PrEP at a Syringe Services Program

NCT04782180 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20210017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up

  Tenofovir diphosphate levels will be quantified using a validated dried blood spot (DBS) assay. The outcome will be reported as the mean intracellular concentration (fmol/punch) at the 6-month follow-up visit. This measure reflects intracellular drug exposure and adherence.

  6 months

Secondary Outcomes (1)

• Time to PrEP Initiation Post Negative HIV Rapid Test

  up to 12 months

Study Arms (1)

Rapid PrEP group

EXPERIMENTAL

Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.

Drug: Descovy 200Mg 25Mg Tablet; Behavioral: PrEP

Interventions

Descovy 200Mg 25Mg Tablet DRUG

daily Descovy tab by mouth

Rapid PrEP group

PrEP BEHAVIORAL

PrEP will be provided in a community setting by community-based harm reduction program.

Rapid PrEP group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Interventions

emtricitabine tenofovir alafenamide; Tablets

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Hansel Tookes, Professor of Medicine
• Organization: University of Miami

hetookes@miami.edu

305-689-7030

Study Officials

• Hansel Tookes

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: February 1, 2022
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)