A Pharmacist-run PrEP Program for Women

NCT05755204 | Terminated FDA Drug

• 1 other identifier: OIC_011
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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)

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Uptake of LA-CAB vs. TDF/FTC for PrEP

  proportion of women who initiate LA-CAB vs. TDF/FTC for PrEP

  48 weeks

• Persistence on LA-CAB vs. TDF/FTC for PrEP

  proportion of women who remain on LA-CAB vs. TDF/FTC for PrEP

  48 weeks

Secondary Outcomes (16)

• Persistence on LA-CAB vs. TDF/FTC for PrEP

  24 weeks

• Uptake of LA-CAB vs. TDF/FTC for PrEP

  24 weeks

• HIV incidence

  24 weeks

• HIV incidence

  48 weeks

• Awareness of and willingness to initiate PrEP

  Baseline

Other Outcomes (4)

• Perception and experience with healthcare provider (HCP) and PrEP delivery setting

  24 weeks

• Perception and experience with healthcare provider (HCP) and PrEP delivery setting

  48 weeks

• HCP (healthcare provider) implementation processes and workload in this unique PrEP delivery model

  24 weeks

Study Arms (2)

Apretude group

High-risk women who choose to initiate intramuscular q8week LA-CAB (Apretude) with or without oral lead in for HIV PrEP

Drug: LA-CAB

Truvada group

High-risk women who choose to initiate daily oral TDF/FTC (Truvada) for HIV PrEP

Drug: TDF/FTC

Interventions

LA-CAB DRUG

Intramuscular LA-CAB for PrEP

Also known as: Apretude

Apretude group

TDF/FTC DRUG

Oral TDF/FTC for PrEP

Also known as: Truvada

Truvada group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cisgender women at high-risk of HIV acquisition residing in metro-Orlando

You may qualify if:

• 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:
• Non-reproductive potential defined as:
• Pre-menopausal IOCBP with one of the following:
• Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy Documented Bilateral Oophorectomy Post-menopausal IOCBP defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. IOCBP on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
• Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in IOCBP (see Appendix 7) from at least 14 days prior to the first dose of study medication. Participants will be counseled on the recommendation to continue use of a highly effective method of contraception for at least 14 days after discontinuation of oral CAB and at least 52 weeks after discontinuation of LA-CAB due to the unknown risk to the fetus. This discussion will be recorded in the participant's source notes.
• The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. All subjects participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of STI transmission to an uninfected partner.

You may not qualify if:

• 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.
• Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication Participants with a current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding
• \*\*Please note this protocol does not exclude participants who have previously received PrEP medications including IM LA-CAB or oral TDF/FTC
• ALT ≥5x ULN, OR ALT ≥3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin)
• CreCl\<50 ml/min for those who elect to start TDF/FTC
• Any other screening grade 3 or 4 lab abnormalities that are unexplained or deemed by the investigator to be a contraindication for study participation

Sponsors & Collaborators

• Orlando Immunology Center: lead

Study Sites (1)

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

MeSH Terms

Interventions

cabotegravir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: June 21, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)