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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Emory University | OTHER |
| University of North Carolina | OTHER |
| George Washington University |
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The investigators propose to deliver and test a life skills intervention targeting the key domains that fuel HIV disparities among adolescent (ages 13-18) same-sex attracted men in the United States. This RCT will yield important information regarding the delivery of a developmentally-appropriate HIV prevention program that reaches racial/ethnic and socioeconomically diverse sample of adolescent men across four regions in the United States.
From 2000-2010, the annual number of new HIV diagnoses among MSM aged 13-24 years old more than doubled. There are stark racial and ethnic disparities in the incidence of new HIV infections among YMSM; 13- 24 year old racial and ethnic minority MSM now represent a rapidly growing share of all new HIV infections. Although the likelihood of HIV acquisition is greater at older ages, many of the cognitive and behavioral risk factors that contribute to the risk of HIV infection rates develop in adolescence. As adolescent MSM (AMSM; 13-18 years old) begin to develop and express gender and sexual identities, to experiment and begin sexual behaviors, and to begin to establish a sense of self, there is the opportunity to parallel this period of growth with targeted, tailored interventions that equip AMSM with the life skills they need to reduce their vulnerability to HIV risk and to establish the life skills necessary to manage risk. The investigators developed a mobile-friendly WebApp intervention focused on life skills training with links to local resources. In the proposed activities, the investigators will adapt the life skills intervention for four U.S regions heavily impacted by HIV, and revise the content to include materials that are age-appropriate for 13 to 18 year-olds. Given the role that stigma and social isolation plays in the lives of many AMSM, the investigators also propose to embed a peer-to-peer motivational interviewing component, allowing participants to access motivational interviewing counseling via VSee video-chat. With a large and diverse sample (n=500), the investigators will test the efficacy of the intervention, now referred to as iCON+, on cognitive and behavioral HIV-related outcomes using a two-arm randomized control design. In addition, the investigators examine whether structural characteristics in a region (e.g., race/ethnicity segregation, HIV prevalence) influence the efficacy of the proposed intervention.
The following Specific Aims are proposed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life Skills Coaching | Experimental | Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function. |
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| Community Resources | Active Comparator | Participants in the control arm will receive access to a directory of local resources in their community. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life Skills Coaching | Behavioral | The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location. |
| Measure | Description | Time Frame |
|---|---|---|
| Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time | The investigators will measure HIV prevention self-efficacy over time, using a 4-point scale (1=Very Easily; 2=Easily; 3=Somewhat Easily; 4=Not Easily) where lower scores indicate a better outcome. | 6-month, 12-month |
| HIV Knowledge Over Time | The investigators will measure HIV prevention knowledge over time using 13 True or False statements (0=Incorrect; 1=Correct) regarding HIV transmission. Scores can range from 0 to 13, where higher scores indicate a better outcome. | 6-month, 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships | The investigators will estimate participants' likelihood of engaging in one or more same-sex sexual partnerships during follow-up periods. | 6-month, 12-month |
| Number of Participants Engaging in HIV Testing Behavior |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| University of Michigan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Life Skills Coaching | Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function. Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location. |
| 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 | Yes | No | No | Study Protocol | Nov 6, 2020 | Apr 5, 2023 |
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| OTHER |
| San Diego State University | OTHER |
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| Community Resources | Behavioral | The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions. |
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The investigators will estimate the number of participants who tested for HIV two or more times over the trial period. |
| 12-month |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| FG001 | Community Resources | Participants in the control arm will receive access to a directory of local resources in their community. Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Life Skills Coaching | Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function. Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location. |
| BG001 | Community Resources | Participants in the control arm will receive access to a directory of local resources in their community. Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Same-sex sexual behaviors | Participants reporting prior lifetime sexual behavior with a male partner | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time | The investigators will measure HIV prevention self-efficacy over time, using a 4-point scale (1=Very Easily; 2=Easily; 3=Somewhat Easily; 4=Not Easily) where lower scores indicate a better outcome. | Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table. | Posted | Mean | Standard Deviation | units on a scale | 6-month, 12-month |
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| Primary | HIV Knowledge Over Time | The investigators will measure HIV prevention knowledge over time using 13 True or False statements (0=Incorrect; 1=Correct) regarding HIV transmission. Scores can range from 0 to 13, where higher scores indicate a better outcome. | Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table. | Posted | Mean | Standard Deviation | score on a scale | 6-month, 12-month |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships | The investigators will estimate participants' likelihood of engaging in one or more same-sex sexual partnerships during follow-up periods. | Posted | Count of Participants | Participants | 6-month, 12-month |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Engaging in HIV Testing Behavior | The investigators will estimate the number of participants who tested for HIV two or more times over the trial period. | Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table. | Posted | Count of Participants | Participants | 12-month |
|
Adverse event data were collected over 12 months
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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 | Life Skills Coaching | Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function. Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location. | 0 | 300 | 0 | 300 | 2 | 300 |
| EG001 | Community Resources | Participants in the control arm will receive access to a directory of local resources in their community. Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions. | 0 | 300 | 0 | 300 | 3 | 300 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HIV Infection | Infections and infestations | Systematic Assessment | Count of participants who self-disclosed a change in their HIV status after testing for HIV during the study period |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Bauermeister | University of Pennsylvania | 215-898-9993 | bjose@upenn.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2023 | Feb 23, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2019 | May 3, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| D012725 | Sexual Behavior |
| D000294 | Adolescent Behavior |
| D006716 | Homosexuality |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091444 | Community Resources |
| ID | Term |
|---|---|
| D004472 | Health Care Economics and Organizations |
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| Title | Measurements |
|---|---|
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| Ages 17-18 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 12 Month Follow-up |
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| Units | Counts |
|---|---|
| Participants |
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