Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men
1 other identifier
interventional
600
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Mar 2018
Longer than P75 for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedResults Posted
Study results publicly available
May 6, 2023
CompletedMay 6, 2023
May 1, 2023
3.9 years
May 10, 2017
February 23, 2023
May 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
6-month, 12-month
Number of Participants Engaging in HIV Testing Behavior
12-month
Study Arms (2)
Life Skills Coaching
EXPERIMENTALParticipants 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.
Community Resources
ACTIVE COMPARATORParticipants in the control arm will receive access to a directory of local resources in their community.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Assigned a male sex at birth and identifying as male at time of enrollment,
- Be between the ages of 13-18 (inclusive),
- Speak and read English,
- Report same-sex attractions and/or behaviors,
- Live in one of the zip codes of the 109 counties included in this trial,
- Access to internet
You may not qualify if:
- Being assigned a sex other than male at birth,
- Identifying as a gender other than male at time of enrollment,
- Being younger than 13 or older than 18 years of age,
- Not speaking and reading English,
- Reporting no same-sex attractions and/or behaviors,
- Living outside of the 109 counties included in the four regions selected for this trial,
- Currently incarcerated,
- No access to internet.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- University of Michigancollaborator
- Emory Universitycollaborator
- University of North Carolinacollaborator
- George Washington Universitycollaborator
- San Diego State Universitycollaborator
Study Sites (2)
Emory University
Atlanta, Georgia, 30322, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jose Bauermeister
- Organization
- University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 16, 2017
Study Start
March 23, 2018
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
May 6, 2023
Results First Posted
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share