A Digital Intervention for HIV Prevention in Black Adolescent Girls

NCT04108988 | Completed Results DMC

• 2 other identifiers: 20000264871R21HD098031-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and evaluate an innovative behavioral HIV prevention videogame intervention to bolster motivation and provide skill-building opportunities to improve Black adolescent girls' ability to negotiate around risk including advocating for partner HIV/sexually transmitted infection (STI) testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.

Conditions

HIV; Risk Reduction Behavior

Keywords

Black adolescent girls

Outcome Measures

Primary Outcomes (6)

• Feasibility Assessed Using Change in Retention Rates

  Feasibility of this intervention is assessed by the percent of total questionnaires returned out of all distributed at each time point to assess retention rates. Rates \>80% indicate high retention.

  Baseline, 1 month and 4 months

• Acceptability Assessed Via Self-reported Survey

  Acceptability of the intervention condition is assessed via self-reported survey at the post gameplay time point using the game experience and satisfaction questionnaire, which is a 10-item scale with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 10-40. Data were collected from participants in the experimental group only. Higher scores indicate stronger agreement with the statement.

  1 month

• Acceptability Assessed by Favorite Investidate Activities

  Participants were asked to indicate (from a list) their favorite activity in the game. The data presented here indicates the total number of participants in the experimental group that selected each activity as their favorite.

  Month 4

• Total Time Playing

  The mean total time spent playing the videogame

  Month 4

• Change From Baseline at 4 Months: HIV/STI Testing- Self

  HIV/STI Testing- self will be used to determine if individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. Investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments. Data presented here shows the number of participants who said YES they had been tested out of the total number of participants in each group that responded to the question.

  Baseline, 1 month and 4 months

• Change From Baseline at 4 Months: HIV/STI Testing- Partner

  HIV/STI Testing- partner will be used to test the hypothesis that individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. The investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments.

  Baseline, 1 month and 4 months

Secondary Outcomes (25)

• Change in Use of Condoms

  Baseline, 1 month and 4 months

• Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES)

  Baseline, 1 month, 4 months

• Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS)

  Baseline, 1 month, 4 months

• Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS

  Baseline, 1 month and 4 months

• Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS

  Baseline, 1 month and 4 months

Study Arms (2)

InvestiDate Intervention

EXPERIMENTAL

One Night Stan will be adapted as a multiplayer videogame called InvestiDate based on the card game prototype with a focus on a slightly younger age group.

Behavioral: InvestiDate

Non-Health Related Game

PLACEBO COMPARATOR

Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate.

Other: Non-Health Related Video Game

Interventions

InvestiDate BEHAVIORAL

Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).

InvestiDate Intervention

Non-Health Related Video Game OTHER

Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).

Non-Health Related Game

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Both phases (includes focus groups- Phase 1)
• Black (race)
• Heterosexual
• Currently enrolled in high school
• Pilot Test (Phase 2)
• Ability to participate in web-based videogame
• Willing to sit for at least 60 minutes (to play the game)
• No HIV testing in the last 12 months
• Ability to provide assent or parental/guardian consent

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kimberly Hieftje

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

• Budge M, Opara I, Weser VU, Sands BE, Hieftje KD. Black Adolescent Females' Perceptions of PrEP for HIV Risk Reduction. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231206934. doi: 10.1177/23259582231206934.

  PMID: 37853731 DERIVED

• Weser V, Opara I, Budge M, Duncan L, Fernandes CF, Hussett-Richardson S, Sands B, Hieftje K. Pilot-testing a Multiplayer HIV and Sexually Transmitted Infection Prevention Video Game Intervention for Black Adolescent Girls: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 23;12:e43666. doi: 10.2196/43666.

  PMID: 36689272 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Kimberly Hieftje
• Organization: Yale School of Medicine

kimberly.hieftje@yale.edu

(203) 737-3301

Study Officials

• Kimberly Hieftje, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: February 1, 2022
• Primary Completion: September 24, 2022
• Study Completion: September 24, 2022
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-10

Locations

US (1)