American Indian and Alaska Native Men Who Have Sex With Men HIV & Substance Abuse Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Change in High Risk Sexual Behavior as assessed by National Institute on Drug Abuse (NIDA) HIV Risk Behavior questionnaire
研究概览
简要总结
This is a pilot study of the feasibility of the virtually reality, online, culturally grounded HIV prevention intervention for Native American men who have sex with men. The project will include 90 Native American men who have sex with men (MSM) from across the continental United States as well as Alaska and Hawaii.
The investigators will use a randomized clinical trial with a waitlist control condition to evaluate the intervention's impact on HIV / Sexually Transmitted Infections (STI) testing behavior, condom use, and substance use harm reduction. Specifically, investigators will ask participants to spend 3 weeks exploring a virtual reality environment hosted in the Second Life® platform. The island consists of 3 levels: Learning Level, Skills building level, and Experiential level.
In the Learning level the participant's avatar will have the opportunity to attend up to 2 free Motivational Interviewing sessions to establish their goals for their time on the island. Additionally, they will explore 4 learning paths each covering a knowledge objective: HIV Testing, Condom Use & Condom Use Negotiation, Safer Sex, and Harm Reduction. Each path will present knowledge via videos, interactive games, stories, and teachings. After completing level 1, participants will move on to the Skills building level. Here participants will have the opportunity to role play scenarios (e.g., obtaining an HIV test, requesting PrEP from their doctor, negotiating condom use) with pre-program virtual actors. All scenarios are based on the knowledge gained in the Learning Level. Participants will also engage on mini-quests for additional knowledge and in-world rewards. Finally, in the third level participants will be able to practice the skills learned in interactions with other participants' avatars.
If efficacious, this online HIV prevention intervention has the potential for widespread dissemination and could be particularly helpful for rural and reservation-based Native MSM who often have difficulty accessing services and support.
详细描述
Recruitment
Recruitment is nationwide via online ads in Gay, Bisexual, Trans, and Questioning (GBTQ) dating sites such as Grindr, GROWLr, Jack'd, etc. Investigators will send emails and flyers to partners in GBTQ and Two-Spirit organizations for them to advertise within their listservs and centers. Finally, investigators and project consultants will reach out to other researchers and community partners asking them to advertise the project within their own communities and organizations. Investigators expect a certain amount of "word-of-mouth" recruitment to occur as well.
Screening
- Participants are screened over the phone using a screening script.
- Men who screen out will be given a community resource list either by mail or email.
- If a person is eligible, but declines to participate, they will be given a brief one item exit question regarding general reason for nonparticipation.
- If needed, participants are walked through the process of creating a free Second Life® (SL) account and downloading the SL software onto their computer.
Online Consent
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years old or older
- •Self-identified as American Indian or Alaska Native
- •Either: enrolled in their Tribe; eligible for enrollment in their Tribe; OR at least ¼ blood quantum (across all tribes).
- •Male (assigned "male" gender at birth or assigned "female" gender at birth but now identify as "male")
- •Have access to a computer with internet access and the ability to download the Second Life® software.
- •Reside within the United States of America
- •Have engaged in sexual intercourse with a man in the previous 3 months.
- •Have used substance (drugs or alcohol) in the previous 3 months.
- •Either unknown HIV status or HIV negative.
排除标准
- •Suicidal ideation, plan, or attempt in the previous 2 weeks.
- •Younger than 18 years old
- •Non-Native American
研究组 & 干预措施
Wait List Control
Participants wait 3 weeks before receiving the intervention.
Experimental Vr2L 2Spirit
Participants immediately begin their participation in the virtual world.
干预措施: Vr2L 2Spirit (Behavioral)
结局指标
主要结局
Change in High Risk Sexual Behavior as assessed by National Institute on Drug Abuse (NIDA) HIV Risk Behavior questionnaire
时间窗: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Survey that measures injection and sexual risk behaviors for contracting HIV.
Change in HIV Testing behavior as assessed by STI / HIV Testing Self Efficacy
时间窗: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Survey that measures changes in confidence regarding STI and / or HIV testing behavior.
Change in Alcohol Use as assessed by Alcohol Use Disorders Identification Test (AUDIT)
时间窗: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Screening test developed for measuring excessive drinking.
Change in Drug Use as assessed by Phen-X Toolkit for 30-Day Use
时间窗: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
This measure can be used to assess the participant's recent consumption of a substance.
次要结局
未报告次要终点
研究者
Karina Walters
Associate Dean for Research; William P. and Ruth Gerberding Endowed University Professor
University of Washington