Clinical trials: PrEP
Sexually Transmitted Diseases, HIV
CRUSH-PrEP for Women Project
UCSF is conducting an evaluation of a demonstration project. The aims of the CRUSH-PrEP for Women project are to integrate the delivery of a comprehensive PrEP package for HIV-negative at-risk women into primary care settings.
- Trial name
- NCT02852226
- Testing
- Pre Exposure Prophylaxis, Characteristics of women who enroll, referral sources of women who enroll
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Prevention
Linking Women to PrEP Care
Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population.
- Trial name
- NCT03281343
- Testing
- Motivational Interviewing & Patient Navigator, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Rhode Island Hospital
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
Patient Satisfaction and Efficacy of Bowel-preparation
Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study
An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine…
- Trial name
- NCT05192551
- Testing
- Bowel-prep (Plenvu as experimental arm)
- Where
- 5 sites in Sweden
- Volunteers
- 1,000 people
- Sponsor
- Karolinska Institutet
Bacterial Resistance
Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics
1. Background: Over 1 million intravitreal injections are performed annually in the United States. The most devastating complication related to these injections is endophthalmitis, with an incidence of 0.02 - 0.1% per injection.
- Trial name
- NCT02223338
- Testing
- Ciprofloxacin, Standard Aseptic Technique
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Loma Linda University
HIV Infections, Contraception
Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time.
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction, PrEP
- Trial name
- PHARAOH (NCT07516548)
- Testing
- Long-acting injectable cabotegravir (CAB-LA), No PrEP
- Where
- Botswana
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Contact With or Exposure to Human Immunodeficiency Virus
ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil.
- Trial name
- ImPrEP LEN (NCT07497594)
- Testing
- Lenacapavir long-acting, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- 8 sites in Brazil
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
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
Cerebral Palsy (CP)
Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy
This exploratory randomized controlled trial will examine the feasibility and preliminary effects of a remote PREP intervention compared to an attention control for transition-age youth with cerebral palsy and their caregivers.
- Trial name
- NCT07424079
- Testing
- Pathways and Resources for Engagement and Participation, Attention Control Condition
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Missouri-Columbia
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
HIV, PrEP
Increasing PrEP Awareness and Demand Among Black Cisgender Women
This study will develop HIV pre-exposure prophylaxis (PrEP) awareness materials for and with Black cis women and gather feedback on the usefulness of these materials at health care sites.
- Trial name
- IPAD-BCW (NCT05896423)
- Testing
- PrEP awareness materials
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Northwestern University
PrEP Uptake, Stimulant Abuse
Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage…
- Conditions
- PrEP Uptake, Stimulant Abuse, Adherence, Medication
- Trial name
- NCT03137342
- Testing
- Pepped on PrEP Package
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Brown University
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 Infections
Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission
This study will assess the impact of an HIV-1 RNA testing intervention targeting adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and meet specific risk criteria for acute HIV…
- Trial name
- TMP (NCT03508908)
- Testing
- HIV-1 RNA testing
- Where
- Kenya
- Volunteers
- 2,887 people
- Sponsor
- University of Oxford
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
Bowel Preparation Before Colonoscopy
A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy
The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation…
- Trial name
- NCT01984008
- Testing
- Picosulfate sodium, magnesium oxide, citric acid
- Where
- Taiwan
- Volunteers
- 631 people, healthy volunteers welcome
- Sponsor
- Universal Integrated Corp.
HIV Prevention
The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial
The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been…
- Trial name
- PROTECT (NCT06845774)
- Testing
- CDC PrEP with active referral, TelePrEP
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hilary L Surratt, PhD
Alcohol Consumption, PrEP Uptake
Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Purpose: To evaluate short-term efficacy and implementation of Treat4All, an alcohol reduction evidence-based intervention, for decreasing heavy drinking and optimizing HIV outcomes (viral suppression among People with HIV (PWH)…
- Conditions
- Alcohol Consumption, PrEP Uptake, Recent Heavy Drinking, HIV Prevention
- Trial name
- Treat4All (NCT06668363)
- Testing
- Treat4All, Standard of care (control arm)
- Where
- Malawi
- Volunteers
- 130 people
- Sponsor
- University of North Carolina, Chapel Hill