An interventional study of Vr2L 2Spirit in HIV and Substance Use, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
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.
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
Online Consent
An email is sent to the participant with consent information and baseline assessment links. Prior to beginning the baseline assessment in REDCap, participants will read and confirm their consent (click "I agree to participate" or "I do not wish to participate"). Once participants consent online, they are assigned a study survey ID number and take the baseline assessment.
Assessments
The assessment is conducted via Research Electronic Data Capture (REDCap) a mature, secure web application for building and managing online surveys and databases. After completing the baseline assessment, participants are randomly assigned to either the Immediate or the 3-week Waitlist group. Participants in the immediate group will be asked to complete 3 online assessments (Baseline, end of intervention, and 3-month follow up). Participants in the Waitlist group will be asked to complete 4 an additional assessment at the end of their wait period. Participants will be paid in Tango gift cards for each survey completed.
IMMEDIATE participants. After completing the Baseline assessment, they will receive an email containing: their Tango card information, the invitation to the private island, their unique Personal Identification Number (PIN) for accessing the private island as well as a Second Life® How-to guide and a community resource list.
WAITLIST participants. After completing the baseline assessment, they will enter a 3-week wait period. At the end of the 3-week wait period, they complete the Baseline 2 (End of waitlist) survey in REDCap. They will then proceed through the same steps as the Immediate group.
Intervention
The intervention in the Virtual Two Spirit (Vr2L 2Spirit) project is conducted exclusively online through the SL® platform. SL is a free and 3-dimensional online virtual world developed by Linden Lab.
Accessing the Vr2L 2Spirit Island
SL® consists of both public and private virtual spaces. The Vr2L 2Spirit island is a private island and only those avatars who have been authorized access by study staff are able to find it and enter it. Participants cannot grant access to other people.
The Vr2L 2Spirit island.
The island is split into three levels: 1) learning paths, 2) skill building, and 3) experimental. Access to the levels are locked hierarchically, meaning that until participants complete a lower level they will not gain access to the higher levels; however, once they successfully complete a level they are welcomed to return to it as often as they like. Participants are expected to complete each level in approximately one week; although they are allowed to complete it sooner and some may take a bit longer. We will encourage participants to move through the intervention in 3 weeks. Participants will be paid in Tango gift cards for each level completed whether they complete it in 2 days or in two weeks. If necessary, staff will use reminder emails, texts, in-world messages, and phone calls to encourage participants to complete the level in the allotted time.
Participants will be informed that their avatars' actions, interactions, and conversations with the programmed scenarios and with other avatars are considered data, and will be analyzed as part of the research study.
Level 1 - The Learning Level: 1st Week.
Learning Paths. The main component of level 1 is the learning paths. There are 4 learning paths that cover different areas of HIV prevention: safer sex, harm reduction, condom use, and HIV testing. Each learning paths consists of some combination of videos, scripted interactions, interactive exercises, and small quests or games.
While walking the paths, learning participants will have the opportunity to collect traditional medicines or materials (e.g., corn, prairie sage, birch bark, flowering tobacco). These collectibles can be turned into the lodge where the participant will learn about the traditional uses of these materials.
As participants move through the learning paths, they will gain in-world coins for completing tasks. The coins gained in the Vr2L 2Spirit island are specific to the Vr2L 2Spirit island only. Participants can use these coins to purchase in-world rewards such as additional customization for their avatar (e.g., clothing, hats, accessories, tattoos).
Level 2 - The City Level: 2nd Week.
The city level or skill-building level contains the clinic, the park, the bookstore, the Q-center, the nightclub, and the city store. The purpose of the city level is for participants to practice the knowledge gained in level 1 through quests, challenges, and role-play scenarios.
Challenges. There are six city challenges created to reinforce participants' knowledge. All challenges must be completed before gaining access to the Level 3 - Bathhouse.
Role play scenarios. Throughout the city participants will encounter a series of role-play scenarios related to harm reduction, safer sex, condom use, and HIV testing. The role-plays are scripted; however, they allow participants to make decisions throughout the interactions which will allow them to experience likely outcomes based on their choices. In order to move on to level 3, they must complete each scenario at least once.
Level 3 - The Experiential Level: 3rd Week.
Physically located in the city space of the Vr2L 2Spirit island, the area is nevertheless locked to participants until they complete all the challenges on level 2. Once participants have gained access, they will be in a "free play" area; although their interactions are still monitored and recorded. The participants is reminded of this through signage upon entering the locker room. There are no scripted interactions in this space. Interactions will be limited to other participants' avatars only.
End of Intervention Assessment Debrief Phone Call
On the next business day after the participant has completed one-week in Level 3 , they will receive the prompt to take the next online survey in REDCap.
Participants will also be contacted to schedule a debriefing interview with study staff. Participants will be asked debriefing questions about their experience in the virtual world.
Three Month Follow-up Assessment
Approximately three months after the participant completes Level 3 of the island, they will receive an email asking them to complete the final (follow-up) survey.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 79 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants wait 3 weeks before receiving the intervention.
Participants immediately begin their participation in the virtual world.
Behavioral: Vr2L 2Spirit
Three weeks exploring the Vr2L 2Spirit island. Week 1: Learning Level. Contains the Vr2L 2Spirit island orientation, the learning paths covering HIV testing, harm reduction, safer sex, and condom use \& condom use negotiation, the lodge, the in-world Motivational Interviewing (MI) counseling, and leisure activities. Week 2: Skills Building Level. The purpose of the city level is for participants to practice the knowledge gained in the Learning level through quests, challenges, and role play scenarios. Week 3: Experiential Level. Experiential interactions with other participants where they can practice the knowledge and skills they gained in the previous levels.
Change in Drug Use as assessed by Phen-X Toolkit for 30-Day Use
This measure can be used to assess the participant's recent consumption of a substance.
Time frame: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Change in Alcohol Use as assessed by Alcohol Use Disorders Identification Test (AUDIT)
Screening test developed for measuring excessive drinking.
Time frame: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Change in High Risk Sexual Behavior as assessed by National Institute on Drug Abuse (NIDA) HIV Risk Behavior questionnaire
Survey that measures injection and sexual risk behaviors for contracting HIV.
Time frame: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Change in HIV Testing behavior as assessed by STI / HIV Testing Self Efficacy
Survey that measures changes in confidence regarding STI and / or HIV testing behavior.
Time frame: Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up
Plan to share: No
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