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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06145854

Enrollment

100

Registered

2023-11-24

Start date

2024-01-02

Completion date

2027-03-31

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

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.

Interventions

DRUGCabotegravir Injection [Apretude]

Apretude for PrEP

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 incidence of bacterial STIs through weeks 20, 44 and 92	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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026