Clinical trials: PrEP, open to volunteers
Gonorrhea Female, Chlamydia Females
The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
Globally, new HIV infections are concentrated in eastern and southern Africa where the infections are largely acquired by women outside of known key populations.
- Conditions
- Gonorrhea Female, Chlamydia Females, Syphilis Female, Trichomonas Vaginalis
- Trial name
- IN-STEP (NCT06743204)
- Testing
- Self-Reported Risk Screening for PrEP and Diagnostic STI testing, Self-reported risk screening for PrEP and syndromic management for STIs
- Where
- Uganda
- Volunteers
- 5,560 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Drug Use Disorders, PrEP Uptake
Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP).
- Conditions
- Drug Use Disorders, PrEP Uptake, PrEP Adherence, HIV Risk Behavior
- Trial name
- NCT07281378
- Testing
- Tailored Positive Affect Intervention, Contingency Management
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Florida
Anal Cancer, Squamous Intraepithelial Lesions
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV.
- Conditions
- Anal Cancer, Squamous Intraepithelial Lesions, HSIL, High Grade Squamous Intraepithelial Lesions, LSIL, Low-Grade Squamous Intraepithelial Lesions
- Trial name
- SCOPE (NCT07029152)
- Testing
- Anal smear, Self-administered questionnaire, EQ-5D-5L questionnaire
- Where
- 8 sites in Belgium
- Volunteers
- 296 people
- Sponsor
- Universitair Ziekenhuis Brussel
HIV Prevention, Latino Men Who Have Sex With Men
PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men
This type 3 Hybrid Effectiveness-Implementation study will evaluate PrEP \& Soccer, a multicomponent and multilevel implementation strategy delivered by a pharmacy chain to increase PrEP knowledge and initial PrEP appointment…
- Conditions
- HIV Prevention, Latino Men Who Have Sex With Men, Pharmacy
- Trial name
- NCT07263048
- Testing
- PrEP & Soccer PrEP Navigation, CVS Health brochure
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- University of Miami
Major Depressive Disorder in Patients Taking PrEP
Mental Health and PreP
According to ANSM, by June 2023, almost 85,000 people living in France had initiated medical monitoring for HIV PrEP since 2016.
- Trial name
- SAM-P (NCT06944691)
- Testing
- Major depressive disorder scale
- Volunteers
- 600 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HIV Prevention
Pharmacies in HIV Prevention: Fellowship, Fundamentals, and Sustainable Finances
Quantify the impact of an online Virtual Community of Practice (VCoP) to increase pharmacist knowledge and accelerate provision of pre-exposure prophylaxis (PrEP) for HIV prevention.
- Trial name
- NCT07829250
- Testing
- Virtual Community of Practice, Enhanced Standard of Care
- Volunteers
- 500 people
- Sponsor
- University of Washington
Medication Adherence, HIV/AIDS
A Mobile Gaming App to Improve Adherence to PrEP
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi.
- Trial name
- NCT05762705
- Testing
- Multilevel Gaming Adherence Intervention, Treatment as Usual +
- Where
- 3 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
HIV Prevention
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with…
- Trial name
- PICASSO (NCT06485154)
- Testing
- TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
- Where
- 3 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- University of Witwatersrand, South Africa
HIV
Decision Support Tool to Integrate PrEP Into Emergency Departments
This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent…
- Trial name
- NCT07279129
- Testing
- Decision support tool, PrEP Delivery
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- George Washington University
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
HIV Infection, Sexually Transmitted Infection
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men
- Trial name
- NCT07658976
- Testing
- HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package
- Where
- 5 sites in United States, Argentina and 2 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Pre-Exposure Prophylaxis (PrEP), HIV Prevention
A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)
People using HIV self-testing (HIVST) need access to quality HIV-prevention programming, including education and exploration of pre-exposure prophylaxis (PrEP) - an effective biomedical prevention tool that continues to expand in…
- Trial name
- DASH (NCT07614165)
- Testing
- PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- University of Michigan
HIV
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the…
- Trial name
- ALIGN (NCT07390409)
- Testing
- Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- South Africa
- Volunteers
- 3,700 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
HIV Infection Primary, Hepatitis, Viral, Human
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other…
- Conditions
- HIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and Hepatitis
- Trial name
- SeVIHPrEP (NCT05492565)
- Testing
- Tenofovir Disoproxil Fumarate 300 MG Oral Tablet
- Where
- Spain
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Hospitales Universitarios Virgen del Rocío
HIV Infections, Contraception
DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics.
- Conditions
- HIV Infections, Contraception, PrEP
- Trial name
- DYNAMIC PrEP (NCT07597824)
- Testing
- Observational cohort (PrEP use in real-world settings)
- Where
- Botswana
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
HIV, Contingency Management
J-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV Services Among Justice-involved Black Men Who Have Sex With Men and Other Key Populations
The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system.
- Conditions
- HIV, Contingency Management, Justice Involved Populations, Status Neutral Interventions
- Trial name
- J-RISE (NCT06477588)
- Testing
- Health Navigation, Health Navigation, Employment Navigation plus Contingency Management Intervention
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV Prevention, HIV Related Stigma
Evaluation of mHealth Intervention to Promote HIV Prevention and Overcome Stigma Among Transgender Women (EMPOW.HER)
This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand.
- Conditions
- HIV Prevention, HIV Related Stigma, PrEP Adherence
- Trial name
- NCT07509827
- Testing
- Mobile Healthy Choices (mHC)+SPC, FRESH + SPC, mHC + FRESH + SPC
- Where
- 3 sites in Thailand
- Volunteers
- 108 people
- Sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
Colorectal Neoplasms, Surgery
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy…
- Trial name
- TESEO (NCT05148494)
- Testing
- Fleet Enema, Pico-Salax
- Where
- Canada
- Volunteers
- 66 people
- Sponsor
- Nova Scotia Health Authority
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Prevention
Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program
Though broadening PrEP (Pre-Exposure Prophylaxis) availability to Louisiana pharmacies addresses key access issues for Louisiana's population, there is no current baseline data which explore current pharmacist and pharmacies'…
- Trial name
- NCT06530225
- Testing
- Education and Mentoring for Prescribing Pharmacists
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Xavier University of Louisiana.