NCT03713034

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

An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
OTHER	PlayTest!	Participants in the PlayTest! intervention arm played the game on their assigned iPads once per week for an hour over the course of 4-5 weeks.
OTHER	Control games	Participants in the control arm played the games on their assigned iPads once per week for an hour over the course of 4-5 weeks.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2018-10-19
• Last updated: 2024-02-15
• Results posted: 2022-01-18

Locations

1 site across 1 country: United States