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Completed

NCT Number: NCT03646032

Sexually Active Adolescent Focused Education

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).

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Key information

Conditions

Health Risk Behaviors Behavior Communicable Diseases Disease Attributes Genital Diseases Health Behavior Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAAFE

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Benten Technologies, Inc.

Industry

Collaborators

  • Medstar Health Research Institute
  • University of Alabama at Birmingham

Registry information

Official study title

An mHealth Education Intervention for Encouraging STI Testing Uptake

Acronym: SAAFE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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