Clinical trials: Pre-exposure Prophylaxis
HIV Prevention Program
Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis Services for Cisgender Women
The goal of the "PrEP CGW" pilot study is evaluate the feasibility and acceptability of a clinic-level intervention to improve HIV prevention and Pre-exposure Prophylaxis (PrEP) services for women.
- Trial name
- PrEP CGW (NCT07318532)
- Testing
- The women's PrEP Project (W-PrEP)
- Where
- United States
- Volunteers
- 745 people, healthy volunteers welcome
- Sponsor
- Medstar Health Research Institute
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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
PrEP, PrEP Adherence Monitoring
Prevention ICONA Dedicated Ensemble
Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the…
- Conditions
- PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection
- Trial name
- PrIDE (NCT07186244)
- Where
- 53 sites in Italy
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Fondazione ICONA
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
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, Infertility
Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples
Human immunodeficiency virus (HIV) infection has now become a treatable disease and many infected individuals are interested in having a family.
- Trial name
- PrEP-HIVD (NCT02572505)
- Testing
- Truvada
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Pre-Exposure Prophylaxis
Effect of Social Media Support and Financial Incentives on PrEP Adherence
The purpose of this study is to determine if social media support and financial incentives improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24 living in the Washington, DC area who are at…
- Trial name
- NCT03078153
- Testing
- Financial Incentive, Social Media Group
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- George Washington University
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: An Implementation Evaluation
The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral…
- Trial name
- NCT06319105
- Testing
- Standard intervention: Offer PrEP choice
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
HIV Infection
Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India
Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use.
- Trial name
- PrEP-India (NCT02148094)
- Testing
- Truvada
- Where
- 2 sites in India
- Volunteers
- 1,325 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
HIV-1-infection
PrEPsmart 2-1-1 Pilot
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.
- Trial name
- NCT06631365
- Testing
- PrEPsmart mobile app, Truvada
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Sex Work, Pre-Exposure Prophylaxis
Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
Using a participatory implementation science framework, I will test whether an adapted and community empowered group healthcare model, Centering PrEP+, is a feasible and acceptable health system intervention to improve the health…
- Trial name
- C-PrEP+ (NCT05929521)
- Testing
- C-PrEP+
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Illinois at Chicago
Pre-exposure Prophylaxis, HIV Prevention
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding…
- Conditions
- Pre-exposure Prophylaxis, HIV Prevention, Pregnancy Related
- Trial name
- PrIMO (NCT06158126)
- Testing
- Initiating daily oral PrEP during pregnancy, Already using daily oral PrEP at the time of pregnancy diagnosis, Initiating injectable PrEP during pregnancy
- Where
- Malawi
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation…
- Trial name
- ImPrepCab (NCT05515770)
- Testing
- Cabotegravir Injection
- Where
- Brazil
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Evandro Chagas National Institute of Infectious Disease
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
Pre-Exposure Prophylaxis (PrEP)
eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for men who have sex with men (MSM) and transgender women (TW).
- Trial name
- eSTEP (NCT06159582)
- Testing
- eSTEP, Usual Care
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- San Diego State University
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study
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
- NCT03652623
- Testing
- TDF/FTC
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
Pre-Exposure Prophylaxis (PrEP)
Impact of Nursing Involvement on Implementation of HIV Prevention Services
Women comprise 20% of new Human Immunodeficiency Virus (HIV) diagnoses in the United States (U.S.) with 86% attributed to heterosexual contact.
- Trial name
- PrEP-RN (NCT05095818)
- Testing
- PrEP-RN
- Where
- United States
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infection, Sexually Transmitted Infection
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men
- Trial name
- NCT07658976
- Testing
- HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package
- Where
- 5 sites in United States, Argentina and 2 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Infections
The Women TDF-FTC Benchmark Study
The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated…
- Trial name
- NCT05057858
- Testing
- co-formulated 300 mg TDF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Washington