NCT02685410

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

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2016

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

February 12, 2016

Last Update Submit

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

EXPERIMENTAL

The pilot testing of the One Nigh Stan prototype intervention will utilize 20 young black women aged 18-24 as participants.

Other: One Night Stan Prototype

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.

One Night Stan Pilot Testing Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • African-American race
  • Female
  • Ages 18 to 24 yeats

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Study Officials

  • Kimberly D Hieftje, PhD

    Yale University

    PRINCIPAL INVESTIGATOR
  • Lynn Fiellin, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

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

Locations