Formative Research for an HIV Videogame for Young Black Women
1 other identifier
interventional
21
1 country
1
Brief Summary
As part of Yale's Play2Prevent (www.Play2Prevent.org) program to develop videogame-based interventions targeting risk reduction and prevention in youth and young adults, this study is designed to develop a paper prototype and intervention design manual of an online social-network game, One Night Stan, with the goal of risk reduction and HIV/STI prevention in young black women. The ultimate plan is to incorporate focus group participants input and feedback into the development of a conceptual model, intervention manual, and videogame intervention prototype. This prototype will then be tested using 20 participants and will utilize a pre-post design to evaluate the effectiveness of the program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2016
CompletedFebruary 13, 2017
February 1, 2017
3.5 years
February 12, 2016
February 10, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Condom Use
The program will be assessed by determining if an increase in the incidence of condom use by participants occurred after 2 weeks exposure to the program.
2 Weeks
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
The program will be assessed by determining if a decrease in the incidence of risk behaviors associated with HIV/STI transmission by participants occurred after 2 weeks exposure to the program.
2 Weeks
Secondary Outcomes (31)
Incidence of Condom Use
Baseline
Incidence of Condom Use
4 Weeks
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
Baseline
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
4 Weeks
Incidence of Vulnerability to Risky Sexual Behaviors
Baseline
- +26 more secondary outcomes
Other Outcomes (1)
Satisfaction with Game Play/Acceptability and Feasibility
2 Weeks
Study Arms (1)
One Night Stan Pilot Testing Group
EXPERIMENTALThe pilot testing of the One Nigh Stan prototype intervention will utilize 20 young black women aged 18-24 as participants.
Interventions
The One Night Stan prototype, will be a social network game with the goal of risk reduction and HIV/STI prevention in young black women.
Eligibility Criteria
You may qualify if:
- African-American race
- Female
- Ages 18 to 24 yeats
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly D Hieftje, PhD
Yale University
- PRINCIPAL INVESTIGATOR
Lynn Fiellin, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2016
First Posted
February 18, 2016
Study Start
January 1, 2013
Primary Completion
June 18, 2016
Study Completion
June 18, 2016
Last Updated
February 13, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share