LYPS Intervention for HIV Prevention

(LYPS Trial)

Not yet recruiting at 3 trial locations
ER
NL
Overseen ByNancy Liu
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Westat
Must be taking: PrEP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.

Who Is on the Research Team?

KH

Keith Horvath

Principal Investigator

San Diego State University

AP

Audrey Pettifor

Principal Investigator

UNC Chapel Hill

LH

Lisa Hightow-Weidman, MD, MPH

Principal Investigator

Florida State University

SH

Sybil Hosek, PhD

Principal Investigator

University of Illinois at Chicago

KM

Kate Muessig

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

Inclusion Criteria

Is not living with HIV
Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC
Willing to provide informed consent to participate in the study
See 5 more

Exclusion Criteria

Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results
I am currently in another HIV medication or prevention study.
Is currently incarcerated or pending incarceration
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are enrolled and randomized into either the LYPS intervention or enhanced standard of care (eSOC) control condition

1 week
1 visit (in-person)

Treatment

Participants receive PrEP and PrEP care through community delivery or clinic-based care, supplemented by a mobile app for adherence support

36 weeks
Quarterly visits for oral PrEP, bi-monthly for injectable PrEP

Follow-up

Participants are monitored for PrEP adherence and persistence, including blood collection and self-interviews

9 months
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • LYPS

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: LYPS InterventionExperimental Treatment1 Intervention
Group II: Enhanced Standard of Care (eSOC) Control ConditionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Westat

Lead Sponsor

Trials
49
Recruited
39,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

The Emmes Company, LLC

Industry Sponsor

Trials
149
Recruited
1,052,000+
Peter Ronco profile image

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman profile image

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

Florida State University

Collaborator

Trials
234
Recruited
41,100+