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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
3T Tune in! Turn on! Turn up! and General Health Materials Website
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.

United States1 site
  • ETR Associates

    Scotts Valley, California, 95066

Other trials in United States

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 groups in NCT04135443
Study groupRoleWhat they receive
3T Tune in! Turn on! Turn up!ExperimentalThe 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 MaterialsActive comparatorThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted22 Oct 2019
  2. Study start1 Mar 2021
  3. Primary completion9 Nov 2022
  4. Study completion29 Nov 2022

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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