Clinical trial NCT02685410: Formative Research for an HIV Videogame for Young Black Women
Official title: Formative Research for an HIV Videogame for Young Black Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
STI Prevention
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of Condom Use
timeFrame: 2 Weeks
measure: Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
timeFrame: 2 Weeks
Secondary outcomes:
measure: Incidence of Condom Use
timeFrame: Baseline
measure: Incidence of Condom Use
timeFrame: 4 Weeks
measure: Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
timeFrame: Baseline
measure: Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
timeFrame: 4 Weeks
measure: Incidence of Vulnerability to Risky Sexual Behaviors
timeFrame: Baseline
measure: Incidence of Vulnerability to Risky Sexual Behaviors
timeFrame: 2 Weeks
measure: Incidence of Vulnerability to Risky Sexual Behaviors
timeFrame: 4 Weeks
measure: HIV/STI Knowledge
timeFrame: Baseline
measure: HIV/STI Knowledge
timeFrame: 2 Weeks
measure: HIV/STI Knowledge
timeFrame: 4 Weeks
measure: Subjective Sexual Norms
timeFrame: Baseline
measure: Subjective Sexual Norms
timeFrame: 2 Weeks
measure: Subjective Sexual Norms
timeFrame: 4 Weeks
measure: Sexual Intentions
timeFrame: Baseline
measure: Sexual Intentions
timeFrame: 2 Weeks
measure: Sexual Intentions
timeFrame: 4 Weeks
measure: Multi-dimensional Condom Attitudes Scale
timeFrame: Baseline
measure: Multi-dimensional Condom Attitudes Scale
timeFrame: 2 Weeks
measure: Multi-dimensional Condom Attitudes Scale
timeFrame: 4 Weeks
measure: Sexual Risk Behavior Beliefs
timeFrame: Baseline
measure: Sexual Risk Behavior Beliefs
timeFrame: 2 Weeks
measure: Sexual Risk Behavior Beliefs
timeFrame: 4 Weeks
measure: Self-Efficacy in Sexual Risk Behaviors
timeFrame: Baseline
measure: Self-Efficacy in Sexual Risk Behaviors
timeFrame: 2 Weeks
measure: Self-Efficacy in Sexual Risk Behaviors
timeFrame: 4 Weeks
measure: Condom Self-Efficacy
timeFrame: Baseline
measure: Condom Self-Efficacy
timeFrame: 2 Weeks
measure: Condom Self-Efficacy
timeFrame: 4 Weeks
measure: Sexual Communication
timeFrame: Baseline
measure: Sexual Communication
timeFrame: 2 Weeks
measure: Sexual Communication
timeFrame: 4 Weeks
Other outcomes:
measure: Satisfaction with Game Play/Acceptability and Feasibility
timeFrame: 2 Weeks
Locations:
city: New haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly D Hieftje, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Lynn Fiellin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: