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.

• Sponsor: Midway Specialty Care Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06145854
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Anticipated Duration (Months): 39.6
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Drug: Cabotegravir Injection [Apretude]

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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.
• Anticipated Study Start Date: Dec 11, 2023
• Anticipated Primary Completion Date: Oct 30, 2026
• Anticipated Study Completion Date: Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Cisgender Females	Drug: Cabotegravir Injection [Apretude]; Apretude for PrEP

Outcome Measures

Primary Outcome Measures

1. Describe the percent of cisgender females persistent on CAB-LA over 44 weeks. [44 Weeks]

Secondary Outcome Measures

1. Describe incidence of bacterial STIs through weeks 20, 44 and 92 [Weeks 20, 44 and 92]

2. 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]

3. Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females [Weeks 20, 44 and 92]

4. 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]

5. 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]

6. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Midway Specialty Care Center	Orlando	Florida	United States	32819
2	Midway Specialty Care Center	Temple Terrace	Florida	United States	33617
3	Midway Specialty Care Center	West Palm Beach	Florida	United States	33401

Sponsors and Collaborators

• Midway Specialty Care Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Midway Specialty Care Center
• ClinicalTrials.gov Identifier: NCT06145854
• Other Study ID Numbers: 2022-01
• First Posted: Nov 24, 2023
• Last Update Posted: Nov 24, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cabotegravir

Study Results

No Results Posted as of Nov 24, 2023