Clinical trials: Pre-exposure Prophylaxis (PrEP)
HIV
Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)
This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure…
- Trial name
- NCT01906255
- Where
- United States
- Volunteers
- 10,577 people
- Sponsor
- Gilead Sciences
HIV Infection, Sexually Transmitted Infections
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis…
- Conditions
- HIV Infection, Sexually Transmitted Infections, Pre-exposure Prophylaxis, Systems Navigation
- Trial name
- NJIRA (NCT06200545)
- Testing
- PrEP eligibility assessment, Rapid HIV antibody testing prior to provision and/or refill of PrEP, PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
- Where
- Malawi
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV/AIDS
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2.
- Trial name
- PrEPDSA (NCT03637244)
- Testing
- Decision Support Aid and PrEP for Black Canadians
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
HIV Prevention
Study for IFE4PrEP Intervention on PrEP Uptake by Southern African American Women
Purpose: This study is partnering with communities to identify the best ways to provide HIV prevention communication and services for women living in public housing who have been disproportionately affected by HIV but underserved…
- Trial name
- IFE4PrEP (NCT05087927)
- Testing
- Gain framing plus demographically targeted photos, Loss framing plus demographically targeted photos, Gain framing plus not demographically targeted photos
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Pre-exposure Prophylaxis, PrEP
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the…
- Trial name
- PrEP ED (NCT07462611)
- Testing
- PrEP Uptake with Rapid Start, Pre-Exposure Prophylaxis (PrEP) Persistence
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men
The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).
- Trial name
- NCT05243030
- Testing
- Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM), Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Human Immunodeficiency Virus
Improving TelePrEP Initiation and Retention Outcomes in the US: The MISTR+ Study
This study uses a rapid randomized controlled trial (RCT) design to examine HIV pre-exposure prophylaxis (PrEP) delivered through telehealth.
- Trial name
- NCT07821671
- Testing
- No Marginal Cost Interventions, Low-Marginal Cost Interventions, Standard of Care
- Where
- United States
- Volunteers
- 223,165 people
- Sponsor
- Emory University
PrEP Adherence Monitoring
Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and…
- Trial name
- DOT-DBS (NCT02022657)
- Testing
- Truvada
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
HIV, STI
Feasibility and Impact of Online HIV/STI Screening Addressed to PrEP Users in Spain
Non-blinded randomized controlled non-inferiority trial to evaluate the feasibility, acceptability and impact of an innovative internet-accessed HIV and STIs screening intervention (TÉSTATE PrEP) addressed to gays, bisexuals and…
- Trial name
- TESTATE_PrEP (NCT05752643)
- Testing
- Online follow up
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Fundació Institut Germans Trias i Pujol
HIV Infection, Prep Prescription
Sexual Risks in Prep Users
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar…
- Conditions
- HIV Infection, Prep Prescription, Vaccinations, Sexually Transmitted Diseases
- Trial name
- PREP (NCT03975517)
- Testing
- PrEP
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Strasbourg, France
HIV Infections
Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks
This study has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women.
- Trial name
- NCT03293290
- Testing
- PrEP
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Yale University
HIV/AIDS, Contraception
Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP
This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA.
- Trial name
- DynamoPrEP (NCT03197961)
- Testing
- tenofovir/emtricitabine, DMPA
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Sharon Achilles
Human Immunodeficiency Virus
Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men
The proposed study will involve adolescent (17-24 years old) men who have sex with men (described as YMSM hereafter) who meet eligibility criteria to participate.
- Trial name
- NCT04865341
- Testing
- IMB, Information-Only Control
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
HIV/AIDS
Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya.
- Trial name
- PrIYA-SP (NCT03875950)
- Testing
- Clinician training intervention
- Where
- Kenya
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU).
- Trial name
- NCT01772823
- Testing
- 3MV, PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 12 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
E-Health for Zero Infections - Facilitating Access to and Use of HIV Pre-Exposure Prophylaxis (PrEP) in the Netherlands
Offering PrEP care online and reducing the frequency of monitoring may increase access to HIV PrEP. The objective of this study is to assess the non-inferiority of an internet-based HIV PrEP-service and reduced frequency of…
- Trial name
- EZI-PREP (NCT05093036)
- Testing
- Variations in PrEP care delivery at public health services
- Where
- 4 sites in Netherlands
- Volunteers
- 469 people, healthy volunteers welcome
- Sponsor
- Public Health Service of Amsterdam
HIV/AIDS, Sexually Transmitted Diseases
Comparison of Men's Prevention Apps to Research Efficacy
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP…
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
- Trial name
- COMPARE (NCT03965221)
- Testing
- LYNX, MyChoices
- Where
- 8 sites in United States
- Volunteers
- 381 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Treatment Adherence and Compliance
PrEP iT! Mobile App Intervention
The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM).
- Trial name
- PrEP iT! (NCT04509076)
- Testing
- PrEP iT! (plus usual PrEP care), Usual PrEP care
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- San Diego State University
HIV Pre-exposure Prophylaxis Use
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir.
- Trial name
- NCT07335289
- Testing
- Choice of follow up, Follow up via standard clinic
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital