A Digital Intervention for HIV Prevention in Black Adolescent Girls

HIV Clinical Trial

Official title:

A Digital Intervention for HIV Prevention in Black Adolescent Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108988
• Other study ID #: 2000026487
• Secondary ID: 1R21HD098031-01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 24, 2022

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 24, 2022
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Risk Reduction Behavior

Intervention

Behavioral:
• InvestiDate
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).

Other:
• Non-Health Related Video Game
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).

Locations

Country	Name	City	State
United States	Kimberly Hieftje	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Total Time Playing	The mean total time spent playing the videogame	Month 4
Primary	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
Primary	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	Change in Use of Condoms	At each time point, participants responded to the item "Did you use a condom the last time you had sex?" Response options were "yes", "no", and "I have never had sex". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question.	Baseline, 1 month and 4 months
Secondary	Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES)	The CUSES is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. 10 of the 28 items were administered and scores were summed for each item for each participant. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. The possible range of scores is 0-40, with higher scores indicating greater self-efficacy.	Baseline, 1 month, 4 months
Secondary	Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS)	The SRBBS measure includes 3 items (e.g., "How sure ate you that you could use a condom correctly or explain to your partner how to use a condom correctly?") measured on a scale from 1 (not sure at all) to 5 (extremely sure). For each participant a mean of the 3 items was calculated. Scores range from 1-5 with higher scores indicating higher levels of self-efficacy.	Baseline, 1 month, 4 months
Secondary	Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS	This subscale includes three items (e.g., "Imagine that you met someone at a party. He or she wants to have sex with you. Even though you are very attracted to each other, you're not ready to have sex. How sure are you that you could keep from having sex") rated on a scale ranging from 1 (not sure at all) to 5 (extremely sure). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of self-efficacy for refusing sex.	Baseline, 1 month and 4 months
Secondary	Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS	Self-efficacy for communication was assessed using the SECM subscale of the SRBBS. This subscale includes three items (e.g., "Imagine that you and your partner have been having sex but have not used condoms. You really want to start using condoms. How sure are you that you could tell that person that you want to use condoms") rated on a scale ranging from 1 (not sure at all) to 5 (extremely sure). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of communication.	Baseline, 1 month and 4 months
Secondary	Change in Self-efficacy for PrEP	Self-Efficacy for using PrEP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of self-efficacy.	Baseline, 1 month and 4 months
Secondary	Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS	Attitudes about condom use were assessed using the ACU subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) attitudes about condom use and positive scores indicating positive (healthy) attitudes about condom use.	Baseline, 1 month and 4 months
Secondary	Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS	Attitudes about sexual intercourse were assessed using the ASI subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) attitudes about condom use and positive scores indicating positive (healthy) attitudes about sexual intercourse.	Baseline, 1 month and 4 months
Secondary	Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP	Intentions were measured with one item ("I intend to find a clinic in my community where I can speak to a doctor or health care provider about PrEP"). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating stronger intentions.	Baseline, 1 months and 4 months
Secondary	Change in Sexually Transmitted Infections (STI)/HIV Knowledge	STI/HIV knowledge was assessed using 12 questions for which participants could answer "true", "false", or "not sure". The answers were recoded as correct or incorrect, with "not sure" being coded as incorrect, and a sum was calculated for each participant. Scores range from 0 - 12 with higher scores indicating more STI-HIV knowledge.	Baseline, 1 months and 4 months
Secondary	Change in Norms About Condom Use (NCU) Assessed Using the NCU Subscale of the SRBBS	Norms about condom use were assessed using the NCU subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) perceived about condom use and positive scores indicating positive (healthy) perceived norms about sexual intercourse.	Baseline, 1 months and 4 months
Secondary	Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS	Norms about sexual intercourse were assessed using the NSI subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) perceived about condom use and positive scores indicating positive (healthy) perceived norms about sexual intercourse.	Baseline, 1 months and 4 months
Secondary	Change in Perceived Norms About PrEP	Perceived norms about the use of PrEP were assessed using a 2 item survey. Both items were rated from 1 (not at all) to 4 (a lot). A mean of the two items was calculated for each participant with score ranging from 1-4. Higher scores indicate more positive perceived norms about the use of PrEP.	Baseline, 1 months and 4 months
Secondary	Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS	The BCU subscale includes six items assessed on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). A mean score was calculated for each participant with score ranging from 1-5. Higher scores indicating more perceived barriers to condom use.	Baseline, 1 months and 4 months
Secondary	Change in Behavior of Purchasing Condoms	Participants reported on whether they had purchased condoms ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question.	Baseline, 1 month and 4 months
Secondary	Change in Behavior of Having Looked up a Place to Get HIV or STI Testing	Participants reported on whether they had looked up a place to get HIV or STI testing ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question.	Baseline, 1 month and 4 months
Secondary	Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI	Participants reported on whether they had talked with a partner about getting tested for HIV or STIs ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question.	Baseline, 1 month and 4 months
Secondary	Change in Birth Control Use	Participants were asked to indicate if they used birth control last time they had sex. The response options were "yes", "no", and "I have never had sex". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question.	Baseline, 1 month and 4 months
Secondary	Change in Behavior Regarding Refusal to Have Sex	At 1 month and 4 months, participants were asked if they had refused to have sex with a partner because he would not use a condom in the time since they first played the videogame over zoom as part of this research study. The response options were "yes" or "no".	1 month and 4 months
Secondary	Number of Participants Refusal to Have Sex	At baseline participants were asked to indicate if they had refused to have sex with a partner because he would not use a condom ever. Response options were "always", "most of the time", "about half the time", "sometimes", and "never".	Baseline
Secondary	Number of Participants That Asked Partner About Previous Condom Use	At baseline participants were asked how often they ask their sexual partners whether or not they have used a condom in previous sexual encounters? Response options were "always", "most of the time", "about half the time", "sometimes", and "never".	Baseline
Secondary	Number of Times Participants Asked Partner About Previous Condom Use	At 1 month and 4 months, participants were asked how many times they discussed condom use with a sexual partner since first playing the videogame on zoom as part of this research study.	1 month and 4 months
Secondary	Number of Times Participants Talked to Family or Adults About HIV	Participants were asked how many times they had talked with their family or other adults about HIV ever (baseline) or since they played the videogame on zoom as part of this research study (1 month, 4 months).	baseline, 1 month and 4 months
Secondary	Number of Times Participants Engaged in Sexual Intercourse	Participants were asked how many times they had engaged in sexual intercourse ever (baseline, post-intervention) or since playing the videogame on zoom as part of this research study (1 month, 4 months).	baseline, 1 month and 4 months
Secondary	Number of Times Participants Engaged in Anal Sex	Participants were asked how many times they had engaged in anal sex ever (baseline) or since playing the videogame on zoom as part of this research study (1 month, 4 months).	baseline, 1 month and 4 months