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Sexually Active Adolescent Focused Education

NCT ID: NCT03646032

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2019-07-15

Brief Summary

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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

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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.

Conditions

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Health Risk Behaviors

Keywords

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Mobile dating simulation game Sexual education HIV STI Consent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

SAAFE

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role collaborator

Benten Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Tony Ma

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tony Ma, MS

Role: PRINCIPAL_INVESTIGATOR

Benten Technologies, Inc.

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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SAAFE

Identifier Type: -

Identifier Source: org_study_id