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NCT03049904
American Indian and Alaska Native Men Who Have Sex With Men HIV & Substance Abuse Research
NA trial testing Vr2L 2Spirit in HIV in 79 participants. Completed in 30 March 2018.
30 March 2018
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 79 |
| Start date | 19 February 2017 |
| Primary completion | 30 March 2018 |
| Estimated completion | 30 March 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vr2L 2Spirit
Conditions studied
- HIV — all drugs for HIV →
- Substance Use — all drugs for Substance Use →
Sponsor
University of Washington
Who can join
18 and older, male only, with HIV or Substance Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03049904
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03049904 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Washington
- Last refreshed: 30 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03049904.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing