Cisgender female patients starting long-acting Cabotegravir for HIV prevention
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.
Midway Specialty Care Center · NCT06145854
This study looks at how well cisgender women do with a new long-acting HIV prevention treatment called Cabotegravir to see if it works better than the usual daily pills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Midway Specialty Care Center (other) |
| Locations | 3 sites (Orlando, Florida and 2 other locations) |
| Trial ID | NCT06145854 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the real-world clinical outcomes of cisgender female patients who initiate long-acting Cabotegravir (CAB-LA) for HIV prevention. The study focuses on patients who have been prescribed CAB-LA, assessing their experiences and health outcomes over time. By analyzing data from multiple locations in Florida, the study aims to provide insights into the effectiveness and safety of this new preventive option compared to traditional oral PrEP regimens.
Who should consider this trial
Good fit: Ideal candidates for this study are cisgender females aged 18 and older who have tested negative for HIV and are prescribed CAB-LA.
Not a fit: Patients who are transgender, cisgender males, or those with certain health conditions such as severe hepatotoxicity or active breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of long-acting HIV prevention methods, potentially leading to improved health outcomes for women at risk of HIV.
How similar studies have performed: While this approach is relatively novel, other studies have shown promise in evaluating long-acting HIV prevention methods, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orlando, Florida and 2 other locations
- Midway Specialty Care Center — Orlando, Florida, United States (RECRUITING)
- Midway Specialty Care Center — Temple Terrace, Florida, United States (NOT_YET_RECRUITING)
- Midway Specialty Care Center — West Palm Beach, Florida, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiv