Recruiting

Digital Health Intervention

Sponsor:

Hektoen Institute for Medical Research

Code:

NCT05848570

Conditions

HIV Infections

Sexual Behavior

Eligibility Criteria

Sex: All

Age: 13 - 34

Healthy Volunteers: Accepted

Interventions

Keeping it LITE

Study Details

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.

Conditions

HIV Infections

Sexual Behavior

Study ID

NCT05848570

Start date

Mar 23, 2023

Status verified date

Apr, 2023

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 34

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Keeping it LITE

observational cohort only

Primary outcome measure

  • Sexual Behavior Questionnaire [ Time Frame: past 6 months ]
  • HIV Testing Result [ Time Frame: past 12 months ]

Central Contacts and Locations

Central contacts

Locations

John H. Stroger, Jr. Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

Sybil Hosek, PhD

More Information

Sponsor

Hektoen Institute for Medical Research

Last update posted

May 8, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hektoen Institute for Medical Research on 2023-05-08.