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Completed

NCT Number: NCT04782180

PrEP at a Syringe Services Program

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Descovy 200Mg 25Mg Tablet

Drug

daily Descovy tab by mouth

PrEP

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2021
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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