Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06145854

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Midway Specialty Care Center, Orlando, Florida, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabotegravir Injection [Apretude]

Drug

Apretude for PrEP

Primary outcomes

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

    Time frame: 44 Weeks

Secondary outcomes

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

    Time frame: 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

    Time frame: Weeks 20, 44 and 92

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: Weeks 20, 44 and 92

Sponsors and collaborators

Lead sponsor

Midway Specialty Care Center

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2023
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.