A Pharmacist-run, Community-based PrEP Program for High-risk Women-the OPTIMIZE Study

Orlando Immunology Center1 site in 1 country2 target enrollmentJune 21, 2023

ConditionsHIV Prevention

InterventionsLA-CAB TDF/FTC

DrugsLA-CAB TDF/FTC

Overview

Phase: Not Applicable
Intervention: LA-CAB
Conditions: HIV Prevention
Sponsor: Orlando Immunology Center
Enrollment: 2
Locations: 1
Primary Endpoint: Persistence on LA-CAB vs. TDF/FTC for PrEP
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for lack of retention in PrEP care)

Detailed Description

This is a 48-week, open-label, single center pharmacist-run study to assess PrEP uptake and persistence among women at high-risk of HIV-1 acquisition in metro-Orlando at a community-based organization called Let's Beehive. All participants in the study will chose whether they want to start IM LA-CAB (with or without the oral lead-in) vs. daily oral TDF/FTC for PrEP. The study will include a Screening Phase (up to 56 days), and an open-label phase (Day 1 up to Week 48). Approximately 50 women defined as "high-risk" for HIV-1 infection who have a confirmed negative HIV test will be enrolled. All insured participants will be responsible for using their insurance plan to obtain coverage for their chosen PrEP medication, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs. For participants who are under-or-uninsured, the study sponsor will provide financial coverage for approximately 20 participants (10 on LA-CAB and 10 on TDF/FTC) to receive PrEP medication and undergo study-required laboratory testing at no cost.

Registry

clinicaltrials.gov

Start Date

June 21, 2023

End Date

October 15, 2024

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

Orlando Immunology Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18-65 years at the time of signing the informed consent
•Cisgender women with a negative/non-reactive HIV test (for those who choose LA-CAB, a negative or non-reactive HIV Ag/Ab assay and negative qualitative HIV-1 RNA test will be used to confirm negative HIV status, for those who choose TDF/FTC, a negative HIV Ag/Ab assay alone will be used to confirm negative HIV status)
•If insured, must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
•If un-or-underinsured, must be enrolled in the study sponsor's assistance program which will provide study medications and study-required laboratory tests at no cost
•Must be at "high-risk" of sexually acquired HIV-1 infection which will be defined as any condomless vaginal or anal sex in the past 6 months plus ≥1 of the following:
•Partner living with HIV with unknown viral load
•≥1 sex partner of unknown HIV status
•Bacterial STI in the past 6 months (GC/Chlamydia or syphilis)
•Cisgender women
•An individual of child-bearing potential (IOCBP) is eligible to participate if they are not pregnant \[as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a negative urine hCG test at Day 1 (a local serum hCG test at Day 1 is allowed if it can be done, and results obtained, within 24 hours prior to Day 1)\], not lactating, and at least one of the following conditions applies:

Exclusion Criteria

•IOCBP who are breastfeeding or plan to become pregnant or breastfeed during the study
•Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
•Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HbsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
•Subjects positive for HbsAg are excluded. Subjects negative for anti-HBs but positive for anti-HBc (negative HbsAg status) and positive for HBV DNA are excluded.
•Note: Subjects positive for anti-HBc (negative HbsAg status) and positive for antiHBs (past and/or current evidence) are immune to HBV and are not excluded. AntiHBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM.
•Evidence of Hepatitis C virus (HCV) infection based on the results of testing at Screening for Hepatitis C antibody (HCV Ab) and HCV RNA as follows:
•Subjects positive for HCV Ab and HCV RNA are excluded Subjects positive for HCV Ab with a negative HCV RNA test are permitted to enroll
•History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
•Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate.