Clinical trials: Pre-Exposure Prophylaxis of HIV Infection
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
GonoScreen: Efficacy of Screening STIs in MSM
A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs.
- Trial name
- GonoScreen (NCT04269434)
- Testing
- No Screening
- Where
- 5 sites in Belgium
- Volunteers
- 1,014 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
HIV Infections, STI
EASY-TESTS: Evaluation of the Acceptability of Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex With Men (MSM) Who Accepted Targeted HIV/STI Testing, Recruited Through a Community-based Outreach Approach, Both Digital and In-person.
Acceptability of a PrEP program among MSM and TG visiting a geolocated community application or a community physical place of sociability and having accepted a targeted screening for HIV, Hepatitis B, C and STIs.
- Trial name
- EASY-TESTS (NCT05949814)
- Testing
- acceptability of a PrEP program among HIV-negative MSM and TG
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Centre de santé sexuelle Le 190
HIV, Prevention
Implementation of PrEP to HIV in Brazilian Transgender Women
Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining the informed consent and confirmation of eligibility within 45 days after the screening visit.
- Trial name
- PrEParadas (NCT03220152)
- Testing
- emtricitabine / tenofovir 200/300 mg
- Where
- Brazil
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,998 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Pre-Exposure Prophylaxis, HIV Infections
Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- PrEPARE (NCT05482360)
- Testing
- PrEP Optimization Interventions
- Where
- Kenya
- Volunteers
- 5,173 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pharmacokinetic Study in Healthy Volunteers
Single Dose Truvada in HIV-negative Men and Women
This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®.
- Trial name
- TAIL (NCT01326221)
- Testing
- tenofovir + emtricitabine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV
A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention
The clinical study will evaluate the feasibility and acceptability of a culturally tailored behavioral intervention to improve uptake of pre-exposure prophylaxis for HIV prevention among at-risk Latino men who have sex with men.
- Trial name
- NCT05434390
- Testing
- Estoy PrEParado/ I am PrEPared intervention, Usual Care
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Drug Interaction
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among…
- Trial name
- NCT04590417
- Testing
- Estradiol valerate 2 mg, cyproterone acetate 25 mg
- Where
- Thailand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre
HIV Prevention, Conception
Safer Conception for Women - Understanding Use of Periconception PrEP
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk.
- Trial name
- NCT03194308
- Testing
- PrEP for Safer Conception
- Where
- South Africa
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV/AIDS
The Prevention Options for Women Evaluation Research (POWER) Cohort
The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
- Trial name
- NCT03490058
- Testing
- Truvada
- Where
- 3 sites in Kenya, South Africa
- Volunteers
- 2,255 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV
Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting
This is an open-label, single center study to evaluate implementation of a pharmacist-managed delivery of L4P in a community pharmacy setting and the impact of twice-yearly vs. quarterly PrEP visits on STI rates.
- Trial name
- L4PinPharm (NCT07210125)
- Testing
- Lenacapavir long-acting, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Kelley-Ross & Associates, Inc.
HIV Infection
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
This study will evaluate the safety and acceptability of intermittent and daily pre-exposure prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV discordant couples, and it will directly…
- Trial name
- NCT00931346
- Testing
- FTC/TDF
- Where
- Uganda
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
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
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, Contraception
Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP
This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA.
- Trial name
- DynamoPrEP (NCT03197961)
- Testing
- tenofovir/emtricitabine, DMPA
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Sharon Achilles
HIV Prevention, Pre-exposure Prophylaxis
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the…
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis, STI
- Trial name
- HOT4PrEP (NCT05856942)
- Testing
- Health service - home-based PrEP monitoring
- Where
- United States
- Volunteers
- 458 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa
This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either…
- Trial name
- AXIS (NCT06138600)
- Testing
- Cabotegravir Injection [Apretude], Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
HIV/AIDS, Sexually Transmitted Diseases
Comparison of Men's Prevention Apps to Research Efficacy
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP…
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
- Trial name
- COMPARE (NCT03965221)
- Testing
- LYNX, MyChoices
- Where
- 8 sites in United States
- Volunteers
- 381 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Pre-Exposure Prophylaxis
HIV Pre-Exposure Prophylaxis Among an Unrecognized Sexual Minority Population
The Alternative Sexualities Health Research Alliance (TASHRA) will work collaboratively with Gilead Sciences, Inc. to study Pre-Exposure Prophylaxis (PrEP) uptake and adherence; levels of stigma around PrEP use; and changes in…
- Trial name
- PrEP4Kink (NCT05815030)
- Testing
- video informational/educational intervention
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- The Alternative Sexualities Health Research Alliance