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

HIV Infections Clinical Trial

— LITE-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848570
• Other study ID #: 1UG3AI169631-01
• Status: Recruiting
• Start date: March 23, 2023
• Est. completion date: May 2027

Study information

• Verified date: April 2023
• Source: Hektoen Institute for Medical Research
• Contact: Sybil Hosek, PhD
• Phone: 3128648030
• Email: shosek[@]cookcountyhhs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: May 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Sexual Behavior

Intervention

Other:
• Keeping it LITE
observational cohort only

Locations

Country	Name	City	State
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Hektoen Institute for Medical Research	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Behavior Questionnaire	oral, anal and vaginal sex episodes	past 6 months
Primary	HIV Testing Result	HIV seroconversion	past 12 months
Secondary	PrEP uptake	initiation of pre-exposure prophylaxis for HIV prevention	past 6 months