Clinical trials: Pre-exposure Prophylaxis
HIV
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered…
- Trial name
- PrEPBrasil (NCT01989611)
- Testing
- emtricitabine / tenofovir 200/300 mg
- Where
- 3 sites in Brazil
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV/AIDS, Pre-exposure Prophylaxis
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
Our proposed study will: provide a novel exploration of facilitators and barriers to PrEP; allow us to target hard to reach populations, including men who have sex with men (MSM) and substance users (both of which are top funding…
- Trial name
- NCT04064567
- Testing
- PrEP-LINK, Enhanced Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
HIV/AIDS
Navigating Insurance Coverage Expansion (NICE)
The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care…
- Trial name
- NICE (NCT04263441)
- Testing
- NICE Intervention
- Where
- 3 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Human Immunodeficiency Virus (HIV)
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention…
- Trial name
- SPARK (NCT02037594)
- Testing
- Sexual Health Counseling, Enhanced Adherence Intervention, PrEP Information (Active Control)
- Where
- United States
- Volunteers
- 438 people, healthy volunteers welcome
- Sponsor
- Hunter College of City University of New York
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection better than a…
- Trial name
- NCT07071623
- Testing
- MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF)
- Where
- 30 sites in Kenya, South Africa and 1 more
- Volunteers
- 4,580 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Help-Seeking Behavior, Pre-exposure Prophylaxis Use
Moon and Sun Brothers: A Community Prevention Intervention (Hermanos de Luna y Sol)
The goal of this quasi-experimental, community intervention is to reduce HIV sexual risk among Latino immigrant bisexual men or men who have sex with men.
- Conditions
- Help-Seeking Behavior, Pre-exposure Prophylaxis Use, Condomless Sex, Risky Health Behavior
- Trial name
- NCT07475702
- Testing
- Moon and Sun Brothers: A Community Prevention Intervention
- Where
- 2 sites in United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- San Francisco State University
HIV Infections, Domestic Violence
Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women
Pre-exposure prophylaxis may be a viable option for African American women at-risk for HIV infection, but few studies have identified optimal strategies to reach African American women in need of Pre-Exposure Prophylaxis nor…
- Trial name
- NCT05139069
- Testing
- Trauma-Informed Toolkit
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV, Substance Use
Couples Health CoOp Plus
This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+).
- Conditions
- HIV, Substance Use, Stigma, Social
- Trial name
- CHC+ (NCT05310773)
- Testing
- Community Stigma Awareness and Education Workshop, Couples Health CoOp Plus (CHC+)
- Where
- South Africa
- Volunteers
- 962 people, healthy volunteers welcome
- Sponsor
- RTI International
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
HIV/AIDS
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2.
- Trial name
- PrEPDSA (NCT03637244)
- Testing
- Decision Support Aid and PrEP for Black Canadians
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
HIV Prevention
The CATALYST Study
The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at…
- Trial name
- NCT05937698
- Where
- 28 sites in Kenya, Lesotho and 3 more
- Volunteers
- 6,069 people, healthy volunteers welcome
- Sponsor
- FHI 360
Ebola Vaccine
Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure
This study is a multi-center, open label, randomized phase 3b trial to assess the durability of Immunity induced by the Ebolavirus Vaccine VSV-EBOV ( with or without booster vaccination) in individuals at potential occupational…
- Trial name
- PREPARE (NCT05959421)
- Testing
- ERVEBO® (rVSV∆G-ZEBOV-GP)
- Where
- 2 sites in Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
HIV Infections, HIV Prevention
Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
Many people who are experiencing homelessness are at high risk for HIV, but they often have trouble getting HIV prevention or treatment.
- Conditions
- HIV Infections, HIV Prevention, Homeless Persons, Homelessness
- Trial name
- CONNECT (NCT07870603)
- Testing
- CONNECT (status-neutral, nurse-led on-site HIV service delivery), Standard of Care (referral-based outreach)
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Donaldson Conserve
HIV
IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya
This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions…
- Trial name
- NCT03988387
- Testing
- Peer Support (PS), Reminder and Resource Transfer (RRT), daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV, Pre-exposure Prophylaxis
Case Management Dyad
The overall goal of this study is to test whether dyadic and focused case management coupled with contingency management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates…
- Conditions
- HIV, Pre-exposure Prophylaxis, Case Management, Contingency Management
- Trial name
- CM2 (NCT06162897)
- Testing
- Dyadic Case Management
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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 Infections, Sexual Behavior
HIV and STIs Clinical Study in Germany
The BRAHMS study is a prospective observational cohort study aiming to investigate how often people that are at risk to get infected with HIV contract HIV and how long people stay in the study.
- Conditions
- HIV Infections, Sexual Behavior, Risk Reduction
- Trial name
- NCT03884816
- Testing
- Determine the Incidence and Retention Rate
- Where
- 10 sites in Germany
- Volunteers
- 1,017 people, healthy volunteers welcome
- Sponsor
- Hendrik Streeck
HIV Infections
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs).
- Trial name
- NCT00119106
- Testing
- Tenofovir disoproxil
- Where
- Thailand
- Volunteers
- 2,413 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention