Sexually Active Adolescent Focused Education
- Conditions
- Health Risk Behaviors
- Interventions
- Behavioral: ControlBehavioral: SAAFE
- Registration Number
- NCT03646032
- Lead Sponsor
- Benten Technologies, Inc.
- Brief Summary
SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and perception of sexual risks by AAAs, and (2) secondarily detect intention to be tested for STIs and to change sexual risk behavior (i.e., use a condom).
- Detailed Description
A total of 200 African American adolescents (AAA) males and females will be recruited from Washington, DC (n=100) and Birmingham, Alabama (n=100). At both data collection sites, participants will be randomly assigned to one of two groups during the pilot. The two groups are:
1. Intervention group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected participants who will receive a download of the SAAFE game and play for at least 30 minutes and as long as an hour, if desired.
2. Control group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected participants. This group will receive dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- African American female or male
- Between 15-21 years of age
- Pregnant women
- The first 6 weeks post-partum
- Adolescents younger than 15
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control Control group (n=200) - will consist of 100 AAA males / 100 AAA females randomly selected participants. This group will receive the standard of care by launching a mobile app that will play a dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI. Intervention group SAAFE Intervention group (n=200) - will consist of 100 AAA males / 100 AAA females randomly selected participants who will receive a download of the SAAFE game and play for at least 30 minutes and as long as an hour, if desired.
- Primary Outcome Measures
Name Time Method Knowledge about HIV/STIs 1 month During the pilot, adolescents will be asked if they would like to download the game to play on their own mobile device and complete a pre- and post-game assessment designed to measure their knowledge on HIV/STIs by assessing the level of knowledge around risky sexual activity.
- Secondary Outcome Measures
Name Time Method Intention to use a condom 1 month We will ask participants on a scale of 1-5, their intent to use a condom.
System Usability and Acceptability Metrics 1 month We will ask participants to answer the questions based on their current impressions on the game.
Perception of sexual risks 1 month During the pilot, adolescents will be asked if they would like to download the game to play on their own mobile device and complete a pre- and post-game assessment designed to measure their perceived risk
Consent 1 month We will ask participants on a 4-point Likert scale (strongly agree to strongly disagree)
Intention to be tested for STIs 1 month We will ask participants on a scale of 1-5 their intent to get tested for HIV and most common STI's.
Trial Locations
- Locations (2)
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States