American Indian and Alaska Native Men Who Have Sex With Men HIV & Substance Abuse Research

NCT03049904 | Completed DMC

• 2 other identifiers: STUDY000005975K24DA031613
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Substance Use

Keywords

Indian, North America; Male, Two-Spirit; HIV Prevention; MSM

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and Post Intervention (1 month); Baseline and 3 month Follow-up

Study Arms (2)

Wait List Control

NO INTERVENTION

Participants wait 3 weeks before receiving the intervention.

Experimental Vr2L 2Spirit

EXPERIMENTAL

Participants immediately begin their participation in the virtual world.

Behavioral: Vr2L 2Spirit

Interventions

Vr2L 2Spirit BEHAVIORAL

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.

Experimental Vr2L 2Spirit

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Assigned "male" gender at birth or assigned "female" gender at birth but now identify as "male"
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suicidal ideation, plan, or attempt in the previous 2 weeks.
• Women
• Younger than 18 years old
• Non-Native American

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karina L Walters, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research; William P. and Ruth Gerberding Endowed University Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 10, 2017
• Study Start: February 19, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)