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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04135443
Enrollment
178
Registered
2019-10-22
Start date
2021-03-01
Completion date
2022-11-29
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Healthy relationships

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.

Interventions

BEHAVIORAL3T Tune in! Turn on! Turn up!

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.

BEHAVIORALGeneral Health Materials Website

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

Sponsors

dfusion Inc
CollaboratorINDUSTRY
ETR Associates
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

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.

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).

Eligibility

Sex/Gender
MALE
Age
14 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Condomless Anal Intercourse or Condomless Vaginal Intercourse3-months post baselineEngaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months

Secondary

MeasureTime frameDescription
Self-reported STI/HIV Testing in Last Three Months3-months post baselineNumber of times reported having been tested for STI, including HIV in the last 3 months
Dyadic Communication Scale3-months post baselineScale 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
Sexual Partners, no Condom, in the Last 3 Months3-months post baseline\# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Condom Self-Efficacy Scale3-months post baselineScale 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
Attitudes Towards Lube3-months post baselineScale 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
Condom Attitudes Scale3-months post baselineScale 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

Countries

United States

Participant flow

Participants by arm

ArmCount
3T Tune in! Turn on! Turn up!
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.
89
General Health Website Materials
The control intervention featured 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).
89
Total178

Baseline characteristics

Characteristic3T Tune in! Turn on! Turn up!General Health Website MaterialsTotal
Age, Continuous18.28 Years
STANDARD_DEVIATION 1.18
18.20 Years
STANDARD_DEVIATION 1.25
18.23 Years
STANDARD_DEVIATION 1.21
Engaged in condomless receptive or insertive anal or condomless vaginal intercourse last 3 months57 Participants54 Participants111 Participants
Race/Ethnicity, Customized
Black/African American
89 Participants89 Participants178 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
89 Participants89 Participants178 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 890 / 89
other
Total, other adverse events
0 / 890 / 89
serious
Total, serious adverse events
0 / 890 / 89

Outcome results

Primary

Condomless Anal Intercourse or Condomless Vaginal Intercourse

Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months

Time frame: 3-months post baseline

Population: All participants with complete data on baseline and follow-up survey.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
3T Tune in! Turn on! Turn up!Condomless Anal Intercourse or Condomless Vaginal Intercourse49 Participants
General Health Website MaterialsCondomless Anal Intercourse or Condomless Vaginal Intercourse50 Participants
p-value: 0.9495% CI: [0.511, 2.063]Regression, Logistic
Secondary

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

Time frame: 3-months post baseline

Population: Participants with complete data on baseline and follow-up survey for outcome.

ArmMeasureValue (MEAN)Dispersion
3T Tune in! Turn on! Turn up!Attitudes Towards Lube3.40 score on a scaleStandard Deviation 0.63
General Health Website MaterialsAttitudes Towards Lube3.40 score on a scaleStandard Deviation 0.6
p-value: 0.89Regression, Linear
Secondary

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

Time frame: 3-months post baseline

Population: Participants with complete baseline and follow-up survey data for outcome.

ArmMeasureValue (MEAN)Dispersion
3T Tune in! Turn on! Turn up!Condom Attitudes Scale3.02 score on a scaleStandard Deviation 0.5
General Health Website MaterialsCondom Attitudes Scale2.90 score on a scaleStandard Deviation 0.44
p-value: 0.375Regression, Linear
Secondary

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

Time frame: 3-months post baseline

Population: Participants with complete data on baseline and follow-up survey for outcome.

ArmMeasureValue (MEAN)Dispersion
3T Tune in! Turn on! Turn up!Condom Self-Efficacy Scale3.21 score on a scaleStandard Deviation 0.69
General Health Website MaterialsCondom Self-Efficacy Scale3.07 score on a scaleStandard Deviation 0.74
p-value: 0.313Regression, Linear
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 1 - 5, with a higher score indicating better outcomes

Time frame: 3-months post baseline

Population: Participants with complete data on baseline and follow-up survey for outcome.

ArmMeasureValue (MEAN)Dispersion
3T Tune in! Turn on! Turn up!Dyadic Communication Scale3.22 score on a scaleStandard Deviation 0.62
General Health Website MaterialsDyadic Communication Scale3.22 score on a scaleStandard Deviation 0.45
p-value: 0.702Regression, Linear
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

Time frame: 3-months post baseline

Population: Participants with complete data on baseline and follow-up for outcome.

ArmMeasureValue (MEAN)Dispersion
3T Tune in! Turn on! Turn up!Self-reported STI/HIV Testing in Last Three Months1.04 Times tested, self reportedStandard Deviation 1.7
General Health Website MaterialsSelf-reported STI/HIV Testing in Last Three Months0.60 Times tested, self reportedStandard Deviation 1.36
p-value: 0.455Regression, Linear
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

Time frame: 3-months post baseline

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026