Clinical trials: PrEP
HIV, Pre-exposure Prophylaxis
Life Steps for PrEP for Youth
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in…
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Trial name
- LSPY (NCT03805451)
- Testing
- Life Steps for PrEP for Youth
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: The PERSIST Trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis…
- Trial name
- NCT07221747
- Testing
- Standard of Care (SoC), Enhanced continuation support package
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
HIV/AIDS
PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests…
- Trial name
- NCT06566430
- Testing
- PrEP My Way intervention, PrEP My Way intervention without STI testing, Enhanced standard of care
- Where
- Kenya
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Colonoscopy
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
- Trial name
- NCT00425594
- Testing
- HalfLytely and Bisacodyl Tablets - Formulation 1, HalfLytely and Bisacodyl Tablets - Formulation 2, NuLYTELY
- Where
- 26 sites in United States
- Volunteers
- 150 people
- Sponsor
- Braintree Laboratories
Abdominal Pain, Inflammatory Bowel Diseases
Examining the Effect of Ondansetron on Bowel Prep Success
This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient…
- Conditions
- Abdominal Pain, Inflammatory Bowel Diseases, Eosinophilic Gastroenteritis, Diarrhea
- Trial name
- NCT05439772
- Testing
- Ondansetron
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- State University of New York - Downstate Medical Center
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
HIV Infections, Pregnancy Related
Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV…
- Conditions
- HIV Infections, Pregnancy Related, Depression, Anxiety
- Trial name
- TENDAI4PrEP (NCT06226155)
- Testing
- TENDAI4PrEP, Enhanced treatment as usual
- Where
- Zimbabwe
- Volunteers
- 165 people
- Sponsor
- Massachusetts General Hospital
Flexible Nasendoscopy
Nasal Prep for Nasendoscopy in Children
Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in outpatients.
- Trial name
- NCT01351298
- Testing
- 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride, 0.05% xylometazoline hydrochloride, Isotonic normal saline
- Where
- Canada
- Volunteers
- 69 people
- Sponsor
- Children's & Women's Health Centre of British Columbia
Acceptability of Health Care, Adherence, Medication
Project Engage: Oral PrEP Acceptability
This study is a two-arm open label acceptability study that will examine acceptability of, and adherence to, once daily dosing regimen of F/TDF (Truvada) and an investigational once daily dosing regimen of F/TAF (Descovy) under…
- Trial name
- NCT05458765
- Testing
- emtricitabine/tenofovir alafenamide, Emtricitabine / Tenofovir Disoproxil Oral Tablet
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Sexually Transmitted Diseases, Safe Sex
P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes "best…
- Conditions
- Sexually Transmitted Diseases, Safe Sex, Adherence, Medication
- Trial name
- P3 (NCT03320512)
- Testing
- P3, P3+, Control
- Where
- 9 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Adherence, Medication, Smartphone Application
Effectiveness of Smartphone Application for Adherence Support (Vuka+)
This is a Type I Hybrid effectiveness-implementation trial to evaluate an HIV Pre-Exposure Prophylaxis (PrEP) medication adherence, persistence and social support app (Vuka+) for adolescent girls and young women (AGYW) in South…
- Trial name
- NCT06897059
- Testing
- Vuka+ application
- Where
- South Africa
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
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
Hiv, Sexual Behavior
Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM
This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
- Trial name
- NCT05769270
- Testing
- Peer Navigation and Coping Skills, Treatment as Usual
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Infection
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis…
- Trial name
- NCT01865786
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Gilead Sciences
Digestive System Disease
Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy
The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol…
- Trial name
- EASYKID (NCT03008460)
- Testing
- Eziclen®/Izinova®, Klean-Prep®
- Where
- 24 sites in Czechia, France and 4 more
- Volunteers
- 250 people
- Sponsor
- Ipsen
HIV
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships
The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools.
- Trial name
- STEP-UP (NCT07246057)
- Testing
- STEP-UP, Philadelphia TelePrEP Program Direct-to-Consumer Model
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV-1
Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue…
- Trial name
- PREVENIR-PEV (NCT03869944)
- Testing
- Lamivudine Oral Solution
- Where
- Burkina Faso
- Volunteers
- 97 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV, Sexually Transmitted Infections
Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP for Transgender Women in Uganda
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years.
- Conditions
- HIV, Sexually Transmitted Infections, PrEP, Transgender Women
- Trial name
- NCT04328025
- Testing
- Peer-delivered HIV self-testing, STI self-sampling and PrEP
- Where
- Uganda
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Makerere University
HIV-1-infection
Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda
Purpose: The purpose of the project is to evaluate a peer support intervention aimed at improving uptake of and adherence to oral PrEP.
- Trial name
- Peers for PREP (NCT05516602)
- Testing
- Peer Support
- Where
- Uganda
- Volunteers
- 394 people, healthy volunteers welcome
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit