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Intervention to Encourage HIV Testing and Counseling Among Adolescents

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HIV prevention videogame
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus

Eligibility Criteria

15 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participants must: 1) be 15-16 years of age and 2) be able to participate in a mobile videogame (willing to sit with a tablet computer for 60 minutes/session to play the game).

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HIV prevention videogame

    Arm Description

    Participants will play PlayForward on a tablet computer for 1 hour, two times per week for 3 weeks.

    Outcomes

    Primary Outcome Measures

    Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team,
    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.
    Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team.
    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.

    Secondary Outcome Measures

    Satisfaction/acceptability of the HIV prevention videogame measured by self-report questionnaire developed by the study team.

    Full Information

    First Posted
    June 21, 2016
    Last Updated
    February 10, 2017
    Sponsor
    Yale University
    Collaborators
    Digitalmill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02812329
    Brief Title
    Intervention to Encourage HIV Testing and Counseling Among Adolescents
    Official Title
    Intervention to Encourage HIV Testing and Counseling Among Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    Digitalmill

    4. Oversight

    5. Study Description

    Brief Summary
    This study aims to minimize risk of human immunodeficiency virus (HIV) in adolescent boys and girls, ages 15-16, by promoting HIV testing and counseling (HTC) through the use of an interactive videogame. With input from focus groups of adolescents, the investigators will adapt an HIV prevention videogame, PlayForward: Elm City Stories, for adolescents ages 15-16 . The investigators will then pilot test the videogame in 30 adolescents to assess the acceptability and feasibility of the videogame. They will also assess whether the videogame increased the participants' intentions to obtain HTC, whether they actually obtained HTC, and whether the videogame increased knowledge of HIV.
    Detailed Description
    Adolescents are at high risk of contracting human immunodeficiency virus (HIV). To help them to minimize their risk and maintain their uninfected status, it is critical to give them the information, motivation, and skills to get HIV testing and counseling (HTC). The current proposal focuses on adapting an existing HIV prevention videogame, PlayForward: Elm City Stories (R01HD062080), developed for 11-14 year olds, to include a primary focus on promoting access to and uptake of HTC in adolescent boys and girls, ages 15-16. PlayForward, an engaging and interactive videogame grounded in social learning theory and the theory of planned behavior, was developed through extensive work with its target audience to focus on the delay of sexual initiation in young teens and is currently demonstrating preliminary efficacy in a large randomized controlled trial (RCT). In this Phase I proposal, PlayForward will be adapted for use in a slightly older age group with the primary outcome of encouraging them (increasing intentions) to obtain HTC and increasing knowledge about HIV/AIDS. Working with the multi-disciplinary team of the play2PREVENT (p2P) Lab, we will conduct the formative work with our target audience and content experts to modify PlayForward for a focus on promoting HTC. To this end, our specific aims for this Phase I proposal targeting HTC in 15-16 year old adolescents are to: Aim 1: Translate our culturally and socially-tailored videogame PlayForward to focus on HTC in an older age group of 15-16 year old boys and girls by: Developing a conceptual model of the theoretical mechanisms of behavior change to be applied specifically within the game. We will develop this model with input from 4 focus groups of 5 adolescents each (n = 20, aged 15-16) and the extant literature. This model will inform the development of a set of intervention manuals ("Game Playbooks") targeting the new outcome. Aim 2: Modify aspects of the PlayForward game to reflect this new focus by pilot testing it with 30 adolescents, aged 15-16 to determine in a pre-post design: The intervention's acceptability and feasibility using self-report data on the game play experience. Preliminary evidence of the efficacy of the intervention by collecting data on i) intentions to seek HTC; ii) actual obtaining of HTC; and iii) knowledge about HIV/AIDS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HIV prevention videogame
    Arm Type
    Experimental
    Arm Description
    Participants will play PlayForward on a tablet computer for 1 hour, two times per week for 3 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HIV prevention videogame
    Intervention Description
    Assess acceptability and efficacy of a HIV prevention videogame
    Primary Outcome Measure Information:
    Title
    Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team,
    Description
    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.
    Time Frame
    After 3 weeks of using the videogame
    Title
    Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team.
    Description
    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.
    Time Frame
    Three weeks after 3 weeks of using the videogame
    Secondary Outcome Measure Information:
    Title
    Satisfaction/acceptability of the HIV prevention videogame measured by self-report questionnaire developed by the study team.
    Time Frame
    After 3 weeks of using the videogame

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: participants must: 1) be 15-16 years of age and 2) be able to participate in a mobile videogame (willing to sit with a tablet computer for 60 minutes/session to play the game). Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lynn E. Fiellin, M.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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