Clinical trial NCT03155841: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Sexual Behavior
Adolescent Behavior
Homosexuality
Keywords: Prevention
Internet
Adolescence
LGBT
Sexuality
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Emory University
name: University of North Carolina
name: George Washington University
name: San Diego State University
First posted: 2017-05-16
Enrollment: 600
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time
timeFrame: 6-month, 12-month
measure: HIV Knowledge Over Time
timeFrame: 6-month, 12-month
Secondary outcomes:
measure: Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
timeFrame: 6-month, 12-month
measure: Number of Participants Engaging in HIV Testing Behavior
timeFrame: 12-month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: