Sexually Active Adolescent Focused Education

Study Overview
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Brief Summary
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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
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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: 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. 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.

Official Title
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An mHealth Education Intervention for Encouraging STI Testing Uptake

Conditions
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Health Risk Behaviors

Intervention / Treatment
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* Behavioral: SAAFE
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American female or male Between 15-21 years of age Exclusion Criteria: Pregnant women The first 6 weeks post-partum Adolescents younger than 15

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: SAAFE<br>* After completing the pre-game assessment, participants will be asked to play the SAAFE game for at least 30 minutes and up to 1 hour . At the conclusion of the game, participants will be provided with a post-game assessment about their perception of risk, knowledge of specific protective behaviors, and whether they plan to change behaviors.<br>|
| Active Comparator: Control group<br>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. | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge about HIV/STIs | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of sexual risks | 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 | 1 month | 
| Intention to be tested for STIs | We will ask participants on a scale of 1-5 their intent to get tested for HIV and most common STI's. | 1 month | 
| Intention to use a condom | We will ask participants on a scale of 1-5, their intent to use a condom. | 1 month | 
| Consent | We will ask participants on a 4-point Likert scale (strongly agree to strongly disagree) | 1 month | 
| System Usability and Acceptability Metrics | We will ask participants to answer the questions based on their current impressions on the game. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, STI, Mobile dating simulation game, Sexual education, Consent