Sexually Active Adolescent Focused Education

Health Risk Behaviors Clinical Trial

— SAAFE  

Official title:

An mHealth Education Intervention for Encouraging STI Testing Uptake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646032
• Other study ID #: SAAFE
• Status: Completed
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: December 2019
• Source: Benten Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Risk Behaviors

Intervention

Behavioral:
• SAAFE
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.
• Control
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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Benten Technologies, Inc.	Medstar Health Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Intention to use a condom	We will ask participants on a scale of 1-5, their intent to use a condom.	1 month
Secondary	Consent	We will ask participants on a 4-point Likert scale (strongly agree to strongly disagree)	1 month
Secondary	System Usability and Acceptability Metrics	We will ask participants to answer the questions based on their current impressions on the game.	1 month