Clinical trials: HIV Pre-Exposure Prophylaxis
Hiv
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily…
- Trial name
- SCOPE-PP (NCT05322629)
- Testing
- PrEP adherence biofeedback, Standard of care counseling
- Where
- South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Pre-exposure Prophylaxis, HIV Infections
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in…
- Trial name
- NCT05417620
- Testing
- Social Media Campaign, PrEP Champions, Community Mobilization
- Where
- South Africa
- Volunteers
- 601 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Sexually Transmitted Infections (STIs), HIV
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.
- Conditions
- Sexually Transmitted Infections (STIs), HIV, PrEP
- Trial name
- STI_PrEPare (NCT06860945)
- Testing
- No Intervention: Observational Cohort
- Where
- 26 sites in Spain
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario de Valme
Point of Care STI Testing
Point of Care STI Testing
The proposed research hypothesizes that point-of-care testing (POCT) for sexually transmitted infections (STIs) gonorrhea and chlamydia will be a feasible, acceptable, and appropriate implementation strategy for improving HIV…
- Trial name
- NCT06844045
- Testing
- Gonorrhea/chlamydia Point-of-Care Testing
- Where
- United States
- Volunteers
- 6,460 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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)
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
HIV Prevention
PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea (NG), Chlamydia trachomatis…
- Trial name
- PALESA (NCT06030856)
- Testing
- STI test kits (NG, CT and TV) for home use, Self Administered Behavioural Risk Assessment
- Where
- South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Wits RHI Research Centre Clinical Research Site
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
Introducing PrEP Into HIV Combination Prevention - Kenya
Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers (FSWs) and young women (YW) as part of a defined package of HIV combination prevention intervention for 12 months in 5 sites in Kenya.
- Trial name
- IPCP-Kenya (NCT02755350)
- Testing
- Truvada
- Where
- Kenya
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- LVCT Health
Men or Transgender Women Who Have Sex With Men
HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW
This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
- Trial name
- NCT03745495
- Where
- 7 sites in Thailand
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre
HIV Infections
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV…
- Trial name
- NCT04692077
- Testing
- Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
- Where
- 4 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv
Efficacy Trial of Life Simulation Game to Routinize Adolescent HIV Testing
This study will aim to assess the acceptability, usability and efficacy of using state-of-the-art video game technology to increase HIV testing among adolescents and young adults (AYA) ages 13-24.
- Trial name
- NCT04917575
- Testing
- Mobile Game, Mobile Application
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- George Washington University
HIV Infections, Sexually Transmitted Infection
User-friendly HIV Testing and Counseling Services
Multicenter cohort study of individuals reporting behavioral risks of HIV acquisition, recruited among those presenting for testing for HIV and other sexually transmitted infections.
- Conditions
- HIV Infections, Sexually Transmitted Infection, Hepatitis B, Chronic, Hepatitis C
- Trial name
- NCT04585165
- Where
- 6 sites in Thailand
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
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
Pre-Exposure Prophylaxis (PrEP), HIV
Peer-led Community-based PrEP Delivery Among Youth in Brazil
The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver…
- Trial name
- COMPrEP (NCT06661356)
- Testing
- COMPrEP
- Where
- 2 sites in Brazil
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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)
Adolescent Behavior, HIV/AIDS
Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2)…
- Conditions
- Adolescent Behavior, HIV/AIDS, PrEP
- Trial name
- NCT03897725
- Testing
- Telehealth Coaching
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections
Getting to Zero Among HHI MSM in the American South
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating…
- Trial name
- NCT05075967
- Testing
- Health Access Coalitions, Social Media, Peer Support
- Where
- United States
- Volunteers
- 2,700 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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