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Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men

Primary Purpose

HIV Infections, Sexually Transmitted Diseases, Sexual Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Skills Coaching
Community Resources
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Prevention, Internet, Adolescence, LGBT, Sexuality

Eligibility Criteria

13 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Assigned a male sex at birth and identifying as male at time of enrollment,
  2. Be between the ages of 13-18 (inclusive),
  3. Speak and read English,
  4. Report same-sex attractions and/or behaviors,
  5. Live in one of the zip codes of the 109 counties included in this trial,
  6. Access to internet

Exclusion Criteria:

  1. Being assigned a sex other than male at birth,
  2. Identifying as a gender other than male at time of enrollment,
  3. Being younger than 13 or older than 18 years of age,
  4. Not speaking and reading English,
  5. Reporting no same-sex attractions and/or behaviors,
  6. Living outside of the 109 counties included in the four regions selected for this trial,
  7. Currently incarcerated,
  8. No access to internet.

Sites / Locations

  • Emory University
  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Life Skills Coaching

Community Resources

Arm Description

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.

Participants in the control arm will receive access to a directory of local resources in their community.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 10, 2017
Last Updated
May 3, 2023
Sponsor
University of Pennsylvania
Collaborators
University of Michigan, Emory University, University of North Carolina, George Washington University, San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT03155841
Brief Title
Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men
Official Title
Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of Michigan, Emory University, University of North Carolina, George Washington University, San Diego State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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: Adapt a multilevel, online life skills intervention to address HIV vulnerability among AMSM living in four heavily impacted regions constituting diverse racial/ethnic and geographic areas (Chicago-Detroit; Atlanta-Washington, DC; Memphis- New Orleans; San Francisco-San Diego) in the US. Test the efficacy of our intervention, as compared to a delayed intervention condition, to improve cognitive (e.g., comfort discussing sexuality; HIV prevention attitudes, norms, self-efficacy, behavioral intentions) and behavioral (e.g., condom use, HIV testing, PrEP use) factors using a prospective RCT design. Examine the differential efficacy of our intervention in improving psychosocial mediators (e.g., personal competency) associated with our outcomes; and, Examine how socio-ecological determinants at the individual (e.g., race/ethnicity, urbanity) and regional (e.g., socioeconomic disadvantage, HIV prevalence) level are associated with intervention efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Adolescent Behavior, Homosexuality
Keywords
Prevention, Internet, Adolescence, LGBT, Sexuality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Life Skills Coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Resources
Arm Type
Active Comparator
Arm Description
Participants in the control arm will receive access to a directory of local resources in their community.
Intervention Type
Behavioral
Intervention Name(s)
Life Skills Coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time
Description
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.
Time Frame
6-month, 12-month
Title
HIV Knowledge Over Time
Description
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.
Time Frame
6-month, 12-month
Secondary Outcome Measure Information:
Title
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
Description
The investigators will estimate participants' likelihood of engaging in one or more same-sex sexual partnerships during follow-up periods.
Time Frame
6-month, 12-month
Title
Number of Participants Engaging in HIV Testing Behavior
Description
The investigators will estimate the number of participants who tested for HIV two or more times over the trial period.
Time Frame
12-month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men

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