Clinical trials: in Malawi
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
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
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
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
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 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
HIV-1-infection
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous…
- Trial name
- NCT04024488
- Testing
- Youth TI-CBT Intervention Arm, Youth Discussion Control Arm, Caregiver TI-CBT Intervention Arm
- Where
- 8 sites in Botswana, Malawi and 2 more
- Volunteers
- 484 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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
Human Immunodeficiency Virus 1 Positive, Skin Kaposi Sarcoma
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection.
- Trial name
- NCT03601806
- Testing
- Laboratory Biomarker Analysis, Pomalidomide
- Where
- 3 sites in Kenya, Malawi and 1 more
- Volunteers
- 26 people
- Sponsor
- AIDS Malignancy Consortium
HIV Infection
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if…
- Trial name
- NCT04860323
- Testing
- Analytical Treatment Interruption
- Where
- 11 sites in Botswana, Malawi and 2 more
- Volunteers
- 13 people
- Sponsor
- HIV Vaccine Trials Network
HIV Prevention
Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use…
- Trial name
- NCT06394323
- Testing
- Behavioral: My Choice for HIV Prevention (MyChoice)
- Where
- Malawi
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Helminthiasis, Filariasis
Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children…
- Trial name
- NCT03014167
- Testing
- Albendazole
- Where
- 3 sites in Benin, India and 1 more
- Volunteers
- 357,716 people, healthy volunteers welcome
- Sponsor
- University of Washington
SARS-CoV-2, COVID-19
Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Trial name
- NCT04403880
- Testing
- Sample collection
- Where
- 53 sites in United States, Malawi and 4 more
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT05480800
- Testing
- Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose, Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose, Typhoid conjugate vaccine (TCV) low dose
- Where
- 2 sites in Belgium, Malawi
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in…
- Trial name
- NCT03164564
- Testing
- Oral CAB, Oral TDF/FTC, CAB LA
- Where
- 20 sites in Botswana, Eswatini and 5 more
- Volunteers
- 3,224 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Early ART to Limit Infection and Establishment of Reservoir
The study was done to: Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1 See how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body…
- Trial name
- EARLIER (NCT02859558)
- Testing
- elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
- Where
- 30 sites in United States, Brazil and 4 more
- Volunteers
- 195 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections
Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy
The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.
- Trial name
- NCT03965923
- Testing
- Dapivirine (DPV) Vaginal Ring (VR), Truvada Tablet
- Where
- 4 sites in Malawi, South Africa and 2 more
- Volunteers
- 1,104 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HPV Infection, Cervical Cancer
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of…
- Conditions
- HPV Infection, Cervical Cancer, HIV Infections
- Trial name
- NCT04092257
- Testing
- VIA and thermocoagulation
- Where
- Malawi
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center