Clinical trials: Pre-Exposure Prophylaxis
Coronavirus Infection
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel
Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of…
- Trial name
- EPICOS (NCT04334928)
- Testing
- Emtricitabine/tenofovir disoproxil, Hydroxychloroquine
- Where
- 65 sites in Spain
- Volunteers
- 1,002 people, healthy volunteers welcome
- Sponsor
- Plan Nacional sobre el Sida (PNS)
HIV Infection
Partners Demonstration Project of PrEP and ART
The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and…
- Trial name
- NCT02775929
- Testing
- FTC-TDF PrEP, ART
- Where
- 4 sites in Kenya, Uganda
- Volunteers
- 1,013 people
- Sponsor
- University of Washington
Cognitive Dysfunction
Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence.
- Trial name
- NCT05912374
- Testing
- standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB), enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
HIV/AIDS
Packaging PrEP to Prevent HIV Among WWID
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV.
- Trial name
- NCT03304912
- Testing
- PrEP Education and option to accept a PrEP prescription
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Drexel University
HIV Pre-Exposure Prophylaxis
Supporting Tailored And Responsive PrEP in Rural North Carolina
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61).
- Trial name
- STARR-NC (NCT05984030)
- Testing
- PrEP Navigation Services, Telehealth PrEP Services Referral, HealthMpowerment Digital Health Intervention - Enhanced
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Alcohol Misuse, HIV
Gathering Online for Dialogue and Discussion to Enhance Social Support
The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency…
- Conditions
- Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis
- Trial name
- GODDESS (NCT05753683)
- Testing
- mHealth-Women's CoOp, Virtual Group
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV Infections
Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral…
- Trial name
- NCT07772791
- Testing
- Weekly WhatsApp Adherence Messages
- Where
- Brazil
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV
IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
IPrEP Men's Study is a prospective cohort study enrolling male clients (MC) of female sex workers (FSW) in Kisumu, Kenya. HIV-negative MC participants will be offered oral PrEP (emtricitabine/tenofovir [FTC/TDF]) combined with…
- Trial name
- NCT04898699
- Testing
- UrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit, Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]
- Where
- Kenya
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Columbia University
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-1-infection
10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks.
- Trial name
- NCT05890963
- Testing
- ART, 10E8.4/iMab, VRC07-523LS
- Where
- Tanzania
- Volunteers
- 20 people
- Sponsor
- David Ho
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55.
- Trial name
- NCT06943378
- Testing
- Monoclonal antibody JST-010
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Just-Evotec Biologics
Human Immunodeficiency Virus
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP)…
- Trial name
- NCT05323123
- Testing
- SPARK, HealthMpowerment, PrEP Education
- Where
- 3 sites in United States, Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Columbia University
Monkey Pox, Monkey Diseases
Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada.
- Trial name
- MonkeyVax (NCT05438953)
- Testing
- Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)
- Where
- France
- Volunteers
- 164 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Prophylaxis, COVID-19
HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces…
- Conditions
- Prophylaxis, COVID-19, Health Care Worker, Hydroxychloroquine
- Trial name
- HERO (NCT04352946)
- Testing
- Hydroxychloroquine Pre-Exposure Prophylaxis
- Where
- United States
- Volunteers
- 374 people, healthy volunteers welcome
- Sponsor
- GeoSentinel Foundation
Pre-exposure HIV Prophylaxis (PrEP)
Sexual Health Impact of Using Pre-exposure HIV Prophylaxis
Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).
- Trial name
- SatisPreP (NCT05269199)
- Where
- 7 sites in France
- Volunteers
- 56 people
- Sponsor
- University Hospital, Clermont-Ferrand
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV
A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and…
- Trial name
- NCT01902472
- Where
- United States
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
HIV Infections
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
African American (AA) women are more vulnerable to HIV infection than other women. Truvada, when used as pre-exposure prophylaxis (PrEP), is one of the most effective approaches for HIV prevention; however, PrEP use among AA…
- Trial name
- IWPrEP (NCT03930654)
- Testing
- iPrEP, Usual Care
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
HIV, Human Immunodeficiency Virus
Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.
- Conditions
- HIV, Human Immunodeficiency Virus, ART
- Trial name
- NCT06176859
- Testing
- HIV PrEP Delivery
- Where
- South Africa
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Prevention, Pre-exposure Prophylaxis (PrEP)
A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis (PrEP), Risk Reduction, Adherence, Medication
- Trial name
- PrEP-3D RCT (NCT05474313)
- Testing
- PrEP-3D package, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.