Formative Research for an HIV Videogame for Young Black Women

NCT ID: NCT02685410

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Prevention STI Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One Night Stan Pilot Testing Group

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

Group Type EXPERIMENTAL

One Night Stan Prototype

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One Night Stan Prototype

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* African-American race
* Female
* Ages 18 to 24 yeats
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kimberly D Hieftje, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Lynn Fiellin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1301011336

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The LEARN Study for CVD Prevention
NCT05242952 COMPLETED NA