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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-34
SponsorHektoen Institute for Medical Research

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

under age 13

over age 34

Trial population

Self-identified sexual and gender minority adolescents and young adults ages 13-34.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Keeping it LITE

    Other intervention

    observational cohort only

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Sexual Behavior Questionnaire

oral, anal and vaginal sex episodes

Time frame
past 6 months
2

HIV Testing Result

HIV seroconversion

Time frame
past 12 months

Secondary outcomes

1

PrEP uptake

initiation of pre-exposure prophylaxis for HIV prevention

Time frame
past 6 months

Other outcomes

Sponsors and contacts

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Hektoen Institute for Medical Research

Lead sponsor

National Institutes of Health (NIH)

Collaborator