Health Risk BehaviorsSAAFENCT03646032
Sexually Active Adolescent Focused Education
A study testing SAAFE in people with Health Risk Behaviors, run by Benten Technologies, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Risk Behaviors
- What is being tested?
- SAAFE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2019to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- African American female or male
- Between 15-21 years of age
Who cannot join
- Pregnant women
- The first 6 weeks post-partum
- Adolescents younger than 15
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: An mHealth Education Intervention for Encouraging STI Testing Uptake
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).
Read the detailed 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:
- 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.
- Conditions
- Health Risk Behaviors
- Being tested
- SAAFE, Control
- Keywords
- Mobile dating simulation game, Sexual education, HIV, STI, Consent
- Medical subject headings
- Health Risk Behaviors, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAAFEBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (5)
Perception of sexual risks
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
Measured: 1 month
Intention to be tested for STIs
We will ask participants on a scale of 1-5 their intent to get tested for HIV and most common STI's.
Measured: 1 month
Intention to use a condom
We will ask participants on a scale of 1-5, their intent to use a condom.
Measured: 1 month
Consent
We will ask participants on a 4-point Likert scale (strongly agree to strongly disagree)
Measured: 1 month
System Usability and Acceptability Metrics
We will ask participants to answer the questions based on their current impressions on the game.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start8 May 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Risk BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benten Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, Medstar Health Research Institute
- Responsible party
- Principal investigator, Tony Ma, Benten Technologies, Inc.
- Investigators
- Tony Ma, MS, Principal investigator, Benten Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646032
- Sponsor's protocol ID
- SAAFE
- Acronym
- SAAFE
- Status last verified
- Dec 2019
- First submitted
- 21 Aug 2018
- Last updated
- 16 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Education Intervention for Encouraging STI Testing Uptake
- ClinicalTrials.gov ID
- NCT03646032
- Acronym / sponsor ID
- SAAFE / SAAFE
- Conditions
- Health Risk Behaviors
- Keywords
- Mobile dating simulation game, Sexual education, HIV, STI, Consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Benten Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, Medstar Health Research Institute
- Study start
- 8 May 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: SAAFEIntervention 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. |
| Control group | Active comparator | Behavioral: ControlControl 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. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- African American female or male
- Between 15-21 years of age
Key exclusion criteria (3 listed)
- Pregnant women
- The first 6 weeks post-partum
- Adolescents younger than 15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAAFEAfter 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. | Behavioural | Intervention group |
| ControlThis 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. | Behavioural | Control group |
Primary outcome
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.
5 secondary outcomes
Perception of sexual risks
Time frame: 1 month
Intention to be tested for STIs
Time frame: 1 month
Intention to use a condom
Time frame: 1 month
Consent
Time frame: 1 month
System Usability and Acceptability Metrics
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: Yes
Related trials for Health Risk Behaviors
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
RecruitingObservational study
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Cardiovascular (CV) Risk
Recruiting
ChangeGradients: Promoting Adolescent Health Behavior Change
Alcohol Drinking, Self Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Ma, MS principal investigator
Benten Technologies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAAFE in people with Health Risk Behaviors, run by Benten Technologies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about HIV/STIs (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.