Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135443
• Other study ID #: 3T
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 2022

Study information

• Verified date: July 2022
• Source: ETR Associates
• Contact: Tamara Kuhn, MS
• Phone: 8314402104
• Email: tamara.kuhn[@]dfusioninc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study features a 2-arm cluster 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 14-17 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, to be downloaded to their own device, and asked to use it during a three month period. Those in the control arm will be asked to download a general health app and use it during the same three month period. Participants will complete brief online surveys at baseline and at 3- and 6-months following the conclusion of the app-use period to assess effectiveness in changing sexual risk behaviors and communication and condom use behaviors and attitudes.

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 14-17. 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 14-17. Reaching this aim requires continued development of the app technology, including the multimedia interactive activities, games, data collection, activity randomization, and a messaging/forum system. 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 cluster 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 14-17 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, to be downloaded to their own device, and asked to use it during a three month period. Those in the control arm will be asked to download a general health app and use it during the same three month period. Participants will complete brief online surveys at baseline and at 3- and 6-months following the conclusion of the app-use period to assess effectiveness in changing sexual risk behaviors and relationship and communication behaviors and attitudes.

Recruitment. We will use a chain-referral technique for recruiting, starting with a group of 100 "seeds" recruited using a multi-pronged strategy including: 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 (see letters of support.) 2) Using Google Adwords. Placing study advertisements on Google based on keyword for participant recruitment; 3) Using Social Media Advertising including targeted advertising on social media sites and sponsoring study posts with social media influencers in the YBMSM community. To minimize contamination, we will randomize initial seeds and all persons in their recruitment chain to either the treatment arm or the attention control arm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Health Knowledge, Attitudes, Practice
• HIV Infections
• HIV/AIDS and Infections
• Sexual Behavior

Intervention

Behavioral:
• 3T Tune in! Turn on! Turn up!
A sex positive multimedia interactive mobile app delivered HIV/STI intervention developed for use by YBMSM ages 14-17. 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 App
The control group will download a mobile app that addresses general health behaviors, specifically drinking more water.

Locations

Country	Name	City	State
United States	ETR	Scotts Valley	California

Sponsors (2)

Lead Sponsor	Collaborator
ETR Associates	Dfusion Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condomless anal intercourse or condomless vaginal intercourse	Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months	Baseline, before intervention period
Primary	Condomless anal intercourse or condomless vaginal intercourse	Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months	3 months post intervention period
Primary	Condomless anal intercourse or condomless vaginal intercourse	Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months	6 months post intervention period
Secondary	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	Baseline, before intervention period
Secondary	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	3 months post intervention period
Secondary	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	6 months post intervention period
Secondary	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	Baseline, before intervention period
Secondary	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	3 months post intervention period
Secondary	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	6 months post intervention period
Secondary	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 6 - 30, with a higher score indicating better outcomes	Baseline, before intervention period
Secondary	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 6 - 30, with a higher score indicating better outcomes	3 months post intervention period
Secondary	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 6 - 30, with a higher score indicating better outcomes	6 months post intervention period
Secondary	Condom Pleasure Scale	Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes	Baseline, before intervention period
Secondary	Condom Pleasure Scale	Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes	3 months post intervention period
Secondary	Condom Pleasure Scale	Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes	6 months post intervention period
Secondary	Condom Turn Off Scale	Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes	Baseline, before intervention period
Secondary	Condom Turn Off Scale	Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes	3 months post intervention period
Secondary	Condom Turn Off Scale	Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes	6 months post intervention period