Clinical trials: in Haiti
Tuberculosis
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB).
- Trial name
- NCT07124559
- Testing
- Rifapentine, Isoniazid, Dolutegravir
- Where
- 11 sites in Botswana, Haiti and 4 more
- Volunteers
- 144 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary Tuberculosis
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary…
- Trial name
- RAD-TB (NCT06192160)
- Testing
- Isoniazid, Rifampicin, Pyrazinamide
- Where
- 30 sites in Botswana, Brazil and 12 more
- Volunteers
- 315 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Pulmonary, Tuberculosis Infection
Short-course Regimens for the Treatment of Pulmonary Tuberculosis
The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as…
- Trial name
- CRUSH-TB (NCT05766267)
- Testing
- Rifabutin, Delamanid, Bedaquiline
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 288 people
- Sponsor
- Centers for Disease Control and Prevention
HIV Infection
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among…
- Trial name
- NCT02140255
- Testing
- Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r)
- Where
- 47 sites in United States, Argentina and 11 more
- Volunteers
- 1,120 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome.
- Trial name
- NCT07595042
- Testing
- Isoniazid, Rifampin, Pyrazinamide
- Where
- 29 sites in Argentina, Australia and 14 more
- Volunteers
- 900 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Pulmonary, HIV
Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis
The PRESCIENT trial is a Phase IIc, open-label, randomized trial that compared a 12-week regimen of bedaquiline (BDQ), clofazimine (CFZ), pyrazinamide (PZA), and delamanid (DLM) with standard treatment for drug-susceptible…
- Trial name
- PRESCIENT (NCT05556746)
- Testing
- Bedaquiline (BDQ), Clofazimine (CFZ), Pyrazinamide (PZA)
- Where
- 2 sites in Haiti, South Africa
- Volunteers
- 94 people
- Sponsor
- Brigham and Women's Hospital
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Tuberculosis
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB).
- Trial name
- NCT04311502
- Testing
- Rifapentine, Rifampicin, Isoniazid
- Where
- 6 sites in Haiti, India and 3 more
- Volunteers
- 104 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial
This phase IV trial compares 3 different dosing schedules to find the optimal number of doses for HPV vaccination in children and adolescents living with HIV.
- Trial name
- OPTIMO (NCT04265950)
- Testing
- Recombinant Human Papillomavirus Nonavalent Vaccine
- Where
- 3 sites in Brazil, Haiti and 1 more
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Malnutrition, Child, Development, Child
Grandi Byen: Test of an Integrated Parenting and Nutrition Intervention
The premise of this trial is that a combined nutrition (eggs) and parenting behavior intervention (responsive parenting combined with the reinforcement of animal source foods and improved WASH) will synergistically result in…
- Conditions
- Malnutrition, Child, Development, Child, Parenting
- Trial name
- NCT04785352
- Testing
- Nutrition Intervention, Grandi Byen
- Where
- Haiti
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Latent Tuberculosis
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care…
- Trial name
- ASTERoiD (NCT03474029)
- Testing
- Rifapentine daily for 6 weeks, Rifapentine and Isoniazid weekly for 12 weeks, Rifampin and Isoniazid daily for 12 weeks
- Where
- 21 sites in United States, Australia and 6 more
- Volunteers
- 3,400 people
- Sponsor
- Centers for Disease Control and Prevention
Hypertension, Diabetes
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Investigators will establish a longitudinal cohort of ~3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease…
- Conditions
- Hypertension, Diabetes, Obesity, Kidney Diseases
- Trial name
- NCT03892265
- Testing
- Observational Study
- Where
- Haiti
- Volunteers
- 3,005 people
- Sponsor
- Weill Medical College of Cornell University
HIV Infection
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure.
- Trial name
- NCT05154513
- Testing
- Cohort 1
- Where
- 28 sites in United States, Botswana and 9 more
- Volunteers
- 163 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Heart Failure
Haiti Community Health Workers (CHW) Adaptation
Evidence-based interventions to improve linkage and outcomes for heart failure (HF) patients requires input from stakeholders: patients, community health workers (CHWs), healthcare staff, and health system administrators.
- Trial name
- NCT05091710
- Testing
- HF follow up care, HF Standard of Care (SOC)
- Where
- Haiti
- Volunteers
- 30 people
- Sponsor
- Boston Medical Center
HIV, Cardiovascular Diseases
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).
- Trial name
- REPRIEVE (NCT02344290)
- Testing
- Pitavastatin
- Where
- 137 sites in United States, Botswana and 11 more
- Volunteers
- 7,769 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Telemedicine, Pediatrics
Improving Nighttime Access to Care and Treatment; Part 4-Haiti
Children in resource-limited settings who develop illness at night are often isolated from care, resulting in progression to an emergency.
- Trial name
- INACT4-H (NCT05480930)
- Testing
- paper-based clinical decision support (dCDS) tool, digital clinical decision support (dCDS) tool
- Where
- Haiti
- Volunteers
- 7,124 people
- Sponsor
- University of Florida
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Violence by Teachers
Preventing Violence by Teachers in Primary Schools in Haiti
Violence has severe and long-lasting negative consequences for children's and adolescents' well-being and academic functioning, which can hinder communities' and societies' economic growth.
- Trial name
- ICC-T_HAITI (NCT05081622)
- Testing
- Interaction Competencies with Children - for Teachers (ICC-T)
- Where
- Haiti
- Volunteers
- 1,064 people, healthy volunteers welcome
- Sponsor
- Bielefeld University
Tuberculosis
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB).
- Trial name
- S31/A5349 (NCT02410772)
- Testing
- rifapentine, rifapentine and moxifloxacin, control
- Where
- 33 sites in United States, Brazil and 11 more
- Volunteers
- 2,516 people
- Sponsor
- Centers for Disease Control and Prevention