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Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-17 Attracted to Men

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ClinicalTrials.gov Identifier: NCT04135443
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
DFUSION, INC.
Information provided by (Responsible Party):
ETR Associates

Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS and Infections Sexual Behavior Health Knowledge, Attitudes, Practice Behavioral: 3T Tune in! Turn on! Turn up! Behavioral: General Health App Not Applicable

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 14-17. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two arm cluster randomized controlled trial. Because the evaluation is using cluster randomization, the participants will be randomized by cluster into an attention control or intervention group. There will be 100 seeds. Each seed will receive 3 referral coupons. Upon completing a baseline survey the seed will be randomized into treatment or control condition. Any participant using a referral coupon will be placed in the same condition as the initial seed with which they are associated. After randomization, participants will be granted access to download and install their assigned mobile app (3T or a general health app).
Masking: None (Open Label)
Masking Description: Participants are randomly assigned to their condition without being made aware of their assigned condition as "attention control" or "intervention." Each condition downloads and uses an app so study activities are similar, reducing the likelihood participants will be aware of their assigned condition.
Primary Purpose: Prevention
Official Title: Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 will include more than 30 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and communication forums. 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. The intervention/app is intended to be used regularly (e.g., two times per week) during the 90 day active participation period.
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.

Active Comparator: General Health App
Participants will download a general health mobile app (focused on promoting drinking water). The control mobile app is intended to be used regularly during the 90 day active participation period.
Behavioral: General Health App
The control group will download a mobile app that addresses general health behaviors, specifically drinking more water.




Primary Outcome Measures :
  1. Condomless anal intercourse or condomless vaginal intercourse [ Time Frame: Baseline, before intervention period ]
    Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months

  2. Condomless anal intercourse or condomless vaginal intercourse [ Time Frame: 3 months post intervention period ]
    Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months

  3. Condomless anal intercourse or condomless vaginal intercourse [ Time Frame: 6 months post intervention period ]
    Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months


Secondary Outcome Measures :
  1. Sexual partners, no condom, in the last 3 months [ Time Frame: Baseline, before intervention period ]
    # partners with whom had anal or vaginal sex without using condoms in the last 3 months

  2. Sexual partners, no condom, in the last 3 months [ Time Frame: 3 months post intervention period ]
    # partners with whom had anal or vaginal sex without using condoms in the last 3 months

  3. Sexual partners, no condom, in the last 3 months [ Time Frame: 6 months post intervention period ]
    # partners with whom had anal or vaginal sex without using condoms in the last 3 months

  4. Self-reported STI/HIV testing in last three months [ Time Frame: Baseline, before intervention period ]
    Number of times reported having been tested for STI, including HIV in the last 3 months

  5. Self-reported STI/HIV testing in last three months [ Time Frame: 3 months post intervention period ]
    Number of times reported having been tested for STI, including HIV in the last 3 months

  6. Self-reported STI/HIV testing in last three months [ Time Frame: 6 months post intervention period ]
    Number of times reported having been tested for STI, including HIV in the last 3 months

  7. Dyadic Communication Scale [ Time Frame: Baseline, before intervention period ]
    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

  8. Dyadic Communication Scale [ Time Frame: 3 months post intervention period ]
    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

  9. Dyadic Communication Scale [ Time Frame: 6 months post intervention period ]
    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

  10. Condom Pleasure Scale [ Time Frame: Baseline, before intervention period ]
    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

  11. Condom Pleasure Scale [ Time Frame: 3 months post intervention period ]
    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

  12. Condom Pleasure Scale [ Time Frame: 6 months post intervention period ]
    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

  13. Condom Turn Off Scale [ Time Frame: Baseline, before intervention period ]
    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

  14. Condom Turn Off Scale [ Time Frame: 3 months post intervention period ]
    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

  15. Condom Turn Off Scale [ Time Frame: 6 months post intervention period ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. self-identification of being aged 14-17;
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135443


Contacts
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Contact: Tamara Kuhn, MS 8314402104 tamara.kuhn@dfusioninc.com
Contact: Karin Coyle, PhD 8314402140 karin.coyle@etr.org

Locations
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United States, California
ETR
Scotts Valley, California, United States, 95066
Contact: Karin Coyle, PhD    831-440-2140    karin.coyle@etr.org   
Principal Investigator: Karin Coyle, PhD         
Sponsors and Collaborators
ETR Associates
DFUSION, INC.
Investigators
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Principal Investigator: Tamara Kuhn, MS dfusion
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Responsible Party: ETR Associates
ClinicalTrials.gov Identifier: NCT04135443    
Other Study ID Numbers: 3T
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ETR Associates:
Healthy relationships
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases