NCT04108988

A Digital Intervention for HIV Prevention in Black Adolescent Girls

Completed NA Results posted Last updated 8 November 2023

What this trial tests

NA trial testing InvestiDate in HIV in 117 participants. Completed in 24 September 2022.

Timeline

1 February 2022

Primary endpoint
24 September 2022

24 September 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	117
Start date	1 February 2022
Primary completion	24 September 2022
Estimated completion	24 September 2022
Sites	1 location across United States

Drugs / interventions tested

• InvestiDate
• Non-Health Related Video Game

Conditions studied

• HIV — all drugs for HIV →
• Risk Reduction Behavior — all drugs for Risk Reduction Behavior →

Sponsor

Yale University

Who can join

Adults 14 to 18, female only, with HIV or Risk Reduction Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility Assessed Using Change in Retention Rates Primary · Baseline, 1 month and 4 months

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

Group	Value	95% CI
InvestiDate Intervention	97.5
Non-Health Related Game	97.4

1 month

Group	Value	95% CI
InvestiDate Intervention	97.5
Non-Health Related Game	100

4 months

Group	Value	95% CI
InvestiDate Intervention	92.5
Non-Health Related Game	100

Acceptability Assessed Via Self-reported Survey Primary · 1 month

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.

I would play this game again

Group	Value	95% CI
InvestiDate Intervention	3.64	± 0.54

I was frustrated with this game

Group	Value	95% CI
InvestiDate Intervention	1.54	± 0.56

I would make decisions in real life like I made them in the game

Group	Value	95% CI
InvestiDate Intervention	3.44	± 0.75

I liked the way the game looked

Group	Value	95% CI
InvestiDate Intervention	3.51	± 0.68

I felt connected to the characters in the game

Group	Value	95% CI
InvestiDate Intervention	3.03	± 0.67

I felt responsible for the choices I made in the game

Group	Value	95% CI
InvestiDate Intervention	3.54	± 0.51

I liked talking with other players about what was happening in the game

Group	Value	95% CI
InvestiDate Intervention	3.51	± 0.56

I enjoyed playing the game agree

Group	Value	95% CI
InvestiDate Intervention	3.75	± 0.44

Acceptability Assessed by Favorite Investidate Activities Primary · Month 4

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.

Investigate a guy

Group	Value	95% CI
InvestiDate Intervention	21

Trivia

Group	Value	95% CI
InvestiDate Intervention	11

Presentation

Group	Value	95% CI
InvestiDate Intervention	3

Chat with a guy

Group	Value	95% CI
InvestiDate Intervention	3

Chat with a doctor

Group	Value	95% CI
InvestiDate Intervention	0

Chat with a friend

Group	Value	95% CI
InvestiDate Intervention	0

Videos with advice from Chelsea and Brandon

Group	Value	95% CI
InvestiDate Intervention	1

Total Time Playing Primary · Month 4

The mean total time spent playing the videogame

Group	Value	95% CI
InvestiDate Intervention	105.56	± 12.92

Change From Baseline at 4 Months: HIV/STI Testing- Self Primary · Baseline, 1 month and 4 months

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

Baseline

Group	Value	95% CI
InvestiDate Intervention	4
Non-Health Related Game	8

1 month

Group	Value	95% CI
InvestiDate Intervention	2
Non-Health Related Game	9

4 months

Group	Value	95% CI
InvestiDate Intervention	4
Non-Health Related Game	8

Change From Baseline at 4 Months: HIV/STI Testing- Partner Primary · Baseline, 1 month and 4 months

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

Group	Value	95% CI
InvestiDate Intervention	8
Non-Health Related Game	10

1 month

Group	Value	95% CI
InvestiDate Intervention	8
Non-Health Related Game	11

4 months

Group	Value	95% CI
InvestiDate Intervention	4
Non-Health Related Game	8

Change in Use of Condoms Secondary · Baseline, 1 month and 4 months

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

Group	Value	95% CI
InvestiDate Intervention	11
Non-Health Related Game	9

1 month

Group	Value	95% CI
InvestiDate Intervention	7
Non-Health Related Game	8

4 months

Group	Value	95% CI
InvestiDate Intervention	4
Non-Health Related Game	7

Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES) Secondary · Baseline, 1 month, 4 months

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

Group	Value	95% CI
InvestiDate Intervention	24.5	± 6.35
Non-Health Related Game	27.52	± 5.7

1 month

Group	Value	95% CI
InvestiDate Intervention	29.3	± 5.46
Non-Health Related Game	26.61	± 5.56

4 months

Group	Value	95% CI
InvestiDate Intervention	28.3	± 6.07
Non-Health Related Game	28.09	± 6.64

Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS) Secondary · Baseline, 1 month, 4 months

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

Group	Value	95% CI
InvestiDate Intervention	2.87	± 0.99
Non-Health Related Game	3.02	± 1.07

1 month

Group	Value	95% CI
InvestiDate Intervention	3.71	± 1.13
Non-Health Related Game	3.33	± 1.09

4 months

Group	Value	95% CI
InvestiDate Intervention	3.62	± 1.06
Non-Health Related Game	3.57	± 0.74

Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS Secondary · Baseline, 1 month and 4 months

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

Group	Value	95% CI
InvestiDate Intervention	4.03	± 0.81
Non-Health Related Game	3.98	± 0.87

1 month

Group	Value	95% CI
InvestiDate Intervention	4.4	± 0.75
Non-Health Related Game	3.88	± 0.94

4 months

Group	Value	95% CI
InvestiDate Intervention	4.4	± 0.83
Non-Health Related Game	4.07	± 0.88

Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS Secondary · Baseline, 1 month and 4 months

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

Group	Value	95% CI
InvestiDate Intervention	4.14	± 0.67
Non-Health Related Game	4.13	± 0.77

1 month

Group	Value	95% CI
InvestiDate Intervention	4.45	± 0.62
Non-Health Related Game	4.06	± 0.87

4 months

Group	Value	95% CI
InvestiDate Intervention	4.37	± 0.74
Non-Health Related Game	4.05	± 0.87

Change in Self-efficacy for PrEP Secondary · Baseline, 1 month and 4 months

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

Group	Value	95% CI
InvestiDate Intervention	4.16	± 0.78
Non-Health Related Game	4.13	± 0.75

1 month

Group	Value	95% CI
InvestiDate Intervention	4.51	± 0.57
Non-Health Related Game	4.16	± 0.71

4 months

Group	Value	95% CI
InvestiDate Intervention	4.42	± 0.82
Non-Health Related Game	4.32	± 0.69

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Black Adolescent Females' Perceptions of PrEP for HIV Risk Reduction.
   Budge M, Opara I, Weser VU, Sands BE, et al · · 2023 · cited 2× · PMID 37853731 · DOI 10.1177/23259582231206934
2. Pilot-testing a Multiplayer HIV and Sexually Transmitted Infection Prevention Video Game Intervention for Black Adolescent Girls: Protocol for a Randomized Controlled Trial.
   Weser V, Opara I, Budge M, Duncan L, et al · · 2023 · cited 1× · PMID 36689272 · DOI 10.2196/43666