Clinical trials: open to volunteers, in Malawi
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
Female Genital Schistosomiasis
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
Female Genital Schistosomiasis (FGS) is a neglected complication of Schistosoma haematobium infection affecting an estimated 56 million women and girls globally, with a high burden in sub-Saharan Africa.
- Trial name
- WINGS-4-FGS (NCT07915518)
- Testing
- Praziquantel 80, Prednisolone, Diclofenac
- Where
- 4 sites in Côte d’Ivoire, Democratic Republic of the Congo and 2 more
- Volunteers
- 800 people
- Sponsor
- Brian Ngwira
Acute Conditions
Massive Online Open Validation and Evaluation of Large Language Models for Resource Constrained Settings - a Study of Contextual Awareness, Safety, and Accuracy
Healthcare settings in low and middle income countries, clinicians are frequently required to manage a wide range of acute conditions under the constraints of time pressure, limited diagnostic resources, and variable availability…
- Trial name
- SilentMOOVE (NCT07914140)
- Testing
- Non interventional study
- Where
- 4 sites in Kenya, Malawi and 1 more
- Volunteers
- 3,000 people
- Sponsor
- Ecole Polytechnique Fédérale de Lausanne
Malaria, Cerebral
DON in Pediatric Cerebral Malaria
The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria.
- Trial name
- NCT05478720
- Testing
- 6-diazo-5-oxo-L-norleucine (DON)
- Where
- 2 sites in Malawi
- Volunteers
- 152 people
- Sponsor
- Douglas Postels, MD, MS
Syphilis, Congenital
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with "all-risk" asymptomatic congenital syphilis.
- Trial name
- Cares-1 (NCT06921213)
- Testing
- Linezolid (LZD), Amoxicillin, Benzathine Penicillin G
- Where
- 3 sites in Indonesia, Malawi and 1 more
- Volunteers
- 90 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Sexually Transmitted Infection (STI), Gonorrhea
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
This study is for people who may get sexually transmitted infections (STIs). Approximately 580 African adolescent and young adult women ages 13-34 in Africa will be included in this study.
- Conditions
- Sexually Transmitted Infection (STI), Gonorrhea, Syphilis, Chlamydia
- Trial name
- NCT07884240
- Testing
- Doxycycline hyclate, Standard of Care for STI prevention
- Where
- 4 sites in Botswana, Eswatini and 2 more
- Volunteers
- 580 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Skin Ageing, Skin
Skin Type Determination Using Image Artificial Intelligence
Skin color, how easily a person burns or tans in the sun (skin phototype), and the amount of chronic sun damage in the skin are important factors in skin health.
- Trial name
- SPAI (NCT07765303)
- Testing
- Skin imaging and skin characteristic assessment
- Where
- 13 sites in Australia, Brazil and 9 more
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Region Skane
Breastfeeding, HIV Prevention
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among…
- Trial name
- LINK (NCT06506188)
- Testing
- LINK model
- Where
- Malawi
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Prevention
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to: 1. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing. 2.
- Trial name
- PAC-Man (NCT06493357)
- Testing
- PAC-Man, Standard of Care
- Where
- 3 sites in Malawi
- Volunteers
- 2,426 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Pneumonia, Pneumonia - Bacterial
Urine Pneumococcal Antigen Project
Background: Pneumonia caused by the bacteria Streptococcus pneumoniae is a leading cause of death among children under five years of age, especially in sub-Saharan Africa.
- Trial name
- UPAP (NCT07181200)
- Where
- Malawi
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Preterm Birth, Low Birthweight Neonate
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact…
- Conditions
- Preterm Birth, Low Birthweight Neonate, Periodontitis, Gingivitis
- Trial name
- XaPPP (NCT07424846)
- Testing
- Xylitol Chewing gum, Sorbitol chewing gum
- Where
- Malawi
- Volunteers
- 6,000 people
- Sponsor
- University of Washington
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)
HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
Persons living with HIV (PLWH) in sub-Saharan Africa (SSA), lymphadenopathy often portends one of a number of life-threatening diseases including tuberculosis, lymphoma, and multicentric Castleman disease (MCD).
- Conditions
- HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Trial name
- NCT07793006
- Testing
- Lymph Node or Core Needle Biopsy, Fine Needle Aspiration, Tiny Isothermal Nucleic acid Amplification System (TINY)
- Where
- Malawi
- Volunteers
- 500 people
- Sponsor
- Indiana University
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)
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
Postpartum Health, Infant Health
Group Postpartum and Well-Child Care for Maternal and Infant Health
The proposed study will evaluate the effectiveness of an integrated group postpartum and well-child care model, compared to individual (usual) postnatal and well-child care, on maternal and child health outcomes.
- Trial name
- NCT07414901
- Testing
- Group Care
- Where
- 16 sites in Malawi
- Volunteers
- 1,125 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University