PrEP at a Syringe Services Program

Phase 4

Completed

• Conditions: Hiv; Substance Use Disorders
• Interventions: Drug: Descovy 200Mg 25Mg Tablet; Behavioral: PrEP

• Registration Number: NCT04782180
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2022-02-01
• Status Verified: 2024-11
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rapid PrEP group	Descovy 200Mg 25Mg Tablet	Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
Rapid PrEP group	PrEP	Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.

Primary Outcome Measures

Name	Time	Method
Intracellular level of tenofovir diphosphate	6 months	assessed via dried blood spot

Secondary Outcome Measures

Name	Time	Method
time to PrEP initiation post negative HIV rapid test	up to 12 months	number of days between receiving negative test result and initiating PrEP via self-report

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States