Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention

NCT ID: NCT05848570

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2027-05-31

Brief Summary

Despite advances in HIV diagnostics, care and prevention strategies, infection rates among adolescent and young adult sexual and gender minorities (SGM) continue to rise in the United States (US). There is an urgent need to describe the epidemiology and trajectories of HIV acquisition in this population and to offer age and culturally appropriate scalable prevention interventions to those at highest risk of infection in the US. This project will engage and retain young SGM in an innovative longitudinal cohort, enroll participants in a dynamic established digital health retention platform (HMP; HealthMPowerment), monitor HIV risk and prevention behaviors and explore the socioecological factors that influence the use of new HIV prevention technologies (UG3 phase), while also allowing targeted testing of novel digital health interventions (UH3 phase). In Aim 1, the investigators will enroll and retain a large (n=6000; 3000/year), diverse cohort of sexually active, SGM adolescents and young adults, ages 13-34, using innovative digital recruitment, engagement and retention strategies. Over the course of the study, the investigators will longitudinally characterize the sexual behavior, HIV transmission risk, and PrEP uptake trajectories of SGM youth utilizing epidemiological trajectory analyses to identify the most effective points of intervention (Aim 2). This study will capitalize upon productive existing partnerships and digital health expertise to articulate the drivers of the ongoing HIV epidemic among the most vulnerable populations in the US in order to identify the most effective, expeditious and scalable strategies to address this ongoing public health crisis.

Conditions

HIV Infections; Sexual Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Keeping it LITE

observational cohort only

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For young adults ages 18-34: self-identified SGM young adults ages 18-34 who meet at least one of the following criteria:

• 1) condomless anal or vaginal intercourse (CAI) with a cisgender man in the last 6 months OR
• 2) sex with cisgender men and bacterial STI in the last 6 months OR
• 3) anal or vaginal sex with a known HIV-infected partner in the last 6 months.
• For adolescents 13-17: self-identified SGM adolescents ages 13-17 who have engaged in any sexual activity (e.g., oral, anal or vaginal sex)

Exclusion Criteria

• under age 13
• over age 34

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Hektoen Institute for Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sybil Hosek, PhD

Role: CONTACT

shosek@cookcountyhhs.org

3128648030

Audrey French, MD

Role: CONTACT

afrench@cookcountyhhs.org

Facility Contacts

Sybil Hosek, PhD

Role: primary

shosek@cookcountyhhs.org

312-864-8030

Meena Malhotra, MA

Role: backup

mmalhotra@cookcountyhhs.org

Other Identifiers

1UG3AI169631-01

Identifier Type: NIH

Identifier Source: org_study_id

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