Clinical trials: in Malawi
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
HIV/AIDS
Video-Intervention to Inspire Treatment Adherence for Life for Adolescents
This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and…
- Trial name
- VS4A (NCT07064785)
- Testing
- Video-based ART adherence counseling, Standard of Care (SOC)
- Where
- 32 sites in Malawi
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
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
Intimate Partner Violence (IPV), Earning Outcomes
What Works to Prevent Violence - Malawi Moyo Olemekeza
Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote…
- Conditions
- Intimate Partner Violence (IPV), Earning Outcomes, Norms, Social
- Trial name
- WW-M-MO (NCT07502183)
- Testing
- SASA! Together, MO
- Where
- Malawi
- Volunteers
- 1,700 people
- Sponsor
- George Washington University
HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health
Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants.
- Conditions
- HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health, Depression During Pregnancy, PMTCT
- Trial name
- NCT06659315
- Testing
- Couples Problem Solving Therapy
- Where
- Malawi
- Volunteers
- 180 people
- Sponsor
- University of California, San Francisco
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
Dysbiosis, Inflammation Gum
Microbiome Alterations With Xylitol (MAX) in Pregnancy
The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation…
- Conditions
- Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications, Microbioata
- Trial name
- MAX (NCT06329596)
- Testing
- Xylitol gum, Sorbitol gum
- Where
- Malawi
- Volunteers
- 80 people
- Sponsor
- Baylor College of Medicine
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: The PERSIST Trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis…
- Trial name
- NCT07221747
- Testing
- Standard of Care (SoC), Enhanced continuation support package
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Malaria, Malaria Vaccines
A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa
The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been introduced.
- Trial name
- EPI-MAL-003 (NCT03855995)
- Testing
- Whole blood sample
- Where
- 6 sites in Ghana, Kenya and 1 more
- Volunteers
- 77,953 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Low Birthweight, Preterm Birth
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package: Implementation Research
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) aims to improve feeding and growth outcomes among low birthweight (LBW; <2.5kg) or preterm (<37 weeks gestational age) infants admitted to…
- Trial name
- LIFT-UP (NCT06390943)
- Testing
- Facility-based feeding support package plus (FB-FSP+), Transition-to-home feeding support package plus (TTH-FSP+)
- Where
- 5 sites in India, Malawi and 1 more
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
HIV, Prevention
Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the…
- Conditions
- HIV, Prevention, Pregnancy
- Trial name
- NCT06435026
- Testing
- FTC/TDF 200mg/300mg, FTC/TDF 300mg/450mg, FTC/TDF 400mg/600mg
- Where
- 2 sites in Malawi, Zimbabwe
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Intimate Partner Violence (IPV), Norms, Social
What Works - Malawi SASA! Together
Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote…
- Conditions
- Intimate Partner Violence (IPV), Norms, Social, Gender Inequitable Behavior
- Trial name
- WW-M-SASA! (NCT06783400)
- Testing
- SASA! Together
- Where
- Malawi
- Volunteers
- 4,800 people, healthy volunteers welcome
- Sponsor
- George Washington University
Kaposi Sarcoma, HIV
Kaposi Sarcoma Chemotherapy and Research (KS-CARE)
This prospective, nonrandomized, open-label, single-arm, cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed HIV-associated Kaposi Sarcoma (HIV-KS).
- Trial name
- KS-CARE (NCT06480773)
- Testing
- standard of care chemotherapy
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 127 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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
HIV
DSD Models at Malawi Sentinel Sites (SENTINEL 2-Malawi)
To achieve global goals for the treatment of HIV, many countries are piloting and scaling up differentiated service delivery models (DSD).
- Trial name
- SENTINEL2MW (NCT05901727)
- Testing
- No intervention
- Where
- Malawi
- Volunteers
- 15,520 people
- Sponsor
- Boston University
Tuberculosis
Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
- Trial name
- CoVPN3008TB (NCT06585683)
- Testing
- Clinical Evaluation at Day 4, Laboratory Evaluation at Day 4, Clinical Evaluation at week 26
- Where
- 41 sites in Botswana, Eswatini and 5 more
- Volunteers
- 5,694 people
- Sponsor
- COVID-19 Prevention Network
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
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
Malaria, Malaria Vaccine, Insecticide-treated Bednets
RTSS Vaccine and PBO Net Impact on Malaria Infection and Transmission in Malawi
The overall goal of this study is to assess the impact of RTS,S (malaria) vaccination and PBO nets on malaria infection and transmission, independently and how they interact when they are introduced together.
- Trial name
- RTSS/PBO (NCT04327440)
- Testing
- RTS,S/AS01 malaria vaccine, PBO bed nets
- Where
- Malawi
- Volunteers
- 1,691 people, healthy volunteers welcome
- Sponsor
- Michigan State University
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