Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Hiv Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145854
• Other study ID #: 2022-01
• Status: Recruiting
• Start date: January 2, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: Midway Specialty Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2027
• Est. primary completion date: October 30, 2026
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Drug:
• Cabotegravir Injection [Apretude]
Apretude for PrEP

Locations

Country	Name	City	State
United States	Midway Specialty Care Center	Orlando	Florida
United States	Midway Specialty Care Center	Temple Terrace	Florida
United States	Midway Specialty Care Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Midway Specialty Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.		44 Weeks
Secondary	Describe incidence of bacterial STIs through weeks 20, 44 and 92		Weeks 20, 44 and 92
Secondary	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
Secondary	Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females		Weeks 20, 44 and 92
Secondary	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
Secondary	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
Secondary	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