Clinical trials: in Malawi
Alcohol Consumption, PrEP Uptake
Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Purpose: To evaluate short-term efficacy and implementation of Treat4All, an alcohol reduction evidence-based intervention, for decreasing heavy drinking and optimizing HIV outcomes (viral suppression among People with HIV (PWH)…
- Conditions
- Alcohol Consumption, PrEP Uptake, Recent Heavy Drinking, HIV Prevention
- Trial name
- Treat4All (NCT06668363)
- Testing
- Treat4All, Standard of care (control arm)
- Where
- Malawi
- Volunteers
- 130 people
- Sponsor
- University of North Carolina, Chapel Hill
SARS-CoV-2 Infection
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.
- Trial name
- SCORPIO-HR (NCT05305547)
- Testing
- S-217622
- Where
- 196 sites in United States, Argentina and 15 more
- Volunteers
- 2,093 people
- Sponsor
- Shionogi
HIV, Noncommunicable Diseases
UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO
This is an implementation research study that will adapt and pilot test the Transitional Of Care Model (TCM), originally conceived and developed in the USA, for targeted use as a post-discharge intervention for adults…
- Trial name
- MLATHO (NCT06931431)
- Testing
- Transition of Care Model (TCM)
- Where
- Malawi
- Volunteers
- 75 people
- Sponsor
- University of North Carolina, Chapel Hill
Prematurity, Neurodevelopmental Disorders
Prevention of Developmental Delay and Xylitol (PDDaX) Study
The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as…
- Trial name
- NCT05361122
- Testing
- Maternal Use of Xylitol Chewing Gum During Pregnancy, No Maternal Xylitol Chewing Gum Use During Pregnancy
- Where
- Malawi
- Volunteers
- 1,000 people
- Sponsor
- University of Washington
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)
Kwashiorkor, Marasmus
Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition
The need for oral antibiotics as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not been studied in a prospective trial.
- Trial name
- NCT01000298
- Testing
- Amoxicillin, Cefdinir
- Where
- Malawi
- Volunteers
- 2,767 people
- Sponsor
- Washington University School of Medicine
HIV-1-infection
Pausing Antiretroviral Treatment Under Structured Evaluation
The main purpose of this study is to see if it is safe to give the study antibodies (3BNC117-LS-J and 10-1074-LS-J) by intravenous infusion to people with HIV (PWH), and to see if they cause any side effects.
- Trial name
- PAUSE (NCT06031272)
- Testing
- 3BNC117-LS-J, 10-1074-LS-J
- Where
- 9 sites in Botswana, Malawi and 1 more
- Volunteers
- 32 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Severe Acute Malnutrition, Cognitive Impairment
Choline to Improve Malnutrition and Enhance Cognition
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi.
- Conditions
- Severe Acute Malnutrition, Cognitive Impairment, Wasting, Kwashiorkor
- Trial name
- CHIME-SAM (NCT06154174)
- Testing
- C-RUTF (Ready-to-Use Therapeutic Food with added choline), S-RUTF (Ready-to-Use Therapeutic Food without added choline), Amoxicillin
- Where
- 10 sites in Malawi
- Volunteers
- 1,500 people
- Sponsor
- Washington University School of Medicine
Cervical Cancer Prevention
Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention
The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are: 1.
- Trial name
- NCT07015957
- Testing
- In-person training, Virtual training, Coaching
- Where
- Malawi
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- New York University
Multicentric Castleman Disease
Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi
The purpose of this study is to determine the safety and efficacy of first-line, risk-stratified Rituximab-based Multicentric Castleman Disease (MCD) treatment in Malawi in a single-arm, phase II clinical trial.
- Trial name
- NCT04585893
- Testing
- Rituximab, Etoposide
- Where
- Malawi
- Volunteers
- 15 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Malaria,Falciparum, Anemia in Children
Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP).
- Trial name
- NCT06083688
- Testing
- Dihydroartemisinin-Piperaquine, Chloroquine, Sulfadoxine-pyrimethamine-amodiaquine
- Where
- Malawi
- Volunteers
- 788 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
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
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Gonococcal Infection
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero.
- Trial name
- NCT04350138
- Testing
- Meningococcal Group B Vaccine
- Where
- 13 sites in United States, Malawi and 1 more
- Volunteers
- 2,606 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Esophageal Cancer
Treatment Outcomes of Esophageal Cancer
This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC).
- Trial name
- NCT05177393
- Testing
- Assessment of patient-reported outcomes (PROs)
- Where
- 6 sites in Kenya, Malawi and 1 more
- Volunteers
- 2,476 people
- Sponsor
- University of California, San Francisco
Anxiety, Depression
Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi
The main objective of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health…
- Trial name
- ALIGN (NCT06399991)
- Testing
- Champion strategy, Adapted LOCI leadership and climate alignment strategy plus champion strategy
- Where
- 12 sites in Malawi
- Volunteers
- 1,080 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Acute Myeloid Leukaemia
Leukemia Adapted Protocol
In resource-constrained settings such as Malawi, survival rates for pediatric acute myeloid leukemia (AML) are dismally low compared to high-resource environments.
- Trial name
- LEAP (NCT06928909)
- Testing
- Intensity-adapted pediatric acute myeloid treatment guidelines
- Where
- Malawi
- Volunteers
- 30 people
- Sponsor
- Baylor College of Medicine
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Apnea Infant
Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes
A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BreathAlert, a low cost battery-powered monitor that detects and corrects apnea.
- Trial name
- NCT07704320
- Testing
- BreathAlert (low cost respiratory rate and apnea monitor)
- Where
- Malawi
- Volunteers
- 60 people
- Sponsor
- William Marsh Rice University
Major Depressive Disorder, Mild Neurocognitive Disorder
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with…
- Conditions
- Major Depressive Disorder, Mild Neurocognitive Disorder, HIV
- Trial name
- NCT06705478
- Testing
- Pramipexole ER, Escitalopram
- Where
- 41 sites in United States, Botswana and 12 more
- Volunteers
- 186 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Premature Birth
Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 antenatal clinics in Blantyre District, Malawi.
- Trial name
- NCT03673709
- Testing
- Antenatal Care
- Where
- 7 sites in Malawi
- Volunteers
- 1,887 people, healthy volunteers welcome
- Sponsor
- University of Illinois at Chicago