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Sexually Active Adolescent Focused Education

An mHealth Education Intervention for Encouraging STI Testing Uptake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03646032
Acronym
SAAFE
Enrollment
178
Registered
2018-08-24
Start date
2019-05-08
Completion date
2019-07-15
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Risk Behaviors

Keywords

Mobile dating simulation game, Sexual education, HIV, STI, Consent

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.

Interventions

BEHAVIORALSAAFE

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.

BEHAVIORALControl

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.

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
Medstar Health Research Institute
CollaboratorOTHER
Benten Technologies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

A total of 200 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 i.e., intervention and control during the pilot.

Eligibility

Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Knowledge about HIV/STIs1 monthDuring 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

MeasureTime frameDescription
Perception of sexual risks1 monthDuring 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
Intention to be tested for STIs1 monthWe will ask participants on a scale of 1-5 their intent to get tested for HIV and most common STI's.
Intention to use a condom1 monthWe will ask participants on a scale of 1-5, their intent to use a condom.
Consent1 monthWe will ask participants on a 4-point Likert scale (strongly agree to strongly disagree)
System Usability and Acceptability Metrics1 monthWe will ask participants to answer the questions based on their current impressions on the game.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026