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

NCT04135443 | Completed Results

• 1 other identifier: 3T
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS and Infections; Sexual Behavior; Health Knowledge, Attitudes, Practice

Keywords

Healthy relationships

Outcome Measures

Primary Outcomes (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

  3-months post baseline

Secondary Outcomes (6)

• Sexual Partners, no Condom, in the Last 3 Months

  3-months post baseline

• Self-reported STI/HIV Testing in Last Three Months

  3-months post baseline

• Dyadic Communication Scale

  3-months post baseline

• Condom Attitudes Scale

  3-months post baseline

• Condom Self-Efficacy Scale

  3-months post baseline

Study Arms (2)

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.

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).

Behavioral: General Health Materials Website

Interventions

3T Tune in! Turn on! Turn up! BEHAVIORAL

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.

3T Tune in! Turn on! Turn up!

General Health Materials Website BEHAVIORAL

The control group will receive access to a website containing general health promotion materials.

General Health Website Materials

Eligibility Criteria

• Age: 14 Years - 19 Years
• Gender Eligibility Details: self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• ETR Associates: lead
• dfusion Inc: collaborator

Study Sites (1)

ETR Associates

Scotts Valley, California, 95066, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Sexual Behavior; Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Small sample size limits generalizability; one short-term follow-up (3-month) survey limits insights on impacts; limited app use likely linked to lack of treatment effects, and the study lacked sufficient data to better understand all factors contributing to limits in app use; COVID impacted planned study recruitment and timeline.

Results Point of Contact

• Title: Tamara Kuhn, Vice President and Research Scientist
• Organization: dfusion, Inc

tamara.kuhn@dfusioninc.com

831-222-5003

Study Officials

• Tamara Kuhn, MS

  dfusion Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are randomly assigned to their condition without being made aware of their assigned condition as "attention control" or "intervention." Each condition accesses materials online.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 22, 2019
• Study Start: March 1, 2021
• Primary Completion: November 9, 2022
• Study Completion: November 29, 2022
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)