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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

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: HIV prevention videogame Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention to Encourage HIV Testing and Counseling Among Adolescents
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIV prevention videogame
Participants will play PlayForward on a tablet computer for 1 hour, two times per week for 3 weeks.
Behavioral: HIV prevention videogame
Assess acceptability and efficacy of a HIV prevention videogame




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812329


Sponsors and Collaborators
Yale University
Digitalmill
Investigators
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Principal Investigator: Lynn E. Fiellin, M.D. Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02812329    
Other Study ID Numbers: 1604017531
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases