Clinical trials: Human Immunodeficiency Virus Exposure
Antiretroviral Toxicity
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.
- Trial name
- SMARTT (NCT01310023)
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 5,169 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
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 Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention
Demonstration Project on the Feasibility to Implement PrEP in MSM and TG Women
The purpose of the study is to evaluating the acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered…
- Trial name
- NCT03043326
- Testing
- Tenofovir Disoproxil Fumarate and Emtricitabine
- Where
- 5 sites in Peru
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Asociación Civil Impacta Salud y Educación, Peru
HIV Infections, Sexually Transmitted Diseases, Bacterial
Mobile Enhanced Prevention Support for People Leaving Jail
This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail.
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C, Substance Use Disorders
- Trial name
- MEPS (NCT04036396)
- Testing
- Mobile Enhanced Prevention Support, Usual Care plus Customized Referrals
- Where
- 3 sites in United States
- Volunteers
- 233 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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, STIs
Combatting HIV Or Other STIs Early (CHOOSE)
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people.
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Trial name
- CHOOSE (NCT07510048)
- Testing
- Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Westat
HIV-1 Infections
HIV PrEP Priming of Immune Effectors
Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who…
- Trial name
- PREPPIE (NCT02593409)
- Testing
- TDF/FTC
- Where
- Uganda
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
Adherence, Medication, Adolescent Behavior
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
A randomized controlled clinical trial looking at the effect of use of a mobile phone application in addition to standard care compared to standard care alone at a youth-friendly clinic in young men who have sex with men and…
- Conditions
- Adherence, Medication, Adolescent Behavior, HIV Prevention, Sexual Health
- Trial name
- YouthPrEP (NCT03778892)
- Testing
- 'Project Raincoat' Mobile Phone Application
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
HIV Infections
Pre-Exposure Prophylaxis Using TMC278LA
Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV…
- Trial name
- NCT01049932
- Testing
- TMC278LA
- Where
- 4 sites in United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- St Stephens Aids Trust
Improving Perceptions of HIV Risk, Improving Uptake of Pre-exposure Prophylaxis for HIV
Manicaland PrEP Uptake Through Interactive Counselling Trial
Primary Objective: The purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of…
- Trial name
- NCT03565575
- Testing
- Interactive tablet-based quiz
- Where
- 8 sites in Zimbabwe
- Volunteers
- 1,055 people, healthy volunteers welcome
- Sponsor
- Simon Gregson
HIV, Pre-exposure Prophylaxis
Life Steps for PrEP for Youth
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in…
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Trial name
- LSPY (NCT03805451)
- Testing
- Life Steps for PrEP for Youth
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV/AIDS
Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men.
- Trial name
- NCT00775294
- Testing
- Maraviroc
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Pharmacy-based PrEP Delivery in Kenya
A cluster-randomized control trial (cRCT) testing different cost-sharing models for the delivery of HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) services at private pharmacies in Kenya.
- Trial name
- NCT05842122
- Testing
- Client-sustained delivery of pharmacy PrEP/PEP, Implementor-sustained delivery of pharmacy PrEP/PEP, Counselor-supported delivery of pharmacy PrEP/PEP
- Where
- 2 sites in Kenya
- Volunteers
- 5,808 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
HIV Infection
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).
- Trial name
- NCT01533272
- Testing
- Tenofovir, emtricitabine, maraviroc, Tenofovir, emtricitabine, lopinavir/r
- Where
- Spain
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Hospital Clinic of Barcelona
HIV
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships
The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools.
- Trial name
- STEP-UP (NCT07246057)
- Testing
- STEP-UP, Philadelphia TelePrEP Program Direct-to-Consumer Model
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV Infections
Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
The goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for PrEP program in a community pharmacy setting.
- Trial name
- IDCaPP (NCT05867212)
- Testing
- Cabotegravir Injection [Apretude]
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kelley-Ross & Associates, Inc.
HIV Infections
Project Minority AIDS Prevention: Reaching Black and Hispanic MSM About PrEP and TasP Using Social Media
This project has the potential to improve the implementation science of treatment as prevention and pre-exposure prophylaxis uptake as a public health strategy for reducing new HIV infections in the United States.
- Trial name
- MAP (NCT03404531)
- Testing
- Social Media Messages Intervention Group, Website Only Group
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV
Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
- Trial name
- NCT01602822
- Testing
- Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Kenneth H. Mayer, MD