NCT05848570

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Mar 2023May 2027

Study Start

First participant enrolled

March 23, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 8, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

April 13, 2023

Last Update Submit

April 27, 2023

Conditions

HIV InfectionsSexual Behavior

Outcome Measures

Primary Outcomes (2)

  • Sexual Behavior Questionnaire

    oral, anal and vaginal sex episodes

    past 6 months

  • HIV Testing Result

    HIV seroconversion

    past 12 months

Secondary Outcomes (1)

  • PrEP uptake

    past 6 months

Interventions

Keeping it LITEOTHER

observational cohort only

Eligibility Criteria

Age13 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • For young adults ages 18-34: self-identified SGM young adults ages 18-34 who meet at least one of the following criteria:
  • \) condomless anal or vaginal intercourse (CAI) with a cisgender man in the last 6 months OR
  • \) sex with cisgender men and bacterial STI in the last 6 months OR
  • \) 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)

You may not qualify if:

  • under age 13
  • over age 34

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

HIV InfectionsSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Central Study Contacts

Sybil Hosek, PhD

CONTACT

3128648030shosek@cookcountyhhs.org

Audrey French, MD

CONTACT

afrench@cookcountyhhs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 8, 2023

Study Start

March 23, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 8, 2023

Record last verified: 2023-04

Locations

US(1)