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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases; Sexual Behavior; Adolescent Behavior; Homosexuality
• Intervention / Treatment: Behavioral: Life Skills Coaching; Behavioral: Community Resources

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:

1. 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.
2. 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.
3. Examine the differential efficacy of our intervention in improving psychosocial mediators (e.g., personal competency) associated with our outcomes; and,
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: Community Resources; Participants in the control arm will receive access to a directory of local resources in their community.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	The investigators will estimate the number of participants who tested for HIV two or more times over the trial period.	12-month

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: San Diego State University; University of Michigan; Emory University; George Washington University; University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Adolescence; Internet; Sexuality; LGBT
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: U01MD011274 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No