Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03049904 |
| Other study ID # |
STUDY00000597 |
| Secondary ID |
5K24DA031613 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 19, 2017 |
| Est. completion date |
March 30, 2018 |
Study information
| Verified date |
April 2018 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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
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.
1. Orientation. After the participants' avatar authentication is completed, they will
teleport to the orientation caves. Here they will receive a brief orientation to the
Vr2L 2Spirit island and a refresher on basic SL skills needed to successfully navigate
the virtual experience. Afterward they are free to explore the Vr2L 2Spirit island.
2. In-World Counseling. Participants will have the option of receiving up to two free
Motivational Interviewing (MI) counseling sessions in the Vr2L 2Spirit island with an MI
trained counselor. The counseling sessions will be confidential and will be an
opportunity for participants to discuss their goals during their participation in this
study.
3. 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.
1. Safer sex. Includes information on Pre-Exposure Prophylaxis (PrEP): what it is, how
to use it, and how to obtain it. It also covers the risks of sexual intercourse
with multiple partners and ways participants can protect themselves and their
partners. Additionally, it covers strategic positioning, sero-sorting and its
risks. Finally, it addresses partner's behavior and ways in which the participant
can protect themselves and their partner.
2. Harm reduction. Includes a definition of harm reduction, information on how one can
reduce harm from IDU, other substances, and binge drinking. Finally, it addresses
how to decrease IDU risk of HIV exposure.
3. Condom use / condom negotiation. Includes information on the different types of
condoms, how to use them, and how to bring up and negotiate condom use with your
partner.
4. HIV Testing. Includes information on types of HIV tests, where to find testing
sites, the testing experience, and what happens after your HIV results are back.
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).
4. The Lodge. It contains the MI counseling rooms, a smudging station, the collectibles
station, the store containing avatar accessories (e.g., clothing, hats, sunglasses,
jewelry). There is also a receptionist available to answer participants' questions.
5. Leisure activities. Level 1 also contains many opportunities for leisure activities such
as horseback riding, canoeing, wind surfing, drum circle and a camp fire among others.
These activities are not a required portion of the interaction and are instead created
to enhance the immersion experience, provide fun and relaxation alongside the learning
experience, and allow for participants to build camaraderie with their fellow
participants.
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.
1. Challenges. There are six city challenges created to reinforce participants' knowledge.
All challenges must be completed before gaining access to the Level 3 - Bathhouse.
1. HIV Test. In the clinic, the avatar will have the opportunity to take a Rapid
Response HIV test at the clinic. The participant will have the option of selecting
their avatar's HIV status or be randomly assigned an HIV status after taking the
test.
2. PrEP. If HIV negative, avatar will have the option of requesting a prescription for
Pre-Exposure Prophylaxis (PrEP) at the city clinic. Participants will receive
counseling regarding PrEP and will be able to purchase the PrEP prescription at the
city store.
3. Condoms. Avatars will be required to pick up free latex condoms at the city clinic.
They also have the option of purchasing polyurethane, polyisoprene, or sheepskin
condoms at the city store.
4. Needle exchange. Avatars will be required to find a dirty needle in the city and
exchange it for a clean needle at the clinic. Using the dirty or clean needle is
not required.
5. Book challenge. Hidden around the city landscape are six books. Every time an
avatar finds a book, they are given a fact related to HIV prevention.
6. Role play scenarios. More information below.
2. 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.
1. Drug use. This role-play will allow participants to practice the skills around harm
reduction with intravenous drug use (IDU).
2. Anonymous / Casual sex. This role-play allows the participant the opportunity to
practice skills around anonymous / casual sexual intercourse.
3. Binge drinking. This role-play allows the participant the opportunity to practice
skills around harm reduction related to binge drinking.
4. Condom use. This role-play allows the participant the opportunity to practice
skills around condom use and condom use negotiation.
5. Teaching opportunity. This role-play allows the participant the opportunity to
assume the role of teacher. They will encounter a younger Native American man who
has questions about the four content areas. The participant will have the
opportunity to answer the stranger's questions thus reinforcing their own
knowledge.
6. HIV Testing. This role-play scenario allows the participant to gain further
knowledge about the HIV testing experience.
3. At the end of level 2. After completing all the city challenges, participants are
granted access to Level 3 - Experiential.
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.
