Sexually Active Adolescent Focused Education (SAAFE)

Benten Technologies

Status: Completed

Conditions: Health Risk Behaviors

Treatments: Behavioral: SAAFE; Behavioral: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03646032

SAAFE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: SAAFE

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control