Clinical trials: Pre-exposure Prophylaxis
HIV/AIDS, PrEP
Pre-Exposure Prophylaxis in the Emergency Department
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually.
- Trial name
- PrEPPED (NCT04429971)
- Testing
- PrEP screening program, PrEP starter pack
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
HIV Prevention
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil.
- Trial name
- PRISM Brazil (NCT04114955)
- Testing
- Manas por Manas
- Where
- 2 sites in Brazil
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
PrEP, PrEP Adherence Monitoring
Prevention ICONA Dedicated Ensemble
Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the…
- Conditions
- PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection
- Trial name
- PrIDE (NCT07186244)
- Where
- 53 sites in Italy
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Fondazione ICONA
Drug Interaction
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among…
- Trial name
- NCT04590417
- Testing
- Estradiol valerate 2 mg, cyproterone acetate 25 mg
- Where
- Thailand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre
Clinician Attitudes About PrEP
Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
This is a three phase study designed to examine clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human Immunodeficiency Virus (HIV) prevention strategy, and to identify…
- Trial name
- NCT01751659
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Hiv
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages.
- Trial name
- NCT04233931
- Testing
- PrEP medication adherence mobile app
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
HIV Infections
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
African American (AA) women are more vulnerable to HIV infection than other women. Truvada, when used as pre-exposure prophylaxis (PrEP), is one of the most effective approaches for HIV prevention; however, PrEP use among AA…
- Trial name
- IWPrEP (NCT03930654)
- Testing
- iPrEP, Usual Care
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Pre-exposure Prophylaxis, HIV
Predictors of Health Service Utilizations Among Key Population in Washington DC
The primary objective of the proposed study is to investigate how PrEP use might result in an increase in the utilization of health and social services offered at a local community-based organization.
- Conditions
- Pre-exposure Prophylaxis, HIV, Health Behavior
- Trial name
- NCT06046079
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Us Helping Us, People Into Living, Inc.
IPV, HIV
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and…
- Conditions
- IPV, HIV, PrEP
- Trial name
- NCT05599581
- Testing
- Tu'Washindi
- Where
- 2 sites in Kenya
- Volunteers
- 1,562 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV-1-infection
Longer-Acting PrEP in Transgender and Gender Diverse Texans
The long-term goal of this project is to increase uptake and adherence of LA-PrEP in TGD populations in Texas. The central hypothesis is that strategies to increase uptake of LA- PrEP that are patient centered and understand the…
- Trial name
- NCT05044286
- Testing
- no intervention
- Where
- United States
- Volunteers
- 565 people, healthy volunteers welcome
- Sponsor
- University of Texas at Austin
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077151
- Testing
- PrEP Demonstration Project
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
Infection, Human Immunodeficiency Virus
Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)
This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects.
- Trial name
- NCT02076178
- Testing
- 744 Tablet, 744 LA Injection
- Where
- 10 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infection
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- NCT01505114
- Testing
- Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Infertility
Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples
Human immunodeficiency virus (HIV) infection has now become a treatable disease and many infected individuals are interested in having a family.
- Trial name
- PrEP-HIVD (NCT02572505)
- Testing
- Truvada
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
Safety Issues
Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days.
- Trial name
- NCT06087913
- Testing
- TAF/EVG vaginal insert
- Where
- 3 sites in United States, Kenya and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
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
HIV Infection
Study in Healthy Volunteers of the Safety and Metabolism of Different Doses of the Anti-HIV Drug TMC278LA.
TMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278 is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been developed so the drug stays in the bloodstream for a…
- Trial name
- NCT01275443
- Testing
- 300mg TMC278LA, 150mg TMC278LA, 1200mg TMC278LA
- Where
- United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- St Stephens Aids Trust
HIV Prevention
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women
This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones.
- Trial name
- NCT03060785
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infections
Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral…
- Trial name
- NCT07772791
- Testing
- Weekly WhatsApp Adherence Messages
- Where
- Brazil
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation