HivNCT06145854
Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP
An observational study of Hiv, run by Midway Specialty Care Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hiv
- What is being tested?
- Cabotegravir Injection [Apretude]
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jan 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: 100 cisgender females (including 15 cisgender females with history of substance use and 15 cisgender females with unstable housing)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Midway Specialty Care Center
Orlando, Florida, 32819
Midway Specialty Care Center
Temple Terrace, Florida, 33617
Midway Specialty Care Center
West Palm Beach, Florida, 33401
About this study
Official 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.
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.
- Conditions
- Hiv
- Being tested
- Cabotegravir Injection [Apretude]
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir Injection [Apretude]Drug
Apretude for PrEP
| Study group | Role | What they receive |
|---|---|---|
| Cisgender Females | Not described Receives: Drug: Cabotegravir Injection [Apretude] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
Measured: 44 Weeks
Secondary outcomes (6)
Describe incidence of bacterial STIs through weeks 20, 44 and 92
Measured: 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
Measured: Weeks 20, 44 and 92
Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females
Measured: 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.
Measured: 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.
Measured: 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
Measured: Weeks 20, 44 and 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start2 Jan 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midway Specialty Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuelle Allseits, Midway Specialty Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145854
- Sponsor's protocol ID
- 2022-01
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06145854
- Acronym / sponsor ID
- 2022-01
- Conditions
- Hiv
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Midway Specialty Care CenterUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisgender Females | – | Drug: Cabotegravir Injection [Apretude] |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 100 cisgender females (including 15 cisgender females with history of substance use and 15 cisgender females with unstable housing)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Transgender females or males
- Cisgender males
- Cisgender female who is actively breastfeeding
- Severe hepatotoxicity
- Evidence of Hepatitis B Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir Injection [Apretude]Apretude for PrEP | Drug | Cisgender Females |
Primary outcome
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
Time frame: 44 Weeks
6 secondary outcomes
Describe incidence of bacterial STIs through weeks 20, 44 and 92
Time frame: 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
Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by Midway Specialty Care Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks. (time frame: 44 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.