Cisgender Female Patients Who Start on Long Acting Cabote... | NCT06145854

Studies
Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

NCT06145854

Sponsor

Midway Specialty Care Center

Status

Active, not recruiting

Last Update Posted

Nov 3, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Interventions

Cabotegravir Injection [Apretude]

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2024Actual

Primary Completion Date

Oct 30, 2026Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Nov 17, 2023

First Submission Date that Met QC Criteria

Nov 17, 2023

First Posted Date

Nov 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2025

Last Update Posted Date

Nov 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cisgender Females			Drug: Cabotegravir Injection [Apretude]

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabotegravir Injection [Apretude]	Drug	Apretude for PrEP	Cisgender Females

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

100 cisgender females (including 15 cisgender females with history of substance use and 15 cisgender females with unstable housing)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Midway Specialty Care Center		Orlando	Florida	32819	United States
Midway Specialty Care Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C584914	cabotegravir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided