Clinical trials: Long-acting Injectable Cabotegravir for PrEP
HIV Infections
The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation…
- Trial name
- ImPrepCab (NCT05515770)
- Testing
- Cabotegravir Injection
- Where
- Brazil
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Evandro Chagas National Institute of Infectious Disease
HIV, Substance Use Disorder (SUD)
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are…
- Conditions
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- Trial name
- ASCEND (NCT07199335)
- Testing
- APRETUDE (cabotegravir)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
HIV Infections
Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
The goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for PrEP program in a community pharmacy setting.
- Trial name
- IDCaPP (NCT05867212)
- Testing
- Cabotegravir Injection [Apretude]
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kelley-Ross & Associates, Inc.
HIV Infection, Sexual and Reproductive Health
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period.
- Trial name
- PtC (NCT06807736)
- Testing
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Where
- South Africa
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: An Implementation Evaluation
The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral…
- Trial name
- NCT06319105
- Testing
- Standard intervention: Offer PrEP choice
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
The TAIL-PrEP Study
The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention…
- Trial name
- NCT06868641
- Testing
- TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing LEN
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV Infections, Contraception
Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time.
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction, PrEP
- Trial name
- PHARAOH (NCT07516548)
- Testing
- Long-acting injectable cabotegravir (CAB-LA), No PrEP
- Where
- Botswana
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in…
- Trial name
- PILLAR (NCT05374525)
- Testing
- APRETUDE, Cabotegravir OLI
- Where
- 17 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: The PERSIST Trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis…
- Trial name
- NCT07221747
- Testing
- Standard of Care (SoC), Enhanced continuation support package
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
HIV Infections, Opioid Use
Optimizing CAB-LA as PrEP for Women Who Inject Drugs
The goal of this study is to elicit information crucial for designing strategies to support engagement in cabotegravir, a long-acting injectable form of pre-exposure prophylaxis (PrEP) to reduce HIV risk among women who inject…
- Conditions
- HIV Infections, Opioid Use, Trauma, Psychological
- Trial name
- NCT05799339
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Alexis Roth
Prevention
Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.
The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly…
- Trial name
- CABOPrEP (NCT06273943)
- Testing
- Cabotegravir Tablets, for oral use., Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use
- Where
- 8 sites in France
- Volunteers
- 322 people
- Sponsor
- ANRS, Emerging Infectious Diseases