Clinical trials: in Malawi
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
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
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 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
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Coinfection
HIV And Parasitic Infection (HAPI) Study
The overall goal of this study is to determine if periodic de-worming of persons living with HIV in intestinal parasite-endemic regions will lead to decreased morbidity and mortality associated with HIV by reducing immune…
- Trial name
- HAPI (NCT05323396)
- Testing
- Antiparasitic medication
- Where
- Malawi
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Low Birthweight, Pre-Term
Low-birthweight Infant Feeding Exploration
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs).
- Trial name
- LIFE (NCT04002908)
- Where
- 3 sites in India, Malawi and 1 more
- Volunteers
- 3,188 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
HIV Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus
Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness
Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV…
- Trial name
- PRACTICE (NCT05343390)
- Testing
- Enhanced implementation package, Standard implementation package
- Where
- 33 sites in Malawi
- Volunteers
- 841 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV/AIDS, Alcohol Abuse
An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.
- Trial name
- NCT04906616
- Testing
- Mlambe
- Where
- Malawi
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV/AIDS
VITAL Start: Brief Facility-based Video Intervention
This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize…
- Trial name
- VITAL (NCT03654898)
- Testing
- VITAL Start: Video-based pre-ART counseling, Standard of Care
- Where
- Malawi
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
HIV Infections, Sexually Transmitted Infections
Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections
The intervention includes provision of transport reimbursement for men who will undergo voluntary medical male circumcision (VMMC), intensified health education by a VMMC mobilizer and a male and female VMMC champion and use of a…
- Trial name
- VMMC-RITe (NCT04677374)
- Testing
- Standard of care, Intensified Health Education, SMS/telephonic Tracing
- Where
- Malawi
- Volunteers
- 2,242 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.
- Trial name
- NCT04140266
- Testing
- Dapivirine (DPV) Vaginal Ring (VR)-004, Truvada Tablet
- Where
- 4 sites in Malawi, South Africa and 2 more
- Volunteers
- 394 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rotavirus Infections
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
- Trial name
- NCT03483116
- Testing
- RV3-BB
- Where
- Malawi
- Volunteers
- 711 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute