Clinical trials: Pre-exposure Prophylaxis
HIV/AIDS
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.
- Trial name
- CHAPS (NCT03986970)
- Testing
- Tenofovir
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Wits Health Consortium (Pty) Ltd
HIV
Likely Use of PrEP for African American YMSM
HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has been approved by the FDA as a method for reducing HIV transmission rates in the population, particularly young men who have sex with men…
- Trial name
- NCT02810249
- Testing
- No intervention used
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Duke University
Rabies
Rabies Immunization Concomitant With JEV in Children
Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries.
- Trial name
- NCT00703521
- Testing
- Rabies vaccine
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Pre-Exposure Prophylaxis, HIV Infections
Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- PrEPARE (NCT05482360)
- Testing
- PrEP Optimization Interventions
- Where
- Kenya
- Volunteers
- 5,173 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV, PrEP
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC…
- Conditions
- HIV, PrEP, PrEP Adherence
- Trial name
- LYPS (NCT07438041)
- Testing
- LYPS, Enhanced Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Westat
Virus Diseases, Rabies
A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.
The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM…
- Trial name
- NCT02545517
- Testing
- Rabipur, Blood sampling, Purified Chick-Embryo Cell Rabies Vaccine
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
- Trial name
- NCT02732730
- Testing
- Truvada, Drug level counseling at Weeks 8 and 13
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
eVusheld Assessment reaL wORld Effectiveness in DoD Health System
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR DoD (NCT05569408)
- Testing
- EVUSHELD
- Where
- United States
- Volunteers
- 4,724 people
- Sponsor
- AstraZeneca
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077138
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections, Sexually Transmitted Diseases
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner…
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Blood-Borne Infections, Communicable Disease
- Trial name
- NCT05307991
- Testing
- PrEP, STI testing, Assisted partner notification
- Where
- Malawi
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Pre-Exposure Prophylaxis (PrEP), HIV
Peer-led Community-based PrEP Delivery Among Youth in Brazil
The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver…
- Trial name
- COMPrEP (NCT06661356)
- Testing
- COMPrEP
- Where
- 2 sites in Brazil
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
HIV-1-infection
Uganda PrEP and Harm Reduction Evaluation
This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to…
- Trial name
- NCT05040308
- Testing
- Integrating PrEP delivery
- Where
- Uganda
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Washington
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection as well as or…
- Trial name
- NCT07044297
- Testing
- MK-8527, FTC/TDF
- Where
- 81 sites in United States, Argentina and 14 more
- Volunteers
- 4,390 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Rabies Prevention
Early Rabies Vaccine Immunization in Primary School Children
700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region.
- Trial name
- I49P1 (NCT01107275)
- Testing
- rabies vaccine
- Where
- Thailand
- Volunteers
- 703 people, healthy volunteers welcome
- Sponsor
- Provincial Public Health Office, Phetchabun
Immuno-Deficiency, COVID-19
PREP (Pre-Exposure Prophylaxis) of COVID-19
This is a study of immunocompromised individuals who have received or plan to receive a drug called EVUSHELD. This study is looking at any serious adverse events that might happen after receiving EVUSHELD, the levels of EVUSHELD…
- Trial name
- PrEP (NCT05461378)
- Testing
- Evusheld
- Where
- United States
- Volunteers
- 138 people
- Sponsor
- Ghady Haidar
HIV Preexposure Prophylaxis
The SwissPrEPared Study
Nested within the SwissPrEPared Program, the "SwissPrEPared Study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for PrEP prescription over a period of 3 years.
- Trial name
- NCT03893188
- Where
- 41 sites in Switzerland
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Zurich
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR C19 IL (NCT05712096)
- Testing
- EVUSHELD
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- AstraZeneca
HIV
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the…
- Trial name
- ALIGN (NCT07390409)
- Testing
- Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- South Africa
- Volunteers
- 3,700 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation