Health Knowledge, Attitudes, Practice, HIV/AIDS and Infections, Sexual Behavior
Conditions
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
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.
The control group will receive access to a website containing general health promotion materials.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Condomless Anal Intercourse or Condomless Vaginal Intercourse | 3-months post baseline | Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported STI/HIV Testing in Last Three Months | 3-months post baseline | Number of times reported having been tested for STI, including HIV in the last 3 months |
| Dyadic Communication Scale | 3-months post baseline | 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 |
| Sexual Partners, no Condom, in the Last 3 Months | 3-months post baseline | \# partners with whom had anal or vaginal sex without using condoms in the last 3 months |
| Condom Self-Efficacy Scale | 3-months post baseline | 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 |
| Attitudes Towards Lube | 3-months post baseline | 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 |
| Condom Attitudes Scale | 3-months post baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 178 |
Baseline characteristics
| Characteristic | 3T Tune in! Turn on! Turn up! | General Health Website Materials | Total |
|---|---|---|---|
| Age, Continuous | 18.28 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 months | 57 Participants | 54 Participants | 111 Participants |
| Race/Ethnicity, Customized Black/African American | 89 Participants | 89 Participants | 178 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 89 Participants | 89 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 89 |
| other Total, other adverse events | 0 / 89 | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3T Tune in! Turn on! Turn up! | Condomless Anal Intercourse or Condomless Vaginal Intercourse | 49 Participants |
| General Health Website Materials | Condomless Anal Intercourse or Condomless Vaginal Intercourse | 50 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3T Tune in! Turn on! Turn up! | Attitudes Towards Lube | 3.40 score on a scale | Standard Deviation 0.63 |
| General Health Website Materials | Attitudes Towards Lube | 3.40 score on a scale | Standard Deviation 0.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3T Tune in! Turn on! Turn up! | Condom Attitudes Scale | 3.02 score on a scale | Standard Deviation 0.5 |
| General Health Website Materials | Condom Attitudes Scale | 2.90 score on a scale | Standard Deviation 0.44 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3T Tune in! Turn on! Turn up! | Condom Self-Efficacy Scale | 3.21 score on a scale | Standard Deviation 0.69 |
| General Health Website Materials | Condom Self-Efficacy Scale | 3.07 score on a scale | Standard Deviation 0.74 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3T Tune in! Turn on! Turn up! | Dyadic Communication Scale | 3.22 score on a scale | Standard Deviation 0.62 |
| General Health Website Materials | Dyadic Communication Scale | 3.22 score on a scale | Standard Deviation 0.45 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3T Tune in! Turn on! Turn up! | Self-reported STI/HIV Testing in Last Three Months | 1.04 Times tested, self reported | Standard Deviation 1.7 |
| General Health Website Materials | Self-reported STI/HIV Testing in Last Three Months | 0.60 Times tested, self reported | Standard Deviation 1.36 |
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