NCT02812329

Brief Summary

This study aims to minimize risk of human immunodeficiency virus (HIV) in adolescent boys and girls, ages 15-16, by promoting HIV testing and counseling (HTC) through the use of an interactive videogame. With input from focus groups of adolescents, the investigators will adapt an HIV prevention videogame, PlayForward: Elm City Stories, for adolescents ages 15-16 . The investigators will then pilot test the videogame in 30 adolescents to assess the acceptability and feasibility of the videogame. They will also assess whether the videogame increased the participants' intentions to obtain HTC, whether they actually obtained HTC, and whether the videogame increased knowledge of HIV.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

June 21, 2016

Last Update Submit

February 10, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team,

    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.

    After 3 weeks of using the videogame

  • Efficacy of a HIV prevention videogame measured by self-report questionnaire developed by the study team.

    Efficacy measure will include items on intentions around HIV Testing/Counseling and knowledge of HIV.

    Three weeks after 3 weeks of using the videogame

Secondary Outcomes (1)

  • Satisfaction/acceptability of the HIV prevention videogame measured by self-report questionnaire developed by the study team.

    After 3 weeks of using the videogame

Study Arms (1)

HIV prevention videogame

EXPERIMENTAL

Participants will play PlayForward on a tablet computer for 1 hour, two times per week for 3 weeks.

Behavioral: HIV prevention videogame

Interventions

Assess acceptability and efficacy of a HIV prevention videogame

HIV prevention videogame

Eligibility Criteria

Age15 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • participants must: 1) be 15-16 years of age and 2) be able to participate in a mobile videogame (willing to sit with a tablet computer for 60 minutes/session to play the game).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Lynn E. Fiellin, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 24, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 13, 2017

Record last verified: 2017-02