Clinical trials: in Mozambique
HIV-1-infection
Investigating the Optimal Management of Dolutegravir Resistance
The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen.
- Trial name
- NCT06762054
- Testing
- Continue DTG-based antiretroviral therapy, Enhanced adherence counselling
- Where
- 9 sites in Kenya, Lesotho and 2 more
- Volunteers
- 6,624 people
- Sponsor
- University of Nairobi
Malaria, Falciparum Malaria
Malaria Molecular Surveillance in Mozambique (Phase 2)
Mozambique is among the ten countries with the highest burden of malaria worldwide, with an estimated 10.3 million cases in 2021.
- Conditions
- Malaria, Falciparum Malaria, Malaria in Pregnancy
- Trial name
- GenMoz2 (NCT06529237)
- Testing
- LDH-based malaria rapid diagnostic test, Malaria rapid diagnostic test
- Where
- Mozambique
- Volunteers
- 18,750 people, healthy volunteers welcome
- Sponsor
- Centro de Investigacao em Saude de Manhica
Tuberculosis, Diagnostics
Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)
Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years.
- Conditions
- Tuberculosis, Diagnostics, Global Health
- Trial name
- NCT05989802
- Testing
- Oral swab molecular testing, Automated Cough Sound Analysis, Automated Lung Sound Analysis
- Where
- 3 sites in Mozambique, South Africa and 1 more
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tuberculosis in Children
Impact of an Innovative Childhood TB Diagnostic Approach Decentralized to District Hospital and Primary Health Care Levels on Childhood Tuberculosis Case Detection and Management in High Tuberculosis Incidence Countries (TB-Speed Decentralisation)
The TB-Speed Decentralisation study aims to increase childhood Tuberculosis (TB) case detection at district hospital (DH) and Primary health Care (PHC) levels using adapted and child-friendly specimen collection methods, i.e.
- Trial name
- NCT04038632
- Testing
- Decentralization of Childhood TB Diagnosis
- Where
- 59 sites in Cambodia, Cameroon and 4 more
- Volunteers
- 3,106 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Tuberculosis, HIV
Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV)
TB-Speed HIV is a prospective multicentre management study evaluating the safety and feasibility of the recently proposed PAANTHER TB treatment decision algorithm for HIV-infected children with presumptive TB.
- Trial name
- NCT04121026
- Testing
- External validation of the PAANTHER TB treatment decision algorithm
- Where
- 7 sites in Côte d’Ivoire, Mozambique and 2 more
- Volunteers
- 278 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Tuberculosis, Multidrug-Resistant
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less…
- Trial name
- NCT02354014
- Testing
- Bedaquiline (TMC207), Background Regimen (BR)
- Where
- 11 sites in Mozambique, Philippines and 4 more
- Volunteers
- 60 people
- Sponsor
- Janssen Research & Development, LLC
Infectious Disease, Febrile Illness
A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
The overall aim of the study is to provide evidence that introducing novel biomarkers evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and…
- Conditions
- Infectious Disease, Febrile Illness, Child, Only
- Trial name
- NCT06422338
- Testing
- IMCI-enhanced by suPAR levels (SoC + suPAR POC)
- Where
- 2 sites in Gabon, Mozambique
- Volunteers
- 5,212 people
- Sponsor
- Barcelona Institute for Global Health
Tuberculosis, Tuberculosis, Pulmonary
Shortened Regimen for Drug-susceptible TB in Children
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium Tuberculosis
- Trial name
- SMILE-TB (NCT06253715)
- Testing
- Isoniazid, Rifampin, Pyrazinamide
- Where
- 9 sites in India, Indonesia and 5 more
- Volunteers
- 860 people
- Sponsor
- Johns Hopkins University
Human Papillomavirus Infection
Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years
Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly…
- Trial name
- NCT06281119
- Testing
- Cervavac as three dose regimen, Cervavac as two dose regimen, Gardasil as three dose regimen
- Where
- 4 sites in Kenya, Mozambique and 1 more
- Volunteers
- 450 people
- Sponsor
- Serum Institute of India Pvt. Ltd.
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Preparing for Maternal GBS Vaccine Trials in Africa
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.
- Conditions
- Group B Streptococcus, Invasive Bacterial Diseases (IBD), Maternal Immunization
- Trial name
- PROTECT (NCT06833957)
- Where
- 10 sites in Kenya, Malawi and 2 more
- Volunteers
- 18,100 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Severe Malaria
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
- Trial name
- NCT04675931
- Testing
- Cipargamin, IV Artesunate, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 254 people
- Sponsor
- Novartis Pharmaceuticals
Severe Malaria, Uncomplicated Malaria
Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX
Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. A new tool is developed that, based on expression analysis of sexual stage biomarkers, will estimate sexual conversion…
- Conditions
- Severe Malaria, Uncomplicated Malaria, Asyptomatic Plasmodium Infection
- Trial name
- IMMETASEX (NCT06064591)
- Where
- 3 sites in Belgium, Burkina Faso and 1 more
- Volunteers
- 458 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Tuberculosis, Diagnoses Disease
Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV
Stool4TB aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that…
- Trial name
- Stool4TB (NCT05047315)
- Where
- 3 sites in Eswatini, Mozambique and 1 more
- Volunteers
- 1,967 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Depression, Adolescent Behavior
Adolescent Depression Screening and Treatment in Mozambican Primary Care
This is a cluster-randomized pilot trial of depression screening and treatment implementation at four Youth-friendly Health Services (YFHS) in primary care clinics, two in Maputo City and two in Maputo Province.
- Trial name
- NCT05476237
- Testing
- Group Interpersonal Therapy for Adolescents (IPT-AG), Treatment as Usual (TAU)
- Where
- 4 sites in Mozambique
- Volunteers
- 95 people
- Sponsor
- Columbia University
Infectious Disease, Infections
L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)
In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis.
- Conditions
- Infectious Disease, Infections, Child, Only
- Trial name
- NCT06426147
- Testing
- L-citrulline
- Where
- 2 sites in Ethiopia, Mozambique
- Volunteers
- 2,200 people
- Sponsor
- Barcelona Institute for Global Health
Malaria
MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention
As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement…
- Trial name
- MULTIPLY (NCT05085340)
- Testing
- Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)
- Where
- 3 sites in Mozambique, Sierra Leone and 1 more
- Volunteers
- 94,252 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Mental Health Disorder
Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH)
The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health…
- Trial name
- SAIA-MH (NCT05103033)
- Testing
- Systems Analysis and Improvement Approach for Mental Health (SAIA-MH)
- Where
- 16 sites in Mozambique
- Volunteers
- 155 people
- Sponsor
- University of Washington
Rotavirus Infections, Environmental Enteric Dysfunction
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique.
- Conditions
- Rotavirus Infections, Environmental Enteric Dysfunction, Enteric Infections
- Trial name
- NCT03313128
- Testing
- Sanitation
- Where
- Mozambique
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Tuberculosis, HIV-1-infection
Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression
DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults…
- Conditions
- Tuberculosis, HIV-1-infection, Immuno-Deficiency
- Trial name
- DATURA (NCT04738812)
- Testing
- Intensified TB treatment (initial phase), WHO standard TB treatment (initial phase)
- Where
- 6 sites in Cambodia, Cameroon and 4 more
- Volunteers
- 1,330 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Seropositivity, Tuberculosis
Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis…
- Conditions
- HIV Seropositivity, Tuberculosis, Household Contact
- Trial name
- 1 to 3 (NCT05118490)
- Testing
- Daily rifapentine and isoniazid for 4 weeks, Weekly rifapentine and isoniazid for 12 weeks
- Where
- 4 sites in India, Indonesia and 2 more
- Volunteers
- 1,000 people
- Sponsor
- The Aurum Institute NPC