There are about 292 clinical studies being (or have been) conducted in Zambia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to evaluate the acceptability, feasibility and effectiveness of a caregiver-assisted oral fluid-based HIV test to screen children for HIV in Zambia. The results of this study are intended to support expanded access to HIV testing and treatment services for children, and to ensure that all newly diagnosed children are linked to clinical care.
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 and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL over 48 weeks: - Intensified TB treatment regimen: increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks and albendazole for 3 days - WHO standard TB treatment regimen. The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.
The objective of this study is to test the preliminary efficacy of a novel couples' counseling intervention to promote the health of pregnant women living with HIV in Lusaka, Zambia.
The goal of this project is to test tools that will be part of a platform for training and supervision of mental health and psychosocial support helpers, including providers without specialized training in mental health. This platform, entitled Ensuring Quality in Psychological Support, is an online resource being developed to include: materials for evaluating core and specific competencies, training on core competencies, implementation guidance to conduct competency-based training. The Ensuring Quality in Psychological Support platform is designed to aid trainers and supervisors working with providers being trained to deliver World Health Organization and non-World Health Organization low-intensity psychological interventions. The research will address two study objectives: Objective 1. Determine feasibility, acceptability, and perceived utility of the Ensuring Quality in Psychological Support platform; Objective 2. Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools. To maximize generalizability of findings, Ensuring Quality in Psychological Support will be evaluated in seven countries: Ethiopia, Kenya, Lebanon, Peru, Uganda, Zambia and Jordan. The sites are varied by types of psychological intervention, beneficiaries, experience of trainers, and background of trainees. In each site, trainers will train non-specialist providers on a low-intensity psychological intervention.
Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world. This study will assess protection against rotavirus infection and investigate immune correlates of protection following vaccination with a novel trivalent VP8 subunit rotavirus vaccine used alone or in combination with oral rotavirus vaccine.
This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
HIV-CORE 006 is a Phase 1 double-blind placebo-controlled trial, in which the mosaic immunogens are delivered by a prime-boost regimen of non-replicating simian adenovirus followed by non-replicating poxvirus MVA. Volunteers will be randomised to receive either the vaccine regimen or placebo at 2 vaccination visits 4 weeks apart. The vaccine regimen consists of a single mosaic prime ChAdOx1.tHIVconsv1 (C1) and a dual boost of MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) administered simultaneously. The trial will recruit healthy African adults 18-50 years of age, who are HIV-uninfected and at low risk of HIV infection. The trial is designed to enrol 88 healthy men and women, who will be randomised to receive either the vaccine regimen or placebo in a ratio of 72:16: - Vaccine Arm (ChAdOx1.tHIVconsv1 prime followed by MVA.tHIVconsv3 and MVA.tHIVconsv4 boost at 4 weeks after enrolment); 72 vaccine recipients; - Placebo Arm; 16 recipients To maintain blinding, all volunteers will receive two injections with half dose into the deltoid region of each arm of ChAdOx1.tHIVconsv1 or placebo at enrolment, and two injections (MVA.tHIVconsv3 or placebo into one deltoid region and MVA.tHIVconsv4 or placebo into the other) at 4 weeks after enrolment. The primary goal of assessing safety and immunogenicity will be served by weighting the randomisation toward vaccinees.
A global study for a better understanding of the cardiovascular conditions that increase the risk of developing severe COVID-19, and a better characterization of cardiovascular complications in hospitalized patients with COVID-19.
In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. However, to date neither the WHO nor the Zambia Ministry of Health has provided detailed guidance on how to implement this recommendation. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 health facilities in Zambia. The survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.
High dietary salt is associated with immune activation, elevated levels of inflammatory cytokines and hypertension in murine models. Hypertension is independently associated with inflammation in both murine studies and studies in humans. In people living with HIV, these interactions are not well established. The aim of this study is to determine the effect of excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood pressure between individuals with and without hypertension among people living with HIV and HIV negative persons.