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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155841
• Other study ID #: U01MD011274
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• HIV Infections
• Homosexuality
• Sexual Behavior
• Sexually Transmitted Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia

Sponsors (6)

Lead Sponsor	Collaborator
University of Pennsylvania	Emory University, George Washington University, San Diego State University, University of Michigan, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6-month, 12-month
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.	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.	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.	12-month