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Clinical Trials/NCT02685410
NCT02685410
Completed
N/A

Formative Research for an HIV Videogame for Young Black Women

Yale University1 site in 1 country21 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Prevention
Sponsor
Yale University
Enrollment
21
Locations
1
Primary Endpoint
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
Status
Completed
Last Updated
9 years ago

Overview

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.

Detailed Description

The specific aims of this study are to: Develop an online social network game for HIV/STI risk reduction and prevention by conducting a first set of focus groups with a total of 25 participants (5 focus groups with 5 participants each) in order to better understand preferences for online social network and gaming platforms, characteristics and design. These collected data, established theoretical constructs, and the literature will be harnessed to develop a conceptual model for HIV/STI risk reduction and prevention in this specific population of women. From the data collected and the new conceptual model, an intervention manual will be created that will incorporate a culturally and socially-tailored online social network game intervention paper prototype and design manual. In an iterative fashion, a second series of focus groups will be conducted (5 groups with 5 participants each for a total of 25 participants) to refine the intervention. To pilot test the prototype intervention we will determine, in a pre-post design: (a) the intervention's acceptability and feasibility based on self-report data on the game experience and (b) preliminary evidence of the efficacy of the intervention collecting data on 1) HIV/STI knowledge 2) intentions/attitudes regarding condom use and HIV/STI partner testing 3) self-efficacy to insist on condom use and HIV/STI partner testing 4) self-efficacy and beliefs related to sexual risk behaviors, 4) perceived social norms, and 5) behaviors related to condom use and partner HIV/STI testing. The focus of this registration record will be the participants and collected outcomes used to assess the prototype of the social network game. Assessments will be conducted at baseline, 2 weeks after playing the game and at 4 weeks post follow up.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 18, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • African-American race
  • Ages 18 to 24 yeats

Exclusion Criteria

  • Failure to meet all inclusion criteria will exclude individuals from participation in the study

Outcomes

Primary Outcomes

Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission

Time Frame: 2 Weeks

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.

Incidence of Condom Use

Time Frame: 2 Weeks

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.

Secondary Outcomes

  • Incidence of Condom Use(4 Weeks)
  • Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission(4 Weeks)
  • Incidence of Vulnerability to Risky Sexual Behaviors(4 Weeks)
  • HIV/STI Knowledge(4 Weeks)
  • Subjective Sexual Norms(4 Weeks)
  • Sexual Risk Behavior Beliefs(4 Weeks)
  • Sexual Intentions(4 Weeks)
  • Multi-dimensional Condom Attitudes Scale(4 Weeks)
  • Self-Efficacy in Sexual Risk Behaviors(4 Weeks)
  • Condom Self-Efficacy(4 Weeks)
  • Sexual Communication(4 Weeks)

Study Sites (1)

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