HIV InfectionsLITE-2NCT05848570
Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention
An observational study of HIV Infections and Sexual Behavior, run by Hektoen Institute for Medical Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexual Behavior
- What is being tested?
- Keeping it LITE
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Self-identified sexual and gender minority adolescents and young adults ages 13-34.
Who may be able to join
- 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)
Who cannot join
- under age 13
- over age 34
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Audrey French, MD contact
United States1 site, 1 recruiting
- Recruiting
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612
Sybil Hosek, PhD, 312-864-8030, shosek@cookcountyhhs.org
Meena Malhotra, MA, mmalhotra@cookcountyhhs.org
About this study
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
- Being tested
- Keeping it LITE
- Medical subject headings
- HIV Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeping it LITEOther
observational cohort only
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Behavior Questionnaire
oral, anal and vaginal sex episodes
Measured: past 6 months
HIV Testing Result
HIV seroconversion
Measured: past 12 months
Secondary outcomes (1)
PrEP uptake
initiation of pre-exposure prophylaxis for HIV prevention
Measured: past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start23 Mar 2023
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hektoen Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848570
- Sponsor's protocol ID
- 1UG3AI169631-01
- Acronym
- LITE-2
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention
- ClinicalTrials.gov ID
- NCT05848570
- Acronym / sponsor ID
- LITE-2 / 1UG3AI169631-01
- Conditions
- HIV Infections, Sexual Behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Hektoen Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Self-identified sexual and gender minority adolescents and young adults ages 13-34.
Key inclusion criteria (5 listed)
- For young adults ages 18-34: self-identified SGM young adults ages 18-34 who meet at least one of the following criteria:
- 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)
Key exclusion criteria (2 listed)
- under age 13
- over age 34
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keeping it LITEobservational cohort only | Other | – |
Primary outcome
Sexual Behavior Questionnaire
Time frame: past 6 months
oral, anal and vaginal sex episodes
HIV Testing Result
Time frame: past 12 months
HIV seroconversion
1 secondary outcome
PrEP uptake
Time frame: past 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey French, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexual Behavior, run by Hektoen Institute for Medical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sybil Hosek, PhD (3128648030, shosek@cookcountyhhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Behavior Questionnaire (time frame: past 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.