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NCT04782180 Clinical Trial

PrEP at a Syringe Services Program

Hiv Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04782180
Other study ID # 20210017
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2022
Est. completion date November 1, 2025

Study information
Verified date April 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date November 1, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intracellular level of tenofovir diphosphate assessed via dried blood spot 6 months
Secondary time to PrEP initiation post negative HIV rapid test number of days between receiving negative test result and initiating PrEP via self-report up to 12 months
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