Clinical trials: PrEP
Pre-Exposure Prophylaxis (PrEP)
Impact of Nursing Involvement on Implementation of HIV Prevention Services
Women comprise 20% of new Human Immunodeficiency Virus (HIV) diagnoses in the United States (U.S.) with 86% attributed to heterosexual contact.
- Trial name
- PrEP-RN (NCT05095818)
- Testing
- PrEP-RN
- Where
- United States
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Surgical Site Infection, Surgical Wound Infection
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
ROSSINI 2 is a phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor), multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of several in-theatre…
- Conditions
- Surgical Site Infection, Surgical Wound Infection, Surgery--Complications, Surgery
- Trial name
- ROSSINI 2 (NCT03838575)
- Testing
- 2% alcoholic chlorhexidine skin prep (SKIN PREP), Iodophor Antimicrobial Incise Drapes (DRAPE), Gentamicin-impregnated implants/ sponges (SPONGE)
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,610 people
- Sponsor
- University of Birmingham
HIV Infection, Sexual and Reproductive Health
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period.
- Trial name
- PtC (NCT06807736)
- Testing
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Where
- South Africa
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
HIV Infections, Pregnancy Related
PrEP Implementation for Mothers in Antenatal Care
In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at risk receive PrEP while no women not at HIV…
- Trial name
- PrIMA (NCT03070600)
- Testing
- Universal PrEP Counseling, Targeted PrEP Counseling
- Where
- 20 sites in Kenya
- Volunteers
- 4,447 people
- Sponsor
- University of Washington
HIV, Sexually Transmitted Diseases
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men…
- Conditions
- HIV, Sexually Transmitted Diseases, Risk Reduction, Pre-Exposure Prophylaxis
- Trial name
- NCT03177512
- Testing
- LYNX Mobile App
- Where
- 2 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
IPV, HIV
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and…
- Conditions
- IPV, HIV, PrEP
- Trial name
- NCT05599581
- Testing
- Tu'Washindi
- Where
- 2 sites in Kenya
- Volunteers
- 1,562 people, healthy volunteers welcome
- Sponsor
- RTI International
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
Acne Vulgaris
Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.
- Trial name
- NCT00651469
- Testing
- YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
- Where
- 27 sites in United States
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- Bayer
HIV-I, Human Immunodeficiency Virus Type 1
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection.
- Conditions
- HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
- Trial name
- Impower-022 (NCT04644029)
- Testing
- Islatravir, FTC/TDF
- Where
- 24 sites in United States, South Africa and 1 more
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV
TelePharm PrEP/PEP
In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between…
- Trial name
- NCT07561658
- Testing
- Telehealth delivery of pharmacy PrEP/PEP, Standard pharmacy PrEP/PEP delivery
- Where
- Kenya
- Volunteers
- 1,580 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
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
Strabismus
The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Determine whether the application of povidone-iodine ophthalmic solution onto the ocular surface causes a change in respiration in children undergoing strabismus surgery with general anesthesia.
- Trial name
- NCT03349515
- Testing
- Provodine-Iodine Solution, Group B will receive three drops in each eye of ophthalmic balanced salt solution.
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
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
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
Human Immunodeficiency Virus
Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
This study evaluates the use of a social-network approach to encourage African-American men who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV infection.
- Trial name
- SNAP (NCT03823209)
- Testing
- Social Network, Brief HIV Prevention Counseling
- Where
- 2 sites in United States
- Volunteers
- 352 people
- Sponsor
- Medical College of Wisconsin
Pre-Exposure Prophylaxis, HIV
PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months.
- Conditions
- Pre-Exposure Prophylaxis, HIV, Telemedicine
- Trial name
- PrEPTECH2 (NCT04902820)
- Testing
- PrEPTECH website, Online PrEP resource list
- Where
- United States
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ETR Associates
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults
The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.
- Trial name
- NCT05262426
- Testing
- Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool, Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
HIV, Antenatal Care
Enhancing Communication on Relationship Preservation, Safer Conception and PrEP to Promote HIV Testing in Uganda
Our novel communication strategy aims to promote HIV testing in Uganda with reassuring messages about the ability to have stable relationships and healthy families with the increased availability of pre-exposure prophylaxis…
- Conditions
- HIV, Antenatal Care, Antiretroviral Therapy, Pre-Exposure Prophylaxis
- Trial name
- NCT06647797
- Testing
- HOPE Clinical Communication Campaign
- Where
- 2 sites in Uganda
- Volunteers
- 22,359 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
HIV
TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults…
- Trial name
- NCT04000724
- Testing
- Text Messaging (Text+Step), WebApp (App+Step), Information/No Step
- Where
- 5 sites in United States
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
PrEP Adherence, Sexually Transmitted Infections (STIs)
STI Testing to Enhance PrEP Use in Pregnancy
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy.
- Conditions
- PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
- Trial name
- STEP-UP (NCT06919614)
- Testing
- Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
- Where
- Botswana
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Botswana Harvard AIDS Institute Partnership