Clinical trials: HIV Pre-Exposure Prophylaxis
Hepatitis C, HIV Infections
Coaching for HCV and HIV
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment…
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Trial name
- NCT04314414
- Testing
- PRC brief motivational interview intervention, Phone contact
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Boston Medical Center
HIV Infections, Substance Use Disorders
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill.
- Trial name
- PrEPSteps (NCT03512418)
- Testing
- PrEPsteps, Digital pill, Truvada
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Brigham and Women's Hospital
HIV Prevention
Pre-Exposure Prophylaxis for Transgender Women in the US and South America
A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention…
- Trial name
- NCT04742491
- Testing
- Immediate Intervention Arm, Deferred Intervention Arm
- Where
- 5 sites in United States, Brazil
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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
Human Immunodeficiency Virus
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP)…
- Trial name
- NCT05323123
- Testing
- SPARK, HealthMpowerment, PrEP Education
- Where
- 3 sites in United States, Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV Prevention
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM…
- Trial name
- PATH-PrEP (NCT01781806)
- Testing
- emtricitabine 200mg/tenofovir 300mg
- Where
- 2 sites in United States
- Volunteers
- 328 people
- Sponsor
- University of California, Los Angeles
Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial
Alignment of PrEP Use With HIV Risk in Young Women and Men
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs.
- Conditions
- Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial, HIV Infections
- Trial name
- NCT04664998
- Testing
- Daily oral PrEP
- Where
- Uganda
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV
Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk
This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for…
- Trial name
- NCT05084716
- Testing
- Enhanced PrEP provision
- Where
- 2 sites in Uganda
- Volunteers
- 885 people, healthy volunteers welcome
- Sponsor
- RAND
HIV Infections, Opioid-Related Disorders
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
The purpose of this study is to develop and test a serious injection-related injections (SIRI) checklist aimed at increasing evidence-based treatment for rural people who use drugs (PWUD) including innovative, long-acting…
- Conditions
- HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
- Trial name
- SHAPE (NCT05480956)
- Testing
- SIRI Checklist, Enhanced Peer Recovery Coach, SIRI Checklist + Enhanced Peer Recovery Coach
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
HIV-1-infection, Antenatal Care
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV…
- Trial name
- NCT04330989
- Testing
- iNSC and Adherence supporter training
- Where
- Malawi
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV/AIDS
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR).
- Trial name
- POPPi (NCT04030520)
- Testing
- POPPi, Comparison
- Where
- Uganda
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections
A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young…
- Trial name
- Masibambane (NCT04833127)
- Testing
- Gender-Enhanced -- Masibambane, Individually accessed
- Where
- South Africa
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
HIV Prevention
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk…
- Trial name
- PeerPrEP (NCT04982250)
- Testing
- Enhanced peer PrEP referral + HIVST delivery
- Where
- Kenya
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
HIV Infections, Pre-exposure Prophylaxis
PrEP Readiness Interventions for Supporting Motivation
The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men…
- Conditions
- HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders
- Trial name
- PRISM (NCT04205487)
- Testing
- Motivational Interviewing (MI), Contingency Management (CM)
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Florida International University
HIV, Prophylaxis
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW
This is a research study to determine the best way to dose Truvada®, an oral medication licensed to be taken as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, in transgender women who are also taking feminizing…
- Conditions
- HIV, Prophylaxis, Transgender
- Trial name
- NCT04760691
- Testing
- Truvada alone, Truvada plus Leuprolide 11.25mg intramuscular injection, Truvada plus Estradiol 1 mg
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Pre-Exposure Prophylaxis
Supporting Tailored And Responsive PrEP in Rural North Carolina
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61).
- Trial name
- STARR-NC (NCT05984030)
- Testing
- PrEP Navigation Services, Telehealth PrEP Services Referral, HealthMpowerment Digital Health Intervention - Enhanced
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV, HIV Pre-exposure Prophylaxis
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1)…
- Trial name
- NCT06045507
- Testing
- MK-8527
- Where
- 18 sites in United States, Israel and 1 more
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Prevention
Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when…
- Trial name
- AEGiS (NCT02584140)
- Testing
- Text Messaging, Adherence Counseling, Daily Oral PrEP
- Where
- 5 sites in United States
- Volunteers
- 136 people
- Sponsor
- University of California, Los Angeles
HIV Infections
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in…
- Trial name
- NCT03164564
- Testing
- Oral CAB, Oral TDF/FTC, CAB LA
- Where
- 20 sites in Botswana, Eswatini and 5 more
- Volunteers
- 3,224 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infections, HIV Infections
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
- Trial name
- Partners PrEP (NCT00557245)
- Testing
- Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
- Where
- 9 sites in Kenya, Uganda
- Volunteers
- 4,758 people, healthy volunteers welcome
- Sponsor
- University of Washington