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

NCT03713034 | Completed Results

• 2 other identifiers: 1604017531_II5R42HD088317-03
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Keywords

HIV testing and counseling (HTC)

Outcome Measures

Primary Outcomes (1)

• Attitudes Around HIV Testing and Counseling

  HTC attitudes were assessed with 7 items (e.g., "I feel it is important for me to get tested for HIV"). The items were scored on a 5-point scale ranging from - 2 (strongly disagree) to +2 (strongly agree) with positive values indicating healthier attitudes towards HTC. Participants had the option to respond "not sure" which was given a neutral score of 0. A mean of the seven items was calculated for each participant. A few items were reverse coded, because the lower value was indicating healthier attitudes. Not sure was coded as a neutral option. Higher scores equal more positive attitudes toward HIV testing and counseling.

  Baseline, 4 weeks, 3 months and 6 months

Secondary Outcomes (19)

• Intentions to Get Tested for HIV

  Baseline, 4 weeks, 3 months and 6 months

• Number of Students Tested for HIV at Month 1

  Month 1

• Number of Students Tested for HIV at Month 2

  Month 2

• Number of Students Tested for HIV at Month 3

  Month 3

• Number of Students Tested for HIV at Month 4

  month 4

Study Arms (2)

Active Game

EXPERIMENTAL

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.

Other: PlayTest!

Control Game

ACTIVE COMPARATOR

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.

Other: Control games

Interventions

PlayTest! 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.

Active Game

Control games 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.

Control Game

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Failure to meet any of the eligibility criteria

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Limitations and Caveats

This study was impacted by COVID. Please refer to attached data analysis document that highlights how COVID impacted the project and data collection.

Results Point of Contact

• Title: Tyra Pendergrass Boomer
• Organization: Yale University

tyra.pendergrass@yale.edu

(203) 737-6101

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 15, 2024
• Results First Posted: January 18, 2022

Record last verified: 2024-02

Locations

US (1)