Combatting HIV Or Other STIs Early (CHOOSE) in an RCT of mHealth Tool Support

(CHOOSE Trial)

Not yet recruiting at 5 trial locations

Overseen By Nancy Liu

Age: < 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Westat

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.

Who Is on the Research Team?

Susan Buchbinder

Principal Investigator

San Francisco Department of Public Health

Albert Liu

Principal Investigator

San Francisco Department of Public Health

Are You a Good Fit for This Trial?

Inclusion Criteria

* Age 13-24 years, inclusive;

* Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime;

* Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package;

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Standard of Care and PrEP Choice at Enrollment Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit.

Group II: Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9 Active Control 1 Intervention

Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit.

Who Is Running the Clinical Trial?

Westat

Lead Sponsor

Trials

49

Recruited

39,700+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

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