Clinical trials: in Zambia
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
Bioneer Q-RFIA Clinical Evaluation
Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both…
- Trial name
- NCT05117788
- Testing
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
- Where
- 5 sites in Kenya, Moldova and 3 more
- Volunteers
- 2,350 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Low Birth Weight, Kangaroo Mother Care
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were…
- Conditions
- Low Birth Weight, Kangaroo Mother Care, Postpartum Depression, Neurodevelopmental Outcome
- Trial name
- KMC PPD (NCT06545760)
- Testing
- Kangaroo mother care (KMC) support for > 2 days, Kangaroo mother care (KMC) support for < 2 days
- Where
- Zambia
- Volunteers
- 1,908 people
- Sponsor
- University of Alabama at Birmingham
TB - Tuberculosis, PTLD
Intergrated Service Delivery for Lung Health Conditions
The Advancing Lung Health in Zambia project aims to improve access to integrated screening, diagnosis, and management of tuberculosis (TB) and other priority respiratory diseases at community and primary healthcare levels.
- Conditions
- TB - Tuberculosis, PTLD, COPD (Chronic Obstructive Pulmonary Disease), Computer Aided Diagnosis
- Trial name
- TB REACH W11 (NCT07816523)
- Testing
- Intergrated lung health screening, AI-Enabled Cough Sound Screening for Tuberculosis, Post-TB Lung Disease evaluation
- Where
- Zambia
- Volunteers
- 20,300 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Severe Malaria, Thrombocytopenia
Platelet-Directed Whole Blood Transfusion Strategy for Malaria
Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
- Trial name
- PLATFORM (NCT05711485)
- Testing
- Whole blood transfusion
- Where
- 2 sites in United States, Zambia
- Volunteers
- 132 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women
A Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV- Negative Women
A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women
- Trial name
- CAPRISA 012C (NCT07810062)
- Testing
- Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS
- Where
- Zambia
- Volunteers
- 990 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
HIV Infection
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among…
- Trial name
- NCT02140255
- Testing
- Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r)
- Where
- 47 sites in United States, Argentina and 11 more
- Volunteers
- 1,120 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Positive, Pregnant Adolescent Girls
Pregnant and Parenting Teens Living With HIV in Lusaka, Zambia
The overall objective of the Pregnant and Parenting Girls (P2G) Program evaluation was to measure resilience among pregnant and parenting girls (18 years and above) living with HIV in Lusaka who have benefitted from the…
- Conditions
- HIV Positive, Pregnant Adolescent Girls, 10-19 Years Old, Teen Mothers
- Trial name
- P2G (NCT07807670)
- Testing
- P2G comprehensive package
- Where
- Zambia
- Volunteers
- 1,257 people
- Sponsor
- Centre for Infectious Disease Research in Zambia
Tuberculosis
Assessing Diagnostics At Point-of-care for Tuberculosis
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide.
- Trial name
- ADAPT (NCT05941052)
- Testing
- Tongue swab-based molecular assays
- Where
- 3 sites in Nigeria, Philippines and 1 more
- Volunteers
- 1,350 people
- Sponsor
- University of California, San Francisco
Pre-Exposure Prophylaxis
Zambia Healthy Choices Project for Emerging Adults Living With HIV
This project will develop and implement a multi-component intervention using mobile health technology to improve HIV self-management and reduce substance use.
- Trial name
- NCT06415357
- Testing
- Mobile Healthy Choices (mHC), Motivational Text Messaging (MTM), Standard ART Counseling
- Where
- Zambia
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Tuberculosis
Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults
The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered…
- Trial name
- NCT06062238
- Testing
- M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine
- Where
- 54 sites in Indonesia, Kenya and 3 more
- Volunteers
- 20,080 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Malaria, Anemia
Evaluation of a Comprehensive School Health Programme in Zambia
In Zambia, the health and well-being of children aged 5 to 14 has often been overlooked, leading to various health challenges affecting their development and education.
- Conditions
- Malaria, Anemia, Diarrhea
- Trial name
- NCT06560853
- Testing
- Comprehensive School Health Programme, Deworming and vitamin A supplementation delivery
- Where
- 6 sites in Zambia
- Volunteers
- 28,700 people, healthy volunteers welcome
- Sponsor
- London School of Economics and Political Science
Severe Acute Malnutrition, HIV
An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of…
- Conditions
- Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions, Child Malnutrition
- Trial name
- Co-SAM (NCT05994742)
- Testing
- Rifampicin, Azithromycin, Isoniazid
- Where
- 9 sites in Kenya, Zambia and 1 more
- Volunteers
- 674 people
- Sponsor
- Queen Mary University of London
Tuberculosis, Lung Diseases
Alternative Diagnoses in Patients About to Start Empiric Tuberculosis Treatment
This study is being conducted to determine whether in patients who are diagnosed with tuberculosis on a clinical basis (where tuberculosis is not found in the sputum) might have other lung diseases than tuberculosis.
- Trial name
- ALTTB (NCT06737029)
- Testing
- Enhanced diagnostic workup
- Where
- Zambia
- Volunteers
- 311 people
- Sponsor
- Stichting Longartsen voor Afrika
Maternal Health, Pregnancy Outcomes
Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
The overarching goal of the ARCH Survey is to establish a prospective longitudinal pregnancy surveillance study in Lusaka, Zambia, to precisely characterize the pregnancy rate and outcomes of women of reproductive age prior to…
- Trial name
- ARCH (NCT05154331)
- Where
- Zambia
- Volunteers
- 5,500 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV - Human Immunodeficiency Virus
CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation
The primary purpose of this study is to assess the burden of advanced HIV disease (CD4 cell count <200 or <350 cells/μL) among new patients and those returning to care after a gap in treatment, and the extent to which low…
- Trial name
- CAIR (NCT07760324)
- Where
- Zambia
- Volunteers
- 151 people
- Sponsor
- Centre for Infectious Disease Research in Zambia
Alcohol and Substance-Related Mental Disorders
Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia
This is a randomized controlled trial (RCT) evaluating the effectiveness of a screening, brief intervention, and referral to treatment (SBIRT) stepped-care system in reducing unhealthy AOD use among Congolese refugees and the…
- Trial name
- NCT05471921
- Testing
- SBIRT, Treatment as usual
- Where
- 2 sites in United States, Zambia
- Volunteers
- 400 people
- Sponsor
- Columbia University
HIV, Common Mental Health Problems
Mpata Yathu Trial for Young Women in Zambia
This randomized controlled trial evaluates Mpata Yathu ("Our Space"), a trauma-informed, church-based counseling intervention for adolescent girls and young women in Lusaka, Zambia who have experienced gender-based violence and…
- Conditions
- HIV, Common Mental Health Problems, PTSD - Post Traumatic Stress Disorder, Depression Disorder
- Trial name
- MYT (NCT07132905)
- Testing
- Mpata Yathu ("Our Space")
- Where
- 2 sites in Zambia
- Volunteers
- 180 people
- Sponsor
- University of California, San Francisco
HIV Antiretroviral Therapy (ART) Adherence
Optimizing Care Delivery to Support Reengagement in PLWH Returning to HIV Care After Treatment Lapses in Zambia
1.0 Introduction The scale-up of human immunodeficiency virus (HIV) treatment services has expanded rapidly in Zambia, facilitated by evolution of the HIV response from centralized services to decentralized care and now towards…
- Trial name
- Reengagement (NCT06803316)
- Where
- Zambia
- Volunteers
- 658 people
- Sponsor
- Centre for Infectious Disease Research in Zambia
Depression, Anxiety
Description of the Lived Experiences of Family Caregivers for People With Mental Health Comorbidities
Mental health problems such as depression, trauma and anxiety are common in low-resource contexts, such as Zambia. Comorbidity, or having multiple mental health problems, is the norm.
- Conditions
- Depression, Anxiety, Trauma
- Trial name
- MCE (NCT07760701)
- Where
- Zambia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia