Clinical trials: Human Immunodeficiency Virus Exposure
HIV
Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South…
- Trial name
- NCT02043015
- Testing
- Condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT)
- Where
- 3 sites in United States, South Africa
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Infections
The Women TAF-FTC Benchmark Study
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure…
- Trial name
- NCT05140954
- Testing
- co-formulated 25mg TAF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Prevention
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
- Trial name
- NCT04558554
- Testing
- pharmacy-based PrEP delivery
- Where
- 2 sites in Kenya
- Volunteers
- 1,216 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young…
- Trial name
- Masibambane (NCT04833127)
- Testing
- Gender-Enhanced -- Masibambane, Individually accessed
- Where
- South Africa
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
HIV-1-infection, Methamphetamine-dependence
Effect of Methamphetamine on Residual Latent HIV Disease Study
The most commonly used illicit stimulant in HIV-infected individuals is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation.
- Trial name
- EMRLHD (NCT03825536)
- Testing
- Oral Methamphetamine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Francisco
HIV, Pre-exposure Prophylaxis
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM).
- Trial name
- NCT04426656
- Testing
- Phone application
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Adherence, Medication, Risk Behavior
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies.
- Conditions
- Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
- Trial name
- NCT03387462
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Hiv
PK of TAF and TDF for PrEP in Pregnant and Postpartum Women
This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum.
- Trial name
- PrEP-PP PK (NCT04937881)
- Testing
- Tenofovir alafenamide, Tenofovir Disoproxil Fumarate
- Where
- South Africa
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Adherence, Patient, Pre-Exposure Prophylaxis
mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual…
- Conditions
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- Trial name
- P3-T (NCT04413708)
- Testing
- P3-T PrEP Adherence App
- Where
- Thailand
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Prevention
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil.
- Trial name
- PRISM Brazil (NCT04114955)
- Testing
- Manas por Manas
- Where
- 2 sites in Brazil
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Prevention, Transgender Health
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be…
- Trial name
- I-BrEATHe (NCT04050371)
- Testing
- 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV/AIDS, Pre-exposure Prophylaxis
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
Our proposed study will: provide a novel exploration of facilitators and barriers to PrEP; allow us to target hard to reach populations, including men who have sex with men (MSM) and substance users (both of which are top funding…
- Trial name
- NCT04064567
- Testing
- PrEP-LINK, Enhanced Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
HIV Infections
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa).
- Trial name
- NCT00625404
- Testing
- Truvada
- Where
- 4 sites in Kenya, South Africa and 1 more
- Volunteers
- 2,120 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Exposure, HIV Infection
Early Versus Delayed BCG Vaccination of HIV-exposed Infants
In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries.
- Trial name
- NCT02062580
- Testing
- BCG
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
HIV-I Infection
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain…
- Trial name
- PrEP-PP (NCT03902418)
- Testing
- emtricitabine/tenofovir
- Where
- South Africa
- Volunteers
- 1,195 people
- Sponsor
- University of California, Los Angeles
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
Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission
The OPENS Trial: Offering Women PrEP (Aim 2)
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel…
- Conditions
- Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
- Trial name
- NCT05619497
- Testing
- Clinic-wide Trainings, Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)
- Where
- United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV/AIDS
Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya.
- Trial name
- PrIYA-SP (NCT03875950)
- Testing
- Clinician training intervention
- Where
- Kenya
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Washington