Clinical trials: HIV Pre-exposure Prophylaxis
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
Pre-exposure Prophylaxis, HIV Infections
Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa
The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South…
- Trial name
- NCT06274060
- Testing
- Case management, Food vouchers, PrEP support buddy
- Where
- South Africa
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pre-Exposure Prophylaxis of HIV Infection
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF)…
- Trial name
- PURPOSE 5 (NCT06513312)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Where
- 14 sites in France, United Kingdom
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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 Pre-exposure Prophylaxis, PrEP
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the…
- Trial name
- PrEP ED (NCT07462611)
- Testing
- PrEP Uptake with Rapid Start, Pre-Exposure Prophylaxis (PrEP) Persistence
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
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
Pre-exposure Prophylaxis, HIV Prevention
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding…
- Conditions
- Pre-exposure Prophylaxis, HIV Prevention, Pregnancy Related
- Trial name
- PrIMO (NCT06158126)
- Testing
- Initiating daily oral PrEP during pregnancy, Already using daily oral PrEP at the time of pregnancy diagnosis, Initiating injectable PrEP during pregnancy
- Where
- Malawi
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Prevention, HIV Pre-exposure Prophylaxis
Client-Centered Care Coordination for Black Men Who Have Sex With Men
The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM).
- Trial name
- NCT06056544
- Testing
- Client Centered Care Coordination
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Healthy, HIV Pre-exposure Prophylaxis
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
- Trial name
- NCT06580587
- Testing
- MK-8527
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
HIV, HIV Pre-exposure Prophylaxis
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1)…
- Trial name
- NCT06045507
- Testing
- MK-8527
- Where
- 18 sites in United States, Israel and 1 more
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
HIV Infection, Sexually Transmitted Infections
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis…
- Conditions
- HIV Infection, Sexually Transmitted Infections, Pre-exposure Prophylaxis, Systems Navigation
- Trial name
- NJIRA (NCT06200545)
- Testing
- PrEP eligibility assessment, Rapid HIV antibody testing prior to provision and/or refill of PrEP, PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
- Where
- Malawi
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Bias, Implicit, HIV
Intervention to Reduce Implicit Bias in Pharmacies
This study will follow the ADAPT-ITT model to apply the Prejudice Habit Breaking Intervention (PHBI) to pharmacists who have experience with or are willing to prescribe PrEP.
- Conditions
- Bias, Implicit, HIV, Pre-exposure Prophylaxis
- Trial name
- NCT06487351
- Testing
- The adapted PHBI, The NIH Implicit Bias course
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Infections, STI
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different…
- Conditions
- HIV Infections, STI, HIV Pre-exposure Prophylaxis
- Trial name
- CombineApp (NCT06205368)
- Testing
- Combine mobile app, Motivational interview, HIV/STI testing
- Where
- United States
- Volunteers
- 473 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Prevention, Pre-exposure Prophylaxis
Stick2PrEP Cisgender Women and Trans Individuals
Taking a daily anti-HIV pill can protect people from HIV infection. This is called preexposure prophylaxis [PrEP]. Many cisgender women and trans individuals do not know this medication is available; others struggle to take the…
- Trial name
- S2P:CWTI (NCT05165745)
- Testing
- Individualized Feedback
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV Pre-exposure Prophylaxis, HIV Prevention and Care
MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
The primary goal of this randomized controlled trial is to learn if a decision support tool called MyPrEP Plus can help transgender women make decisions about taking pre-exposure prophylaxis (PrEP) for HIV prevention.
- Conditions
- HIV Pre-exposure Prophylaxis, HIV Prevention and Care, Mobile Health Technology (mHealth), Adherence
- Trial name
- NCT07146139
- Testing
- MyPrEP Plus Package, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV, Violence, Gender-Based
Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to intimate partner violence and are working with a domestic violence service…
- Conditions
- HIV, Violence, Gender-Based, Pre-Exposure Prophylaxis
- Trial name
- NCT05614492
- Testing
- Individual PrEP Decision Aid, CDC PrEP Video, Shared PrEP Decision Aid
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Prevention, Pre-exposure Prophylaxis
Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her
The overarching objective for the pilot study is to test the feasibility of using a mobile medical unit as a delivery mode combined with enhanced Pre-exposure Prophylaxis (PrEP) messaging to increase awareness of PrEP and access…
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis, PrEP, Prevention
- Trial name
- IFE4Her (NCT05644834)
- Testing
- I'm Fully Empowered for Her (IFE4Her)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of North Carolina, Chapel Hill