Clinical trial NCT04108988: A Digital Intervention for HIV Prevention in Black Adolescent Girls
Official title: A Digital Intervention for HIV Prevention in Black Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Risk Reduction Behavior
Keywords: Black adolescent girls
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-09-30
Enrollment: 117
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This study will develop and evaluate a multiplayer videogame aimed at Black adolescent girls with the intent of teaching the ability to negotiate around risk including advocating for partner HIV/STI testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.

The intervention will be developed and delivered as a social, multiplayer videogame, a compelling context for Black adolescent girls who constantly interact and seek counsel from their peers. To this end, the Specific Aims, focusing on Black adolescent girls aged 14-18 years, are to:

1. (Phase 1) Translate the culturally and socially-tailored card game One Night Stan to a multiplayer videogame called InvestiDate using game design and content experts and focus group input from 30 Black adolescent girls.
2. (Phase 2) Conduct a pilot randomized controlled trial comparing the multiplayer videogame InvestiDate (the new adaptation of the One Night Stan intervention) vs. an attention/control non-health-related multiplayer videogame with 80 participants collecting assessment data at baseline, one, and four months to:

   1. Determine the intervention's acceptability and feasibility by collecting quantitative and qualitative data on Black adolescent girls' satisfaction and gameplay experience of the intervention.
   2. Determine the preliminary impact of the intervention on knowledge (information), intentions/attitudes (motivation), social norms, and behavioral skills as related to: i) HIV/STI testing and partner testing and ii) condom use, and iii) sexual risk behavior reduction, such as alcohol and drug use.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: Feasibility Assessed Using Change in Retention Rates
timeFrame: Baseline, 1 month and 4 months
measure: Acceptability Assessed Via Self-reported Survey
timeFrame: 1 month
measure: Acceptability Assessed by Favorite Investidate Activities
timeFrame: Month 4
measure: Total Time Playing
timeFrame: Month 4
measure: Change From Baseline at 4 Months: HIV/STI Testing- Self
timeFrame: Baseline, 1 month and 4 months
measure: Change From Baseline at 4 Months: HIV/STI Testing- Partner
timeFrame: Baseline, 1 month and 4 months
Secondary outcomes:
measure: Change in Use of Condoms
timeFrame: Baseline, 1 month and 4 months
measure: Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES)
timeFrame: Baseline, 1 month, 4 months
measure: Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS)
timeFrame: Baseline, 1 month, 4 months
measure: Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS
timeFrame: Baseline, 1 month and 4 months
measure: Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS
timeFrame: Baseline, 1 month and 4 months
measure: Change in Self-efficacy for PrEP
timeFrame: Baseline, 1 month and 4 months
measure: Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS
timeFrame: Baseline, 1 month and 4 months
measure: Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS
timeFrame: Baseline, 1 month and 4 months
measure: Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP
timeFrame: Baseline, 1 months and 4 months
measure: Change in Sexually Transmitted Infections (STI)/HIV Knowledge
timeFrame: Baseline, 1 months and 4 months
measure: Change in Norms About Condom Use (NCU) Assessed Using the NCU Subscale of the SRBBS
timeFrame: Baseline, 1 months and 4 months
measure: Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS
timeFrame: Baseline, 1 months and 4 months
measure: Change in Perceived Norms About PrEP
timeFrame: Baseline, 1 months and 4 months
measure: Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS
timeFrame: Baseline, 1 months and 4 months
measure: Change in Behavior of Purchasing Condoms
timeFrame: Baseline, 1 month and 4 months
measure: Change in Behavior of Having Looked up a Place to Get HIV or STI Testing
timeFrame: Baseline, 1 month and 4 months
measure: Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI
timeFrame: Baseline, 1 month and 4 months
measure: Change in Birth Control Use
timeFrame: Baseline, 1 month and 4 months
measure: Change in Behavior Regarding Refusal to Have Sex
timeFrame: 1 month and 4 months
measure: Number of Participants Refusal to Have Sex
timeFrame: Baseline
measure: Number of Participants That Asked Partner About Previous Condom Use
timeFrame: Baseline
measure: Number of Times Participants Asked Partner About Previous Condom Use
timeFrame: 1 month and 4 months
measure: Number of Times Participants Talked to Family or Adults About HIV
timeFrame: baseline, 1 month and 4 months
measure: Number of Times Participants Engaged in Sexual Intercourse
timeFrame: baseline, 1 month and 4 months
measure: Number of Times Participants Engaged in Anal Sex
timeFrame: baseline, 1 month and 4 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Kimberly Hieftje
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly Hieftje, PhD
role: PRINCIPAL_INVESTIGATOR
References: