Phase 4 N=90 Prevention

PrEP at a Syringe Services Program

Hiv · Substance Use Disorders

Bottom Line

View on ClinicalTrials.gov: NCT04782180 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up — NA fmol/punch

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Descovy 200Mg 25Mg Tablet (Drug); PrEP (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up	NA	—
SECONDARY Time to PrEP Initiation Post Negative HIV Rapid Test	—	—

Summary

The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.

Eligibility Criteria

Inclusion Criteria

over the age of 18
speak either English or Spanish
ability to provide informed consent
currently enrolled in the syringe services program
have a negative HIV rapid test result
estimated creatinine clearance > 30 ml/minute

Exclusion Criteria

do not meet the above criteria of inclusion
decline to participate
test positive for HIV via rapid test
are pregnant or plan on becoming pregnant
have symptoms acute HIV.
Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04782180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.