NCT03646032

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

May 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

August 21, 2018

Last Update Submit

December 12, 2019

Conditions

Health Risk Behaviors

Keywords

Mobile dating simulation gameSexual educationHIVSTIConsent

Outcome Measures

Primary Outcomes (1)

  • Knowledge about HIV/STIs

    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.

    1 month

Secondary Outcomes (5)

  • Perception of sexual risks

    1 month

  • Intention to be tested for STIs

    1 month

  • Intention to use a condom

    1 month

  • Consent

    1 month

  • System Usability and Acceptability Metrics

    1 month

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

SAAFEBEHAVIORAL

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 group
ControlBEHAVIORAL

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.

Control group

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • African American female or male
  • Between 15-21 years of age

You may not qualify if:

  • Pregnant women
  • The first 6 weeks post-partum
  • Adolescents younger than 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Health Risk BehaviorsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tony Ma, MS

    Benten Technologies, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 24, 2018

Study Start

May 8, 2019

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

US(2)