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
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus
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:
-
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
NCT ID
NCT02812329
First Posted
June 21, 2016
Last Updated
February 10, 2017
Sponsor
Yale University
Collaborators
Digitalmill
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
Learn more about this trial
Intervention to Encourage HIV Testing and Counseling Among Adolescents
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