Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP
Real World Clinical Outcomes in Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP: An Observational, Multisite Prospective 2 Year Study in the Southern U.S.
1 other identifier
observational
100
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 24, 2023
CompletedStudy Start
First participant enrolled
January 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
November 3, 2025
October 1, 2025
2.8 years
November 17, 2023
October 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
44 Weeks
Secondary Outcomes (6)
Describe incidence of bacterial STIs through weeks 20, 44 and 92
Weeks 20, 44 and 92
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
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 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
- +1 more secondary outcomes
Study Arms (1)
Cisgender Females
Interventions
Eligibility Criteria
100 cisgender females (including 15 cisgender females with history of substance use and 15 cisgender females with unstable housing)
You may qualify if:
- Cisgender females, ages 18 years and older
- Negative HIV test at baseline
- Negative Pregnancy test at baseline
- Weigh at least 35 kilograms
- Already Prescribed CAB-LA (Apretude)
You may not qualify if:
- Transgender females or males
- Cisgender males
- Cisgender female who is actively breastfeeding
- Severe hepatotoxicity
- Evidence of Hepatitis B Infection
- History or presence of allergies to cabotegravir or its components
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Midway Specialty Care Center
Orlando, Florida, 32819, United States
Midway Specialty Care Center
Temple Terrace, Florida, 33617, United States
Midway Specialty Care Center
West Palm Beach, Florida, 33401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
November 17, 2023
First Posted
November 24, 2023
Study Start
January 2, 2024
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
November 3, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share