Clinical trials: 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
HIV/AIDS
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR).
- Trial name
- POPPi (NCT04030520)
- Testing
- POPPi, Comparison
- Where
- Uganda
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Cognitive Dysfunction
Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence.
- Trial name
- NCT05912374
- Testing
- standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB), enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
HIV, Human Immunodeficiency Virus
Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.
- Conditions
- HIV, Human Immunodeficiency Virus, ART
- Trial name
- NCT06176859
- Testing
- HIV PrEP Delivery
- Where
- South Africa
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Infections, Syphilis
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)
This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S.
- Trial name
- EHPOC (NCT04793750)
- Testing
- Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
- Where
- 3 sites in United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Safety Issues
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
- Trial name
- RITE PrEP (NCT06274398)
- Testing
- TAF/EVG rectal insert
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Pre-exposure Prophylaxis
Information Seeking About Pre-exposure Prophylaxis
The goal of these two intervention studies is to test promising health communication messaging strategies most likely to enhance Black, Hispanic, and non-Hispanic White YMSM's (young men who have sex with men's) engagement with…
- Trial name
- NCT05728034
- Testing
- Injectable PrEP information, Oral PrEP information
- Where
- United States
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- Penn State University
HIV
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pilot Phase
The investigators will pilot test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using Pre-exposure Prophylaxis (PrEP).
- Trial name
- NCT07225894
- Testing
- Ethnodrama Intervention
- Where
- Kenya
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Duke University
Patient Adherence, HIV Seronegativity
Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals
CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence intervention (iTAB) improves adherence to PrEP…
- Trial name
- NCT03086200
- Testing
- brief Motivational Interviewing
- Where
- 5 sites in United States
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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
IPV, HIV
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and…
- Conditions
- IPV, HIV, PrEP
- Trial name
- NCT05599581
- Testing
- Tu'Washindi
- Where
- 2 sites in Kenya
- Volunteers
- 1,562 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV Pre-Exposure Prophylaxis
Supporting Tailored And Responsive PrEP in Rural North Carolina
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61).
- Trial name
- STARR-NC (NCT05984030)
- Testing
- PrEP Navigation Services, Telehealth PrEP Services Referral, HealthMpowerment Digital Health Intervention - Enhanced
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Behavior, Health
Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention
HIV pre-exposure prophylaxis (or PrEP) is an effective additional preventative measure for reducing the risk of HIV transmission.
- Trial name
- NCT04771312
- Testing
- Mobile app information-only intervention, Mobile app social support network intervention
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
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 Prevention, Pre-Exposure Prophylaxis (PrEP)
PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure Prophylaxis (PrEP)
During the initial encounter, the nurses will complete program enrollment forms (consents and disclosures as approved by IRB), medical history, and risk assessment.
- Trial name
- Prep-RN (NCT06030557)
- Testing
- Truvada
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- CAN Community Health
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
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
GonoScreen: Efficacy of Screening STIs in MSM
A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs.
- Trial name
- GonoScreen (NCT04269434)
- Testing
- No Screening
- Where
- 5 sites in Belgium
- Volunteers
- 1,014 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
HIV Infections, STI
EASY-TESTS: Evaluation of the Acceptability of Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex With Men (MSM) Who Accepted Targeted HIV/STI Testing, Recruited Through a Community-based Outreach Approach, Both Digital and In-person.
Acceptability of a PrEP program among MSM and TG visiting a geolocated community application or a community physical place of sociability and having accepted a targeted screening for HIV, Hepatitis B, C and STIs.
- Trial name
- EASY-TESTS (NCT05949814)
- Testing
- acceptability of a PrEP program among HIV-negative MSM and TG
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Centre de santé sexuelle Le 190