Clinical trials: Pre Exposure Prophylaxis
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
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
Healthy, HIV Pre-exposure Prophylaxis
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
- Trial name
- NCT06580587
- Testing
- MK-8527
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rabies
Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally
Randomized, open-label, prospective, before-and-after comparison study in the same group. Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of…
- Trial name
- NCT05937113
- Testing
- RABIVAX-S
- Where
- Vietnam
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Vietnam Military Medical University
Healthcare Workers, COVID-19
TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)
A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in…
- Conditions
- Healthcare Workers, COVID-19, SARS-CoV 2
- Trial name
- NCT04405271
- Testing
- Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet
- Where
- Argentina
- Volunteers
- 1,378 people, healthy volunteers welcome
- Sponsor
- Hospital Italiano de Buenos Aires
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, Human Immunodeficiency Virus
PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5
Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate burden among gay, bisexual, and other MSM in major centers such as Toronto.
- Trial name
- PREP-5 (NCT02149888)
- Testing
- Tenofovir/emtricitabine
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
HIV/AIDS
Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal
Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to rethink HIV prevention and treatment strategies, especially for key populations such as Female Sex Workers (FSWs).
- Trial name
- NCT02474303
- Testing
- Truvada
- Where
- 4 sites in Senegal
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Réseau Africain de Recherche sur le SIDA
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
Bias, Implicit, HIV
Intervention to Reduce Implicit Bias in Pharmacies
This study will follow the ADAPT-ITT model to apply the Prejudice Habit Breaking Intervention (PHBI) to pharmacists who have experience with or are willing to prescribe PrEP.
- Conditions
- Bias, Implicit, HIV, Pre-exposure Prophylaxis
- Trial name
- NCT06487351
- Testing
- The adapted PHBI, The NIH Implicit Bias course
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Human Papilloma Virus
Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of…
- Trial name
- NCT04950101
- Testing
- anal sampling
- Where
- Belgium
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
HIV/AIDS
The PrEP (Pre-exposure Prophylaxis) SMART Study
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
- Trial name
- NCT04038060
- Testing
- WhatsApp Group, 2-way SMS, Drug level feedback
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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
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
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection better than a…
- Trial name
- NCT07071623
- Testing
- MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF)
- Where
- 30 sites in Kenya, South Africa and 1 more
- Volunteers
- 4,580 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus Transmission
PC4PrEP: Integrating PrEP Into Primary Care
Oral pre-exposure prophylaxis (PrEP) has been proven effective in reducing HIV infection in high-risk men who have sex with men, heterosexually active women and men, and injecting drug users.
- Trial name
- PC4PrEP (NCT03617874)
- Testing
- PC4PrEP- Intervention Clinics, Standard of Care Clinics
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
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
Relationship Dynamics, Pre-exposure Prophylaxis (PrEP) Adherence
CHARISMA Expansion Study
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social…
- Trial name
- CHARISMA (NCT04092114)
- Testing
- Control, CHARISMA Intervention
- Where
- South Africa
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- RTI International