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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03155841

Collaborator

University of Michigan (Other), Emory University (Other), University of North Carolina (Other), George Washington University (Other), San Diego State University (Other)

600

Enrollment

Locations

Arms

47.2

Actual Duration (Months)

300

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Sexually Transmitted Diseases Sexual Behavior Adolescent Behavior Homosexuality	Behavioral: Life Skills Coaching Behavioral: Community Resources	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 23, 2018

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in confidence to engage in HIV prevention behaviors [3-month, 6-month, 9-month, 12-month]
The investigators will measure the change in HIV prevention self-efficacy over time.
Changes in HIV knowledge [3-month, 6-month, 9-month, 12-month]
The investigators will measure the change in HIV prevention knowledge over time.

Secondary Outcome Measures

Change in Number of Risky Sexual Partnerships [3-month, 6-month, 9-month, 12-month]
The investigators will estimate the change in total number of sexual partners of known HIV positive or unknown HIV serostatus with whom participants had anal intercourse without condoms and/or PrEP during the follow-up period.
Change in HIV Testing Behavior [3-month, 6-month, 9-month, 12-month]
The investigators will estimate the proportion of participants who test for HIV two or more times over the trial period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.