HIV/AIDS and InfectionsNCT04135443
Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men
A study testing 3T Tune in! Turn on! Turn up! and General Health Materials Website in people with HIV/AIDS and Infections and Sexual Behavior, run by ETR Associates at 1 site in United States.
Trial summary
This study features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at… Read more about this study
- Who is it for?
- Ages 14 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS and Infections, Sexual Behavior, Health Knowledge, Attitudes, Practice
- What is being tested?
- 3T Tune in! Turn on! Turn up! and General Health Materials Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- self-identification of being aged 14-19;
- ownership of an iphone or Android smartphone
- self-identification of racial identity as black, African American, or biracial; and
- self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender.
- capacity to assent, based on formal assessment
- a willingness to participate after complete understanding of the topics of study, as indicated by a completed assent form
- resides in the US
Who cannot join
- Anyone not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men
This study features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app and those in the control group will be given access to a website with general health materials. Participants will complete brief online surveys at baseline and at 3-months following the baseline to assess effectiveness in changing sexual risk behaviors and communication and condom use behaviors and attitudes.
Read the detailed description
The overarching aim of this proposed Phase II research project is to fill a gap in prevention by completing the development and establishing the effectiveness of 3T: Tune in, Turn on, Turn up, a multimedia interactive sex-positive smartphone app-delivered HIV and other sexually transmitted infection (STI) intervention designed for use by YBMSM ages 14-19. The larger and longer term aims of developing an intervention specifically tailored to this population, utilizing a technology platform to reach youth where they are, is to contribute to a reduction in HIV/STI risk, increase HIV testing, and an increase in the quality of overall sexual health and relationships among YBMSM. To do this 3T emphasizes partner reduction, avoidance of concurrent partners, use of condoms if having anal or vaginal sex, and getting HIV/STI tests. 3T also focuses on improving quality of sexual experience and relationships, helping participants become clearer about what they do/don't want to do sexually, communicating their choices, and learning ways to enhance sexual experience without increasing HIV/STI risk. dfusion and its research partner, ETR, will meet the following specific Phase II aims:
- In conjunction with advisory panel members, develop content and corresponding storyboards for all activities. The curriculum will include content on risk reduction, sexual health and the quality of sexual experiences, and developing healthy relationships;
- Successful development of the first mobile app-delivered STI/HIV prevention program specifically designed for YBMSM aged 14-19. Reaching this aim requires continued development of the app technology, including the multimedia interactive activities, games, data collection, activity randomization, and an asynchronous forum. Research shows that YBMSM use the Internet to find information related to sex and sexuality, find friends and sexual partners, and YBMSM are increasingly using mobile apps, such as Grindr, to meet sex partners.20 The reliance on mobile devices for education and entertainment make it the ideal technology platform for reaching the YBMSM audience;
- Conduct a rigorous evaluation to determine the effectiveness of the intervention to reduce HIV/STI risk.
The evaluation features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app and those in the control arm will be asked to use a website with general health information. Participants will complete brief online surveys at baseline and at 3-months following the baseline to assess effectiveness in changing sexual risk behaviors and relationship and communication behaviors and attitudes.
Recruitment. We will use multiple methods to recruit participants: 1) Engaging Organizations. Approximately 15-20 organizations from across the U.S. that serve YBMSM will be approached to help recruit participants through social media and in-person 2) Using Social Media Advertising including targeted advertising on social media sites and sponsoring study posts with social media influencers in the YBMSM community.
- Being tested
- 3T Tune in! Turn on! Turn up!, General Health Materials Website
- Keywords
- Healthy relationships
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections, Sexual Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T Tune in! Turn on! Turn up!Behavioural
A sex positive multimedia interactive mobile app delivered HIV/STI intervention developed for use by YBMSM ages 14-19. The program employs a theory based approach to address essential knowledge, perceptions of risk, peer norms, attitudes and skill with two primary goals: (1) To reduce HIV/STI the program emphasizes partner reduction, avoidance of concurrent partners, condoms and HIV/STI tests; and (2) To improve sexual health and relationships.
General Health Materials WebsiteBehavioural
The control group will receive access to a website containing general health promotion materials.
| Study group | Role | What they receive |
|---|---|---|
| 3T Tune in! Turn on! Turn up! | Experimental | The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum. The app helps participants to become clearer about what they do/don't want to do sexually, to communicate their choices. It also focuses on ways to increase healthy relationships, enhance sexual experience if having sex while reducing HIV/STI risk. Receives: Behavioral: 3T Tune in! Turn on! Turn up! |
| General Health Website Materials | Active comparator | The control intervention features a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster). Receives: Behavioral: General Health Materials Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condomless Anal Intercourse or Condomless Vaginal Intercourse
Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Measured: 3-months post baseline
Secondary outcomes (6)
Sexual Partners, no Condom, in the Last 3 Months
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Measured: 3-months post baseline
Self-reported STI/HIV Testing in Last Three Months
Number of times reported having been tested for STI, including HIV in the last 3 months
Measured: 3-months post baseline
Dyadic Communication Scale
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 1 - 5, with a higher score indicating better outcomes
Measured: 3-months post baseline
Condom Attitudes Scale
Scale measures attitudes regarding condoms. Average of 21 items on a 4-point scale (1 to 4), with a range of 1 - 4, with a higher score indicating better outcomes
Measured: 3-months post baseline
Condom Self-Efficacy Scale
Scale measures perceived self-efficacy to use condoms. Average of 4 items on a 4-point scale (1 to 4), with a range of 1 - 4, with a higher score indicating better outcomes
Measured: 3-months post baseline
Attitudes Towards Lube
Scale measures attitudes towards lube. Average of 3 items on a 4-point scale (1-4), with a range of 1-4, with a higher score indicating more positive attitudes towards lube
Measured: 3-months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Mar 2021
- Primary completion9 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDS and InfectionsStudies 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
- Model description
- This is a two arm randomized controlled trial. Upon completing a baseline survey participants will be randomized into the intervention or an attention control condition. After randomization, participants will be granted access to their assigned mobile app (3T app or a general health website).
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETR Associates
- Sponsor type
- University, hospital or other
- Collaborators
- dfusion Inc
- Responsible party
- Sponsor
- Investigators
- Tamara Kuhn, MS, Principal investigator, dfusion Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135443
- Sponsor's protocol ID
- 3T
- Status last verified
- Sep 2024
- First submitted
- 20 Oct 2019
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT04135443
- Acronym / sponsor ID
- 3T
- Keywords
- Healthy relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- ETR AssociatesUniversity, hospital or other
- Collaborators
- dfusion Inc
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app and those in the control group will be given access to a website with general health materials. Participants will complete brief online surveys at baseline and at 3-months following the baseline to assess effectiveness in changing sexual risk behaviors and communication and condom use behaviors and attitudes.
Detailed description
The overarching aim of this proposed Phase II research project is to fill a gap in prevention by completing the development and establishing the effectiveness of 3T: Tune in, Turn on, Turn up, a multimedia interactive sex-positive smartphone app-delivered HIV and other sexually transmitted infection (STI) intervention designed for use by YBMSM ages 14-19. The larger and longer term aims of developing an intervention specifically tailored to this population, utilizing a technology platform to reach youth where they are, is to contribute to a reduction in HIV/STI risk, increase HIV testing, and an increase in the quality of overall sexual health and relationships among YBMSM. To do this 3T emphasizes partner reduction, avoidance of concurrent partners, use of condoms if having anal or vaginal sex, and getting HIV/STI tests. 3T also focuses on improving quality of sexual experience and relationships, helping participants become clearer about what they do/don't want to do sexually, communicating their choices, and learning ways to enhance sexual experience without increasing HIV/STI risk. dfusion and its research partner, ETR, will meet the following specific Phase II aims:
- In conjunction with advisory panel members, develop content and corresponding storyboards for all activities. The curriculum will include content on risk reduction, sexual health and the quality of sexual experiences, and developing healthy relationships;
- Successful development of the first mobile app-delivered STI/HIV prevention program specifically designed for YBMSM aged 14-19. Reaching this aim requires continued development of the app technology, including the multimedia interactive activities, games, data collection, activity randomization, and an asynchronous forum. Research shows that YBMSM use the Internet to find information related to sex and sexuality, find friends and sexual partners, and YBMSM are increasingly using mobile apps, such as Grindr, to meet sex partners.20 The reliance on mobile devices for education and entertainment make it the ideal technology platform for reaching the YBMSM audience;
- Conduct a rigorous evaluation to determine the effectiveness of the intervention to reduce HIV/STI risk.
The evaluation features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app and those in the control arm will be asked to use a website with general health information. Participants will complete brief online surveys at baseline and at 3-months following the baseline to assess effectiveness in changing sexual risk behaviors and relationship and communication behaviors and attitudes.
Recruitment. We will use multiple methods to recruit participants: 1) Engaging Organizations. Approximately 15-20 organizations from across the U.S. that serve YBMSM will be approached to help recruit participants through social media and in-person 2) Using Social Media Advertising including targeted advertising on social media sites and sponsoring study posts with social media influencers in the YBMSM community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two arm randomized controlled trial. Upon completing a baseline survey participants will be randomized into the intervention or an attention control condition. After randomization, participants will be granted access to their assigned mobile app (3T app or a general health website).
| Arm | Type | Receives |
|---|---|---|
| 3T Tune in! Turn on! Turn up! | Experimental | Behavioral: 3T Tune in! Turn on! Turn up!The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum. The app helps participants to become clearer about what they do/don't want to do sexually, to communicate their choices. It also focuses on ways to increase healthy relationships, enhance sexual experience if having sex while reducing HIV/STI risk. |
| General Health Website Materials | Active comparator | Behavioral: General Health Materials WebsiteThe control intervention features a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster). |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- self-identification of being aged 14-19;
- ownership of an iphone or Android smartphone
- self-identification of racial identity as black, African American, or biracial; and
- self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender.
- capacity to assent, based on formal assessment
Key exclusion criteria (1 listed)
- Anyone not meeting inclusion criteria
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 |
|---|---|---|
| 3T Tune in! Turn on! Turn up!A sex positive multimedia interactive mobile app delivered HIV/STI intervention developed for use by YBMSM ages 14-19. The program employs a theory based approach to address essential knowledge, perceptions of risk, peer norms, attitudes and skill with two primary goals: (1) To reduce HIV/STI the program emphasizes partner reduction, avoidance of concurrent partners, condoms and HIV/STI tests; and (2) To improve sexual health and relationships. | Behavioural | 3T Tune in! Turn on! Turn up! |
| General Health Materials WebsiteThe control group will receive access to a website containing general health promotion materials. | Behavioural | General Health Website Materials |
Primary outcome
Condomless Anal Intercourse or Condomless Vaginal Intercourse
Time frame: 3-months post baseline
Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
6 secondary outcomes
Sexual Partners, no Condom, in the Last 3 Months
Time frame: 3-months post baseline
Self-reported STI/HIV Testing in Last Three Months
Time frame: 3-months post baseline
Dyadic Communication Scale
Time frame: 3-months post baseline
Condom Attitudes Scale
Time frame: 3-months post baseline
Condom Self-Efficacy Scale
Time frame: 3-months post baseline
Attitudes Towards Lube
Time frame: 3-months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tamara Kuhn, MS principal investigator
dfusion Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3T Tune in! Turn on! Turn up! and General Health Materials Website in people with HIV/AIDS and Infections and Sexual Behavior, run by ETR Associates at 1 site 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 7 inclusion and 1 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Condomless Anal Intercourse or Condomless Vaginal Intercourse (time frame: 3-months post baseline). 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 15 Nov 2024.