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Sexually Active Adolescent Focused Education (SAAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646032
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : December 16, 2019
Sponsor:
Collaborators:
University of Alabama at Birmingham
Medstar Health Research Institute
Information provided by (Responsible Party):
Tony Ma, 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).

Condition or disease Intervention/treatment Phase
Health Risk Behaviors Behavioral: SAAFE Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Primary Purpose: Prevention
Official Title: An mHealth Education Intervention for Encouraging STI Testing Uptake
Actual Study Start Date : May 8, 2019
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention group
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
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.

Active Comparator: Control group
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
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.




Primary Outcome Measures :
  1. Knowledge about HIV/STIs [ Time Frame: 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 :
  1. Perception of sexual risks [ Time Frame: 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

  2. Intention to be tested for STIs [ Time Frame: 1 month ]
    We will ask participants on a scale of 1-5 their intent to get tested for HIV and most common STI's.

  3. Intention to use a condom [ Time Frame: 1 month ]
    We will ask participants on a scale of 1-5, their intent to use a condom.

  4. Consent [ Time Frame: 1 month ]
    We will ask participants on a 4-point Likert scale (strongly agree to strongly disagree)

  5. System Usability and Acceptability Metrics [ Time Frame: 1 month ]
    We will ask participants to answer the questions based on their current impressions on the game.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646032


Locations
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United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Benten Technologies, Inc.
University of Alabama at Birmingham
Medstar Health Research Institute
Investigators
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Principal Investigator: Tony Ma, MS Benten Technologies, Inc.
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Responsible Party: Tony Ma, President, Benten Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03646032    
Other Study ID Numbers: SAAFE
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tony Ma, Benten Technologies, Inc.:
Mobile dating simulation game
Sexual education
HIV
STI
Consent