Clinical trials: Pre-Exposure Prophylaxis, open to volunteers
HIV, PrEP
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC…
- Conditions
- HIV, PrEP, PrEP Adherence
- Trial name
- LYPS (NCT07438041)
- Testing
- LYPS, Enhanced Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Westat
HIV Infections
Getting to Zero Among HHI MSM in the American South
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating…
- Trial name
- NCT05075967
- Testing
- Health Access Coalitions, Social Media, Peer Support
- Where
- United States
- Volunteers
- 2,700 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Prevention, HIV Pre-exposure Prophylaxis
PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)
The goal of this clinical trial is to learn if use of the PEPPI software can improve pharmacist-provided HIV prevention (PEP/PrEP) services. The main questions it aims to answer are: 1.
- Conditions
- HIV Prevention, HIV Pre-exposure Prophylaxis, Access and Linkage to Healthcare, Technology Use
- Trial name
- PEPPI (NCT07683117)
- Testing
- PEPPI Pharmacies
- Where
- United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- EMPOWERX INC
HIV Prevention, HIV Infection Primary
Intervention to Enhance PrEP Persistence
The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care.
- Trial name
- NCT06872307
- Testing
- RAMP-It-Up Initiation, Adherence, and Retention Intervention
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV)
Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a…
- Conditions
- HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV), Opioid Use Disorder
- Trial name
- NCT06799702
- Testing
- Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Georgia
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
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 Infections
Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention
Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination.
- Trial name
- IMPERATIVE (NCT06370923)
- Testing
- Peer Distribution, Community Health Worker Distribution
- Where
- Zimbabwe
- Volunteers
- 3,591 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Human Immunodeficiency Virus, Pre-Exposure Prophylaxis
Universal Test and Connect for HIV Service Delivery in South Africa
The goal of this study is to determine how many patients with HIV or at high risk of getting HIV attend the Emergency Department (ED) in South Africa (SA).
- Conditions
- Human Immunodeficiency Virus, Pre-Exposure Prophylaxis, Emergency Department, South Africa
- Trial name
- UTC: SA (NCT06408142)
- Testing
- HIV testing, In-depth interview
- Where
- South Africa
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infection, Sexual and Reproductive Health
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period.
- Trial name
- PtC (NCT06807736)
- Testing
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Where
- South Africa
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
Pregnancy, HIV Infections
Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.
- Trial name
- NCT07288190
- Testing
- DPP, 2PR, Free Choice
- Where
- 3 sites in Eswatini, Uganda and 1 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Help-Seeking Behavior, Pre-exposure Prophylaxis Use
Moon and Sun Brothers: A Community Prevention Intervention (Hermanos de Luna y Sol)
The goal of this quasi-experimental, community intervention is to reduce HIV sexual risk among Latino immigrant bisexual men or men who have sex with men.
- Conditions
- Help-Seeking Behavior, Pre-exposure Prophylaxis Use, Condomless Sex, Risky Health Behavior
- Trial name
- NCT07475702
- Testing
- Moon and Sun Brothers: A Community Prevention Intervention
- Where
- 2 sites in United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- San Francisco State University
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
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: The PERSIST Trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis…
- Trial name
- NCT07221747
- Testing
- Standard of Care (SoC), Enhanced continuation support package
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
HIV Prevention
Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM).
- Trial name
- C4+3MV (NCT06661343)
- Testing
- C4 Program, C4 + 3MV Program
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Yale University
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 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 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