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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05848570
Acronym
LITE-2
Enrollment
6000
Registered
2023-05-08
Start date
2023-03-23
Completion date
2027-05-31
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexual Behavior

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.

Interventions

OTHERKeeping it LITE

observational cohort only

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Hektoen Institute for Medical Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 34 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sexual Behavior Questionnairepast 6 monthsoral, anal and vaginal sex episodes
HIV Testing Resultpast 12 monthsHIV seroconversion

Secondary

MeasureTime frameDescription
PrEP uptakepast 6 monthsinitiation of pre-exposure prophylaxis for HIV prevention

Countries

United States

Contacts

Primary ContactSybil Hosek, PhD
shosek@cookcountyhhs.org3128648030
Backup ContactAudrey French, MD
afrench@cookcountyhhs.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026