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

NCT ID: NCT03713034

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-10-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Active Game

PlayTest! is an interactive world in which the player, using an avatar they have created, "travels" through life in high school. They face challenges that bring different risks and benefits, requiring them to practice decision-making skills. The player learns skills that aim to empower them to make safe choices in situations that may otherwise increase their risk for HIV/STI infection. The game also provides opportunities for the player to practice advocating for their health by modeling a conversation with a medical professional. PlayTest! incorporates evidence-based tools for behavior change including social learning theory and self-efficacy. message framing, motivational interviewing to identify the variables that must be targeted to increase HTC among adolescents.

Group Type: EXPERIMENTAL

PlayTest!

Intervention Type: OTHER

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.

Control Game

Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. The control games contained not relevant content related to HIV Testing and Counseling.

Group Type: ACTIVE_COMPARATOR

Control games

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Students can be older than 18 as long as they were 18 or younger at the time of signing consent

Exclusion Criteria

• Failure to meet any of the eligibility criteria

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn Fiellin, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Medicine (General Medicine) and in the Child Study Center; Director, Yale Center for Health & Learning Games; Director, play2PREVENT Lab at Yale

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R42HD088317-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1604017531_II

Identifier Type: -

Identifier Source: org_study_id