Clinical trials: Pre Exposure Prophylaxis
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Clinician Attitudes About PrEP
Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
This is a three phase study designed to examine clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human Immunodeficiency Virus (HIV) prevention strategy, and to identify…
- Trial name
- NCT01751659
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV, STIs
Combatting HIV Or Other STIs Early (CHOOSE)
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people.
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Trial name
- CHOOSE (NCT07510048)
- Testing
- Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Westat
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
COVID-19, SARS-CoV-2
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
- Trial name
- SUPERNOVA (NCT05648110)
- Testing
- AZD5156 (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort)
- Where
- 215 sites in United States, Australia and 16 more
- Volunteers
- 3,882 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Gender-Based Violence
Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health
This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya.
- Trial name
- NCT03938818
- Testing
- Tu'Washindi intervention, Control
- Where
- Kenya
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- RTI International
Adherence, Medication, Adolescent Behavior
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
A randomized controlled clinical trial looking at the effect of use of a mobile phone application in addition to standard care compared to standard care alone at a youth-friendly clinic in young men who have sex with men and…
- Conditions
- Adherence, Medication, Adolescent Behavior, HIV Prevention, Sexual Health
- Trial name
- YouthPrEP (NCT03778892)
- Testing
- 'Project Raincoat' Mobile Phone Application
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
HIV - Human Immunodeficiency Virus
HIV Prevention With PrEP Among People on Opioid Replacement Therapy
The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta…
- Trial name
- OAT-PrEP (NCT07160075)
- Testing
- Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
- Where
- 6 sites in Canada
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Cara Spence
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
HIV Prevention
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with…
- Trial name
- PICASSO (NCT06485154)
- Testing
- TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
- Where
- 3 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- University of Witwatersrand, South Africa
HIV-I Infection
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain…
- Trial name
- PrEP-PP (NCT03902418)
- Testing
- emtricitabine/tenofovir
- Where
- South Africa
- Volunteers
- 1,195 people
- Sponsor
- University of California, Los Angeles
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 Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pregnancy, HIV Infections
Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.
- Trial name
- NCT07288190
- Testing
- DPP, 2PR, Free Choice
- Where
- 3 sites in Eswatini, Uganda and 1 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Rabies Vaccine Adverse Reaction
Safety of Rabivax-S for Pre-exposure Prophylaxis
People who are at frequent or continuous risk of exposure to rabies virus should be vaccinated against the disease (pre-exposure prophylaxis).
- Trial name
- NCT03741270
- Testing
- Rabivax-S
- Where
- Saint Kitts and Nevis
- Volunteers
- 159 people
- Sponsor
- Ross University School of Veterinary Medicine
Pre-exposure Prophylaxis, HIV Infections
Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa
The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South…
- Trial name
- NCT06274060
- Testing
- Case management, Food vouchers, PrEP support buddy
- Where
- South Africa
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Adolescent Behavior, HIV/AIDS
Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2)…
- Conditions
- Adolescent Behavior, HIV/AIDS, PrEP
- Trial name
- NCT03897725
- Testing
- Telehealth Coaching
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness in the VA 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-VA (NCT05663957)
- Testing
- Evusheld
- Where
- United States
- Volunteers
- 5,814 people
- Sponsor
- AstraZeneca
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