Clinical trial NCT04135443: Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men
Official title: Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS and Infections
Sexual Behavior
Health Knowledge, Attitudes, Practice
Keywords: Healthy relationships
Lead sponsor: ETR Associates
Sponsor class: OTHER
Collaborators: name: dfusion Inc
First posted: 2019-10-22
Enrollment: 178
Sex: MALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. self-identification of being aged 14-19;
2. ownership of an iphone or Android smartphone
3. self-identification of racial identity as black, African American, or biracial; and
4. self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender.
5. capacity to assent, based on formal assessment
6. a willingness to participate after complete understanding of the topics of study, as indicated by a completed assent form
7. resides in the US

Exclusion Criteria:

* Anyone not meeting inclusion criteria

Primary outcomes:
measure: Condomless Anal Intercourse or Condomless Vaginal Intercourse
timeFrame: 3-months post baseline
Secondary outcomes:
measure: Sexual Partners, no Condom, in the Last 3 Months
timeFrame: 3-months post baseline
measure: Self-reported STI/HIV Testing in Last Three Months
timeFrame: 3-months post baseline
measure: Dyadic Communication Scale
timeFrame: 3-months post baseline
measure: Condom Attitudes Scale
timeFrame: 3-months post baseline
measure: Condom Self-Efficacy Scale
timeFrame: 3-months post baseline
measure: Attitudes Towards Lube
timeFrame: 3-months post baseline
Other outcomes:
Locations:
city: Scotts Valley
country: United States
facility: ETR Associates
state: California
Study officials:
affiliation: dfusion Inc
name: Tamara Kuhn, MS
role: PRINCIPAL_INVESTIGATOR
References: