A Digital Intervention for HIV Prevention in Black Adolescent Girls
NCT ID: NCT04108988
Last Updated: 2023-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2022-02-01
2022-09-24
Brief Summary
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Detailed Description
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The intervention will be developed and delivered as a social, multiplayer videogame, a compelling context for Black adolescent girls who constantly interact and seek counsel from their peers. To this end, the Specific Aims, focusing on Black adolescent girls aged 14-18 years, are to:
1. (Phase 1) Translate the culturally and socially-tailored card game One Night Stan to a multiplayer videogame called InvestiDate using game design and content experts and focus group input from 30 Black adolescent girls.
2. (Phase 2) Conduct a pilot randomized controlled trial comparing the multiplayer videogame InvestiDate (the new adaptation of the One Night Stan intervention) vs. an attention/control non-health-related multiplayer videogame with 80 participants collecting assessment data at baseline, one, and four months to:
1. Determine the intervention's acceptability and feasibility by collecting quantitative and qualitative data on Black adolescent girls' satisfaction and gameplay experience of the intervention.
2. Determine the preliminary impact of the intervention on knowledge (information), intentions/attitudes (motivation), social norms, and behavioral skills as related to: i) HIV/STI testing and partner testing and ii) condom use, and iii) sexual risk behavior reduction, such as alcohol and drug use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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InvestiDate Intervention
One Night Stan will be adapted as a multiplayer videogame called InvestiDate based on the card game prototype with a focus on a slightly younger age group.
InvestiDate
Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
Non-Health Related Game
Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate.
Non-Health Related Video Game
Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
Interventions
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InvestiDate
Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
Non-Health Related Video Game
Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
Eligibility Criteria
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Inclusion Criteria
* Black (race)
* Heterosexual
* Currently enrolled in high school
Pilot Test (Phase 2)
* Ability to participate in web-based videogame
* Willing to sit for at least 60 minutes (to play the game)
* No HIV testing in the last 12 months
* Ability to provide assent or parental/guardian consent
14 Years
18 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Kimberly Hieftje, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Kimberly Hieftje
New Haven, Connecticut, United States
Countries
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References
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Budge M, Opara I, Weser VU, Sands BE, Hieftje KD. Black Adolescent Females' Perceptions of PrEP for HIV Risk Reduction. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231206934. doi: 10.1177/23259582231206934.
Weser V, Opara I, Budge M, Duncan L, Fernandes CF, Hussett-Richardson S, Sands B, Hieftje K. Pilot-testing a Multiplayer HIV and Sexually Transmitted Infection Prevention Video Game Intervention for Black Adolescent Girls: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 23;12:e43666. doi: 10.2196/43666.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Compound
Document Type: Informed Consent Form: Adolescent
Document Type: Informed Consent Form: Parent
Other Identifiers
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2000026487
Identifier Type: -
Identifier Source: org_study_id
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