PrEP at a Syringe Services Program

University of Miami90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hiv Substance Use Disorders

Interventions

Descovy 200Mg 25Mg TabletDRUG

daily Descovy tab by mouth

PrEPBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Time to PrEP Initiation Post Negative HIV Rapid Test

Number of days between receiving negative test result and initiating PrEP via self-report

Time frame: up to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.