<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286907</url>
  </required_header>
  <id_info>
    <org_study_id>HMRF13141651</org_study_id>
    <nct_id>NCT03286907</nct_id>
  </id_info>
  <brief_title>An RCT Promoting HPV Vaccination Among Chinese MSM</brief_title>
  <official_title>A Randomized Controlled Trial Evaluating Efficacy of Promoting Human Papillomavirus (HPV) Vaccination Among Chinese Men Who Have Sex With Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives:&#xD;
&#xD;
      To evaluate efficacies of two online and theory-based interventions [HC: health communication&#xD;
      only and HC-MI health communication plus motivational interviewing (MI)] in increasing uptake&#xD;
      of three doses of HPV vaccines within the 9-month follow-up period among Hong Kong Chinese&#xD;
      men who have sex with men (MSM).&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The HPV vaccination rate of the three groups would be in the order HC-MI group &gt; HC group &gt;&#xD;
      Control group.&#xD;
&#xD;
      Design and subjects:&#xD;
&#xD;
      A three-arm randomized controlled trial (RCT) will be conducted (n= 624). With informed&#xD;
      consent, anonymous surveys will be conducted at baseline, Months 3, 6, and 9. Inclusion&#xD;
      criteria: 1) HK Chinese men aged &gt;18, 2) oral or anal intercourse with men in the last six&#xD;
      months; 3) no intention to leave HK for one month consecutively within the next 12 months, 4)&#xD;
      regular internet access, and 5) willing to be followed up by phone.&#xD;
&#xD;
      Study instruments:&#xD;
&#xD;
      Structured questionnaires&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
      1) Group HC: exposure to web-based, interactive and theory-based health communication&#xD;
      promoting HPV vaccination uptake; 2) Group HC-MI: same exposure as Group HC plus MI; and 3)&#xD;
      Group C: exposure to online materials about mental health (control group).&#xD;
&#xD;
      Main outcome measures:&#xD;
&#xD;
      Uptake of three doses of HPV vaccination within the follow-up period.&#xD;
&#xD;
      Data analysis and expected results:&#xD;
&#xD;
      Intention-to-treat analysis, General Estimation Equation (GEE) and Cox regression methods&#xD;
      will be used. Significance differences in HPV vaccination uptake rates will be found among&#xD;
      the three groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims and objectives&#xD;
&#xD;
        1. The primary objective of the RCT study is to evaluate the relative efficacies of two&#xD;
           online, theory-based and interactive interventions [health communication (HC) and health&#xD;
           communication plus MI (HC-MI)] in increasing uptake of three required doses of HPV&#xD;
           vaccination within a 9-month follow-up period among Hong Kong Chinese MSM who had not&#xD;
           previously taken up any dose of HPV vaccination, as compared to the control group (Group&#xD;
           C)&#xD;
&#xD;
        2. Secondary objectives are to evaluate the relative efficacies of the interventions in&#xD;
           increasing the following responses at the end of the 9-month follow up period:&#xD;
&#xD;
           i) Intention to take up all doses of HPV vaccination in the next 12 months. ii)&#xD;
           Theory-based cognitions supportive of HPV vaccination [e.g. those of the Health Belief&#xD;
           Model (HBM)].&#xD;
&#xD;
           Study design A three-arm parallel RCT will be conducted. Background information and&#xD;
           potential confounder(s) are recorded at baseline. Three post-intervention evaluations&#xD;
           will be performed through short telephone surveys 3, 6 and 9 months after exposure to&#xD;
           the intervention. Participants who have already taken up all three doses of HPV&#xD;
           vaccination at Month 3 or 6 will be asked the termination questionnaire (same as that&#xD;
           for Month 9). Interviewers and data analysts are blinded from participants'&#xD;
           randomization status.&#xD;
&#xD;
           Subject Inclusion criteria: 1) Hong Kong Chinese speaking men of aged ≥18, 2)&#xD;
           self-reported oral or anal intercourse with ≥1 man (last six months); 3) no intention to&#xD;
           leave Hong Kong for &gt;1 month consecutively within the next nine months, 4) regular&#xD;
           internet access and 5) willing to be followed up by phone. Those who have ever received&#xD;
           HPV vaccination will be excluded.&#xD;
&#xD;
           Recruitment procedures Participants will be recruited by outreaching in local&#xD;
           gay-friendly venues. The fieldworkers will explain the study's detail to participants.&#xD;
           Verbal instead of written informed consent will be obtained due to the need to maintain&#xD;
           anonymity; the fieldworkers will sign a form pledging that participants have been fully&#xD;
           briefed and participants' verbal informed consent was obtained. Fieldworkers obtain&#xD;
           multiple contacts (mobile, email and/or other e-contact) from prospective participants.&#xD;
           Participants will also be recruited via the Internet by comparable procedures.&#xD;
&#xD;
           Ethical considerations Fieldworkers guarantee anonymity, the right to quit at any time&#xD;
           and that refusal will not affect participants' chance in using any services. Verbal&#xD;
           instead of written informed consent will be obtained due to the need to maintain&#xD;
           anonymity; the fieldworkers will sign a form pledging that participants have been fully&#xD;
           briefed. In addition, all participants will reconfirm informed consent online before&#xD;
           receiving the online intervention; if the participants select &quot;refuse&quot; for the online&#xD;
           informed consent form, the program will close automatically. Ethics approval was&#xD;
           obtained from the Survey and Behavioral Research Ethics Committee of the CUHK and the&#xD;
           Joint CUHK-NTEC Clinical Research Ethics Committee. All information will be kept in&#xD;
           locked areas.&#xD;
&#xD;
           Randomization In the pre-arranged phone call, fieldworkers brief prospective&#xD;
           participants again and reconfirm participants' informed consent. Participants are&#xD;
           randomly allocated into one of the three groups, with a sealed opaque envelop drawn by&#xD;
           the research staff. Computerized random numbers and block randomization (block size of&#xD;
           12) will be used.&#xD;
&#xD;
           Primary and secondary outcomes The primary outcome of the study is whether the&#xD;
           participant has taken up all three doses of HPV vaccination (at any clinic) within a&#xD;
           9-months follow-up period. Secondary outcomes include intention to take up all three&#xD;
           doses of HPV vaccination in the next 12 months and changes in HBM-related cognitions on&#xD;
           HPV.&#xD;
&#xD;
           The baseline survey After randomization takes place, the fieldworker will administer a&#xD;
           baseline telephone survey to record information on potential confounders (Questionnaire&#xD;
           A: 10-15 minutes).&#xD;
&#xD;
           Evaluation surveys at Months 3, 6 and 9 A short interim phone interview will be&#xD;
           administered at Month 3 and 6 to those who have not taken up three doses of HPV&#xD;
           vaccination at Months 3 and 6 (non-termination) after exposure to intervention,&#xD;
           recording only uptake of HPV vaccination (one dose or two doses, price, venue and date)&#xD;
           during the inter-survey intervals and intention to take up three doses of vaccination in&#xD;
           the next 12 months (Questionnaire B, &lt;5 minutes). Participants present at Month 9 or&#xD;
           having taken up all three dose at Month 3 and 6 (termination) will be asked about HPV&#xD;
           vaccination history, as well as cognitive perceptions and emotional factors included in&#xD;
           the baseline survey (Questionnaire C, about 10 minutes). To reduce loss-to-follow-up,&#xD;
           the investigators will show these questionnaires to the participants at baseline.&#xD;
&#xD;
           Information for validating vaccine uptake All participants, including those who are&#xD;
           vaccinated at the collaborating clinic, will be requested to send the research team an&#xD;
           image of the receipt, hiding personal identification and via the same smartphone number,&#xD;
           social media account, or email previous used in this project, after participants have&#xD;
           taken up each dose of HPV vaccines.&#xD;
&#xD;
           Intervention of the Group HC (Online Health Communication Only Group) Participants will&#xD;
           watch two short health promotion videos (five minutes each), which contain health&#xD;
           communication messages about HPV and HPV vaccination and complete a self-administered&#xD;
           exercise which attempts to increase related knowledge and supportive cognitions. After&#xD;
           completing the tutorials, participants will be requested to answer an online&#xD;
           questionnaire that contains only three simple questions asking about some details of the&#xD;
           two videos. This is to verify exposure to the videos. One's login time for the tutorial&#xD;
           will be recorded by the computer program (another way to cross-check exposure).&#xD;
&#xD;
           Intervention of the Group HC-MI (Online Health Communication Plus MI Group) In addition&#xD;
           to the components received by the Group HC, Group HC-MI will receive motivational&#xD;
           interviewing (MI) of 15 minutes. To increase involvement of the interviewer and rapport,&#xD;
           the interviewer will &quot;wait for&quot; the participants while the participants are performing&#xD;
           the tutorial. [The interviewer will hold (via third line holding) or hang up the phone&#xD;
           while the participant is doing the tutorial and call back 20 minutes afterwards]. The&#xD;
           interviewer will discuss briefly about the tutorial (e.g. participants' responses or&#xD;
           questions) with the participants to enhance support and also to verify exposure to the&#xD;
           tutorial. The interviewer will then conduct a 15-minute MI session with the participant&#xD;
           over phone.&#xD;
&#xD;
           Maintenance of motivation for Group HC and Group HC-MI In order to maintain motivation&#xD;
           formed during the intervention, tailored reminders will be sent by Whatsapp or emails to&#xD;
           all participants of the Group HC and Group HC-MI. A link to the project webpage will be&#xD;
           included in such reminders, prompting participants to access a webpage where&#xD;
           participants can watch a testimonial video about HPV experience presented by a peer MSM,&#xD;
           read comments made by other participants, add participants' own comments and feedback on&#xD;
           others' comments. Such arrangements will provide continuous cues to action for&#xD;
           maintaining motivation. The number of reminders will be standardized to five (at month&#xD;
           1, 2, 4, 6 &amp; 8). The number of reminders sending to participants who have taken up all&#xD;
           three doses of HPV vaccination will be recorded.&#xD;
&#xD;
           The control group (Group C) The health communication messages in Group C will consist of&#xD;
           online messages about prevalence of some common mental health problems among MSM and&#xD;
           introduction of stress reduction exercises. No reminder will be given.&#xD;
&#xD;
           Sample size planning For planning purpose, the investigators conservatively assume 30%&#xD;
           of the automated health communication intervention (Group HC) would show an intention,&#xD;
           and 40% of those with such an intention would actually take up HPV vaccination (i.e. 12%&#xD;
           of Group HC). Regarding the Group HC-MI, the investigators assume the intention would&#xD;
           increase to 60% as MI is a powerful tool; the investigators assume that 50% of its&#xD;
           members with an intention would actually take up the vaccine (hence 30% of Group HC-MI&#xD;
           would be vaccinated). A sample size of 113 per group is needed to achieve the planned&#xD;
           effect sizes and power of .8 and alpha of .0125 for all comparisons (taking into account&#xD;
           multiple comparisons). With an expected loss-to-follow up rate of 35% at month 9, a&#xD;
           sample size of about 174 per group is required (total n=522). To be conservative, the&#xD;
           investigators keep the target sample size of 208 per group (624 in total); which can&#xD;
           detect smallest between-group difference of 16.2% between Group HC (12%) and Group HC-MI&#xD;
           (~28.2%), and detect smallest between-group difference of 10% between Group HC (12%) and&#xD;
           Group C (~2%), at power of .8 and alpha of .0125 (taking into account multiple&#xD;
           comparisons).&#xD;
&#xD;
           Data processing and analysis Test-retest reliability of the baseline questionnaire will&#xD;
           be assessed. For categorical responses, Cohen's Kappa statistics will be tested, while&#xD;
           for continuous responses, intra-class correlation coefficient will be used. Chi-square&#xD;
           test or one-way ANOVA will be conducted to compare differences in background&#xD;
           characteristics of those being followed up and loss to follow-up, and differences in&#xD;
           potential confounders recorded at baseline among the three groups.&#xD;
&#xD;
           Intention-to-treat analysis will be performed to assess relative efficacy of the two&#xD;
           interventions Generalized Estimation Equation (GEE) models will be fit to investigate&#xD;
           significance of differences in primary and secondary outcomes across the three groups,&#xD;
           adjusted for any significant potential confounders. Absolute and relative risk&#xD;
           reductions and corresponding 95% CI will be derived. Cox regression analysis will also&#xD;
           be performed, treating those who are loss to follow-up during the follow-up period and&#xD;
           those who had not taken up all three doses of HPV vaccination at the end of the 9-month&#xD;
           follow-up period as censored cases, and completion of all three doses of HPV vaccination&#xD;
           as the event (endpoint), and intervention group membership as the covariate. Adjustment&#xD;
           for potential confounders (found to be significant at baseline analysis) will be&#xD;
           performed if necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of three required doses of HPV vaccination</measure>
    <time_frame>24 months</time_frame>
    <description>Uptake of three required doses of HPV vaccination within a 24-month follow-up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral intention to take up all doses of HPV vaccination</measure>
    <time_frame>12 months</time_frame>
    <description>&quot;How likely will you take up all three doses of HPV vaccination in the next 12 months?&quot; (Response categories: 1=very unlikely, 4=very likely)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">624</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Online videos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will watch two online videos, complete a self-administered online tutorial, and receive reminders at Month 1, 2, 4, 6 &amp; 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online videos and MI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will watch two online videos, complete a self-administered online tutorial, received motivational interviewing (MI), and receive reminders at Month 1, 2, 4, 6 &amp; 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive online messages about mental health problems and stress reduction exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online videos</intervention_name>
    <description>Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise and receive reminders at month 1, 2, 4, 6 &amp; 8.</description>
    <arm_group_label>Online videos</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online videos and MI</intervention_name>
    <description>Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise, receive 15 minutes motivational interviewing through telephone and reminders at month 1, 2, 4, 6, &amp; 8.</description>
    <arm_group_label>Online videos and MI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Receive online health communication messages about prevalence of some common mental health problems among MSM and introduction of stress reduction exercises</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HK Chinese speaking men of aged ≥18&#xD;
&#xD;
          -  Self-reported oral or anal intercourse with ≥1 man (last six months)&#xD;
&#xD;
          -  No intention to leave HK for &gt;1 month consecutively within the next nine months&#xD;
&#xD;
          -  Regular internet access&#xD;
&#xD;
          -  Willing to be followed up by phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had ever received HPV vaccination&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zixin Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Health Behaviours Research, JC School of Public Health and Primary Care, The Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Health Behaviours Research, the Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>666888</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Zixin Wang</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Uptake of HPV vaccination</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286907
org study id: HMRF13141651
nct id: NCT03286907
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives:

      To evaluate efficacies of two online and theory-based interventions [HC: health communication
      only and HC-MI health communication plus motivational interviewing (MI)] in increasing uptake
      of three doses of HPV vaccines within the 9-month follow-up period among Hong Kong Chinese
      men who have sex with men (MSM).

      Hypothesis:

      The HPV vaccination rate of the three groups would be in the order HC-MI group > HC group >
      Control group.

      Design and subjects:

      A three-arm randomized controlled trial (RCT) will be conducted (n= 624). With informed
      consent, anonymous surveys will be conducted at baseline, Months 3, 6, and 9. Inclusion
      criteria: 1) HK Chinese men aged >18, 2) oral or anal intercourse with men in the last six
      months; 3) no intention to leave HK for one month consecutively within the next 12 months, 4)
      regular internet access, and 5) willing to be followed up by phone.

      Study instruments:

      Structured questionnaires

      Interventions:

      1) Group HC: exposure to web-based, interactive and theory-based health communication
      promoting HPV vaccination uptake; 2) Group HC-MI: same exposure as Group HC plus MI; and 3)
      Group C: exposure to online materials about mental health (control group).

      Main outcome measures:

      Uptake of three doses of HPV vaccination within the follow-up period.

      Data analysis and expected results:

      Intention-to-treat analysis, General Estimation Equation (GEE) and Cox regression methods
      will be used. Significance differences in HPV vaccination uptake rates will be found among
      the three groups.
Aims and objectives

        1. The primary objective of the RCT study is to evaluate the relative efficacies of two
           online, theory-based and interactive interventions [health communication (HC) and health
           communication plus MI (HC-MI)] in increasing uptake of three required doses of HPV
           vaccination within a 9-month follow-up period among Hong Kong Chinese MSM who had not
           previously taken up any dose of HPV vaccination, as compared to the control group (Group
           C)

        2. Secondary objectives are to evaluate the relative efficacies of the interventions in
           increasing the following responses at the end of the 9-month follow up period:

           i) Intention to take up all doses of HPV vaccination in the next 12 months. ii)
           Theory-based cognitions supportive of HPV vaccination [e.g. those of the Health Belief
           Model (HBM)].

           Study design A three-arm parallel RCT will be conducted. Background information and
           potential confounder(s) are recorded at baseline. Three post-intervention evaluations
           will be performed through short telephone surveys 3, 6 and 9 months after exposure to
           the intervention. Participants who have already taken up all three doses of HPV
           vaccination at Month 3 or 6 will be asked the termination questionnaire (same as that
           for Month 9). Interviewers and data analysts are blinded from participants'
           randomization status.

           Subject Inclusion criteria: 1) Hong Kong Chinese speaking men of aged ≥18, 2)
           self-reported oral or anal intercourse with ≥1 man (last six months); 3) no intention to
           leave Hong Kong for >1 month consecutively within the next nine months, 4) regular
           internet access and 5) willing to be followed up by phone. Those who have ever received
           HPV vaccination will be excluded.

           Recruitment procedures Participants will be recruited by outreaching in local
           gay-friendly venues. The fieldworkers will explain the study's detail to participants.
           Verbal instead of written informed consent will be obtained due to the need to maintain
           anonymity; the fieldworkers will sign a form pledging that participants have been fully
           briefed and participants' verbal informed consent was obtained. Fieldworkers obtain
           multiple contacts (mobile, email and/or other e-contact) from prospective participants.
           Participants will also be recruited via the Internet by comparable procedures.

           Ethical considerations Fieldworkers guarantee anonymity, the right to quit at any time
           and that refusal will not affect participants' chance in using any services. Verbal
           instead of written informed consent will be obtained due to the need to maintain
           anonymity; the fieldworkers will sign a form pledging that participants have been fully
           briefed. In addition, all participants will reconfirm informed consent online before
           receiving the online intervention; if the participants select "refuse" for the online
           informed consent form, the program will close automatically. Ethics approval was
           obtained from the Survey and Behavioral Research Ethics Committee of the CUHK and the
           Joint CUHK-NTEC Clinical Research Ethics Committee. All information will be kept in
           locked areas.

           Randomization In the pre-arranged phone call, fieldworkers brief prospective
           participants again and reconfirm participants' informed consent. Participants are
           randomly allocated into one of the three groups, with a sealed opaque envelop drawn by
           the research staff. Computerized random numbers and block randomization (block size of
           12) will be used.

           Primary and secondary outcomes The primary outcome of the study is whether the
           participant has taken up all three doses of HPV vaccination (at any clinic) within a
           9-months follow-up period. Secondary outcomes include intention to take up all three
           doses of HPV vaccination in the next 12 months and changes in HBM-related cognitions on
           HPV.

           The baseline survey After randomization takes place, the fieldworker will administer a
           baseline telephone survey to record information on potential confounders (Questionnaire
           A: 10-15 minutes).

           Evaluation surveys at Months 3, 6 and 9 A short interim phone interview will be
           administered at Month 3 and 6 to those who have not taken up three doses of HPV
           vaccination at Months 3 and 6 (non-termination) after exposure to intervention,
           recording only uptake of HPV vaccination (one dose or two doses, price, venue and date)
           during the inter-survey intervals and intention to take up three doses of vaccination in
           the next 12 months (Questionnaire B, <5 minutes). Participants present at Month 9 or
           having taken up all three dose at Month 3 and 6 (termination) will be asked about HPV
           vaccination history, as well as cognitive perceptions and emotional factors included in
           the baseline survey (Questionnaire C, about 10 minutes). To reduce loss-to-follow-up,
           the investigators will show these questionnaires to the participants at baseline.

           Information for validating vaccine uptake All participants, including those who are
           vaccinated at the collaborating clinic, will be requested to send the research team an
           image of the receipt, hiding personal identification and via the same smartphone number,
           social media account, or email previous used in this project, after participants have
           taken up each dose of HPV vaccines.

           Intervention of the Group HC (Online Health Communication Only Group) Participants will
           watch two short health promotion videos (five minutes each), which contain health
           communication messages about HPV and HPV vaccination and complete a self-administered
           exercise which attempts to increase related knowledge and supportive cognitions. After
           completing the tutorials, participants will be requested to answer an online
           questionnaire that contains only three simple questions asking about some details of the
           two videos. This is to verify exposure to the videos. One's login time for the tutorial
           will be recorded by the computer program (another way to cross-check exposure).

           Intervention of the Group HC-MI (Online Health Communication Plus MI Group) In addition
           to the components received by the Group HC, Group HC-MI will receive motivational
           interviewing (MI) of 15 minutes. To increase involvement of the interviewer and rapport,
           the interviewer will "wait for" the participants while the participants are performing
           the tutorial. [The interviewer will hold (via third line holding) or hang up the phone
           while the participant is doing the tutorial and call back 20 minutes afterwards]. The
           interviewer will discuss briefly about the tutorial (e.g. participants' responses or
           questions) with the participants to enhance support and also to verify exposure to the
           tutorial. The interviewer will then conduct a 15-minute MI session with the participant
           over phone.

           Maintenance of motivation for Group HC and Group HC-MI In order to maintain motivation
           formed during the intervention, tailored reminders will be sent by Whatsapp or emails to
           all participants of the Group HC and Group HC-MI. A link to the project webpage will be
           included in such reminders, prompting participants to access a webpage where
           participants can watch a testimonial video about HPV experience presented by a peer MSM,
           read comments made by other participants, add participants' own comments and feedback on
           others' comments. Such arrangements will provide continuous cues to action for
           maintaining motivation. The number of reminders will be standardized to five (at month
           1, 2, 4, 6 & 8). The number of reminders sending to participants who have taken up all
           three doses of HPV vaccination will be recorded.

           The control group (Group C) The health communication messages in Group C will consist of
           online messages about prevalence of some common mental health problems among MSM and
           introduction of stress reduction exercises. No reminder will be given.

           Sample size planning For planning purpose, the investigators conservatively assume 30%
           of the automated health communication intervention (Group HC) would show an intention,
           and 40% of those with such an intention would actually take up HPV vaccination (i.e. 12%
           of Group HC). Regarding the Group HC-MI, the investigators assume the intention would
           increase to 60% as MI is a powerful tool; the investigators assume that 50% of its
           members with an intention would actually take up the vaccine (hence 30% of Group HC-MI
           would be vaccinated). A sample size of 113 per group is needed to achieve the planned
           effect sizes and power of .8 and alpha of .0125 for all comparisons (taking into account
           multiple comparisons). With an expected loss-to-follow up rate of 35% at month 9, a
           sample size of about 174 per group is required (total n=522). To be conservative, the
           investigators keep the target sample size of 208 per group (624 in total); which can
           detect smallest between-group difference of 16.2% between Group HC (12%) and Group HC-MI
           (~28.2%), and detect smallest between-group difference of 10% between Group HC (12%) and
           Group C (~2%), at power of .8 and alpha of .0125 (taking into account multiple
           comparisons).

           Data processing and analysis Test-retest reliability of the baseline questionnaire will
           be assessed. For categorical responses, Cohen's Kappa statistics will be tested, while
           for continuous responses, intra-class correlation coefficient will be used. Chi-square
           test or one-way ANOVA will be conducted to compare differences in background
           characteristics of those being followed up and loss to follow-up, and differences in
           potential confounders recorded at baseline among the three groups.

           Intention-to-treat analysis will be performed to assess relative efficacy of the two
           interventions Generalized Estimation Equation (GEE) models will be fit to investigate
           significance of differences in primary and secondary outcomes across the three groups,
           adjusted for any significant potential confounders. Absolute and relative risk
           reductions and corresponding 95% CI will be derived. Cox regression analysis will also
           be performed, treating those who are loss to follow-up during the follow-up period and
           those who had not taken up all three doses of HPV vaccination at the end of the 9-month
           follow-up period as censored cases, and completion of all three doses of HPV vaccination
           as the event (endpoint), and intervention group membership as the covariate. Adjustment
           for potential confounders (found to be significant at baseline analysis) will be
           performed if necessary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Uptake of three required doses of HPV vaccination
time frame: 24 months
description: Uptake of three required doses of HPV vaccination within a 24-month follow-up period
measure: Behavioral intention to take up all doses of HPV vaccination
time frame: 12 months
description: "How likely will you take up all three doses of HPV vaccination in the next 12 months?" (Response categories: 1=very unlikely, 4=very likely)
arm group label: Online videos
arm group type: Experimental
description: Participants will watch two online videos, complete a self-administered online tutorial, and receive reminders at Month 1, 2, 4, 6 & 8
arm group label: Online videos and MI
arm group type: Experimental
description: Participants will watch two online videos, complete a self-administered online tutorial, received motivational interviewing (MI), and receive reminders at Month 1, 2, 4, 6 & 8
arm group label: Control group
arm group type: Active Comparator
description: Participants will receive online messages about mental health problems and stress reduction exercises
intervention type: Behavioral
intervention name: Online videos
description: Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise and receive reminders at month 1, 2, 4, 6 & 8.
arm group label: Online videos
intervention type: Behavioral
intervention name: Online videos and MI
description: Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise, receive 15 minutes motivational interviewing through telephone and reminders at month 1, 2, 4, 6, & 8.
arm group label: Online videos and MI
intervention type: Behavioral
intervention name: Control group
description: Receive online health communication messages about prevalence of some common mental health problems among MSM and introduction of stress reduction exercises
arm group label: Control group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zixin Wang, PhD
role: Principal Investigator
affiliation: Centre for Health Behaviours Research, JC School of Public Health and Primary Care, The Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Zixin Wang
investigator title: Research Assistant Professor