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Clinical Trials/NCT02685410
NCT02685410CompletedNot Applicable

Formative Research for an HIV Videogame for Young Black Women

Yale University1 site in 1 country21 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: One Night Stan Prototype (Other)

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)
  • Incidence of Condom Use(Baseline)
  • Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission(Baseline)
  • Incidence of Vulnerability to Risky Sexual Behaviors(Baseline)
  • Incidence of Vulnerability to Risky Sexual Behaviors(2 Weeks)
  • HIV/STI Knowledge(Baseline)
  • HIV/STI Knowledge(2 Weeks)
  • Subjective Sexual Norms(Baseline)
  • Subjective Sexual Norms(2 Weeks)
  • Sexual Intentions(Baseline)
  • Sexual Intentions(2 Weeks)
  • Multi-dimensional Condom Attitudes Scale(Baseline)
  • Multi-dimensional Condom Attitudes Scale(2 Weeks)
  • Sexual Risk Behavior Beliefs(Baseline)
  • Sexual Risk Behavior Beliefs(2 Weeks)
  • Self-Efficacy in Sexual Risk Behaviors(Baseline)
  • Self-Efficacy in Sexual Risk Behaviors(2 Weeks)
  • Condom Self-Efficacy(Baseline)
  • Condom Self-Efficacy(2 Weeks)
  • Sexual Communication(Baseline)
  • Sexual Communication(2 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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