A Digital Intervention for HIV Prevention in Black Adolescent Girls

NCT ID: NCT04108988

Last Updated: 2023-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-09-24

Brief Summary

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The purpose of this study is to develop and evaluate an innovative behavioral HIV prevention videogame intervention to bolster motivation and provide skill-building opportunities to improve Black adolescent girls' ability to negotiate around risk including advocating for partner HIV/sexually transmitted infection (STI) testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.

Detailed Description

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This study will develop and evaluate a multiplayer videogame aimed at Black adolescent girls with the intent of teaching the ability to negotiate around risk including advocating for partner HIV/STI testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.

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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HIV Risk Reduction Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

InvestiDate

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Non-Health Related Video Game

Intervention Type OTHER

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).

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Both phases (includes focus groups- Phase 1)

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 37853731 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36689272 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Compound

View Document

Document Type: Informed Consent Form: Adolescent

View Document

Document Type: Informed Consent Form: Parent

View Document

Other Identifiers

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1R21HD098031-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000026487

Identifier Type: -

Identifier Source: org_study_id

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