Clinical trials: Pre-exposure Prophylaxis (PrEP)
HIV
Likely Use of PrEP for African American YMSM
HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has been approved by the FDA as a method for reducing HIV transmission rates in the population, particularly young men who have sex with men…
- Trial name
- NCT02810249
- Testing
- No intervention used
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Prevention, Conception
Safer Conception for Women - Understanding Use of Periconception PrEP
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk.
- Trial name
- NCT03194308
- Testing
- PrEP for Safer Conception
- Where
- South Africa
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Prevention, Pre-exposure Prophylaxis (PrEP)
A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis (PrEP), Risk Reduction, Adherence, Medication
- Trial name
- PrEP-3D RCT (NCT05474313)
- Testing
- PrEP-3D package, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV Prevention
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Nationally, the HIV case rate among black/ African American (AA) women is nearly 20 times higher than in white women; for Hispanic/Latino women it is 4.5 times higher.
- Trial name
- NCT04018651
- Testing
- PrEP Master Adherence Intervention
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Florida International University
HIV/AIDS
Navigating Insurance Coverage Expansion (NICE)
The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care…
- Trial name
- NICE (NCT04263441)
- Testing
- NICE Intervention
- Where
- 3 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- University of Chicago
PrEP Uptake
PrEP Optimization Among Women to Enhance Retention and Uptake
Black women experience one of the highest incidences of HIV among all subpopulations in the United States, but pre-exposure prophylaxis (PrEP) use among Black cisgender women is very limited.
- Trial name
- POWER Up (NCT05626452)
- Testing
- PrEP Education, Provider training, EMR Optimization
- Where
- United States
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Sexually Transmitted Infections (STIs), HIV
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.
- Conditions
- Sexually Transmitted Infections (STIs), HIV, PrEP
- Trial name
- STI_PrEPare (NCT06860945)
- Testing
- No Intervention: Observational Cohort
- Where
- 26 sites in Spain
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario de Valme
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV Infection, Sexually Transmitted Infection
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men
- Trial name
- NCT07658976
- Testing
- HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package
- Where
- 5 sites in United States, Argentina and 2 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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
Pre-Exposure Prophylaxis (PrEP), HIV Prevention
A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)
People using HIV self-testing (HIVST) need access to quality HIV-prevention programming, including education and exploration of pre-exposure prophylaxis (PrEP) - an effective biomedical prevention tool that continues to expand in…
- Trial name
- DASH (NCT07614165)
- Testing
- PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- University of Michigan
HIV
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the…
- Trial name
- ALIGN (NCT07390409)
- Testing
- Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- South Africa
- Volunteers
- 3,700 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
HIV Infection Primary, Hepatitis, Viral, Human
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other…
- Conditions
- HIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and Hepatitis
- Trial name
- SeVIHPrEP (NCT05492565)
- Testing
- Tenofovir Disoproxil Fumarate 300 MG Oral Tablet
- Where
- Spain
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Hospitales Universitarios Virgen del Rocío
HIV, Pre-exposure Prophylaxis
Life Steps for PrEP for Youth
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in…
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Trial name
- LSPY (NCT03805451)
- Testing
- Life Steps for PrEP for Youth
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs).
- Trial name
- NCT01769456
- Testing
- PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 6 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
STI, Sexually Transmitted Diseases
Assessing the Feasibility and Preliminary Impact of a mHealth App on Reducing STI Risk in Black MSM PrEP Users
The study will recruit 120 Black men who have sex with men (BMSM) from the local area, New Orleans. The main purpose of this research study is to test the effect of a new smartphone application, "PCheck," on reducing the…
- Conditions
- STI, Sexually Transmitted Diseases, Pre-exposure Prophylaxis
- Trial name
- NCT05395754
- Testing
- App Intervention
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
HIV
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered…
- Trial name
- PrEPBrasil (NCT01989611)
- Testing
- emtricitabine / tenofovir 200/300 mg
- Where
- 3 sites in Brazil
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV Infections
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- ADAPT (NCT01327651)
- Testing
- Daily dosing, Time-driven dosing, Event-driven dosing
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
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