HIV PreventionNCT03713034
An Accessible Digital Intervention to Promote HIV Testing/Counseling and Prevention Among Adolescents
A study testing PlayTest! in people with HIV Prevention, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- PlayTest!
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Failure to meet any of the eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health
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.
Read the 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
- Being tested
- PlayTest!, Control games
- Keywords
- HIV testing and counseling (HTC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control gamesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 3 months and 6 months
Secondary outcomes (19)
Intentions to Get Tested for HIV
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.
Measured: Baseline, 4 weeks, 3 months and 6 months
Number of Students Tested for HIV at 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.
Measured: Month 1
Number of Students Tested for HIV at 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.
Measured: Month 2
Number of Students Tested for HIV at 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.
Measured: Month 3
Number of Students Tested for HIV at 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.
Measured: month 4
Number of Students Tested for HIV at 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.
Measured: Month 5
Number of Students Tested for HIV at 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.
Measured: Month 6
Knowledge About HTC
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.
Measured: Baseline, 4 weeks, 3 months, 6 months
Self-efficacy Around HIV Testing and Counseling
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.
Measured: Baseline, 4 weeks, 3 months, 6 months
Self-efficacy Around Overall Health
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.
Measured: Baseline, 4 weeks, 3 months, 6 months
HIV Testing and Counseling Behavior (Self-Report)
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.
Measured: Baseline, 4 Weeks, 3 Months, 6 Months
Perceived Barriers to HIV Testing
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.
Measured: Baseline
Perceived Barriers to HIV Testing
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.
Measured: 4 weeks
Perceived Barriers to HIV Testing
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.
Measured: 3 months
Perceived Barriers to HIV Testing
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.
Measured: 6 months
Perceived Barriers to STI Testing
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 an STI (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.
Measured: Baseline
Perceived Barriers to STI Testing
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 an STI (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.
Measured: 4 weeks
Perceived Barriers to STI Testing
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 an STI (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.
Measured: 3 months
Perceived Barriers to STI Testing
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 an STI (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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lynn Fiellin, MD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713034
- Sponsor's protocol ID
- 1604017531_II
- Other IDs
- 5R42HD088317-03
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2018
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health
- ClinicalTrials.gov ID
- NCT03713034
- Acronym / sponsor ID
- 1604017531_II
- Conditions
- HIV Prevention
- Keywords
- HIV testing and counseling (HTC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Game | Experimental | Other: PlayTest!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. |
| Control Game | Active comparator | Other: Control gamesSome 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet any of the eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active Game |
| Control gamesParticipants in the control arm played the games on their assigned iPads once per week for an hour over the course of 4-5 weeks. | Other | Control Game |
Primary outcome
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.
19 secondary outcomes
Intentions to Get Tested for HIV
Time frame: Baseline, 4 weeks, 3 months and 6 months
Number of Students Tested for HIV at Month 1
Time frame: Month 1
Number of Students Tested for HIV at Month 2
Time frame: Month 2
Number of Students Tested for HIV at Month 3
Time frame: Month 3
Number of Students Tested for HIV at Month 4
Time frame: month 4
Number of Students Tested for HIV at Month 5
Time frame: Month 5
Number of Students Tested for HIV at Month 6
Time frame: Month 6
Knowledge About HTC
Time frame: Baseline, 4 weeks, 3 months, 6 months
Self-efficacy Around HIV Testing and Counseling
Time frame: Baseline, 4 weeks, 3 months, 6 months
Self-efficacy Around Overall Health
Time frame: Baseline, 4 weeks, 3 months, 6 months
HIV Testing and Counseling Behavior (Self-Report)
Time frame: Baseline, 4 Weeks, 3 Months, 6 Months
Perceived Barriers to HIV Testing
Time frame: Baseline
Perceived Barriers to HIV Testing
Time frame: 4 weeks
Perceived Barriers to HIV Testing
Time frame: 3 months
Perceived Barriers to HIV Testing
Time frame: 6 months
Perceived Barriers to STI Testing
Time frame: Baseline
Perceived Barriers to STI Testing
Time frame: 4 weeks
Perceived Barriers to STI Testing
Time frame: 3 months
Perceived Barriers to STI Testing
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Fiellin, MD 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlayTest! in people with HIV Prevention, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes Around HIV Testing and Counseling (time frame: Baseline, 4 weeks, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.