Henry Mugerwa
ID: UNCST-2019-R000420
|
PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES
Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria
Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
|
|
Uganda |
2023-08-10 13:49:44 |
2026-08-10 |
14 |
The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Henry Mugerwa
ID: UNCST-2019-R000420
|
A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission
REFNo: HS5298ES
Primary Objective.
To assess the safety and tolerability of MAM01.
Secondary Objectives.
To assess the safety of MAM01.
To characterize the PK of MAM01 following SC, IV, and IM administration of MAM01.
To assess the formation of anti-drug antibodies (ADAs) to MAM01.
Exploratory Objectives.
To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to a placebo.
To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to placebo.
To assess the protection of MAM01 against events of malaria illness (first/only and all episodes).
To correlate MAM01 concentration with Pf infection risk.
To assess the complexity of Pf infection following administration of MAM01 or placebo.
|
Tororo, Osukuru
Tororo, Kayoro
Tororo, Magola
Kampala, Lubowa
|
Uganda |
2024-12-23 12:23:27 |
2027-12-23 |
139 |
Adults and children, male and female |
Bill & Melinda Gates Medical Research Institute (Gates MRI) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Henry Mugerwa
ID: UNCST-2019-R000420
|
A phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5274ES
Primary Objective: To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD
patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
Secondary Objective: Key secondary objective:
To compare the efficacy of 5 mg/kg of
crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the
annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
VOCs that are HCP-managed at a health
care facility
• VOCs that are HCP-managed via remote
consultation
• VOCs that are self-managed without
recommendations from HCP during the
event
• VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the
event
• To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.
To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.
To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.
To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.
To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,VOCs that are self-managed without
recommendations from HCP during the event,
VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the event, by treatment arm.
To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).
To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.
To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.
To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.
To explore biomarkers [p-selectin (free and
total)] and CRP].
To explore exposure-response relationship.
|
Wakiso, Lubowa
|
Uganda |
2025-04-02 8:43:56 |
2028-04-02 |
10-15 |
SCD participants aged 12 years and older who experienced at 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in the 12 months prior to screening visit. Participants who have been taking HU/HC for at least 6 months at a stable dose for at least 3 months and plan to continue taking at the same dose and schedule until the participant has reached 52 weeks of study
treatment will be permitted. Participants who have not been receiving HU/HC, and/or
erythropoietin stimulating agent must not have received it for at least 6 months prior to the screening visit. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Henry Mugerwa
ID: UNCST-2019-R000420
|
A5402 An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
REFNo: HS6604ES
1.2 Primary Objectives
1.2.1 To compare pramipexole to escitalopram in the treatment of MDD (and comorbid MDD with MND) based on the Beck Depression Inventory-II (BDI-II/BDI-2) total score [Beck 1996] from baseline to week 24.
1.2.2 To evaluate the safety of pramipexole and escitalopram in PWH having MDD (and comorbid MDD with MND) from baseline to week 24.
1.3 Secondary Objectives
1.3.1 To compare pramipexole to escitalopram in the treatment of MDD using MDD caseness, neurocognitive outcomes, and functional status from baseline to week 24.
1.3.2 To compare the depression, neurocognitive, and functional status outcomes in PWH with MDD alone and with comorbid MDD with MND treated with pramipexole versus escitalopram from baseline to week 24.
1.3.3 To compare the impact of pramipexole and escitalopram on all outcomes above by female versus male sex (assigned at birth) from baseline to week 24.
1.3.4 To determine the impact of pramipexole compared to escitalopram on the measure of HIV-1 RNA viral load in the peripheral blood.
1.4 Exploratory Objectives
1.4.1 To characterize associations between escitalopram trough concentrations and treatment efficacy (BDI-II/BDI-2 total score) as well as participant adverse events (adverse event frequency, severity, and discontinuation rates).
1.4.2 To characterize associations between escitalopram trough concentrations and genetic polymorphisms that affect metabolizing enzymes of escitalopram (known metabolizing enzymes include CYP2C19, CYP2D6, and CYP3A4).
1.4.3 To explore associations between cerebrospinal fluid (CSF) concentrations of escitalopram and BDI-II/BDI-2 total score.
1.4.4 To evaluate adverse events potentially related to drug interactions between antiretroviral therapy (ART) and escitalopram and pramipexole, respectively.
1.5 Substudy Objective
1.5.1 CSF Substudy
To compare the impact of pramipexole and escitalopram on biomarker outcomes in a CSF substudy of participants with MDD alone.
|
|
Uganda |
2025-10-29 16:04:25 |
2028-10-29 |
50 |
PWH having a diagnosis of MDD alone or with comorbid MDD and MND
· ≥18 to ≤70 years old both male and female.
People who understand English and Luganda because the site informed consent forms only in Luganda and English |
National Institute of Allergy and Infectious Diseases and CIPLA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Irene Andia Biraro Rebecca
ID: UNCST-2019-R001475
|
A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People with Diabetes.
REFNo: HS1112ES
Primary objective:
To assess the efficacy of preventive therapy with a 12-week course of rifapentine and isoniazid (3HP) against the development of probable or definite TB disease over 24 months in people with Diabetes Mellitus (DM) who are latent TB infection (LTBI) test positive.
Secondary objectives:
• To assess the efficacy of 3HP against the development of possible, probable or definite TB disease over 24-40 months in people with DM who are latent tuberculosis infection test positive
• To compare the proportions who complete treatment between arms
• To compare the occurrence of adverse events between arms
• To compare the rate of TB or death between arms
• To compare the overall mortality rate between arms
• To explore the efficacy of 3HP against development of probable or definite TB in those who are LTBI test positive, across the following sub-groups, separately: study site (n=3); age groups; duration of DM; level of glycaemic control (baseline HbA1C) and body mass index (BMI).
• To assess the efficacy of 3HP against development of probable or definite TB, in two restricted analyses: TST positive and IGRA positive participants.
• To carry out sub-studies including i) an economic modelling and cost effectiveness study, ii) a cohort study of those who are IGRA and TST negative a baseline, iii) a cross-sectional study of HIV and TB prevalence and DM phenotype, (iv) evaluation of point-of care (POC) testing for LTBI, and computer-assisted X-ray, (v) a public health study of patient management, and v) future genetic studies.
|
Kampala, Munyonyo
Wakiso, Kasangati
Kampala, Rubaga
|
Uganda |
2021-06-18 |
2024-06-18 |
1500 |
Inclusion criteria
I. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication (‘known DM’); OR in the absence of anti-diabetic medication an HbA1c of ≥6.5% (48 mmol/mol) or a fasting venous plasma glucose of ≥7. |
National Institute for Medical Research, Mbeya Tanzania |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Isabelle Cohen
ID: UNCST-2025-R020977
|
Evaluating a “nearly free hour” for health centers in rural Uganda
REFNo: SS4726ES
This study has four specific objectives:
1. Evaluate the effects of a discounted, group visits window on ODH health centers, including how many ultrapoor patients visit the clinic during the discounted, group visits window.
2. Compare the discounted window to an all-day discount to understand whether a time-limited discount is (relatively) more effective at screening in the UP.
3. Document the extent to which the discounted window cannibalizes revenue by shifting patients from other times of day to the discounted window.
4. Analyze whether discounts encourage earlier treatment for mild/moderate malaria, and correspondingly reduce visits for severe malaria.
|
|
USA |
2026-01-27 19:41:22 |
2029-01-27 |
25000 |
The total set of districts includes ADJUMANI, AGAGO, ALEBTONG, AMOLATAR, AMURIA, AMURU, APAC, DOKOLO, GULU, KADERAMAIDO, KAGADI, KAKUMIRO, KASSANDA, KATAKWI, KIBAALE, KIKUUBE, KITGUM, KOLE, KUMI, KWANIA, LIRA, MASINDI, MUBENDE, NWOYA, OMORO, OTUKE, OYAM, PADER and SERERE.
The study sample focuses on villages in the catchment areas of existing ODH health clinics. We include villages that are not health clinic locations, from which more than a minimum number of patients visit ODH health clinics in an average week. We expect to sample roughly six villages per health clinic. All patients from a participating village who visit an ODH clinic included in the study will be considered part of the study.
|
Weiss Fund for Research in Development Economics, Princeton University’s Research Program in Development Economics and OneDay Health |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Peter Olupot-Olupot Olupot
ID: UNCST-2020-R014798
|
SMAART-MAP trial
Severe Malaria A Research and Trials
consortium - Multisite Adaptive Platform
trial
REFNo: HS4547ES
OBJECTIVES
The objective of the SMAART-MAP trial is to identify promising adjunctive therapies to take forward into a large Phase III trial in severe malaria with a mortality endpoint. The adaptive platform design enables additional domains to be added so a range of adjunctive therapies can be tested, across multiple clinical presentations of severe malaria, in a timely manner.
PRIMARY OBJECTIVE(S)
To explore within each domain the therapeutic efficacy of the intervention using an early indicator such as a biomarker or clinical assessment at 24-72 hours.
SECONDARY OBJECTIVE(S)
To assess the impact of the interventions on clinical outcomes (readmission and
mortality) on all children 28 days and 90 days after randomization
To assess the impact of the interventions on Grade 3 or 4 adverse events, and adverse
events of any grade related to the interventions or comparators.
To assess the impact of proposed definitions for severe malaria based on platelet counts
≤150,000/µL and plasma pfHRP2 concentrations ≥800 ng/mL on differences between
randomized groups
In a sub study, to determine the performance characteristics of a POC pfHRP2 test
compared with quantitative plasma pfHRP2 concentrations determined from plasma.
|
Mbale, North central
Soroti, Pioneer Ward
Agago, Oreet
|
Uganda |
2024-08-16 11:01:14 |
2027-08-16 |
150 per domain |
Hospitalized children with severe malaria |
Imperial College London |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
ISMAHIL ADENIYI ADEKUNLE
ID: UNCST-2024-R002602
|
EFFECTS OF ETHYL-ACETATE FRACTION OF Bidens pilosa LEAVES ON TESTES AND PITUITARY GLAND OF MALE MICE EXPOSED TO BISPHENOL A
REFNo: HS5372ES
The purpose of this study is to evaluate the impact of B. pilosa on testicular integrity and the pituitary gland of male mice exposed to BPA.
1.3.1 Specific Objectives
i. To assess the effect of B. Pilosa on spermatogenic metrics of the testes such as sperm motility, sperm count, morphology, agglutination, and vitality using routine and extended semen analysis.
ii. To determine the impact of B. pilosa on serum concentration of follicle-stimulating hormone, testosterone, and luteinizing hormone using enzyme-linked immunosorbent assay (ELISA) following BPA exposure.
iii. To assess the changes in testicular oxidative stress biomarkers (such as CAT, SOD, and GSH) and lipid peroxidation using MDA.
iv. To assess the histology, histochemical, and immunohistochemical changes in the testes and pituitary gland following treatment with B. pilosa in BPA exposure using Masson Trichrome, Periodic Acid Schiff (PAS), Hematoxylin and Eosin (H&E), Caspase 3, antiproliferating cell nuclear antigen (PCNA), Bcl-2, alpha-smooth muscle actin (α-SMA), and Bax.
|
Bushenyi, Kampala International University, Western Campus
|
Nigeria |
2025-03-03 11:40:21 |
2028-03-03 |
30 animals |
Animals will be divided into five groups, with six animals in each group (n=6).
Group 1 is the control, 2 ml/kg bw of distilled water.
Group 2—100 mg/kg/day of BPA
Group 3—100 mg/kg/day of BPA + low dose of B. pilosa (250 mg/kg).
Group 4—100 mg/kg/day of BPA + medium dose of B. pilosa (500 mg/kg).
Group 5: 100 mg/kg/day of BPA + high dose of B. pilosa (1000 mg/kg)
All administration will be done via oral administration for 5 weeks (35 days) because sperm maturation in mice takes about 35 days; B. pilosa will be administered after 1 hour of treatment with BPA. At the conclusion of the administration period on the 35th day, as per the approved protocol, animals from all groups will be euthanized after receiving ketamine. Blood samples will be collected from the animals via cardiac puncture and transferred to a plain sample bottle to allow coagulation of the cellular components of the blood. The blood sample is then centrifuged for the collection of serum. The collected serum will be used for hormonal assay (testosterone, LH, and FSH) and determination of oxidative stress biomarkers (CAT, SOD, and GSH).
|
Adeniyi A. Ismahil (self sponsored) |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Jane Achan Edwin
ID: UNCST-2023-R005498
|
Evaluation of the protective efficacy of a spatial repellent to reduce malaria prevalence in Uganda: Study protocol for a cluster-randomized double-blinded control trial: The Mossie-GO trial
REFNo: HS4196ES
The study’s primary objective is to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria infection in children ≤ 5 years of age.
The study’s secondary objective is to measure the impact of the intervention on entomological correlates of transmission including vector densities and host seeking behaviour. Insecticide resistance in the local mosquito population will also be explored.
|
Buikwe, N/A
Jinja, N/A
|
Uganda |
2024-05-23 14:23:11 |
2027-05-23 |
5600 |
The population will include children less than 5 years of age living in selected households in the selected villages. We will include children of both sexes and of all tribes in the selected villages. |
AFRICA POWER |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Jayne Ellis
ID: UNCST-2021-R013987
|
“Integrated management of cryptococcal and opportunistic infections to improve outcomes in advanced HIV disease (IMPROVE study)â€
REFNo: HS1607ES
1) To generate evidence on the safety (adverse events) and feasibility (adherence and tolerability) of 1HP (one month of isoniazid and rifapentine) for TB preventative therapy (TPT) amongst adults with HIV-associated cryptococcal meningitis.
2) To generate preliminary data on potential secondary benefits (reduced loss to follow-up, reduced active TB disease, reduced mortality due to TB) of early (inpatient initiation) 1HP TPT as compared to standard (outpatient initiation) 1HP TPT amongst adults with HIV-associated cryptococcal meningitis.
|
Kampala, Salaama
Mbarara, Mbarara
|
UK |
2021-08-25 |
2024-08-25 |
205 |
Adults (>18 years) with HIV-associated cryptococcal meningitis |
London School Hygiene and Tropical Medicine |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Jackson Orem
ID: UNCST-2021-R012016
|
A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)
REFNo: HS2367ES
To evaluate if changes in serum cytokine levels correlate with clinical response.,To assess the effect of pomalidomide treatment on serum cytokine levels.,To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population.,To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated KS in sub-Saharan Africa and is safe and tolerable.,
|
Adjumani, fill this
Kampala, Mulago
Kampala, Mulago
|
Uganda |
2022-11-08 13:27:55 |
2025-11-08 |
12 |
The study will recruit participants with AIDS-associated Kaposi Sarcoma in Uganda who are 18 years and above. Both sexes are eligible to participate in the study. |
AIDS Malignancy Consortium |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Jackson Orem
ID: UNCST-2021-R012016
|
A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings
REFNo: HS4073ES
To describe the incremental cost-effectiveness ratio per QALY gained (as assessed by PROPr) between PLD and PTX,To assess quality of life across PROMIS domains (i.e., cognitive function, physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with the PROPr tool at start of therapy, mid-treatment, and after treatment with PLD and PTX ,To describe the cost of therapy across AMC sites in sub-Saharan Africa to deliver both PLD and PTX by micro-costing analysis for goods and time-in-motion analysis for services. ,To estimate the objective response rate (defined as the sum of complete and partial responses) for AIDS-KS, response duration and overall survival in each treatment arm. ,To evaluate whether there is sufficient evidence to conclude that PLD is non-inferior to PTX in people with severe AIDS-associated KS receiving concomitant ART in resource-limited settings. ,
|
Kampala, Mulago
|
Uganda |
2024-12-10 14:39:24 |
2027-12-10 |
130 participants overall and up to 40 participants in Uganda |
This study will be done in adults above 18 years, both male and female of all tribes, and will recruit participants with HIV-associated Kaposi Sarcoma in Uganda. |
AIDS Malignancy Consortium |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
James Davis KATUMBA
ID:
|
Uncontrolled asthma among adolescents in selected secondary schools in Kampala City: Prevalence, associated factors, in-school needs, pathways to care and effectiveness of an mHealth Self-management app
REFNo: HS2791ES
To determine the effectiveness, acceptability and feasibility of the KmAsthma self-management app in improving the control of asthma among day scholar secondary school adolescents 12-19 years old in Kampala City Uganda.,To examine pathways to asthma care and their influence on asthma control among secondary school adolescents with asthma in Kampala City Uganda ,To establish the in-school needs associated with asthma control among adolescents in selected secondary schools in Kampala City Uganda ,To determine the prevalence of and factors associated with uncontrolled asthma among adolescents in selected secondary schools in Kampala City Uganda ,To establish the prevalence of and factors associated with uncontrolled asthma, in-school needs, pathways to asthma care, and effectiveness of KmAsthma Self-management app intervention to control asthma among adolescents in selected secondary schools in Kampala City Uganda,
|
Kampala, Kawempe, Rubaga, Makindye, Kampala Central, Nakawa
|
Uganda |
2023-05-02 22:22:49 |
2026-05-02 |
323 |
Secondary school adolescents in Kampala City Uganda who will provide written informed consent (or assent plus consent from parents in case of minors) during the time of the study. |
Self Sponsored |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Janet Nakigudde
ID: UNCST-2019-R000444
|
PROMOTING MENTAL HEALTH OF TEACHERS AND CAREGIVERS USING A PERSONALIZED MHEALTH TOOLKIT IN UGANDA
REFNo: HS4431ES
3. To examine feasibility of mWEL-T and mWEL-P with parents and teachers from urban and rural regions (including examining feasibility of the implementation procedures and intervention efficacy) (n=160, 80 parents and 80 teachers from urban and rural regions).,To conduct a user-centered testing study to optimize usability of the Teacher and Parent versions of mWEL- mWEL-T and mWEL-P,1. To build a school system capacity (by establishing a cross-discipline digital health leadership & learning collaborative (n=10) and training a group of peer-community health workers (P-CHW) (n=30; 15 peer teachers and 15 peer parents) to implement the mWEL that is developed,The aim of the study is to test mWEL a newly developed mobile app and user-engagement strategies for mental health management and promotion targeting teachers and parents,
|
Kampala, kibuli
Nakaseke, Nakaseke
|
Uganda |
2024-07-17 14:03:01 |
2027-07-17 |
For the proposal sample size N=160 for the full sample |
The study will enroll parent, teachers and caregivers of children.
We shall consider parents who are at least 18 years old, and have a child aged 6-14 years in the enrolled school |
This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Janet Nakigudde
ID: UNCST-2019-R000444
|
TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA
REFNo: HS5647ES
General Objective
The overall goal of this study is to address vertical and horizontal scale-up implementation framework gaps in Uganda. This study will test new recommended vertical scale-up and sustainability implementation strategies and study impact and underlying mechanisms when the new scale-up model is applied.
This research will guide the development of evidence-informed theoretical frameworks and processes to effectively institutionalize EBIs in LMICs such as Uganda. To achieve this goal, we will carry out 4 sequential steps (4 aims).
Specific Objectives
1.
To establish a cross-level partnership and strengthen stakeholders/leaders’ advocacy capacity to make evidence-based informed children’s mental health policy and practice decisions and to facilitate the EBI institutionalization through the educations system illustrated in figure 1.
2.
To develop implementation Protocols in collaboration with cross level partners (established in Aim 1) based on a new multilevel train-the-trainer scale-up framework to support the EBI/PD scale-up.
10
3.
Implement the new Protocols for scale-up and test the relative value of additional implementation supports intended to sustain teacher EBI practices through a Hybrid III cRCT.
4.
To explore underlying scale-up and sustainability implementation mechanisms.
|
Arua, Lodonga, Arua Hill
Mityana, Busubizi, Kyanja
Gomba, Kabulasoke, Nakato
Masaka, Ndegeya, Kyanamukaka
Buikwe, Nkokonjeru, Kasenge
Kabale, Bukinda, Nyaruzinga
Bushenyi, Nyakabirizi
Sheema, Nyabubare
Western Region, Burahya
Iganga, Lwawu
Soroti, Kolojjo
Gulu, Awach
|
Uganda |
2025-04-11 16:03:54 |
2028-04-11 |
The study population and sample will consist of approximately 1,594 participants.46 Advocacy Leaders and Education System Leaders, including 10 from the Ministry of Education (MOE)/Ministry of Health (MOH), 12 from Teacher Training Colleges (TTCs), 12 from District Education Offices, and 12 head teachers (one from each school district/region). Additionally, 12 TTCs will be selected based on MOE prioritization and needs, with 96 tutors trained in Evidence-Based Intervention (EBI) implementation (8 per TTC). The study will also include 120 schools that are stratified and randomized, with approximately 1,200 teachers (10-15 per school) and 240 Peer Teacher Trainers (PTTs) selected and trained. |
The study population will consist of participants from diverse backgrounds. The age group of the participants will vary, with Advocacy Leaders and Education System Leaders typically being adults in their 30s and 40s, while teachers, tutors, and Peer Teacher Trainers (PTTs) will range from 20 to 50 years of age. The study will aim for gender balance, with an equal representation of male and female participants. Participants will be drawn from various ethnic groups across Uganda, including, but not limited to, Baganda, Basoga, Banyankole, Bakiga, and other tribal groups, ensuring inclusivity and representation from all regions of Uganda. The study will also reflect the diversity of the Ugandan educational system, capturing perspectives from urban and rural settings, as well as from different educational leadership and teaching roles. |
This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Julius Okuni Boniface
ID: UNCST-2019-R000963
|
A MULTI-COUNTRY, SINGLE-BLINDED, PHASE 2 STUDY TO EVALUATE RAPID DETECTION SYSTEMS OF SARS-COV-2
REFNo: HS1425ES
1. To determine the clinical sensitivity of the test assays compared to the real-time RT-PCR-based method.
2. To determine the specificity of the test assays compared to the real-time RT-PCR-based method.
|
Kampala, Mulago
|
Uganda |
2021-06-16 |
2024-06-16 |
500 |
The age group will be adults from 18 years and above. The samples will be collected from archives at the Biorepository in the Department of Immunology and Molecular Biology, Makerere University. The samples will be from people from patients that had compl |
EDCTP |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
|
A phase II/III, open-label, randomized clinical trial to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
REFNo: HS3240ES
To assess the time to insert the REBOA.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding ‘inevitable’ hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.,To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm,To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.,To assess if the number of participants with acute kidney injury is lower in the intervention arm compared to the comparator arm,To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.,To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm., To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using REBOA). ,
|
Kampala, Kawempe
|
Uganda |
2023-11-13 12:15:41 |
2026-11-13 |
10 women in phase IIb and 212 women in Phase III (222 IN TOTAL) |
Women aged 18 and above years and emancipated minors with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg will be recruited |
Centre For International Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
|
Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial
REFNo: HS5151ES
To evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior. ,To evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; ,The primary objective of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization. ,
|
Kampala, Kawempe
|
Uganda |
2024-11-13 17:36:53 |
2027-11-13 |
700 |
Pregnant women aged 15 years and above |
UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Jef VanPuyenbroeck
ID: UNCST-2025-R017911
|
Monitoring anthelmintic resistance in goats in Nwoya District, Uganda
REFNo: A617ES
Main objective:
To assess the efficacy of anthelmintics commonly used by goat farmers in Nwoya district.
Specific Objectives:
1. To determine the prevalence of GIN infesting goats in Nwoya district.
2. To determine nematode species infesting goats in Nwoya district, through coproculture and molecular speciation.
3. To compare the expenses to perform routine FECRT, with McMaster and Mini-FLOTAC, for monitoring anthelmintic resistance in Uganda.
4. To assess the efficiency of survey designs and fecal egg count methods to determine drug efficacy at a certain cost and endemicity.
|
Nwoya, All
Nwoya, All
Nwoya, All
|
Belgium |
2025-09-26 18:06:25 |
2028-09-26 |
383 |
All goat herds, kept for livelihood purposes, in Nwoya District will be considered to be included in this study.
|
Ghent University |
Agricultural Sciences |
Clinical Trial |
Degree Award |
|
Jenny Löfgren
ID: UNCST-2024-R005428
|
Simulation-based training for mesh inguinal hernia repair under local anaesthesia - a randomized trial
REFNo: HS4058ES
Assess the learning curve of mesh inguinal hernia repair for novice learners and how it is affected by simulation based training prior to supervised surgery on patients.
|
Soroti,
Mubende,
Iganga,
|
Sweden |
2024-05-02 12:38:06 |
2027-05-02 |
440 |
Trainees: intern doctors with an interest in surgery and who are not already routinely performing inguinal hernia mesh repair
Patients: Adult (18 years and above), otherwise healthy (ASA 1-2) men with primary, reducible, groin hernia |
Karolinska Institutet |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
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