Clinical trial NCT05848570: Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention
Official title: Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Sexual Behavior
Lead sponsor: Hektoen Institute for Medical Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-05-08
Enrollment: 6000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-identified sexual and gender minority adolescents and young adults ages 13-34.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sexual Behavior Questionnaire
timeFrame: past 6 months
measure: HIV Testing Result
timeFrame: past 12 months
Secondary outcomes:
measure: PrEP uptake
timeFrame: past 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
Study officials:
References: