Clinical trials: HIV Pre-Exposure Prophylaxis
Overdose Accidental
Naltrexone for Overdose Prevention
The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine).
- Trial name
- NOD (NCT06633900)
- Testing
- IM naltrexone, Usual Care
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
HIV-1-infection
10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks.
- Trial name
- NCT05890963
- Testing
- ART, 10E8.4/iMab, VRC07-523LS
- Where
- Tanzania
- Volunteers
- 20 people
- Sponsor
- David Ho
Human Immunodeficiency Virus (HIV)
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active…
- Trial name
- TMC278LA (NCT02165202)
- Testing
- Rilpivirine
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- PATH
Opioid-use Disorder, HIV Prevention Program
Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to…
- Trial name
- CoMPASS (NCT04738825)
- Testing
- Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)
- Where
- 6 sites in United States
- Volunteers
- 526 people
- Sponsor
- Yale University
HIV Infection
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- NCT01505114
- Testing
- Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pre-exposure Prophylaxis, HIV-1-infection
Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV
This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.
- Trial name
- NCT03226873
- Testing
- Peer Navigation
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
HIV Infections, Pre-Exposure Prophylaxis
Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men
This study is testing feasibility and acceptability of a theoretically based mobile application (app), UPrEPU, to increase adherence to pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) to prevent human…
- Trial name
- NCT04248790
- Testing
- mobile app to improve adherence to PrEP self-management
- Where
- 3 sites in Taiwan
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- National Cheng Kung 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 Transmission, Transtheoretical Model of Change
Partner Services Pre-exposure Prophylaxis (PS-PrEP)
This study evaluates the feasibility (reach, adoption, safety and implementation) and initial efficacy (higher linkage to care) of the Partner Services Pre-exposure Prophylaxis (PS-PrEP) intervention versus phone based…
- Trial name
- PS-PrEP (NCT02749955)
- Testing
- PS-PrEP Intervention Group, PrEPLine Control Group
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV Infections
Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT
The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and…
- Trial name
- LAPIS (NCT06250504)
- Testing
- APRETUDE (cabotegravir) 600 mg\3 mL, DAPIRING (Dapivirine) 25mg Vaginal Ring, tenofovir disoproxil and emtricitabine
- Where
- South Africa
- Volunteers
- 2,052 people, healthy volunteers welcome
- Sponsor
- Africa Health Research Institute
HIV Prevention
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women
This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones.
- Trial name
- NCT03060785
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa
Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2…
- Trial name
- MOBILEMEN (NCT06133686)
- Testing
- Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA), Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
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
HIV, PrEP
Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania
Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania.
- Trial name
- MWOTAJI (NCT07687888)
- Testing
- Pharmacy-based PrEP services, Distribution of HIV self-test kits
- Where
- Tanzania
- Volunteers
- 2,818 people, healthy volunteers welcome
- Sponsor
- Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
HIV, PrEP
Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model
The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men…
- Conditions
- HIV, PrEP, MSM, Behavior Changes
- Trial name
- NCT06931106
- Testing
- HAPA and CEI behavioral intervention, HAPA-based intervention
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Peking University
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 Infections
Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV.
- Trial name
- NCT02213328
- Testing
- Truvada
- Where
- 2 sites in South Africa
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin.
- Trial name
- NCT07600775
- Testing
- MK-8527, Rifampin
- Volunteers
- 14 people
- Sponsor
- Merck Sharp & Dohme LLC