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PrEP at a Syringe Services Program

Primary Purpose

Hiv, Substance Use Disorders

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Descovy 200Mg 25Mg Tablet
PrEP
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hiv

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rapid PrEP group

Arm Description

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

Outcomes

Primary Outcome Measures

Intracellular level of tenofovir diphosphate
assessed via dried blood spot

Secondary Outcome Measures

time to PrEP initiation post negative HIV rapid test
number of days between receiving negative test result and initiating PrEP via self-report

Full Information

First Posted
March 1, 2021
Last Updated
May 9, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04782180
Brief Title
PrEP at a Syringe Services Program
Official Title
Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid PrEP group
Arm Type
Experimental
Arm Description
Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
Intervention Type
Drug
Intervention Name(s)
Descovy 200Mg 25Mg Tablet
Intervention Description
daily Descovy tab by mouth
Intervention Type
Behavioral
Intervention Name(s)
PrEP
Intervention Description
PrEP will be provided in a community setting by community-based harm reduction program.
Primary Outcome Measure Information:
Title
Intracellular level of tenofovir diphosphate
Description
assessed via dried blood spot
Time Frame
6 months
Secondary Outcome Measure Information:
Title
time to PrEP initiation post negative HIV rapid test
Description
number of days between receiving negative test result and initiating PrEP via self-report
Time Frame
up to 12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
self representation of gender identity
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hansel Tookes
Phone
3056897030
Email
hetookes@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansel Tookes
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hansel Tookes
Phone
305-689-7030
Email
hetookes@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Hansel Tookes

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PrEP at a Syringe Services Program

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