Clinical trials: Pre-Exposure Prophylaxis (PrEP)
HIV Prevention
Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use…
- Trial name
- NCT06394323
- Testing
- Behavioral: My Choice for HIV Prevention (MyChoice)
- Where
- Malawi
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
PrEP Adherence Monitoring
Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and…
- Trial name
- DOT-DBS (NCT02022657)
- Testing
- Truvada
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
HIV/AIDS, Adherence, Medication
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine…
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Trial name
- NCT03584282
- Testing
- Text Messaging, Peer Navigation
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections, HIV/AIDS
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP).
- Conditions
- HIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection
- Trial name
- dPEP-KE (NCT04050540)
- Testing
- Doxycycline
- Where
- Kenya
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV/AIDS
Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
This study aims to help young Latino gay and bisexual men access sexual health information, including PrEP. Participants will be randomly assigned to either the patient navigation or the usual care condition and followed for 6…
- Trial name
- NCT04048382
- Testing
- Patient Navigation, Usual Care
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- San Diego State University
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
HIV Prevention
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk…
- Trial name
- PeerPrEP (NCT04982250)
- Testing
- Enhanced peer PrEP referral + HIVST delivery
- Where
- Kenya
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
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
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
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
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
Pre-Exposure Prophylaxis, HIV Infections
Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- PrEPARE (NCT05482360)
- Testing
- PrEP Optimization Interventions
- Where
- Kenya
- Volunteers
- 5,173 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)
This study is a randomized controlled clinical trial of a theoretically based mobile app, HealthMindr, to increase pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) to prevent human immunodeficiency…
- Trial name
- NCT03763942
- Testing
- HealthMindr App, Control App
- Where
- 3 sites in United States
- Volunteers
- 658 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
Pre-exposure Prophylaxis
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of…
- Trial name
- ePrEP (NCT03729570)
- Testing
- ePrEP
- Where
- 4 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Emory University
Human Immunodeficiency Virus
Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men
The proposed study will involve adolescent (17-24 years old) men who have sex with men (described as YMSM hereafter) who meet eligibility criteria to participate.
- Trial name
- NCT04865341
- Testing
- IMB, Information-Only Control
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
HIV Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV/AIDS
Biomedical HIV/AIDS Prevention Program Yunnan
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex…
- Trial name
- B-HAPPY (NCT03992274)
- Testing
- Enhanced implementation of PrEP
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV, Prophylaxis
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW
This is a research study to determine the best way to dose Truvada®, an oral medication licensed to be taken as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, in transgender women who are also taking feminizing…
- Conditions
- HIV, Prophylaxis, Transgender
- Trial name
- NCT04760691
- Testing
- Truvada alone, Truvada plus Leuprolide 11.25mg intramuscular injection, Truvada plus Estradiol 1 mg
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University