<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/NCT04437667</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00108404</org_study_id>
    <secondary_id>1R01MH118982-01</secondary_id>
    <nct_id>NCT04437667</nct_id>
  </id_info>
  <brief_title>HIV-Prevention Smartphone Game Trial</brief_title>
  <official_title>Efficacy Trial for a Smartphone Game to Prevent HIV Among Young Africans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory 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>
      This project, funded by the National Institute of Mental Health, will test the efficacy of an&#xD;
      electronic game to prevent HIV among African adolescents (aged 12-17), delivered via&#xD;
      inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of&#xD;
      their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men&#xD;
      ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya&#xD;
      Medical Research Institute (KEMRI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 912 study participants (youth ages 12-14) will be randomized to the intervention or&#xD;
      control arm upon completion of the baseline survey. The assignments will be generated with&#xD;
      the use of a pseudo-random-number generator with permuted blocks, used to ensure a&#xD;
      sex-balanced and age-balanced assignment to each arm. All participants will be given a&#xD;
      low-cost (&lt;$40) Android phone on which the study game will be loaded. Intervention arm phones&#xD;
      will have app for Tumaini programmed on them, while control arm phones will have a&#xD;
      commercially available game to be determined prior to the start of the randomized clinical&#xD;
      trial. Preference will be given to a game or other app with educational content, for example,&#xD;
      a general knowledge quiz or strategy game. Each app will be standalone and not require data&#xD;
      access or connection to the Internet to function. All participants will be invited to play&#xD;
      their assigned game for at least 10 hours during the November-December school holiday. While&#xD;
      we anticipate that access to smartphones will be widespread at time of roll-out of an&#xD;
      efficacious game, this is not yet the case: for the purposes of this study, phones need to be&#xD;
      provided in order to ensure consistency of technology and avoid SES bias. All other phone&#xD;
      functions aside from the alarm, will be disabled for safety reasons. The game will&#xD;
      automatically record the time spent playing and the choices made in the context of gameplay.&#xD;
      When returning the phones, all participants will be asked to fill out a form identifying&#xD;
      others with whom the game or app was shared and creators of each profile on their study&#xD;
      phones.&#xD;
&#xD;
      In line with the preferences expressed by parents during the feasibility test, the phones&#xD;
      will be provided to participants during the long November-December school holidays and&#xD;
      collected at the end of the holiday. Providing there is no evidence of contamination,&#xD;
      participants will (a) keep the phone throughout the long November-December school holiday;&#xD;
      and (b) receive the phone, loaded with the game, again during the November-December holidays&#xD;
      of the following years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 12, 2020</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Age at first sex</measure>
    <time_frame>Up to month 46</time_frame>
    <description>Age at first sex encounter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting condom use at first sex</measure>
    <time_frame>Up to month 46</time_frame>
    <description>Percentage of participants reporting condom use at first sex</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Binary Risk outcome of &quot;risk&quot; vs &quot;low risk&quot;</measure>
    <time_frame>Up to month 46</time_frame>
    <description>Binary outcome of &quot;risk&quot; group (experienced sexual debut during the study period without condom use at first sex) vs &quot;low risk&quot; group (not yet experienced sexual debut by the end of the study, or used a condom at sexual debut during the study period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in percentage of participants reporting recent sexual activity</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>For participants reporting previous sexual intercourse, self-report of sexual intercourse since previous behavioral survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in percentage of participants reporting recent condom use</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>For participants reporting recent sexual activity, self-report of consistent condom use since previous behavioral survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of sexual partners</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>For participants reporting any past sexual activity, number of different sexual partners</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in percentage of participants with recent alcohol and drug use</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>Percentage of participants that report recent alcohol and drug use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>Knowledge measures will be assessed via Yes/No survey questions and will address HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. A positive value for the change from baseline score indicate an increase in knowledge from the baseline assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy to use a condom correctly; to communicate with a partner about protected sex; to reject peer, partner, and adult pressure to engage in risk behaviors; and, for female participants, to manage menstruation. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in risk assessment</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>Risk assessment will be assessed via a Likert scale, and address perceived risk of certain risk situations/behaviors. Risk items will be scored on a 0-1 scale, with higher scores indicating higher risk assessment. A positive value for the change from baseline score will indicate an increase in assessing risky situations as risky.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in attitudes</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>Attitudes will be assessed via Likert survey questions relating to puberty, HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score will indicate an increase in desirable attitudes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in behavioral intentions</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46</time_frame>
    <description>Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk situations and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total length of gameplay</measure>
    <time_frame>Months 3,18, 28</time_frame>
    <description>Total time playing from game log files</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with new HSV-2 diagnosis</measure>
    <time_frame>Months 1 and 46</time_frame>
    <description>Incidence rates over the course of study of HSV-2 among uninfected participants will be compared by exposure to intervention using Poisson and/or Cox regression methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with new HIV diagnosis</measure>
    <time_frame>Months 1 and 46</time_frame>
    <description>Incidence rates over the course of study of HIV among uninfected participants will be compared by exposure to intervention using Poisson and/or Cox regression methods.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents participants enrolled in the intervention arm will receive the intervention, Tumaini, loaded on a low-cost Android smartphone, during the long November-December school holidays for the first three years of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adolescent participants enrolled in the control arm will receive a commercially available age- and language-appropriate educational game or knowledge quiz loaded on a study-provided low-cost Android smartphone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tumaini Mobile Phone Game</intervention_name>
    <description>Tumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma; and promote parent-child dialogue.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Mobile Phone Game</intervention_name>
    <description>Independent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December).</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Adolescents, male and female, aged 12-14 at recruitment in Kisumu Town, Kenya (n=912)&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Aged 12-14 at time of enrollment&#xD;
&#xD;
          -  Resident in Kisumu Town, Kenya&#xD;
&#xD;
          -  Having basic English literacy (Grade 3-4 on the Flesch-Kincaid Reading Scale, assessed&#xD;
             via a short listening and reading comprehension test at enrollment)&#xD;
&#xD;
          -  Only one child per family&#xD;
&#xD;
          -  Not previously enrolled in formative research or pilot testing of intervention or&#xD;
             survey instruments&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Aged &lt;12 or &gt;14 at time of enrollment&#xD;
&#xD;
          -  Not a resident of Kisumu Town, Kenya&#xD;
&#xD;
          -  Not having basic English literacy&#xD;
&#xD;
          -  Sibling to a child already enrolled in the study&#xD;
&#xD;
          -  Previously involved in formative research or pilot testing of intervention or survey&#xD;
             instruments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate Winskell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kenya Medical Research Institute</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Kate Winskell</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Prevention</keyword>
  <keyword>Sexually transmitted infections (STIs)</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04437667/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04437667
org study id: IRB00108404
secondary id: 1R01MH118982-01
nct id: NCT04437667
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project, funded by the National Institute of Mental Health, will test the efficacy of an
      electronic game to prevent HIV among African adolescents (aged 12-17), delivered via
      inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of
      their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men
      ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya
      Medical Research Institute (KEMRI).
The 912 study participants (youth ages 12-14) will be randomized to the intervention or
      control arm upon completion of the baseline survey. The assignments will be generated with
      the use of a pseudo-random-number generator with permuted blocks, used to ensure a
      sex-balanced and age-balanced assignment to each arm. All participants will be given a
      low-cost (<$40) Android phone on which the study game will be loaded. Intervention arm phones
      will have app for Tumaini programmed on them, while control arm phones will have a
      commercially available game to be determined prior to the start of the randomized clinical
      trial. Preference will be given to a game or other app with educational content, for example,
      a general knowledge quiz or strategy game. Each app will be standalone and not require data
      access or connection to the Internet to function. All participants will be invited to play
      their assigned game for at least 10 hours during the November-December school holiday. While
      we anticipate that access to smartphones will be widespread at time of roll-out of an
      efficacious game, this is not yet the case: for the purposes of this study, phones need to be
      provided in order to ensure consistency of technology and avoid SES bias. All other phone
      functions aside from the alarm, will be disabled for safety reasons. The game will
      automatically record the time spent playing and the choices made in the context of gameplay.
      When returning the phones, all participants will be asked to fill out a form identifying
      others with whom the game or app was shared and creators of each profile on their study
      phones.

      In line with the preferences expressed by parents during the feasibility test, the phones
      will be provided to participants during the long November-December school holidays and
      collected at the end of the holiday. Providing there is no evidence of contamination,
      participants will (a) keep the phone throughout the long November-December school holiday;
      and (b) receive the phone, loaded with the game, again during the November-December holidays
      of the following years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Age at first sex
time frame: Up to month 46
description: Age at first sex encounter.
measure: Percentage of participants reporting condom use at first sex
time frame: Up to month 46
description: Percentage of participants reporting condom use at first sex
measure: Binary Risk outcome of "risk" vs "low risk"
time frame: Up to month 46
description: Binary outcome of "risk" group (experienced sexual debut during the study period without condom use at first sex) vs "low risk" group (not yet experienced sexual debut by the end of the study, or used a condom at sexual debut during the study period).
measure: Change in percentage of participants reporting recent sexual activity
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: For participants reporting previous sexual intercourse, self-report of sexual intercourse since previous behavioral survey.
measure: Change in percentage of participants reporting recent condom use
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: For participants reporting recent sexual activity, self-report of consistent condom use since previous behavioral survey.
measure: Change in number of sexual partners
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: For participants reporting any past sexual activity, number of different sexual partners
measure: Change in percentage of participants with recent alcohol and drug use
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: Percentage of participants that report recent alcohol and drug use.
measure: Change in knowledge
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: Knowledge measures will be assessed via Yes/No survey questions and will address HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. A positive value for the change from baseline score indicate an increase in knowledge from the baseline assessment.
measure: Change in self-efficacy
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy to use a condom correctly; to communicate with a partner about protected sex; to reject peer, partner, and adult pressure to engage in risk behaviors; and, for female participants, to manage menstruation. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment.
measure: Change in risk assessment
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: Risk assessment will be assessed via a Likert scale, and address perceived risk of certain risk situations/behaviors. Risk items will be scored on a 0-1 scale, with higher scores indicating higher risk assessment. A positive value for the change from baseline score will indicate an increase in assessing risky situations as risky.
measure: Change in attitudes
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: Attitudes will be assessed via Likert survey questions relating to puberty, HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score will indicate an increase in desirable attitudes.
measure: Change in behavioral intentions
time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
description: Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk situations and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors.
measure: Total length of gameplay
time frame: Months 3,18, 28
description: Total time playing from game log files
measure: Number of participants with new HSV-2 diagnosis
time frame: Months 1 and 46
description: Incidence rates over the course of study of HSV-2 among uninfected participants will be compared by exposure to intervention using Poisson and/or Cox regression methods.
measure: Number of participants with new HIV diagnosis
time frame: Months 1 and 46
description: Incidence rates over the course of study of HIV among uninfected participants will be compared by exposure to intervention using Poisson and/or Cox regression methods.
arm group label: Intervention Arm
arm group type: Experimental
description: Adolescents participants enrolled in the intervention arm will receive the intervention, Tumaini, loaded on a low-cost Android smartphone, during the long November-December school holidays for the first three years of the study.
arm group label: Control Arm
arm group type: Active Comparator
description: Adolescent participants enrolled in the control arm will receive a commercially available age- and language-appropriate educational game or knowledge quiz loaded on a study-provided low-cost Android smartphone.
intervention type: Behavioral
intervention name: Tumaini Mobile Phone Game
description: Tumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma; and promote parent-child dialogue.
arm group label: Intervention Arm
intervention type: Behavioral
intervention name: Control Mobile Phone Game
description: Independent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December).
arm group label: Control Arm
criteria: 
gender: All
minimum age: 12 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kate Winskell, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Kate Winskell
investigator title: Associate Professor
sharing ipd: No
provided document: 