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NCT Number: NCT05848570

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

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.

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Key information

Age range

13 year–34 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Meena Malhotra, MA

CONTACT

[email protected]

Sybil Hosek, PhD

CONTACT

[email protected]

312-864-8030

Sybil Hosek, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keeping it LITE

Other

observational cohort only

Primary outcomes

  1. Sexual Behavior Questionnaire

    Time frame: past 6 months

    oral, anal and vaginal sex episodes

  2. HIV Testing Result

    Time frame: past 12 months

    HIV seroconversion

Secondary outcomes

  1. PrEP uptake

    Time frame: past 6 months

    initiation of pre-exposure prophylaxis for HIV prevention

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey French, MD

CONTACT

[email protected]

Sybil Hosek, PhD

CONTACT

[email protected]

3128648030

Sponsors and collaborators

Lead sponsor

Hektoen Institute for Medical Research

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: LITE-2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 8, 2023
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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