NCT05848570 · Hektoen Institute for Medical Research
Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention
(LITE-2)
What this study is about
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).
View original scientific description
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
OTHER
Keeping it LITE
observational cohort only
Primary outcome measures
Sexual Behavior Questionnaire
Time frame: past 6 months
oral, anal and vaginal sex episodes
HIV Testing Result
Time frame: past 12 months
HIV seroconversion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2023 · Source of record for eligibility and locations