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NCT06145854Active, not recruiting

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

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.

Source: ClinicalTrials.gov · Last updated 3 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
17 Nov 2023
Start date
2 Jan 2024
Primary completion date
30 Oct 2026
Lead sponsor
Midway Specialty Care Center
Diseases
HIV
NCT number
NCT06145854

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 2 Jan 2024 to the primary completion date, 30 Oct 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Evidence of Hepatitis B Infection
  • History or presence of allergies to cabotegravir or its components

Other

  • Transgender females or males
  • Cisgender males
  • Cisgender female who is actively breastfeeding
  • Severe hepatotoxicity

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: Female

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Midway Specialty Care Center
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Midway Specialty Care Center
Coordinator of this site? Confirm its status
Temple TerraceUnited StatesUnknown status
Midway Specialty Care Center
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.