PrEP at a Syringe Services Program

December 5, 2025 updated by: Hansel Tookes, University of Miami

Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapid PrEP group
Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
Drug: Descovy 200Mg 25Mg Tablet
daily Descovy tab by mouth
Behavioral: PrEP
PrEP will be provided in a community setting by community-based harm reduction program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to PrEP Initiation Post Negative HIV Rapid Test
Time Frame: up to 12 months
Number of days between receiving negative test result and initiating PrEP via self-report
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Hansel Tookes, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

November 11, 2024

Study Completion (Actual)

November 11, 2024

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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