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Intervention to Encourage HIV Testing and Counseling Among Adolescents

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ClinicalTrials.gov Identifier: NCT02812329
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Digitalmill
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE June 21, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date February 13, 2017
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team, [ Time Frame: After 3 weeks of using the videogame ]
    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. [ Time Frame: Three weeks after 3 weeks of using the videogame ]
    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention to Encourage HIV Testing and Counseling Among Adolescents
Official Title  ICMJE Intervention to Encourage HIV Testing and Counseling Among Adolescents
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:

  1. 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.
  2. 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:

  3. The intervention's acceptability and feasibility using self-report data on the game play experience.
  4. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE Behavioral: HIV prevention videogame
Assess acceptability and efficacy of a HIV prevention videogame
Study Arms  ICMJE Experimental: HIV prevention videogame
Participants will play PlayForward on a tablet computer for 1 hour, two times per week for 3 weeks.
Intervention: Behavioral: HIV prevention videogame
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2016)
30
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812329
Other Study ID Numbers  ICMJE 1604017531
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Digitalmill
Investigators  ICMJE
Principal Investigator: Lynn E. Fiellin, M.D. Yale University
PRS Account Yale University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP