Clinical trials: Pre Exposure Prophylaxis
Coronavirus Disease 2019 (COVID-19)
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination…
- Trial name
- ENDURE (NCT05375760)
- Testing
- AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])
- Where
- 16 sites in United States
- Volunteers
- 251 people
- Sponsor
- AstraZeneca
COVID-19, Viral Respiratory Illnesses
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2…
- Trial name
- NCT04359680
- Testing
- Nitazoxanide, Vitamin Super B-Complex
- Where
- 26 sites in United States
- Volunteers
- 1,407 people
- Sponsor
- Romark Laboratories L.C.
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 Infections
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV…
- Trial name
- NCT04692077
- Testing
- Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
- Where
- 4 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Infections
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa).
- Trial name
- NCT00625404
- Testing
- Truvada
- Where
- 4 sites in Kenya, South Africa and 1 more
- Volunteers
- 2,120 people, healthy volunteers welcome
- Sponsor
- FHI 360
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
COVID-19
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known.
- Trial name
- PREPCOV (NCT04481633)
- Testing
- COVID 19 serology, COVID 19 Self-Questionnaire
- Where
- 12 sites in France
- Volunteers
- 547 people
- Sponsor
- University Hospital, Toulouse
Adherence, Patient, Pre-Exposure Prophylaxis
mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual…
- Conditions
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- Trial name
- P3-T (NCT04413708)
- Testing
- P3-T PrEP Adherence App
- Where
- Thailand
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Duke University
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
Pharmacy-based Pre-exposure Prophylaxis
The proposed research will develop a culturally appropriate pharmacy pre-exposure prophylaxis (PrEP) delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods.
- Trial name
- NCT04393935
- Testing
- Pharmacy Delivered PrEP Intervention
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Emory University
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
COVID-19
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.
- Trial name
- PROVENT (NCT04625725)
- Testing
- AZD7442
- Where
- 89 sites in United States, Belgium and 3 more
- Volunteers
- 5,197 people
- Sponsor
- AstraZeneca
HIV Infections, HIV/AIDS
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP).
- Conditions
- HIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection
- Trial name
- dPEP-KE (NCT04050540)
- Testing
- Doxycycline
- Where
- Kenya
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Prevention
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
- Trial name
- NCT04558554
- Testing
- pharmacy-based PrEP delivery
- Where
- 2 sites in Kenya
- Volunteers
- 1,216 people, healthy volunteers welcome
- Sponsor
- University of Washington
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 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/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
Gonorrhea, Chlamydia
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including…
- Conditions
- Gonorrhea, Chlamydia, Syphilis
- Trial name
- NCT03980223
- Testing
- Doxycycline Hyclate Delayed-Release 200 mg
- Where
- 3 sites in United States
- Volunteers
- 641 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections, Sexually Transmitted Diseases, Bacterial
Mobile Enhanced Prevention Support for People Leaving Jail
This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail.
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C, Substance Use Disorders
- Trial name
- MEPS (NCT04036396)
- Testing
- Mobile Enhanced Prevention Support, Usual Care plus Customized Referrals
- Where
- 3 sites in United States
- Volunteers
- 233 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles