A Digital Intervention for HIV Prevention in Black Adolescent Girls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Change From Baseline at 4 Months: HIV/STI Testing- Partner
研究概览
简要总结
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.
详细描述
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:
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(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.
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(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:
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Determine the intervention's acceptability and feasibility by collecting quantitative and qualitative data on Black adolescent girls' satisfaction and gameplay experience of the intervention.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Failure to meet inclusion criteria
结局指标
主要结局
Change From Baseline at 4 Months: HIV/STI Testing- Partner
时间窗: Baseline, 1 month and 4 months
HIV/STI Testing- partner will be used to test the hypothesis that individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. The investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments.
Change From Baseline at 4 Months: HIV/STI Testing- Self
时间窗: Baseline, 1 month and 4 months
HIV/STI Testing- self will be used to determine if individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. Investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments. Data presented here shows the number of participants who said YES they had been tested out of the total number of participants in each group that responded to the question.
Acceptability Assessed by Favorite Investidate Activities
时间窗: Month 4
Participants were asked to indicate (from a list) their favorite activity in the game. The data presented here indicates the total number of participants in the experimental group that selected each activity as their favorite.
Feasibility Assessed Using Change in Retention Rates
时间窗: Baseline, 1 month and 4 months
Feasibility of this intervention is assessed by the percent of total questionnaires returned out of all distributed at each time point to assess retention rates. Rates \>80% indicate high retention.
Acceptability Assessed Via Self-reported Survey
时间窗: 1 month
Acceptability of the intervention condition is assessed via self-reported survey at the post gameplay time point using the game experience and satisfaction questionnaire, which is a 10-item scale with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 10-40. Data were collected from participants in the experimental group only. Higher scores indicate stronger agreement with the statement.
Total Time Playing
时间窗: Month 4
The mean total time spent playing the videogame
次要结局
- Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS(Baseline, 1 month and 4 months)
- Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS(Baseline, 1 month and 4 months)
- Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP(Baseline, 1 months and 4 months)
- Number of Times Participants Asked Partner About Previous Condom Use(1 month and 4 months)
- Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS)(Baseline, 1 month, 4 months)
- Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS(Baseline, 1 month and 4 months)
- Change in Norms About Condom Use (NCU) Assessed Using the NCU Subscale of the SRBBS(Baseline, 1 months and 4 months)
- Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS(Baseline, 1 months and 4 months)
- Change in Behavior of Having Looked up a Place to Get HIV or STI Testing(Baseline, 1 month and 4 months)
- Change in Use of Condoms(Baseline, 1 month and 4 months)
- Change in Self-efficacy for PrEP(Baseline, 1 month and 4 months)
- Change in Perceived Norms About PrEP(Baseline, 1 months and 4 months)
- Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS(Baseline, 1 month and 4 months)
- Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS(Baseline, 1 months and 4 months)
- Change in Birth Control Use(Baseline, 1 month and 4 months)
- Number of Participants Refusal to Have Sex(Baseline)
- Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES)(Baseline, 1 month, 4 months)
- Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI(Baseline, 1 month and 4 months)
- Change in Behavior Regarding Refusal to Have Sex(1 month and 4 months)
- Number of Times Participants Engaged in Sexual Intercourse(baseline, 1 month and 4 months)
- Change in Sexually Transmitted Infections (STI)/HIV Knowledge(Baseline, 1 months and 4 months)
- Change in Behavior of Purchasing Condoms(Baseline, 1 month and 4 months)
- Number of Participants That Asked Partner About Previous Condom Use(Baseline)
- Number of Times Participants Talked to Family or Adults About HIV(baseline, 1 month and 4 months)
- Number of Times Participants Engaged in Anal Sex(baseline, 1 month and 4 months)