N/A
N=117
A Digital Intervention for HIV Prevention in Black Adolescent Girls
HIV · Risk Reduction Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04108988 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Feasibility Assessed Using Change in Retention Rates — 97.5; 97.4; 97.5; 100 percentage of questionnaires returned
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- InvestiDate (Behavioral); Non-Health Related Video Game (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Assessed Using Change in Retention Rates |
97.5; 97.4; 97.5; 100; 92.5; 100 | — |
| PRIMARY Acceptability Assessed Via Self-reported Survey |
3.64; 1.54; 3.44; 3.51; 3.03; 3.54 | — |
| PRIMARY Acceptability Assessed by Favorite Investidate Activities |
21; 11; 3; 3; 0; 0 | — |
| PRIMARY Total Time Playing |
105.56 | — |
| PRIMARY Change From Baseline at 4 Months: HIV/STI Testing- Self |
4; 8; 2; 9; 4; 8 | 0.248 |
| PRIMARY Change From Baseline at 4 Months: HIV/STI Testing- Partner |
8; 10; 8; 11; 4; 8 | 0.246 |
| SECONDARY Change in Use of Condoms |
11; 9; 7; 8; 4; 7 | 0.596 |
| SECONDARY Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES) |
24.5; 27.52; 29.3; 26.61; 28.3; 28.09 | 0.089 |
| SECONDARY Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS) |
2.87; 3.02; 3.71; 3.33; 3.62; 3.57 | 0.095 |
| SECONDARY Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS |
4.03; 3.98; 4.4; 3.88; 4.4; 4.07 | 0.136 |
| SECONDARY Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS |
4.14; 4.13; 4.45; 4.06; 4.37; 4.05 | 0.133 |
| SECONDARY Change in Self-efficacy for PrEP |
4.16; 4.13; 4.51; 4.16; 4.42; 4.32 | 0.210 |
| SECONDARY Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS |
1.64; 1.57; 1.72; 1.54; 1.56; 1.61 | 0.392 |
| SECONDARY Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS |
-0.05; -0.06; 0.09; 0.08; -0.05; 0.11 | 0.411 |
| SECONDARY Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP |
2.58; 2.58; 3.22; 3.08; 3.06; 3.34 | 0.294 |
| SECONDARY Change in Sexually Transmitted Infections (STI)/HIV Knowledge |
7.76; 8.41; 9.06; 8.73; 9.06; 8.43 | 0.031 sig |
| SECONDARY Change in Norms About Condom Use (NCU) Assessed Using the NCU Subscale of the SRBBS |
0.93; 0.98; 1.29; 1.03; 1.17; 1.05 | 0.262 |
| SECONDARY Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS |
0.05; 0.01; 0.19; 0.22; -0.04; 0.25 | 0.116 |
| SECONDARY Change in Perceived Norms About PrEP |
3.21; 3.08; 3.33; 3.51; 3.33; 3.42 | 0.016 sig |
| SECONDARY Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS |
2.53; 2.59; 2.32; 2.49; 2.33; 2.37 | 0.667 |
| SECONDARY Change in Behavior of Purchasing Condoms |
5; 5; 7; 6; 2; 7 | 0.09 |
| SECONDARY Change in Behavior of Having Looked up a Place to Get HIV or STI Testing |
8; 16; 16; 21; 9; 12 | 0.53 |
| SECONDARY Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI |
8; 10; 8; 11; 4; 8 | 0.246 |
| SECONDARY Change in Birth Control Use |
9; 5; 4; 3; 5; 5 | 0.987 |
| SECONDARY Change in Behavior Regarding Refusal to Have Sex |
11; 9; 27; 30; 7; 3 | 0.148 |
| SECONDARY Number of Participants Refusal to Have Sex |
6; 9; 1; 3; 5; 5 | 0.653 |
| SECONDARY Number of Participants That Asked Partner About Previous Condom Use |
9; 7; 3; 3; 4; 3 | 0.977 |
| SECONDARY Number of Times Participants Asked Partner About Previous Condom Use |
1.29; 0.59; 0.92; 1.13 | 0.735 |
| SECONDARY Number of Times Participants Talked to Family or Adults About HIV |
1.60; 6.64; 3.68; 1.82; 1.3; 259.95 | 3.19 |
| SECONDARY Number of Times Participants Engaged in Sexual Intercourse |
14.78; 6.64; 1.58; 0.50; 3.24; 1.26 | 0.473 |
| SECONDARY Number of Times Participants Engaged in Anal Sex |
0.28; 0.08; 0.55; 0.03; 0.03; 0.18 | 0.141 |
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.
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
Data sourced from ClinicalTrials.gov (NCT04108988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.