ClinicalTrials.gg
RecruitingNCT05848570LITE-2Updated May 8, 2023

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

An observational study in HIV Infections and Sexual Behavior, sponsored by Hektoen Institute for Medical Research. Recruiting at 1 site in United States. Open to participants aged 13 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-08.

Sponsored by Hektoen Institute for Medical Research · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
13 Years to 34 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections
  • Sexual Behavior
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 200 across 731 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Hektoen Institute for Medical Research is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 34 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Self-identified sexual and gender minority adolescents and young adults ages 13-34.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • under age 13
  • over age 34
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Patient registry
No

Interventions

  • OtherKeeping it LITE

    observational cohort only

06

What researchers measure

Primary outcomes

  1. Sexual Behavior Questionnaire

    oral, anal and vaginal sex episodes

    Time frame: past 6 months

  2. HIV Testing Result

    HIV seroconversion

    Time frame: past 12 months

Secondary outcomes

  1. PrEP uptake

    initiation of pre-exposure prophylaxis for HIV prevention

    Time frame: past 6 months

07

Study locations

1 of 1 sites recruiting
  • John H. Stroger, Jr. Hospital of Cook County
    Chicago, Illinois 60612, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05848570
Lead sponsor
Hektoen Institute for Medical Research
Responsible party
Sponsor
First posted
May 8, 2023
Start date
Mar 23, 2023
Primary completion
Jan 2027 (estimated)
Completion
May 2027 (estimated)
Last update
May 8, 2023

Study contacts

Sybil Hosek, PhD
Contact
shosek@cookcountyhhs.org
3128648030
Audrey French, MD
Contact
afrench@cookcountyhhs.org

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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