Clinical trials: completed, in Malawi
Tuberculosis, HIV Coinfection
Closing -TB GAPs - for People Living With HIV: TB Guidance for Adaptable Patient-Centered Service
Tuberculosis (TB) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (PLHIV).
- Conditions
- Tuberculosis, HIV Coinfection, Tuberculosis Infection
- Trial name
- TB_GAPS (NCT05342064)
- Testing
- patient-centered TB preventive therapy, TB preventive therapy adherence support
- Where
- 5 sites in Eswatini, Lesotho and 3 more
- Volunteers
- 5,733 people
- Sponsor
- Baylor College of Medicine
AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia
HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV
This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV.
- Conditions
- AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia, HIV Infection
- Trial name
- COVENANT (NCT03284866)
- Testing
- Laboratory Biomarker Analysis, Recombinant Human Papillomavirus Nonavalent Vaccine, Saline
- Where
- 6 sites in Kenya, Malawi and 3 more
- Volunteers
- 535 people
- Sponsor
- AIDS Malignancy Consortium
Moderate Acute Malnutrition
Choline to Prevent SAM in Children With MAM
The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is: Will provision of RUSF with added choline (500mg/day) throughout…
- Trial name
- CHOP-MAM (NCT06214897)
- Testing
- C-RUSF (Ready-to-use Supplemental Food with added Choline), S-RUSF (Ready-to-use Supplemental Food without added Choline)
- Where
- 10 sites in Malawi
- Volunteers
- 1,515 people
- Sponsor
- Washington University School of Medicine
Depression, Anxiety
HIV Engagement and Adolescent Depression Support (HEADS-UP)
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention.
- Conditions
- Depression, Anxiety, Adolescent Behavior, HIV Infections
- Trial name
- HEADS-UP (NCT06173544)
- Testing
- Standard of Care (SOC), Adapted Friendship Bench (AFB), Enhanced Friendship Bench (EFB)
- Where
- 5 sites in Malawi
- Volunteers
- 106 people
- Sponsor
- University of North Carolina, Chapel Hill
Psychosis
Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation
The overall aim of the proposed study is to determine the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted nurse-led, community-based rehabilitation treatment model for community-dwelling…
- Trial name
- ENHANCE (NCT06080477)
- Testing
- Enhanced Usual Care, Adapted ENHANCE Intervention
- Where
- Malawi
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Opportunistic Infections, HIV-Related, Cryptococcal Infections
Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi
This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral…
- Conditions
- Opportunistic Infections, HIV-Related, Cryptococcal Infections, AIDS With Tuberculosis, AIDS-related Kaposi Sarcoma
- Trial name
- NCT05510973
- Testing
- Enhanced package for AHD care
- Where
- 13 sites in Malawi
- Volunteers
- 700 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
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
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
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-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
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
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
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
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)
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 Chicago
HIV Infections
Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit
HIV testing uptake among male partners of pregnant women remains low. But the optimal way to engage the male partners is unknown.
- Trial name
- NCT07488221
- Testing
- Partner Notification Slip plus HIV Self-test kit, Partner Notification Slip only
- Where
- Malawi
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Depressive Disorder
Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform
Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS.
- Trial name
- IC3D (NCT04777006)
- Testing
- Problem Management Plus, Antidepressant Therapy
- Where
- Malawi
- Volunteers
- 487 people
- Sponsor
- RAND
Schizophrenia, Schizoaffective Disorder
SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities
Although psychotic disorders typically affect less than 1% of the population, they are a significant cause of disability worldwide.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizotypal Disorder, Acute and Transient Psychotic Disorder
- Trial name
- SUCCEED (NCT06007105)
- Testing
- SUCCEED Community-Based Intervention
- Where
- 4 sites in Malawi, Nigeria and 2 more
- Volunteers
- 425 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Blood Donation
Enhancing Blood Donation at Schools and Beyond in Malawi
First developed in Zimbabwe, Club 25 is an initiative to promote blood donation among young people, who present a low-risk population for the spread of transfusion transmissible infections (TTIs).
- Trial name
- NCT06138899
- Testing
- Club 25
- Where
- Malawi
- Volunteers
- 35,516 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
SARS-CoV-2 Infection, HIV Infections
Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with…
- Conditions
- SARS-CoV-2 Infection, HIV Infections, COVID-19
- Trial name
- CoVPN3008 (NCT05168813)
- Testing
- Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose
- Where
- 47 sites in Botswana, Eswatini and 5 more
- Volunteers
- 14,237 people
- Sponsor
- COVID-19 Prevention Network