<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/NCT03778892</url>
  </required_header>
  <id_info>
    <org_study_id>2017/472-SON</org_study_id>
    <nct_id>NCT03778892</nct_id>
  </id_info>
  <brief_title>Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand</brief_title>
  <acronym>YouthPrEP</acronym>
  <official_title>Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thai Red Cross AIDS Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International AIDS Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>No</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>
      A randomized controlled clinical trial looking at the effect of use of a mobile phone&#xD;
      application in addition to standard care compared to standard care alone at a youth-friendly&#xD;
      clinic in young men who have sex with men and transgender women aged between 15-19 years at&#xD;
      risk of HIV on PrEP adherence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
      To study PrEP adherence in adolescent MSM who are at high risk of HIV acquisition.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To study&#xD;
&#xD;
        1. Rates of HIV infection&#xD;
&#xD;
        2. Rates of sexually transmitted infections (STIs)&#xD;
&#xD;
        3. Sexual risk taking behaviours In adolescent MSM who are at high risk of HIV infection.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
        1. The investigators hypothesize that youth-focused interventions will produce superior&#xD;
           adherence to PrEP from 50% with standard interventions to 70% with youth focused&#xD;
           interventions.&#xD;
&#xD;
        2. The investigators hypothesize that adherence to PrEP varies by the level of risk&#xD;
           behavior one perceives. Participants who take higher risk behaviors will be more likely&#xD;
           to adhere to PrEP than participants who have lower risk behaviors. STIs are expected to&#xD;
           be more common among participants with higher levels of adherence if they are&#xD;
           participants who have higher risk behaviors.&#xD;
&#xD;
      RESEARCH DESIGN:&#xD;
&#xD;
      Randomised control trial, behavioural intervention&#xD;
&#xD;
      RESEARCH METHODOLOGY&#xD;
&#xD;
        1. Study population Volunteers aged 15 to under 20 years at high risk of HIV infection&#xD;
           receiving PrEP under the 'Princess PrEP' project&#xD;
&#xD;
        2. Inclusion Criteria&#xD;
&#xD;
             -  Adolescent men who have sex with men&#xD;
&#xD;
             -  At high risk of HIV infection (have at least one of the following)&#xD;
&#xD;
                  -  More than 1 sexual partner in the last 6 months&#xD;
&#xD;
                  -  Irregular condom use during sexual intercourse&#xD;
&#xD;
                  -  HIV positive sexual partner&#xD;
&#xD;
             -  Age 15 to under 20 years old&#xD;
&#xD;
             -  A desire to take PrEP to prevent HIV infection&#xD;
&#xD;
             -  Tested HIV negative within 1 month of enrolment&#xD;
&#xD;
             -  Able to provide written consent or assent to take part in the clinical trial&#xD;
&#xD;
        3. Exclusion criteria Signs or symptoms of acute retroviral syndrome that cannot be&#xD;
           confirmed to be due to alternate causes, including unremitting fevers, headaches,&#xD;
           myalgia, fatigue, and lymphadenopathy&#xD;
&#xD;
        4. Study recruitment&#xD;
&#xD;
             -  Eligible persons presenting to the Thai Red Cross Anonymous Clinic (TRCARC) or its&#xD;
                affiliated community based organizations (Rainbow Sky Association Thailand (RSAT)&#xD;
                Ramkamhaeng, Sex Workers in Action Group (SWING) Bangkok will be asked by&#xD;
                counsellors on their interest to join the study.&#xD;
&#xD;
             -  Number of participants to be studied: 200&#xD;
&#xD;
        5. Informed consent process/ informed assent The research doctor will explain to potential&#xD;
           participants about the purposes of the study and allow them to ask any questions they&#xD;
           may have on it, and will be given time to make their decision. If a participant chooses&#xD;
           to join the study, they will be asked for their written consent/assent and a copy of the&#xD;
           informed consent/assent form given to them.&#xD;
&#xD;
             -  Participants aged between 15 and 18 will be asked for assent. As this is a study on&#xD;
                sexual health where disease prevention is of utmost concern, parental consent will&#xD;
                not be asked for.&#xD;
&#xD;
             -  Participants aged 18 to 19 will be asked for consent.&#xD;
&#xD;
        6. Study procedure After informed consent or assent, all youth will commence once daily&#xD;
           TFV/FTC 200/300mg. Volunteers will be randomized into arms 1 (standard intervention) or&#xD;
           2 (novel intervention strategy). Both groups will receive youth-focused counselling by&#xD;
           trained counsellors and have access to an adolescent-friendly sexual health promotion&#xD;
           website and social media page where they can get in contact with counsellors, doctors,&#xD;
           fellow adolescents and function as a platform through which they can learn about good&#xD;
           sexual health practices. Adolescents in arm 2 (novel intervention strategy) will also&#xD;
           receive access to a mobile phone application.&#xD;
&#xD;
      Youth-focused counselling Counsellors will provide counselling that is friendly,&#xD;
      non-judgmental and utilize motivational interviewing techniques where sessions are more&#xD;
      collaborative rather than didactic.&#xD;
&#xD;
      Mobile Phone Application&#xD;
&#xD;
        -  Password protection will ensure user privacy&#xD;
&#xD;
        -  Will allow users to input weekly data on their:&#xD;
&#xD;
             -  Sexual risk e.g. no sexual activity, sex with condoms, sex without condoms&#xD;
&#xD;
             -  PrEP use e.g. whether or not participants take their PrEP&#xD;
&#xD;
        -  The application will calculate a percentage of protection users have based on their data&#xD;
           entry&#xD;
&#xD;
        -  Points can be accumulated for application use, data input to the application, for&#xD;
           attending appointments and also for normal STI and HIV screening results. Points can be&#xD;
           redeemed for cash&#xD;
&#xD;
        -  The overall goal of the application is to increase participant awareness of self-risk&#xD;
           and motivation to protect themselves against HIV and STI infection&#xD;
&#xD;
      Participants will be followed up at months 1, 3 and 6. At each visit, participants will&#xD;
      complete a questionnaire on drug adherence and sexual health risk behaviours.&#xD;
&#xD;
      STI testing will be done as an indirect marker of condom use at visits 1 and 6. This will&#xD;
      involve blood testing for syphilis serology and nucleic acid amplification testing for&#xD;
      gonorrhea, and chlamydia on swab samples.&#xD;
&#xD;
      HIV testing will be done at all visits. TFV-DP DBS will be done at months 1, 3 and 6 to look&#xD;
      at correlation of self-reported and actual measured PrEP compliance.&#xD;
&#xD;
      Drug Concentrations will be measured using the TFV-DP DBS at the Program for HIV Prevention&#xD;
      and Treatment (PHPT), Chiang Mai. TFV-DP DBS levels ≥ 700 fmol/punch will be taken as&#xD;
      adherence&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 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>
    <intervention_model_description>half of study participants will receive the intervention</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP Adherence</measure>
    <time_frame>Weekly self-reported adherence for a period of 6 months following randomization</time_frame>
    <description>Self-Reported Adherence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP Adherence at 3 months</measure>
    <time_frame>Measured at month 3 (measure of 17 day half life of TDF-DP)</time_frame>
    <description>Measured Serum TDF-DP Level (from dried blood spots)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP Adherence at 6 months</measure>
    <time_frame>Measured at month 6 (measure of 17 day half life of TDF-DP)</time_frame>
    <description>Measured Serum TDF-DP Level (from dried blood spots)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV infection rates</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>seroconversion rates whilst on PrEP during study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Urethral Neisseria gonorrhea</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>Rates of Urethral Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) urine testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behaviour Risk-Taking</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>Composite calculated score of risk taking based on self-reported condom use, PrEP tablets taking, number of sexual partners in preceding one month. Scores will equate to risk levels of low, medium, high and very high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Anal Neisseria gonorrhea</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>Rates of Anal Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) from anal swab samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Urethral Chlamydia trachomatis</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>Rates of Urethral Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) urine testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Anal Chlamydia trachomatis</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>Rates of Anal Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) from anal swab samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Syphilis Infection</measure>
    <time_frame>duration of study (6 months)</time_frame>
    <description>Rates of positive treponemal blood tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Hepatitis B infection</measure>
    <time_frame>At initial project visit (month 0)</time_frame>
    <description>Rates of positive HbsAg blood tests</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Adherence, Medication</condition>
  <condition>Adolescent Behavior</condition>
  <condition>HIV Prevention</condition>
  <condition>Sexual Health</condition>
  <condition>Mobile Health</condition>
  <arm_group>
    <arm_group_label>Novel Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>'Project Raincoat' Mobile Phone Application</intervention_name>
    <description>Mobile phone application with weekly input channels for PrEP use, condom use, number of sex partners and sex acts and a calculation of self-HIV risk feedback scoring. Scoring system for attendance of visits, normal blood tests and use of application. Points redeemable for cash. Optional alarm system to remind to take medications and attend visits.</description>
    <arm_group_label>Novel Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent men who have sex with men&#xD;
&#xD;
          -  At high risk of HIV infection (have at least one of the following)&#xD;
&#xD;
               -  More than 1 sexual partner in the last 6 months&#xD;
&#xD;
               -  Irregular condom use during sexual intercourse&#xD;
&#xD;
               -  HIV positive sexual partner&#xD;
&#xD;
          -  Age 15 to under 20 years old&#xD;
&#xD;
          -  A desire to take PrEP to prevent HIV infection&#xD;
&#xD;
          -  Tested HIV negative within 1 month of enrolment&#xD;
&#xD;
          -  Able to provide written consent or assent to take part in the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs or symptoms of acute retroviral syndrome that cannot be confirmed to be due to&#xD;
             alternate causes, including unremitting fevers, headaches, myalgia, fatigue, and&#xD;
             lymphadenopathy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>men who have sex with men or transgender women</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thai Red Cross AIDS Research Center</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Wipaporn Natalie Songtaweesin, MD.</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Researcher</investigator_title>
  </responsible_party>
  <keyword>PrEP adherence</keyword>
  <keyword>Youth</keyword>
  <keyword>Adolescents</keyword>
  <keyword>MSM</keyword>
  <keyword>HIV Prevention</keyword>
  <keyword>Mobile Health</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03778892
org study id: 2017/472-SON
nct id: NCT03778892
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled clinical trial looking at the effect of use of a mobile phone
      application in addition to standard care compared to standard care alone at a youth-friendly
      clinic in young men who have sex with men and transgender women aged between 15-19 years at
      risk of HIV on PrEP adherence.
OBJECTIVES

      Primary Objectives:

      To study PrEP adherence in adolescent MSM who are at high risk of HIV acquisition.

      Secondary Objectives:

      To study

        1. Rates of HIV infection

        2. Rates of sexually transmitted infections (STIs)

        3. Sexual risk taking behaviours In adolescent MSM who are at high risk of HIV infection.

      HYPOTHESES:

        1. The investigators hypothesize that youth-focused interventions will produce superior
           adherence to PrEP from 50% with standard interventions to 70% with youth focused
           interventions.

        2. The investigators hypothesize that adherence to PrEP varies by the level of risk
           behavior one perceives. Participants who take higher risk behaviors will be more likely
           to adhere to PrEP than participants who have lower risk behaviors. STIs are expected to
           be more common among participants with higher levels of adherence if they are
           participants who have higher risk behaviors.

      RESEARCH DESIGN:

      Randomised control trial, behavioural intervention

      RESEARCH METHODOLOGY

        1. Study population Volunteers aged 15 to under 20 years at high risk of HIV infection
           receiving PrEP under the 'Princess PrEP' project

        2. Inclusion Criteria

             -  Adolescent men who have sex with men

             -  At high risk of HIV infection (have at least one of the following)

                  -  More than 1 sexual partner in the last 6 months

                  -  Irregular condom use during sexual intercourse

                  -  HIV positive sexual partner

             -  Age 15 to under 20 years old

             -  A desire to take PrEP to prevent HIV infection

             -  Tested HIV negative within 1 month of enrolment

             -  Able to provide written consent or assent to take part in the clinical trial

        3. Exclusion criteria Signs or symptoms of acute retroviral syndrome that cannot be
           confirmed to be due to alternate causes, including unremitting fevers, headaches,
           myalgia, fatigue, and lymphadenopathy

        4. Study recruitment

             -  Eligible persons presenting to the Thai Red Cross Anonymous Clinic (TRCARC) or its
                affiliated community based organizations (Rainbow Sky Association Thailand (RSAT)
                Ramkamhaeng, Sex Workers in Action Group (SWING) Bangkok will be asked by
                counsellors on their interest to join the study.

             -  Number of participants to be studied: 200

        5. Informed consent process/ informed assent The research doctor will explain to potential
           participants about the purposes of the study and allow them to ask any questions they
           may have on it, and will be given time to make their decision. If a participant chooses
           to join the study, they will be asked for their written consent/assent and a copy of the
           informed consent/assent form given to them.

             -  Participants aged between 15 and 18 will be asked for assent. As this is a study on
                sexual health where disease prevention is of utmost concern, parental consent will
                not be asked for.

             -  Participants aged 18 to 19 will be asked for consent.

        6. Study procedure After informed consent or assent, all youth will commence once daily
           TFV/FTC 200/300mg. Volunteers will be randomized into arms 1 (standard intervention) or
           2 (novel intervention strategy). Both groups will receive youth-focused counselling by
           trained counsellors and have access to an adolescent-friendly sexual health promotion
           website and social media page where they can get in contact with counsellors, doctors,
           fellow adolescents and function as a platform through which they can learn about good
           sexual health practices. Adolescents in arm 2 (novel intervention strategy) will also
           receive access to a mobile phone application.

      Youth-focused counselling Counsellors will provide counselling that is friendly,
      non-judgmental and utilize motivational interviewing techniques where sessions are more
      collaborative rather than didactic.

      Mobile Phone Application

        -  Password protection will ensure user privacy

        -  Will allow users to input weekly data on their:

             -  Sexual risk e.g. no sexual activity, sex with condoms, sex without condoms

             -  PrEP use e.g. whether or not participants take their PrEP

        -  The application will calculate a percentage of protection users have based on their data
           entry

        -  Points can be accumulated for application use, data input to the application, for
           attending appointments and also for normal STI and HIV screening results. Points can be
           redeemed for cash

        -  The overall goal of the application is to increase participant awareness of self-risk
           and motivation to protect themselves against HIV and STI infection

      Participants will be followed up at months 1, 3 and 6. At each visit, participants will
      complete a questionnaire on drug adherence and sexual health risk behaviours.

      STI testing will be done as an indirect marker of condom use at visits 1 and 6. This will
      involve blood testing for syphilis serology and nucleic acid amplification testing for
      gonorrhea, and chlamydia on swab samples.

      HIV testing will be done at all visits. TFV-DP DBS will be done at months 1, 3 and 6 to look
      at correlation of self-reported and actual measured PrEP compliance.

      Drug Concentrations will be measured using the TFV-DP DBS at the Program for HIV Prevention
      and Treatment (PHPT), Chiang Mai. TFV-DP DBS levels ≥ 700 fmol/punch will be taken as
      adherence
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: half of study participants will receive the intervention
primary purpose: Prevention
masking: None (Open Label)
measure: PrEP Adherence
time frame: Weekly self-reported adherence for a period of 6 months following randomization
description: Self-Reported Adherence
measure: PrEP Adherence at 3 months
time frame: Measured at month 3 (measure of 17 day half life of TDF-DP)
description: Measured Serum TDF-DP Level (from dried blood spots)
measure: PrEP Adherence at 6 months
time frame: Measured at month 6 (measure of 17 day half life of TDF-DP)
description: Measured Serum TDF-DP Level (from dried blood spots)
measure: HIV infection rates
time frame: duration of study (6 months)
description: seroconversion rates whilst on PrEP during study
measure: Rates of Urethral Neisseria gonorrhea
time frame: duration of study (6 months)
description: Rates of Urethral Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) urine testing
measure: Behaviour Risk-Taking
time frame: duration of study (6 months)
description: Composite calculated score of risk taking based on self-reported condom use, PrEP tablets taking, number of sexual partners in preceding one month. Scores will equate to risk levels of low, medium, high and very high.
measure: Rates of Anal Neisseria gonorrhea
time frame: duration of study (6 months)
description: Rates of Anal Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) from anal swab samples
measure: Rates of Urethral Chlamydia trachomatis
time frame: duration of study (6 months)
description: Rates of Urethral Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) urine testing
measure: Rates of Anal Chlamydia trachomatis
time frame: duration of study (6 months)
description: Rates of Anal Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) from anal swab samples
measure: Rates of Syphilis Infection
time frame: duration of study (6 months)
description: Rates of positive treponemal blood tests
measure: Rates of Hepatitis B infection
time frame: At initial project visit (month 0)
description: Rates of positive HbsAg blood tests
arm group label: Novel Intervention
arm group type: Experimental
description: Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services
arm group label: Standard Intervention
arm group type: No Intervention
description: Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services
intervention type: Behavioral
intervention name: 'Project Raincoat' Mobile Phone Application
description: Mobile phone application with weekly input channels for PrEP use, condom use, number of sex partners and sex acts and a calculation of self-HIV risk feedback scoring. Scoring system for attendance of visits, normal blood tests and use of application. Points redeemable for cash. Optional alarm system to remind to take medications and attend visits.
arm group label: Novel Intervention
criteria: 
gender: Male
gender based: Yes
gender description: men who have sex with men or transgender women
minimum age: 15 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Wipaporn Natalie Songtaweesin, MD.
investigator title: Principal Investigator, Clinical Researcher
sharing ipd: No