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| Name | Class |
|---|---|
| dfusion Inc | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 baseline |
| Self-reported STI/HIV Testing in Last Three Months |
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Inclusion Criteria:
Exclusion Criteria:
self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Kuhn, MS | dfusion Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETR Associates | Scotts Valley | California | 95066 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Participants were randomly assigned individually to arms. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2023 |
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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).
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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.
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| General Health Materials Website | Behavioral | The control group will receive access to a website containing general health promotion materials. |
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Number of times reported having been tested for STI, including HIV in the last 3 months
| 3-months post baseline |
| 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 | 3-months post baseline |
| 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 | 3-months post baseline |
| 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 | 3-months post baseline |
| 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 | 3-months post baseline |
| 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). Participants were randomly assigned individually to study arms. |
| COMPLETED |
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| NOT COMPLETED |
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Young Black men who are attracted to men.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Engaged in condomless receptive or insertive anal or condomless vaginal intercourse last 3 months | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | All participants with complete data on baseline and follow-up survey. | Posted | Count of Participants | Participants | 3-months post baseline |
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| 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 | Not Posted | 3-months post baseline | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Participants with complete data on baseline and follow-up for outcome. | Posted | Mean | Standard Deviation | Times tested, self reported | 3-months post baseline |
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| 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 | Participants with complete data on baseline and follow-up survey for outcome. | Posted | Mean | Standard Deviation | score on a scale | 3-months post baseline |
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| 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 | Participants with complete baseline and follow-up survey data for outcome. | Posted | Mean | Standard Deviation | score on a scale | 3-months post baseline |
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| 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 | Participants with complete data on baseline and follow-up survey for outcome. | Posted | Mean | Standard Deviation | score on a scale | 3-months post baseline |
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| 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 | Participants with complete data on baseline and follow-up survey for outcome. | Posted | Mean | Standard Deviation | score on a scale | 3-months post baseline |
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Entire study period (Consent through 3 month follow-up), approximately 4 months.
Used clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 89 | 0 | 89 | 0 | 89 |
| EG001 | 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). | 0 | 89 | 0 | 89 | 0 | 89 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Kuhn, Vice President and Research Scientist | dfusion, Inc | 831-222-5003 | tamara.kuhn@dfusioninc.com |
| Dec 11, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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