Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

February 2, 2024 updated by: Midway Specialty Care Center

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Midway Specialty Care Center
        • Contact:
        • Principal Investigator:
          • Emmanuelle Allseits, MD
      • Temple Terrace, Florida, United States, 33617
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Midway Specialty Care Center
        • Contact:
        • Sub-Investigator:
          • Jennifer Kuretski, DNP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cisgender Females
Drug: Cabotegravir Injection [Apretude]
Apretude for PrEP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Describe incidence of bacterial STIs through weeks 20, 44 and 92
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: Weeks 20, 44 and 92
Weeks 20, 44 and 92

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midway Specialty Care Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hiv

Clinical Trials on Cabotegravir Injection [Apretude]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe