PrEP at a Syringe Services Program

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04782180

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv Substance Use Disorders	Drug: Descovy 200Mg 25Mg Tablet Behavioral: PrEP	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapid PrEP group Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.	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.

Arm

Intervention/Treatment

Experimental: Rapid PrEP group

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

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.

Outcome Measures

Primary Outcome Measures

Intracellular level of tenofovir diphosphate [6 months]
assessed via dried blood spot

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Hansel Tookes, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hansel Tookes, Assistant Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04782180

Other Study ID Numbers:

20210017

First Posted:

Mar 4, 2021

Last Update Posted:

Mar 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Substance-Related Disorders

Emtricitabine tenofovir alafenamide

Study Results

No Results Posted as of Mar 7, 2022