Clinical trials: Pre-exposure Prophylaxis
COVID-19
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known.
- Trial name
- PREPCOV (NCT04481633)
- Testing
- COVID 19 serology, COVID 19 Self-Questionnaire
- Where
- 12 sites in France
- Volunteers
- 547 people
- Sponsor
- University Hospital, Toulouse
HIV Prevention
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
- Trial name
- NCT04558554
- Testing
- pharmacy-based PrEP delivery
- Where
- 2 sites in Kenya
- Volunteers
- 1,216 people, healthy volunteers welcome
- Sponsor
- University of Washington
Patient Adherence
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643).
- Trial name
- CCTG595VitD (NCT02367599)
- Testing
- Vitamin D Supplement
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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 Infections
The Women TAF-FTC Benchmark Study
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure…
- Trial name
- NCT05140954
- Testing
- co-formulated 25mg TAF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pre-Exposure Prophylaxis
The Blued+ Combination HIV Prevention Pilot Study in China
The proposed research includes a longitudinal pilot study to assess the feasibility and acceptability of Blued+. This combination HIV prevention intervention will integrate a combination package of HIV prevention services into…
- Trial name
- Blued+ (NCT06647173)
- Testing
- Blued+ Service Platform
- Where
- China
- Volunteers
- 423 people, healthy volunteers welcome
- Sponsor
- Emory University
Pre-Exposure Prophylaxis, HIV Infections
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- NCT04712994
- Testing
- PrEP Optimization Interventions
- Where
- 8 sites in Kenya
- Volunteers
- 1,958 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatitis C, HIV Infections
Coaching for HCV and HIV
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment…
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Trial name
- NCT04314414
- Testing
- PRC brief motivational interview intervention, Phone contact
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Boston Medical Center
HIV Infections, Substance Use Disorders
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill.
- Trial name
- PrEPSteps (NCT03512418)
- Testing
- PrEPsteps, Digital pill, Truvada
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Brigham and Women's Hospital
PrEP Adherence Monitoring
Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and…
- Trial name
- DOT-DBS (NCT02022657)
- Testing
- Truvada
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
HIV Prevention
Pre-Exposure Prophylaxis for Transgender Women in the US and South America
A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention…
- Trial name
- NCT04742491
- Testing
- Immediate Intervention Arm, Deferred Intervention Arm
- Where
- 5 sites in United States, Brazil
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Depression, Pre-Exposure Prophylaxis
Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress.
- Trial name
- NCT05664490
- Testing
- Youth Friendship Bench SA
- Where
- South Africa
- Volunteers
- 116 people
- Sponsor
- University of California, San Francisco
HIV/AIDS
Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya.
- Trial name
- PrIYA-SP (NCT03875950)
- Testing
- Clinician training intervention
- Where
- Kenya
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Washington
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
HIV Prevention
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM…
- Trial name
- PATH-PrEP (NCT01781806)
- Testing
- emtricitabine 200mg/tenofovir 300mg
- Where
- 2 sites in United States
- Volunteers
- 328 people
- Sponsor
- University of California, Los Angeles
Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial
Alignment of PrEP Use With HIV Risk in Young Women and Men
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs.
- Conditions
- Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial, HIV Infections
- Trial name
- NCT04664998
- Testing
- Daily oral PrEP
- Where
- Uganda
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV
Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk
This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for…
- Trial name
- NCT05084716
- Testing
- Enhanced PrEP provision
- Where
- 2 sites in Uganda
- Volunteers
- 885 people, healthy volunteers welcome
- Sponsor
- RAND
HIV Infections, Opioid-Related Disorders
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
The purpose of this study is to develop and test a serious injection-related injections (SIRI) checklist aimed at increasing evidence-based treatment for rural people who use drugs (PWUD) including innovative, long-acting…
- Conditions
- HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
- Trial name
- SHAPE (NCT05480956)
- Testing
- SIRI Checklist, Enhanced Peer Recovery Coach, SIRI Checklist + Enhanced Peer Recovery Coach
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
COVID-19, Corona Virus Infection
Pre-exposure Prophylaxis for SARS-Coronavirus-2
Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
- Conditions
- COVID-19, Corona Virus Infection, ARDS, Acute Respiratory Distress Syndrome
- Trial name
- NCT04328467
- Testing
- Hydroxychloroquine
- Where
- 2 sites in United States
- Volunteers
- 1,483 people
- Sponsor
- University of Minnesota