Intervention to Encourage HIV Testing and Counseling Among Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02812329|
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : February 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: HIV prevention videogame||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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 ]
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
|Principal Investigator:||Lynn E. Fiellin, M.D.||Yale University|