Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-25 @ 8:09 AM
Study NCT ID:
NCT03646032
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexually Active Adolescent Focused Education
Sponsor:
Benten Technologies, Inc.
Organization:
Study Overview
Official Title:
An mHealth Education Intervention for Encouraging STI Testing Uptake
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAAFE
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: