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An Accessible Digital Intervention to Promote HIV Testing/Counseling and Prevention Among Adolescents

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ClinicalTrials.gov Identifier: NCT03713034
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Yale University

Brief Summary:
This is Phase II of a study previously registered on ClinicalTrials.gov (NCT02812329). Phase II focuses on adapting and expanding the reach of a previously developed video game aimed at HIV prevention. The game will be adapted to include web access/distribution and be evaluated using a randomized controlled trial.

Condition or disease Intervention/treatment Phase
HIV Prevention Other: HTC game Other: Control game Not Applicable

Detailed Description:

The specific aims for Phase II of this study are to:

Further adapt and expand our culturally and socially-tailored videogame to have a greater focus on HIV testing and counseling (HTC) in addition to HIV prevention in an older age group of 14-18 year old boys and girls.

This will be accomplished by refining the conceptual model of the theoretical mechanisms of behavior change to be applied specifically within the game. New content will be created with additional input from 4 focus groups of 5 adolescents each (n = 20, aged 14-18) and these participants will also play-test the game. In addition, this model will inform new intervention manuals ("Game Playbooks") targeting these new outcomes. Building the new content from focus groups into the game are intended to adapt and expand its scope.

A system will be established for the newly adapted game for web access/distribution and program integration. Work will continue with commercialization partners on widespread distribution of the adapted game.

The final piece of the study will be to conduct a randomized controlled trial in 296 adolescents (aged 14-18) to evaluate the acceptability and efficacy of the adapted game on its new web-based platform compared with a set of control games.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Active Game

The research staff will orient the participants to the use of either the active or the control videogames. Players in both groups will play through an online tutorial demonstrating the mechanics of the game.

Each player will use a dedicated device to access their game on the web and a set of headphones that they will use during each gameplay session.

Other: HTC game

The research staff will orient the participants to the use of either the active or the control videogames. Players in both groups will play through an online tutorial demonstrating the mechanics of the game.

Each player will use a dedicated device to access their game on the web and a set of headphones that they will use during each gameplay session.


Active Comparator: Control Game

The research staff will orient the participants to the use of either the active or the control videogames. Players in both groups will play through an online tutorial demonstrating the mechanics of the game.

Each player will use a dedicated device to access their game on the web and a set of headphones that they will use during each gameplay session.

Other: Control game

The research staff will orient the participants to the use of either the active or the control videogames. Players in both groups will play through an online tutorial demonstrating the mechanics of the game.

Each player will use a dedicated device to access their game on the web and a set of headphones that they will use during each gameplay session.





Primary Outcome Measures :
  1. HTC Rate [ Time Frame: 6 months ]
    The rate of participants that engage in HIV testing and counseling (HTC) at 6 months will be compared.


Secondary Outcome Measures :
  1. HIV Knowledge [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    HIV/AIDS knowledge will be measured using the HIV-KQ. The HIV-KQ is a 25 item instrument with true and false response options. The higher the correct number of responses, the higher the HIV knowledge.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to participate in a web-based videogame (willing to sit for 60 minutes/session to play the game)
  • Have not been tested for HIV in the past year
  • Ability to provide assent/parental/guardian consent+
  • Have a completed and signed enrollment form for their school's health clinic allowing them, if they choose, to access the clinic for testing and health care

Exclusion Criteria:

  • Failure to meet any of the eligibility 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): NCT03713034


Contacts
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Contact: Lynn Fiellin, MD (203) 737-3347 lynn.sullivan@yale.edu
Contact: Tyra Pendergrass (203) 737-6101 tyra.pendergrass@yale.edu

Locations
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United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Lynn Fiellin         
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Lynn Fiellin, MD Associate Professor of Medicine (General Medicine) and in the Child Study Center; Director, Yale Center for Health & Learning Games; Director, play2PREVENT Lab at Yale

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03713034     History of Changes
Other Study ID Numbers: 1604017531_II
5R42HD088317-03 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
HIV testing and counseling (HTC)