- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02812329
Intervention to Encourage HIV Testing and Counseling Among Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Assess acceptability and efficacy of a HIV prevention videogame
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After 3 weeks of using the videogame
|
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.
|
Three weeks after 3 weeks of using the videogame
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 3 weeks of using the videogame
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn E. Fiellin, M.D., Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1604017531
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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