Clinical trials: Pre-Exposure Prophylaxis of HIV Infection
HIV Prevention
Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via…
- Trial name
- MOVE-LA (NCT07467018)
- Testing
- Community-based healthcare delivery, Lenacapavir
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Los Angeles
Improving Perceptions of HIV Risk, Improving Uptake of Pre-exposure Prophylaxis for HIV
Manicaland PrEP Uptake Through Interactive Counselling Trial
Primary Objective: The purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of…
- Trial name
- NCT03565575
- Testing
- Interactive tablet-based quiz
- Where
- 8 sites in Zimbabwe
- Volunteers
- 1,055 people, healthy volunteers welcome
- Sponsor
- Simon Gregson
HIV, Other STIs
Comparative Effectiveness of Individual Versus Group-Level Interventions to Increase PrEP Uptake and Reduce HIV/STI Incidence
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of…
- Trial name
- NCT06022809
- Testing
- Dada Kwa Dada (individual-level), DADA (group-level)
- Where
- 3 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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 Prevention
A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women
Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV.
- Trial name
- NCT03270969
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
HIV, PrEP
Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania
Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania.
- Trial name
- MWOTAJI (NCT07687888)
- Testing
- Pharmacy-based PrEP services, Distribution of HIV self-test kits
- Where
- Tanzania
- Volunteers
- 2,818 people, healthy volunteers welcome
- Sponsor
- Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
Pre-Exposure Prophylaxis, Telemedicine
mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
If taken every day, PrEP is an effective method for preventing HIV. However, many prescribed PrEP in the U.S. do not take it every day, as prescribed.
- Conditions
- Pre-Exposure Prophylaxis, Telemedicine, Medication Adherence
- Trial name
- SMART PrEP (NCT04990583)
- Testing
- Face-to-Face PrEP Adherence Intervention Based on LifeSteps, Adherence Coaching Facilitated by Carium Adherence App
- Where
- United States
- Sponsor
- Rhode Island Hospital
HIV Prevention
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Nationally, the HIV case rate among black/ African American (AA) women is nearly 20 times higher than in white women; for Hispanic/Latino women it is 4.5 times higher.
- Trial name
- NCT04018651
- Testing
- PrEP Master Adherence Intervention
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Florida International University
HIV Infections, HIV Pre-Exposure Prophylaxis
Vienna HIV Infection Via Sex Study
The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex…
- Conditions
- HIV Infections, HIV Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Gonorrhea
- Trial name
- HIVEX (NCT05326061)
- Where
- Austria
- Volunteers
- 500 people
- Sponsor
- Medical University of Vienna
Covid19, Virus-HIV
Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP
The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.
- Trial name
- NCT04575545
- Testing
- Serology test for COVID-19
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Hôpital Européen Marseille
HIV, Pregnancy
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy.
- Conditions
- HIV, Pregnancy, Pre-Exposure Prophylaxis of HIV Infection
- Trial name
- HFPT (NCT06746675)
- Testing
- Healthy Families PrEP Counselling Intervention
- Where
- Uganda
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Yale University
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
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
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 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, 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.