Clinical trials: Pre Exposure Prophylaxis
Sexually Transmitted Diseases, Safe Sex
P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes "best…
- Conditions
- Sexually Transmitted Diseases, Safe Sex, Adherence, Medication
- Trial name
- P3 (NCT03320512)
- Testing
- P3, P3+, Control
- Where
- 9 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Human Immunodeficiency Virus
Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
This study evaluates the use of a social-network approach to encourage African-American men who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV infection.
- Trial name
- SNAP (NCT03823209)
- Testing
- Social Network, Brief HIV Prevention Counseling
- Where
- 2 sites in United States
- Volunteers
- 352 people
- Sponsor
- Medical College of Wisconsin
HIV Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV, Adolescent Behavior
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific combination HIV prevention package for youth (aged 15-24) in high burden settings.
- Conditions
- HIV, Adolescent Behavior, Gender
- Trial name
- MP3-Youth (NCT01571128)
- Testing
- Male-Specific Intervention Package, Female-Specific Intervention Package, Pre-Exposure Prophylaxis (Females)
- Where
- 3 sites in United States, Kenya
- Volunteers
- 1,215 people, healthy volunteers welcome
- Sponsor
- New York University
HIV
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships
The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools.
- Trial name
- STEP-UP (NCT07246057)
- Testing
- STEP-UP, Philadelphia TelePrEP Program Direct-to-Consumer Model
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV Infection
Factors Affecting PrEP Adherence
The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS).
- Trial name
- NCT02411630
- Testing
- Emtricitabine/tenofovir disoproxil
- Where
- 12 sites in United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness in the VA Health System
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR-VA (NCT05663957)
- Testing
- Evusheld
- Where
- United States
- Volunteers
- 5,814 people
- Sponsor
- AstraZeneca
Virus Diseases, Rabies
A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.
The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM…
- Trial name
- NCT02545517
- Testing
- Rabipur, Blood sampling, Purified Chick-Embryo Cell Rabies Vaccine
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study
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
- NCT03652623
- Testing
- TDF/FTC
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
HIV/AIDS
The Prevention Options for Women Evaluation Research (POWER) Cohort
The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
- Trial name
- NCT03490058
- Testing
- Truvada
- Where
- 3 sites in Kenya, South Africa
- Volunteers
- 2,255 people, healthy volunteers welcome
- Sponsor
- University of Washington
Men or Transgender Women Who Have Sex With Men
HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW
This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
- Trial name
- NCT03745495
- Where
- 7 sites in Thailand
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre
HIV Prevention
PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea (NG), Chlamydia trachomatis…
- Trial name
- PALESA (NCT06030856)
- Testing
- STI test kits (NG, CT and TV) for home use, Self Administered Behavioural Risk Assessment
- Where
- South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Wits RHI Research Centre Clinical Research Site
Pre-Exposure Prophylaxis, HIV Infections
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- NCT04712994
- Testing
- PrEP Optimization Interventions
- Where
- 8 sites in Kenya
- Volunteers
- 1,958 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
PrEP Among MSM and TG in Myanmar
HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%.
- Trial name
- PrEP (NCT04781426)
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg
- Where
- Burma
- Volunteers
- 200 people
- Sponsor
- Myanmar Oxford Clinical Research Unit
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
Rabies
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen
To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the…
- Trial name
- NCT07055295
- Testing
- Rabies Vaccine (Serum-free Vero Cell), Freeze-dried, Verorab®
- Where
- Pakistan
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Rabies
Safety and Immunogenicity of ID vs IM Rabies Vaccine
Background: Burden: Rabies is a viral zoonotic disease that is 100% fatal if left untreated. Globally, Bangladesh is ranked third in terms of rabies infections.
- Trial name
- NCT07345208
- Testing
- Rabies vaccine
- Where
- Bangladesh
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Immuno-Deficiency, COVID-19
PREP (Pre-Exposure Prophylaxis) of COVID-19
This is a study of immunocompromised individuals who have received or plan to receive a drug called EVUSHELD. This study is looking at any serious adverse events that might happen after receiving EVUSHELD, the levels of EVUSHELD…
- Trial name
- PrEP (NCT05461378)
- Testing
- Evusheld
- Where
- United States
- Volunteers
- 138 people
- Sponsor
- Ghady Haidar
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR C19 IL (NCT05712096)
- Testing
- EVUSHELD
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- AstraZeneca