Clinical trials: Pre-exposure Prophylaxis
Relationship Dynamics, Pre-exposure Prophylaxis (PrEP) Adherence
CHARISMA Expansion Study
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social…
- Trial name
- CHARISMA (NCT04092114)
- Testing
- Control, CHARISMA Intervention
- Where
- South Africa
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- RTI International
Treatment Adherence and Compliance
PrEP iT! Mobile App Intervention
The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM).
- Trial name
- PrEP iT! (NCT04509076)
- Testing
- PrEP iT! (plus usual PrEP care), Usual PrEP care
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- San Diego State University
COVID-19
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
- Trial name
- PrEP_COVID (NCT04331834)
- Testing
- Hydroxychloroquine
- Where
- Spain
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
HIV
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase
The investigators will develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.
- Trial name
- NCT06501885
- Testing
- Ethnodrama Intervention
- Where
- Kenya
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Duke University
PrEP Adherence Monitoring
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
- Trial name
- NCT03058835
- Testing
- tenofovir disoproxil and emtricitabine
- Where
- 4 sites in United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Hiv, Contraception Behavior
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia.
- Trial name
- NCT06852508
- Testing
- TwySHE
- Where
- Zambia
- Volunteers
- 324 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
PrEP Uptake, HIV Seronegativity
Pre-exposure Prophylaxis Accessibility Research and Evaluation 2
This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine if providing high-risk subjects with a calculated risk score changes the likelihood of pre-exposure prophylaxis (PrEP) uptake.
- Trial name
- PrEPARE2 (NCT02125773)
- Testing
- Informed Risk Score
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Pre-Exposure Prophylaxis
Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care
Kaiser Permanente Northern California (KPNC) has been a national leader in implementation of HIV preexposure prophylaxis (PrEP), a daily antiretroviral pill that is more than 99% effective in preventing HIV acquisition.
- Trial name
- NCT05991869
- Testing
- Point-of-care decision support intervention
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
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 Infections
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women.
- Trial name
- PrEP (NCT04071470)
- Testing
- Storytelling, PrEP
- Where
- Mozambique
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
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
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
HIV
Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women
Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are used by a person before they are exposed to HIV in order to decrease his or her chance of getting infected.
- Trial name
- MVC-PREP (NCT01749566)
- Testing
- maraviroc
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV, Pregnancy
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy.
- Conditions
- HIV, Pregnancy, Pre-Exposure Prophylaxis of HIV Infection
- Trial name
- HFPT (NCT06746675)
- Testing
- Healthy Families PrEP Counselling Intervention
- Where
- Uganda
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Yale University
HIV/AIDS
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF/FTC in HIV-uninfected cisgender men who have sex with men (MSM).
- Trial name
- SimpPrEP (NCT05813964)
- Testing
- TDF/FTC 300mg/200mg fixed-dose combination tablets, TAF/FTC 25mg/200mg fixed-dose combination tablets
- Where
- 6 sites in France, Thailand
- Volunteers
- 524 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e.
- Trial name
- PrEPVacc (NCT04066881)
- Testing
- Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Control PrEP:TDF/FTC once daily (weeks 0-26)
- Where
- Uganda
- Volunteers
- 1,512 people, healthy volunteers welcome
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
Hiv
PK of TAF and TDF for PrEP in Pregnant and Postpartum Women
This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum.
- Trial name
- PrEP-PP PK (NCT04937881)
- Testing
- Tenofovir alafenamide, Tenofovir Disoproxil Fumarate
- Where
- South Africa
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
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
Opioid Use Disorder, HIV Infections
Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington
The investigators will implement a non-randomized observational clinical trial that will include a pop-up clinic for women who inject drugs (WWID) near venues for exchange sex and drug use in north Seattle.
- Conditions
- Opioid Use Disorder, HIV Infections, Chlamydia, Gonorrhea
- Trial name
- NCT06187064
- Testing
- Mobile Van Clinic
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Washington