Clinical trials: HIV Pre-exposure Prophylaxis
Hiv
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men.
- Trial name
- NCT04633200
- Testing
- DOT mobile app
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
Opioid Use Disorder, HIV Infections
Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington
The investigators will implement a non-randomized observational clinical trial that will include a pop-up clinic for women who inject drugs (WWID) near venues for exchange sex and drug use in north Seattle.
- Conditions
- Opioid Use Disorder, HIV Infections, Chlamydia, Gonorrhea
- Trial name
- NCT06187064
- Testing
- Mobile Van Clinic
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV/AIDS
Packaging PrEP to Prevent HIV Among WWID
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV.
- Trial name
- NCT03304912
- Testing
- PrEP Education and option to accept a PrEP prescription
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Drexel 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
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 Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
The Women TDF-FTC Benchmark Study
The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated…
- Trial name
- NCT05057858
- Testing
- co-formulated 300 mg TDF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV.
- Trial name
- NCT02213328
- Testing
- Truvada
- Where
- 2 sites in South Africa
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-infection/AIDS
WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP)
The objective of this application is to increase PrEP uptake among women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama.
- Trial name
- PrEP (NCT04373551)
- Testing
- Cultural adaptation of a patient-provider communication tool
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- University of Alabama at Birmingham
Adherence, Medication, Risk Behavior
DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies.
- Conditions
- Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
- Trial name
- NCT03771638
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
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
Risk Behavior, HIV/AIDS
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and…
- Conditions
- Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse
- Trial name
- CHRP-BB (NCT03282890)
- Testing
- CHRP-BB
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- University of Connecticut
HIV/AIDS
Biomedical HIV/AIDS Prevention Program Yunnan
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex…
- Trial name
- B-HAPPY (NCT03992274)
- Testing
- Enhanced implementation of PrEP
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Columbia University
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/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/AIDS, Pre-exposure Prophylaxis
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
Our proposed study will: provide a novel exploration of facilitators and barriers to PrEP; allow us to target hard to reach populations, including men who have sex with men (MSM) and substance users (both of which are top funding…
- Trial name
- NCT04064567
- Testing
- PrEP-LINK, Enhanced Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
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, 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
Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
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
- NCT02043015
- Testing
- Condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT)
- Where
- 3 sites in United States, South Africa
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Emory University