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Sexually Active Adolescent Focused Education (SAAFE)

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ClinicalTrials.gov Identifier: NCT03646032
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
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 200 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
Sexual Behavior Behavioral: SAAFE Behavioral: Control Phase 2

Detailed Description:

A total of 400 African American adolescents (AAA) males and females will be recruited from Washington, DC (n=200) and Birmingham, Alabama (n=200). 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=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.
  2. 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 knowledge-based You-tube video on risky sexual behavior, which we will name SAAFE video. They will also receive pamphlets that provide information on testing location and care if they have HIV/STI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: A total of 400 AAA males and females will be recruited from Washington, DC (n=200) and Birmingham, Alabama (n=200). 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 30, 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.

Placebo 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 knowledge-based You-tube video on risky sexual behavior, which we will name SAAFE video. They will also receive pamphlets that provide information on testing location and care if they have HIV/STI.
Behavioral: Control
This group will receive the standard of care by launching a mobile app that will play a knowledge-based You-tube video on risky sexual behavior, which we will name SAAFE video. They will also receive pamphlets that provide information on testing location and care if they have HIV/STI.




Primary Outcome Measures :
  1. Knowledge about HIV/STIs [ Time Frame: 6 months ]
    During the six month 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: 6 months ]
    During the six month 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: 6 months ]
    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: 6 months ]
    We will ask participants on a scale of 1-5, their intent to use a condom.



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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


Contacts
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Contact: Tony Ma, MS (703) 662-5858 ext 143 tonyma@bententech.com
Contact: Katie Chang, MS (703) 662-5858 ext 165 hkchang@bententech.com

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     History of Changes
Other Study ID Numbers: SAAFE
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No