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

• ClinicalTrials.gov Identifier: NCT03713034
• Recruitment Status: Completed
• First Posted: October 19, 2018
• Results First Posted: January 18, 2022
• Last Update Posted: January 18, 2022
• Sponsor: Yale University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Prevention	Other: PlayTest!; Other: Control games	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 296 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Attitudes Around HIV Testing and Counseling [ Time Frame: Baseline, 4 weeks, 3 months and 6 months ]
   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.

Secondary Outcome Measures :

1. Intentions to Get Tested for HIV [ Time Frame: Baseline, 4 weeks, 3 months and 6 months ]
   Intentions were assessed with 7 items (e.g., "I intend to get tested for HIV at some point in the next 3 months" and "I intend to use a school-based health center 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 intentions. Participants had the option to respond "not sure" which was given a neutral score of 0. Higher scores equal greater intentions to get tested for HIV. The total range for scores was -14 to 14.
2. Number of Students Tested for HIV at Month 1 [ Time Frame: Month 1 ]
   The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.
3. Number of Students Tested for HIV at Month 2 [ Time Frame: Month 2 ]
   The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.
4. Number of Students Tested for HIV at Month 3 [ Time Frame: Month 3 ]
   The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.
5. Number of Students Tested for HIV at Month 4 [ Time Frame: month 4 ]
   The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.
6. Number of Students Tested for HIV at Month 5 [ Time Frame: Month 5 ]
   The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.
7. Number of Students Tested for HIV at Month 6 [ Time Frame: Month 6 ]
   The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.
8. Knowledge About HTC [ Time Frame: Baseline, 4 weeks, 3 months, 6 months ]
   Participants' knowledge about HTC was measured with 12 questions (e.g., "If you are tested for HIV, you have to wait a long time to find out the results" and "The earlier HIV is caught, the better chance a person has of effectively managing the virus"). Participants responded true, false, or not sure. Responses were recoded into 1 (correct) or 0 (incorrect; responses of "not sure" were coded as incorrect) and a sum of all 12 items was calculated to provide a HTC knowledge score for each participant (Total range was from 0 to 12.) Higher values represent higher knowledge around HTC.
9. Self-efficacy Around HIV Testing and Counseling [ Time Frame: Baseline, 4 weeks, 3 months, 6 months ]
   Self-efficacy for HTC was assessed with 4 items, rated on a confidence scale (e.g., "How confident are you that you could find information about how and where you can get STI and/or HIV testing?"). The total range was from 0-100. A higher score indicates a higher level of self-efficacy around HTC. A mean of the 4 items was calculated for each participant with higher scores indicating higher self-efficacy for HTC.
10. Self-efficacy Around Overall Health [ Time Frame: Baseline, 4 weeks, 3 months, 6 months ]
    Self-efficacy for managing overall health was assessed with 4 items, rated on a 100% confidence scale (e.g., "How confident are you that you could discuss your health concerns with a health provider?"). The total range was from 0-100%.A mean of the 4 items was calculated for each participant with higher scores indicating higher self-efficacy for managing overall health.
11. HIV Testing and Counseling Behavior (Self-Report) [ Time Frame: Baseline, 4 Weeks, 3 Months, 6 Months ]
    At each time point the participants indicated whether they had ever been tested for HIV with the response options: yes, no, not sure, and decline to answer.
12. Perceived Barriers to HIV Testing [ Time Frame: Baseline ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
13. Perceived Barriers to HIV Testing [ Time Frame: 4 weeks ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
14. Perceived Barriers to HIV Testing [ Time Frame: 3 months ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
15. Perceived Barriers to HIV Testing [ Time Frame: 6 months ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
16. Perceived Barriers to STI Testing [ Time Frame: Baseline ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
17. Perceived Barriers to STI Testing [ Time Frame: 4 weeks ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
18. Perceived Barriers to STI Testing [ Time Frame: 3 months ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.
19. Perceived Barriers to STI Testing [ Time Frame: 6 months ]
    Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Connecticut

Yale School of Medicine

New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

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

Investigators

• Principal Investigator: 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

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol and Statistical Analysis Plan  [PDF] January 17, 2021

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03713034
• Other Study ID Numbers: 1604017531_II; 5R42HD088317-03 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2018
• Results First Posted: January 18, 2022
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

HIV testing and counseling (HTC)