Clinical trials: PrEP
HIV Prevention, HCV
Integrated HIV Prevention and HCV Care for PWID
The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care.
- Conditions
- HIV Prevention, HCV, Opioid Use, Intravenous Drug Usage
- Trial name
- M2HepPrEP (NCT03981445)
- Testing
- ARTAS Adapted Patient Navigation, Adherence Counseling
- Where
- 3 sites in United States, Canada
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV/AIDS
Navigating Insurance Coverage Expansion (NICE)
The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care…
- Trial name
- NICE (NCT04263441)
- Testing
- NICE Intervention
- Where
- 3 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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
HIV
IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya
This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions…
- Trial name
- NCT03988387
- Testing
- Peer Support (PS), Reminder and Resource Transfer (RRT), daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Columbia University
PrEP Test and Treat
Evaluation of a Facility-based Test, Treat, and Prevent HIV Program Among Men Who Have Sex With Men and Transgender Women in Thailand
This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months.
- Trial name
- PrEP (NCT02369887)
- Where
- Thailand
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre
HIV
Comprehensive HIV Prevention Package for MSM in Port Elizabeth
The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South…
- Trial name
- NCT02449733
- Testing
- Condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT)
- Where
- South Africa
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Emory University
PrEP Adherence Monitoring
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
- Trial name
- NCT03058835
- Testing
- tenofovir disoproxil and emtricitabine
- Where
- 4 sites in United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
HIV
Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting
This is an open-label, single center study to evaluate implementation of a pharmacist-managed delivery of L4P in a community pharmacy setting and the impact of twice-yearly vs. quarterly PrEP visits on STI rates.
- Trial name
- L4PinPharm (NCT07210125)
- Testing
- Lenacapavir long-acting, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Kelley-Ross & Associates, Inc.
Patient Adherence, HIV Seronegativity
CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to…
- Trial name
- NCT01761643
- Testing
- SoC + iTab
- Where
- 4 sites in United States
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
- Trial name
- NCT01691768
- Testing
- 1% tenofovir gel
- Where
- 2 sites in South Africa
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Unsafe Sex, Risk-Taking
Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)
The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and…
- Trial name
- DOXYVAC (NCT04597424)
- Testing
- Experimental: doxycycline, Bexsero® vaccine
- Where
- 9 sites in France
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Pre-Exposure Prophylaxis, Hiv
Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)
The aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New Haven area.
- Conditions
- Pre-Exposure Prophylaxis, Hiv, Men
- Trial name
- NCT04417946
- Testing
- PrEP messages, Heath messages
- Where
- 2 sites in United States
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- Yale University
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
The OPENS Trial: Offering Women PrEP (Aim 1)
To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that…
- Trial name
- NCT04621760
- Testing
- HIV Prevention Decision Support Tool (DST), Standard Counseling
- Where
- United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Opioid Use, Opioid-use Disorder
Providing Suboxone and PrEP Using Telemedicine
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe…
- Conditions
- Opioid Use, Opioid-use Disorder, Risk Reduction, Hiv
- Trial name
- NCT04521920
- Testing
- Suboxone, PrEP
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Duke University
Adherence, Medication
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
- Trial name
- NCT04316715
- Testing
- Lifesteps for PrEP, Daily text message reminders
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Miami
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