Clinical trials: HIV Pre-Exposure Prophylaxis, open to volunteers
HIV Infections, Sexually Transmitted Diseases
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic.
- Trial name
- PCORI PrEP (NCT04855773)
- Testing
- PrEPmate, Dot Diary
- Where
- 4 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
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 Pre-exposure Prophylaxis Use
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir.
- Trial name
- NCT07335289
- Testing
- Choice of follow up, Follow up via standard clinic
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Infections, Sexually Transmitted Infection
PrEPwise Pilot Among Black Women in Eastern Virginia
HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher.
- Trial name
- PrEPwise (NCT07398482)
- Testing
- PrEPwise, Usual care
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Boston University
HIV Prevention
Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.
The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Black Women (BW) and increase willingness to prescribe/refer pre-exposure prophylaxis (PrEP) to CBW among…
- Trial name
- PrEP (NCT06864689)
- Testing
- Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
PrEP, HIV
HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy
The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail.
- Conditions
- PrEP, HIV, Incarceration
- Trial name
- Hotspot (NCT06919419)
- Testing
- Multicomponent strategy
- Where
- United States
- Volunteers
- 3,600 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
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
Hiv, Substance Use Disorders
An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs.
Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection.
- Trial name
- NCT06316089
- Testing
- PrEPared for Release
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
HIV Infections, HIV Prevention
Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
Many people who are experiencing homelessness are at high risk for HIV, but they often have trouble getting HIV prevention or treatment.
- Conditions
- HIV Infections, HIV Prevention, Homeless Persons, Homelessness
- Trial name
- CONNECT (NCT07870603)
- Testing
- CONNECT (status-neutral, nurse-led on-site HIV service delivery), Standard of Care (referral-based outreach)
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Donaldson Conserve
HIV Preexposure Prophylaxis
The SwissPrEPared Study
Nested within the SwissPrEPared Program, the "SwissPrEPared Study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for PrEP prescription over a period of 3 years.
- Trial name
- NCT03893188
- Where
- 41 sites in Switzerland
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Zurich
HIV Infections
Optimizing Implementation of Long Acting Injectable PrEP
Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available
- Trial name
- NCT07649551
- Testing
- Plan-Do-Study-Act
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
HIV, Substance Use Disorder (SUD)
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are…
- Conditions
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- Trial name
- ASCEND (NCT07199335)
- Testing
- APRETUDE (cabotegravir)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Substance Use
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at…
- Trial name
- NCT06558825
- Testing
- Integrated Intervention to Promote PrEP Uptake, Standard Treatment Condition
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Pre-exposure Prophylaxis
Long-Acting Injectable HIV PrEP PROs
The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews.
- Trial name
- IMPACT (NCT07379658)
- Testing
- Interview and survey to evaluate patient reported outcomes between the two medications.
- Where
- 3 sites in United States
- Volunteers
- 128 people
- Sponsor
- Anupama Raghuram MD
Alcohol Misuse, HIV
Gathering Online for Dialogue and Discussion to Enhance Social Support
The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency…
- Conditions
- Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis
- Trial name
- GODDESS (NCT05753683)
- Testing
- mHealth-Women's CoOp, Virtual Group
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- RTI International
Stigma, Social, Drug Abuse Illicit
Lower Intersecting HIV-related Stigmas to Facilitate Treatment as Prevention (LIFT)
The purpose of this study is to reduce HIV transmission risk among people who inject drugs (PWID) through a multilevel intervention known as LIFT.
- Conditions
- Stigma, Social, Drug Abuse Illicit, HIV (Human Immunodeficiency Virus)
- Trial name
- LIFT (NCT07541131)
- Testing
- LIFT for People Who Use Drugs, LIFT for MMT Providers
- Where
- Kyrgyzstan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Hiv, Opioid Use Disorder
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention…
- Trial name
- MOST (NCT05669534)
- Testing
- community-friendly health recovery program, Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- University of Connecticut
Point of Care STI Testing
Point of Care STI Testing
The proposed research hypothesizes that point-of-care testing (POCT) for sexually transmitted infections (STIs) gonorrhea and chlamydia will be a feasible, acceptable, and appropriate implementation strategy for improving HIV…
- Trial name
- NCT06844045
- Testing
- Gonorrhea/chlamydia Point-of-Care Testing
- Where
- United States
- Volunteers
- 6,460 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
HIV Prevention
Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program
Though broadening PrEP (Pre-Exposure Prophylaxis) availability to Louisiana pharmacies addresses key access issues for Louisiana's population, there is no current baseline data which explore current pharmacist and pharmacies'…
- Trial name
- NCT06530225
- Testing
- Education and Mentoring for Prescribing Pharmacists
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Xavier University of Louisiana.