sexual debut and had relatively low awareness of disease prevention, similarly demonstrated HPV infection problems right after starting college [,].
At the end of 2020, China initiated a program for cancer prevention jointly issued by 10 ministries, including the National Health Commission, and joined in the action of the “global strategy to accelerate the elimination of cervical cancer” advocated by the World Health Organization [-]. Since the approval of preventive HPV vaccines in mainland China in 2016, the HPV vaccination rate has remained poor, highlighting the importance of understanding the reasons for vaccination refusal and the ways to promote HPV vaccination among young populations [,].
Improving the HPV vaccination rate and vaccination willingness is the most salient way to eliminate cervical cancer [,]. Most published studies on the willingness to undergo HPV vaccination among Chinese college students were conducted before the availability of HPV vaccines in China [-]. Information about the actual rate of HPV vaccination and willingness to undergo HPV vaccination after the approval of HPV vaccines is scarce. Interventions guided by health behavioral theories were widely applied in previous studies [-]. A review conducted in 2018 identified 70 scientific articles providing supportive evidence that education guided by health behavioral theories was effective in promoting HPV vaccination []. However, only a few interventions on the perceptions of HPV vaccination have been published in China, and they involved limited sample sizes and did not involve health behavioral theories [-].
Currently, in China, there is a free HPV vaccination program in pilot regions among school girls less than 14 years old [], but there are no effective strategies to improve HPV vaccine coverage among female college students who are at higher risk of HPV infection and have been suggested to be a “catch-up” population for HPV vaccination in many other countries. The information-motivation-behavioral skills (IMB) model is one of the commonly used theories on health promotion. To our knowledge, no previous study has been performed to evaluate IMB model–based online education for HPV vaccination among female college students from different regions in mainland China, with a follow-up duration of 3 months.
ObjectivesThis study has the following 3 objectives: (1) to evaluate the feasibility and acceptability of the IMB model–based online intervention; (2) to examine whether and how this intervention improves HPV vaccination; and (3) to identify the barriers and facilitators of HPV vaccination among female college students in mainland China.
The protocol for this study was published before the interventions were carried out []. Briefly, this study was a multicenter 2-arm cluster randomized trial. First-year female college students from 7 universities from different geographical locations in mainland China were recruited and randomly assigned 1:1 to either an IMB model–based intervention group or a waitlist control group based on their class. The intervention group received online education to promote the willingness to undergo HPV vaccination for 7 consecutive days, which was guided by the IMB model and conducted on a communication platform called DingTalk (Alibaba Group). The intervention group was compared with the waitlist control group in terms of the perceptions of HPV vaccination and willingness to undergo HPV vaccination. Recruitment of the study participants began in February 2020, and data collection was completed in July 2020. The whole process of participant recruitment, data collection, and intervention was conducted online, which coincided with the outbreak of COVID-19 in China, when Chinese college students were all self-isolated at home. The CHERRIES (Checklist for Reporting Results of Internet E-Surveys) checklist was used to guide the reporting of our web-based survey []. The CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist is presented in [].
Recruitment and EligibilityParticipating students were recruited through notices on campus or advertisements in social media groups, posted in advance by partner teachers. Interested participants scanned the QR code on the notices or advertisements to fill in their class name and provide informed consent regarding the research objectives, requirements, procedures, benefits, and other study-related information. Potential participants were assessed for eligibility before the baseline survey. The eligibility criteria for the study were as follows: (1) female sex; (2) age ≥18 years; (3) first-year college student; (4) no vaccination contraindications; and (5) accessibility to computers or smartphones. Enrolled participants were given a link to either the intervention group or the control group that had already been set up in advance in DingTalk.
Randomization and BlindingIn order to facilitate the management of participants and reduce loss of follow-up, enrolled participants were randomly assigned by class to the intervention and control groups. The investigator in each college, who was blinded to the identity of the participants, used computer software (Excel program, Microsoft Corp) to generate a series of random numbers for both the first-year Arts and Science major classes. Eligible participants were identified as either the intervention group or the control group based on the class name they entered when they scanned the QR code on the recruiting information. Participants, data analysts, and investigators were all blinded to the randomized allocation, and only the research assistants in each center were aware of the allocation.
IMB Model–Based InterventionTheoretical FrameworkThe theoretical framework used to guide this online intervention was the IMB model []. This theory assumes that a person with rich knowledge will have the intention to practice healthy behaviors when he/she has motivation, the ability/skills to complete healthy behaviors, and self-efficacy, and the intention will be easily transformed into actual practice when objective conditions permit [,]. Therefore, we developed 2-day materials to popularize HPV knowledge, 2-day materials on situational stories to motivate participants to vaccinate themselves against HPV, and 3-day materials on objective skills with self-decision making, self-efficacy, and objective conditions for making an appointment and receiving the HPV vaccine. The above intervention materials were designed as online readable texts or videos that could be easily accessed by the target population.
Intervention MaterialsThe intervention materials were developed by the research team based on the IMB model, and were uploaded and shared via the DingTalk platform by research assistants at each center. Upon randomization, the intervention group accessed the materials by scanning the QR code on each of the cover pages of the educational materials. During the daily intervention, we included quizzes on each day’s topics to check and consolidate the knowledge gained by the participants. It took about 10-15 minutes for the participants to read and learn the materials, depending on their learning ability. The forms, contents, and corresponding purposes of the IMB model–based education in this intervention are presented in .
Table 1. Cover pages, contents, and purposes of the information-motivation-behavioral skills model–based 7-day education.Serial numberCover pageContentExamples of the quizzesPurpose1
General facts about HPVa, including HPV infection and related diseases. For example, there are more than a hundred different types of HPV, some of which are high risk and linked to the development of cancers, including cervical cancers.1. What is the transmission route of HPV?
Frequently asked questions and answers about HPV vaccine. For example, how does the HPV vaccine work? What are the recommended ages and populations for vaccination?1. True or false:
A story of a female movie star who died of cervical cancer. Then, a case of a woman who missed HPV vaccination and cervical cancer screening, reached the terminal stage of cancer right after being found symptomatic, and died after painful treatment. Finally, the relevant facts about the screening, treatment, and prognosis of cervical cancer.1. True or false: Persistent HPV infection may cause cervical cancer.
Risk factors and early symptoms of cervical cancer, and ways to prevent and control cervical cancer.1. Regarding the high-risk factors of cervical cancer, which of the following is wrong?
The concept and practice of decision-making and effective communication.1. Application information: Please select the views that support HPV vaccination (multiple choices)
The concept and function of self-efficacy, evaluation of self-efficacy, and ways to improve self-efficacy.What are the ways to improve self-efficacy (multiple choices)?
Provide participants with the objective skills needed for HPV vaccination in the form of invitation letters designed with HTML5 front-end technology, such as appointment platform, price, vaccination venue, etc.The last page is linked to the online questionnaire after the intervention.To provide detailed objective information required for HPV vaccination, making HPV vaccination more accessible and convenient.aHPV: human papillomavirus.
Waitlist Control GroupThe study was carried out when COVID-19 broke out worldwide at the beginning of 2020. In order to increase the compliance of the control group and reduce the probability of compromising the blind nature of the study, the control group was given 7 days of information on COVID-19 prevention, which was organized and presented in the same format and platform as the educational materials in the intervention group. At the end of the study, the waitlist control group received the same educational materials as the intervention group.
Outcomes and MeasurementsThe internet-based questionnaire surveys were administered at 4 time points (baseline, immediately after the intervention, and 1 month and 3 months after the intervention), and participants were given notebooks and pens with the logo of the research institution as incentives.
Background characteristics, including age, major in college, ethnicity, residence, parental residence, education and marital status, monthly living expenses (RMB), family/friends with any cancer, ever received sexual education, currently in a romantic relationship, sexual debut, and attitude toward premarital sex, were measured in this study. These variables are necessary information, basic information, or information related to HPV vaccination as shown in previous literature [].
The primary outcome measures were self-reported willingness to undergo HPV vaccination and uptake of HPV vaccination. At baseline and each follow-up, the participants were asked “Are you willing to get the HPV vaccine in the future?” and “Have you been vaccinated against HPV?” with “Yes” and “No” response options. It should be noted that there were some differences in the way we asked questions regarding the willingness to undergo HPV vaccination. The 3-month questioning time frame was in the “future,” while the baseline and other 2 follow-up questioning time frames were “within the study period.” The differences in outcomes are detailed in the Results section.
The secondary outcome measures were the information/knowledge, motivation, and behavioral skills regarding HPV vaccination, which were designed based on the IMB model. Among them, the information part consisted of 11 questions. For example, “HPV is related to the development of cervical cancer,” with answer options “Agree,” “Disagree,” and “Do not know” (Cronbach α=.78) [-]. Motivation for vaccination was measured by 19 questions. For example, “Getting vaccinated for HPV will help protect me from HPV infection” (Cronbach α=.71) [,-]. Behavioral skills were measured by 10 questions. For example, “I feel confident in my ability to get vaccinated for HPV, even if it is expensive” (Cronbach α=.88) [,]. The answers for these items were measured on a 5-point Likert scale (1=strongly disagree, 2=disagree, 3=neither disagree nor agree, 4=agree, and 5=strongly agree). A description of the baseline results for this study has been published [].
In the 3rd month after the intervention, the participants were asked about their perceptions of the barriers and facilitators of HPV vaccination, such as the reasons for not receiving the HPV vaccine; choices of the HPV vaccine; opinions on promoting HPV vaccination in China; and willingness to receive the HPV vaccine under different scenarios.
Ethics ApprovalThis study was approved by the Institutional Review Board of the Chinese Center for Disease Control and Prevention on October 24, 2019 (approval number: 201918-01).
Statistical AnalysisIBM SPSS Statistics 23.0 (IBM Corp) was used to process the data and conduct statistical comparisons between the intervention and control groups. Independent t tests and chi-square tests were used to compare the distributions of the continuous and categorical variables, respectively. Analyses were conducted based on an intention-to-treat approach, and statistical significance was set at P<.05 (2-sided). The effects of the IMB model–based intervention on knowledge, motivation, behavioral skills, and willingness regarding HPV vaccination were examined using generalized estimating equations (GEEs). We included significant variables in baseline chi-square analysis, and assessed group (intervention and control), time (baseline, immediately after the intervention, and 1 month and 3 months after the intervention), and time × group interaction, with the time × group interaction indicating a differential change by group from baseline to the end of the trial.
The flowchart for participant recruitment is presented in . From February 2020 to March 2020, a total of 4051 female college students were recruited and screened, among whom 83 refused to participate in the study, 101 did not meet the inclusion criteria, and 102 reported that they had been vaccinated with the HPV vaccine prior to the study. Among the participants who met the inclusion criteria, the HPV vaccination rate was 2.6% (102/3867). A total of 3765 participants signed the informed consent and completed the baseline questionnaire (T-baseline). However, 26 participants were not grouped and withdrew from the study. There were eventually 1936 participants in the intervention group and 1803 participants in the control group. A total of 3224 (86.2%) participants completed the postintervention questionnaire (T-postintervention). In the intervention group, 1662 participants completed the IMB model–based intervention, and 1562 participants in the control group received non-HPV–related content in the same period. In addition, a total of 3215 (86.0%) participants (1670 in the intervention group and 1545 in the control group) completed the follow-up assessment 1 month after the intervention (T-1 month). Finally, a total of 3071 (82.1%) participants completed the 3-month follow-up evaluation (T-3 months), including 1582 and 1489 participants in the intervention and control groups, respectively. The proportions of participants in the intervention group and control group who completed the T-postintervention assessment were 85.9% (1662/1936) and 86.6% (1562/1803), respectively, and the difference was not statistically significant (P=.49). The completion rates of the T-1 month assessment in the intervention and control groups were 86.2% (1670/1936) and 86.6% (1562/1803), respectively, and the difference was not statistically significant (P=.62). The completion rates of the T-3 months assessment in the intervention and control groups were 81.7% (1582/1936) and 82.6% (1489/1803), respectively, with no statistically significant difference (P=.49).
Figure 1. The study flowchart. View this figureParticipant CharacteristicsThe participants with at least one follow-up record were included in our analysis. A total of 3484 respondents were identified, and the mean age was 19.12 (SD 0.73) years. Over half of the respondents (1848/3484, 53.0%) were majoring in Arts in college, and 87.7% (3057/3484) were Han Chinese. Most of the respondents (2207/3484, 63.4%) and their parents (2189/3484, 62.8%) lived in urban areas during the study period. Regarding the educational background of the parents, less than half (1591/3484, 45.7%) of them had a junior high school or lower education, and only 24.6% (856/3484) of the parents had a college degree or above. Most of the respondents’ parents (2819/3484, 80.9%) were married at the time of the research, while 6.9% (239/3484) were divorced, 9.8% (340/3484) were unmarried cohabiting, and 2.5% (86/3484) were widowed. Overall, 71.3% (2483/3484) had monthly living expenses ranging from 1000 to 2000 yuan (US$ 144.35 to 288.71), and about a third (842/3484, 24.2%) of all respondents had relatives or friends with cancer. Moreover, 79.2% (2758/3484) of the respondents self-reported having ever received sexual education, while 16.9% (590/3484) were currently in a romantic relationship. Only 2.8% (97/3484) had sexual debut, while 37.6% (1310/3484) said they could accept premarital sex. As shown in , both groups were comparable in terms of their sociodemographic characteristics, except previous sexual intercourse, for which there were more participants in the intervention group than in the control group.
Table 2. Baseline characteristics of the participants.VariableAll (N=3484)Intervention groupaAnalysis for t test.
bA currency exchange rate of 1 RMB=US $0.14435 is applicable.
cSignificant P<.05.
Evaluation of the InterventionBaseline differences were discovered for previous sexual intercourse alone, and as such, all subsequent analyses were adjusted for previous sexual experience ().
Table 3. Generalized estimating equation model of willingness and the 3 dimensions of the information-motivation-behavioral skills model regarding human papillomavirus vaccination between the intervention and control groups.VariableaWillingness to receive the HPVb vaccineInformationMotivationBehavioral skillsaThe generalized estimating equation model was adjusted with the significant variable in the chi-square analysis of baseline data, namely “sexual debut.”
bHPV: human papillomavirus.
cSignificant P<.05.
dTime points: baseline (T-baseline), immediately after the intervention (T-postintervention), 1 month after the intervention (T-1 month), and 3 months after the intervention (T-3 months).
Willingness to Receive the HPV VaccineThe GEE revealed the simple effects of time (T-3 months vs T-baseline, β=1.476; P<.001) and a significant time × group interaction for T-postintervention vs T-baseline (β=0.320; P<.001) and T-1 month vs T-baseline (β=0.183; P=.011), but no group effect (intervention group vs control group; β=0.042, P=.56). Compared with the control group, the intervention group showed a significant increase in the willingness to undergo HPV vaccination immediately and 1 month after the intervention.
HPV InformationThe GEE revealed the simple effects of time (T-postintervention, T-1 month, and T-3 months vs T-baseline; β=0.391, 0.628, and 0.762, respectively; P<.001) and a significant time × group interaction for T-postintervention, T-1 month, and T-3 months vs T-baseline (β=2.202, 1.892, and 1.688, respectively; P<.001), but no group effect (intervention group vs control group; β=0.103; P=.26). Compared with the control group, the intervention group showed a significant increase in HPV information after the intervention.
Motivation for HPV VaccinationThe GEE revealed the simple effects of time (T-postintervention, T-1 month, and T-3 months vs T-baseline; β=−0.055, −0.065, and −0.035, respectively; P<.001) and a significant time × group interaction for T-postintervention, T-1 month, and T-3 months vs T-baseline (β=0.115, 0.085, and 0.053, respectively; P<.001), but no group effect (intervention group vs control group; β=0.002; P=.84). Compared with the control group, the intervention group showed a significant increase in motivation for HPV vaccination after the intervention.
Behavioral Skills for HPV VaccinationThe GEE revealed the simple effects of time for T-postintervention vs T-baseline (β=−0.029; P=.006) and for T-1 month vs T-baseline (β=−0.043; P<.001). A significant time × group interaction was found for T-postintervention and T-1 month vs T-baseline (β=0.104 and 0.062, respectively; P<.001) and for T-3 months vs T-baseline (β=0.059; P=.003), but there was no group effect (intervention group vs control group; β=0.011; P=.52). Compared with the control group, the intervention group showed a significant increase in behavioral skills for HPV vaccination after the intervention.
Intervention Effects on the Willingness to Undergo HPV Vaccination and Practice of HPV Vaccinationshows the main effect of the intervention on the willingness to undergo HPV vaccination from baseline to follow-up. At baseline, the willingness rates to undergo HPV vaccination in the intervention and control groups were 33.33% and 31.96%, respectively, and there was no significant difference between the 2 groups (χ21=0.75; P=.39). Immediately after the intervention, the willingness rates to undergo HPV vaccination in the intervention and control groups were 40.39% and 31.56%, respectively, with statistically significant differences between the 2 groups and within the intervention group from T-baseline to T-postintervention (χ21=27.11; P<.001; and χ21=15.43; P<.001, respectively). At T-1 month, the willingness rates to receive the HPV vaccine in the intervention and control groups were 35.65% and 31.34%, respectively. At this point, the difference between the 2 groups was statistically significant (χ21=6.64; P=.01), but there was no significant difference within the intervention group from T-baseline to T-1 month (χ21=1.40; P=.24). At T-3 months, the willingness rates to undergo HPV vaccination in the intervention and control groups were 70.59% and 66.17%, respectively, with statistically significant differences between the 2 groups and within the intervention group from T-baseline to T-3 months (χ21=6.81; P=.01; and χ21=368.59; P<.001, respectively).
At different time points, the HPV vaccination rates in the intervention and control groups were as follows: T-postintervention, 0.48% and 0.19%, respectively (χ21=1.98; P=.16); T-1 month, 0.72% and 0.65%, respectively (χ21=0.06; P=.81); T-3 months, 2.21% and 1.75%, respectively (χ21=0.86; P=.36).
Table 4. Main effect of the intervention on the willingness to undergo human papillomavirus vaccination from baseline to follow-up.Variable and timeaIntervention groupχ2b (df)P valuebControl groupχ2c (df)P valuecaTime points: baseline (T-baseline), immediately after the intervention (T-postintervention), 1 month after the intervention (T-1 month), and 3 months after the intervention (T-3 months).
bComparison between baseline and different follow-up time points in the intervention group.
cComparison between the intervention and control groups at baseline and each follow-up time point.
dHPV: human papillomavirus.
eAre you willing to get the HPV vaccine in recent months?
fN/A: not applicable.
gSignificant P<.05.
hAre you willing to get the HPV vaccine in the future?
Intervention Effects on IMB Model VariablesHPV-Related InformationCompared with the control group, the participants in the intervention group demonstrated a significant improvement in knowledge scores from baseline to any posttest time point (P<.001). In addition, there were significant changes in knowledge scores from baseline to any posttest time point (P<.001) within the intervention group (A; ).
Figure 2. Trends of the mean scores of information (A), motivation (B), and behavioral skills (C) regarding human papillomavirus (HPV) vaccination in the intervention and control groups over time. View this figureTable 5.
Main effect of the intervention on the mean scores of the information-motivation-behavioral skills model constructs regarding human papillomavirus vaccination from baseline to follow-up.IMBa model constructs and timebIntervention group, mean score (SD)Mean difference within the group (95% CI)tc (df)P
留言 (0)