LITE-2: Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention

Sponsor
Hektoen Institute for Medical Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT05848570
Collaborator
National Institutes of Health (NIH) (NIH)
6,000
1
49.3
121.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Keeping it LITE

Study Design

Study Type:
Observational
Anticipated Enrollment :
6000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention
Actual Study Start Date :
Mar 23, 2023
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Outcome Measures

Primary Outcome Measures

  1. Sexual Behavior Questionnaire [past 6 months]

    oral, anal and vaginal sex episodes

  2. HIV Testing Result [past 12 months]

    HIV seroconversion

Secondary Outcome Measures

  1. PrEP uptake [past 6 months]

    initiation of pre-exposure prophylaxis for HIV prevention

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 34 Years
Sexes Eligible for Study:
All
Accepts 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
    1. sex with cisgender men and bacterial STI in the last 6 months OR
    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 John H. Stroger, Jr. Hospital of Cook County Chicago Illinois United States 60612

Sponsors and Collaborators

  • Hektoen Institute for Medical Research
  • National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hektoen Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT05848570
Other Study ID Numbers:
  • 1UG3AI169631-01
First Posted:
May 8, 2023
Last Update Posted:
May 8, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2023