Keeping It LITE: Exploring HIV Risk in Vulnerable Youth with Limited Interaction and Digital Health Intervention (LITE-2)
LITE 2 is a national longitudinal cohort study specific to sexual AND gender minority adolescents that examines and models the trajectories of sexual behavior, gender identity development, HIV transmission risk and HIV prevention engagement of SGM (inclusive of gender diverse and non-binary individuals) ages 13-34 over time.
This study involves four distinct aims:
Aim 1
To 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.
Aim 2
To 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 3
To examine the efficacy of HMP Enhanced to improve PrEP adherence among HIV-negative youth (n ≥750) and viral suppression among HIV-positive youth (n ≥150) compared to HMP Basic in a randomized clinical trial.
Aim 4
To maximize the impact of the cohort by testing new and innovative digital health devices, HIV/STI diagnostics and interventions, informed by the previous aims as well as emerging NIH prevention priorities.
Study Description
This study aims to utilize a prospective cohort design with limited in-person interaction to monitor and investigate HIV risk and prevention behaviors among young SGM ages 13-34 in the US. Potential participants will be recruited online and retained using a digital research platform. Eligible participants (n=6000, inclusive of ~1500 LITE-1 participants who meet inclusion criteria) will complete baseline questionnaires and HIV self-testing remotely.
Participants will complete quarterly online questionnaires and HIV testing every 12 months through a study-supplied home testing kit. Participants who seroconvert while on study as evidenced by an uploaded and verified HIV test result, as well as those newly diagnosed at baseline (“prevalent positives”), will continue to be followed and will have access to clinical trial opportunities
Co-Principal Investigators
Sybil G. Hosek, PhD | Cook County Health
Audrey L. French, MD | Cook County Health
Lisa Hightow-Weidman, MD, MPH | Institute on Digital Health and Innovation, Florida State University College of Nursing
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)