Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Recruiting

• Conditions: Hiv
• Interventions: Drug: Cabotegravir Injection [Apretude]

• Registration Number: NCT06145854
• Lead Sponsor: Midway Specialty Care Center

Brief Summary

Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2024-01-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30
• Primary Completion: 2026-10-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Cisgender females, ages 18 years and older
2. Negative HIV test at baseline
3. Negative Pregnancy test at baseline
4. Weigh at least 35 kilograms
5. Already Prescribed CAB-LA (Apretude)

Exclusion Criteria

1. Transgender females or males
2. Cisgender males
3. Cisgender female who is actively breastfeeding
4. Severe hepatotoxicity
5. Evidence of Hepatitis B Infection
6. History or presence of allergies to cabotegravir or its components

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cisgender Females	Cabotegravir Injection [Apretude]	-

Primary Outcome Measures

Name	Time	Method
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.	44 Weeks

Secondary Outcome Measures

Name	Time	Method
Describe satisfaction of cisgender female patients while being on CAB-LA through weeks 20, 44 and 92 with the use of satisfaction surveys	Weeks 20, 44 and 92
Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females with substance use and/or unstable housing.	Weeks 20, 44 and 92
Describe incidence of bacterial STIs through weeks 20, 44 and 92	Weeks 20, 44 and 92
Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females	Weeks 20, 44 and 92
Describe percentage of cisgender female patients with HIV prevention failure while on CAB-LA, with detection of HIV, at weeks 20, 44 and 92.	Weeks 20, 44 and 92
Describe percentage of cisgender female patients with weight gain > 10% from baseline on CAB-LA at weeks 20, 44 and 92	Weeks 20, 44 and 92

Trial Locations

Locations (1)

Midway Specialty Care Center; 🇺🇸 West Palm Beach, Florida, United States