Clinical trials: Pre-exposure Prophylaxis
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 Testing, Intention
HST for Female Sex Workers/Drug Users in Kazakhstan
The goal of this behavioral intervention clinical trial is to assess acceptability, feasibility, and preliminary efficacy of a 4-session intervention to increase consistent HIV testing and linkage to care and prevention among HIV…
- Trial name
- AEGIDA (NCT06150937)
- Testing
- AEGIDA intervention arm, AEGIDA control arm
- Where
- Kazakhstan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- City University of New York
HIV-1-infection
PrEPsmart 2-1-1 Pilot
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.
- Trial name
- NCT06631365
- Testing
- PrEPsmart mobile app, Truvada
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV
Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples in Tanzania
This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling…
- Trial name
- DDCP (NCT03098693)
- Testing
- HIV Self-Testing, Immediate Access to ART for HIV infected couple members, Access to PrEP for HIV uninfected couple members
- Where
- Tanzania
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Unsafe Sex, Risk-Taking
Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)
The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and…
- Trial name
- DOXYVAC (NCT04597424)
- Testing
- Experimental: doxycycline, Bexsero® vaccine
- Where
- 9 sites in France
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Pre-exposure Prophylaxis, HIV-1-infection
Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV
This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.
- Trial name
- NCT03226873
- Testing
- Peer Navigation
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
HIV Prevention
Study for IFE4PrEP Intervention on PrEP Uptake by Southern African American Women
Purpose: This study is partnering with communities to identify the best ways to provide HIV prevention communication and services for women living in public housing who have been disproportionately affected by HIV but underserved…
- Trial name
- IFE4PrEP (NCT05087927)
- Testing
- Gain framing plus demographically targeted photos, Loss framing plus demographically targeted photos, Gain framing plus not demographically targeted photos
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Pre-Exposure Prophylaxis
Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers
The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to investigate a strategy for probenecid "boosting" in the setting of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for HIV…
- Trial name
- NCT03202511
- Testing
- Probenecid Oral Tablet, Tenofovir disoproxil fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Indiana University
Recreational Drug Use
Chemsex Engagement and HIV Biomedical Prevention in MSM
HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk.
- Trial name
- NCT05031832
- Testing
- HIV test
- Where
- Hong Kong
- Volunteers
- 733 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
PrEP, HIV
HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy
The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail.
- Conditions
- PrEP, HIV, Incarceration
- Trial name
- Hotspot (NCT06919419)
- Testing
- Multicomponent strategy
- Where
- United States
- Volunteers
- 3,600 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial
Alignment of PrEP Use With HIV Risk in Young Women and Men
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs.
- Conditions
- Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial, HIV Infections
- Trial name
- NCT04664998
- Testing
- Daily oral PrEP
- Where
- Uganda
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Prevention
The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to…
- Trial name
- NCT04048551
- Testing
- Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum, Young Women's Health CoOp (YWHC)
- Where
- South Africa
- Volunteers
- 802 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV Infections
Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention
Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination.
- Trial name
- IMPERATIVE (NCT06370923)
- Testing
- Peer Distribution, Community Health Worker Distribution
- Where
- Zimbabwe
- Volunteers
- 3,591 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Gonorrhea, Chlamydia
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including…
- Conditions
- Gonorrhea, Chlamydia, Syphilis
- Trial name
- NCT03980223
- Testing
- Doxycycline Hyclate Delayed-Release 200 mg
- Where
- 3 sites in United States
- Volunteers
- 641 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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 Infections, Sexually Transmitted Diseases
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic.
- Trial name
- PCORI PrEP (NCT04855773)
- Testing
- PrEPmate, Dot Diary
- Where
- 4 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, 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, HIV Infection Primary
Intervention to Enhance PrEP Persistence
The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care.
- Trial name
- NCT06872307
- Testing
- RAMP-It-Up Initiation, Adherence, and Retention Intervention
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Brown University
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences