JULIET MWANGA-AMUMPAIRE
ID: UNCST-2022-R009420
|
An open-label, multicentre, randomized, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19
REFNo: HS1789ES
Primary objective: to compare the efficacy of alternative treatment strategies versus control on the risk of progression to severe respiratory disease
The secondary objectives are:
 To compare the safety of each study arm to control, up to Day 21 of follow-up
 To compare the rate of hospitalizations due to COVID-19 in each study arm versus control
 To compare the time to hospitalization due to COVID-19 in each study arm versus control
 To compare the rate of hospitalizations for other reason than Covid-19 in each study arm versus control
 To compare the disease-free rate in each study arm versus control
 To compare the death rate in each study arm versus control
 To compare time to worsening of SpO2 < 93in each study arm versus control
 To compare the capacity to prevent severe progression between study arms
 To identify risk factors for severe progression
 To assess efficacy in sub-groups of patients e.g. with pre-existing conditions/co-morbidities, by age group, sex, BMI, timeframe between onset of symptoms and randomization.
|
Mbarara, Mbarara Medical Cell
|
Uganda |
2021-12-07 |
2024-12-07 |
175 |
1. Male or female patients,
2. Adult’s  18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
3. COVID-19 confirmed by molecular biology or validated antigenic test |
Drugs for Neglected Diseases Initiative (DNDi) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
PURPOSE 1: GS-US-412-5624/ A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection. Version 2.0, dated 10 March 2021.
REFNo: HS1920ES
1. Primary Objectives
i) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection.
ii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection.
2. Secondary Objectives/ end points
i) To compare the efficacy of LEN with F/TDF for HIV PrEP in AGYW at risk of HIV infection.
ii) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection in participants adherent to LEN.
iii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection in participants adherent to F/TAF.
iv) To compare the efficacy of F/TAF with F/TDF for HIV PrEP in AGYW at risk of HIV infection.
v) To evaluate the safety and tolerability of LEN, F/TAF, and F/TDF for HIV PrEP in AGYW at risk of HIV infection.
vi) To evaluate the safety and tolerability of LEN and F/TAF for HIV PrEP in AGYW ≥ 16 to < 18 years of age who have sex with male partners and are at risk for HIV infection.
3. Exploratory objectives
i) To assess the adherence rate to LEN as assessed by on-time LEN injection
ii) To assess LEN plasma levels
iii) To assess the adherence rate to F/TAF and F/TDF using intracellular TFV-DP levels in DBS.
iv) To evaluate the acceptability of a once every 26 weeks LEN injection for HIV PrEP in AGYW at risk of HIV infection.
v) To assess LEN plasma levels during pregnancy.
vi) To explore concentrations of hormonal contraceptives in LEN participants.
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Mityana, Mityana
Hoima, Hoima county
Masaka, Masaka
Kalangala, Kalangala
|
Uganda |
2021-11-25 |
2024-11-25 |
The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a randomized blinded study (Randomized Phase). The Incidence Phase of the study will remain open until the backg |
Cisgender AGYW who have sex with male partners, at risk for HIV infection ≥ 16 to ≤ 25 years of age. |
Gilead Sciences Inc. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Kamya Moses
ID: UNCST-2020-R014203
|
Enhancing immunity to malaria in young children with effective chemoprevention
REFNo: HS1763ES
To compare the incidence of malaria from 4 weeks to 4 years of age among children born to mothers randomized to receive intermittent preventative therapy in pregnancy (IPTp) with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP.
To compare the incidence of malaria from 2-4 years of age among children randomized to receive IPT in childhood (IPTc) with monthly DP from 8 weeks to 1 year of age vs. monthly DP from 8 weeks to 2 year of age vs. no IPTc.
To compare innate and adaptive effector and regulatory responses between children randomized to different IPT arms.
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Busia, Masafu
|
Uganda |
2021-11-24 |
2024-11-24 |
924 HIV-uninfected infants |
Children both male and female, 4 weeks to 4 years of age, resident of Busia District |
Division of Microbiology and Infectious Diseases (DMID) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Cissy Kityo
ID: UNCST-2021-R013663
|
ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19
(Adapt Out COVID)
REFNo: HS1813ES
1.1 Co-Primary Objectives
1.1.1 Phases II and III: To evaluate safety of the investigational agent.
1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28.
1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with nasopharyngeal (NP) SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) at study days 3, 7, and 14.
1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic.
1.2 Secondary Objectives
1.2.1 Phases II and III: To determine whether the investigational agent reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28.
1.2.2 Phase II and III: To determine whether the investigational agent reduces the progression of COVID-19-associated symptoms.
1.2.3 Phase II and III: To determine if the investigational agent reduces levels of SARS-CoV-2 RNA in NP swabs.
1.2.4 Phase III: To determine the efficacy of the investigational agent to increase the proportion of participants with NP SARS-CoV-2 RNA below the LLoQ at study day 3.
1.2.5 Phase II: To determine the pharmacokinetics of the investigational agent.
1.2.6 Phase II: To determine efficacy of the investigational agent to obtain pulse oximetry measurement of ≥96% through day 28.
1.2.7 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study week 72.
1.2.8 Phase III: To evaluate if the investigational agent reduces the time to sustained symptom resolution through study day 28.
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Wakiso,
Mpigi,
Mukono,
|
Uganda |
2021-11-22 |
2024-11-22 |
The phase II evaluation will enroll approximately 110 participants per investigational agent (and 110 on placebo) (this includes all participants enrolled under previous protocol versions, irrespectiv |
Outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤240 hours (10 days) prior to study entry and with ≤7 days of symptoms of COVID-19 at study entry, plus the presence |
The National Institute of Allergy and Infectious Diseases, Division of AIDS/NIAID/NIH/DHHS, Rockville, Maryland 20892 USA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Francis Ssali
ID: UNCST-2021-R012134
|
A Phase 2, Open-label, Single-arm, Multicentre Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to less than 12 years) who are Virologically Suppressed (TMC278HTX2002)
REFNo: HS1815ES
Primary Endpoints
• Area under the plasma concentration-time curve from the time of administration up to 24 hours post-dose of RPV, as derived from the intensive PK assessments.
• Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.
Secondary Endpoint
• Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
• Change from baseline Movement.
• Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
• Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.
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Wakiso, Makindye
,
|
Uganda |
2021-11-22 |
2024-11-22 |
lower limit is 3 and Upper limit is 10 |
Participants (boys and girls) aged ≥2 to <12 years with a bodyweight of at least 11 kg |
Janssen Sciences Ireland Unlimited Company |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Jerome Kabakyenga Kahuma
ID: UNCST-2021-R013729
|
The A-Lite vein locator: “a non-invasive assistive medical device designed to improve vein visibility among patients requiring intravenous therapy.â€
REFNo: HS1547ES
Main Objective
1. To assess the efficacy, safety and impact of using an assistive medical device to aid vein visibility among patients requiring intravenous therapy.
Specific Objectives
1. To assess the safety and efficacy of the A-Lite vein locator among 10 adults in Uganda.
2. To investigate non-inferiority by assessing the performance of the A-Lite vein locator with respect to the existing standard of care among 48 adolescents in Uganda.
3. To determine the effectiveness of using the A-Lite vein locator for improving vein visibility among 156 children requiring intravenous cannulation in Uganda.
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Kalungu, Bugonzi
Lira, Junior Quarters
Mbarara, Rwebishekye
Isingiro, Kashojwa
|
Uganda |
2021-11-19 |
2024-11-19 |
214 |
Ages eligible for the study: 1 up to 30 years
Sexes eligible for the study: All
|
International Development Research Centre (IDRC) – Canada and the Government of Uganda |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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ANGELLA MUSIIMENTA
ID: UNCST-2021-R013297
|
My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and medication Adherence in Rural Uganda
REFNo: HS1688ES
Assess the refined My Mobile Wallet intervention for larger scale feasibility, acceptability, and impact on TB treatment adherence and clinical outcomes. We will randomize 162 newly diagnosed TB patients (1:1:1) to SMS texts + incentives Arm A, SMS texts only B, and control Arm C (standard clinic-based TB care); follow-up will be the 6 month-treatment period. Feasibility and acceptability will be assessed per above. Impact will be based on electronically monitored medication adherence (primary), as well as treatment completion, clinic attendance, cure, and mortality (secondary).,Refine the My Mobile Wallet intervention. We will adapt the intervention to address any feasibility and accessibility issues raised in R21 findings. We will then pilot test the refined version of the intervention in 10 TB patients over two months of treatment to ensure optimal functionality. ,Assess the initial feasibility and acceptability of My Mobile Wallet. Forty patients with newly diagnosed TB will use My Mobile Wallet over their 6-month course of treatment. Feasibility will be assessed by appropriate receipt of the cash transfers and SMS texts, and intervention functionality. Acceptability will be assessed using System Usability Scale [53] and interviews based on the Unified Theory of Acceptance and Use of Technology [54].,Determine the optimal design and develop My Mobile Wallet as an intervention to support TB medication adherence. Through client-centered approaches, we will iteratively conduct focus group discussions with up to 30 TB patients to develop an optimal My Mobile Wallet intervention.,
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Mbarara, Kamukuzi
Mbarara,
|
Uganda |
2021-11-19 |
2024-11-19 |
242 |
TB patients (18 and above years old) living not beyond 60 Kilometers from MRRH who are willing to participate in the study |
US National Institute of Health (Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
|
BREATHER Plus: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir- based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa, Version 2.0, Dated 18-Mar-2020; ISRCTN #: 85058577
REFNo: HS1822ES
Major Objective: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub- Saharan Africa
Specific Objectives
To evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment. Output from this RCT will provide evidence on efficacy, safety and acceptability of a novel treatment approach in HIV-infected adolescents in sub-Saharan Africa
To evaluate the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy with weekends off compared with Continuous Therapy with a DTG- based ART regimen
To optimize treatment for HIV-infected adolescents in sub-Saharan Africa
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Kampala, Mulago
Wakiso, Seguku
|
Uganda |
2021-11-15 |
2024-11-15 |
460 |
HIV-infected, non-pregnant, non-breastfeeding adolescents aged 12 to 19 years of age, virologically-suppressed for at least one year, without any history of treatment failure, on 3-drug combination antiretroviral (ART) consisting of dolutegravir with a 2- |
University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC- 2005] |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Namulema Edith
ID:
|
Effectiveness of the ‘LeVe CPAP’ against the standard AIRVO CPAP among Covid-19 patients with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A Cross-Over Randomised Trial.
REFNo: HS1647ES
The main objective of the trial is to compare the clinical effectiveness of the LeVe CPAP device to the standard AIRVO CPAP in the delivery and maintaining continuous positive airway pressures among patients diagnosed with AHRF at Mengo Hospital Uganda.
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Kampala, mengo
|
Uganda |
2021-10-28 |
2024-10-28 |
40 |
Male and Female Adult patients with evidence of acute hypoxaemic respiratory failure admitted at the CTU. Any Tribe. |
Leeds Teaching Hospital National Health Service Trust in the UK |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Khamisi Musanje
ID: UNCST-2021-R012863
|
Acceptability, Feasibility and Effectiveness of a Mindfulness based Intervention to Promote Adherence to Antiretroviral Therapy among Adolescents in Kampala.
REFNo: HS1656ES
1. To adapt and explore acceptability of ACT-DNA-v among users (ALWHA) and providers (HCPs).
2. To measure feasibility of the adapted ACT-DNA-v for use with ALWHA.
3. To examine the impact of ACT-DNA-v on reducing proximal psychosocial barriers to medication adherence (depression, anxiety and stigma) among ALWHA.
4. To measure effectiveness of a mindfulness based intervention (ACT-DNA-v) on self-reported adherence among ALWHA in Kampala, and ascertain its impact on viral load reduction via analysis of data from medical records
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Kampala, Mutundwe
Kampala, Central
|
Uganda |
2021-10-20 |
2024-10-20 |
116 |
Study will be conducted among older adolescents 14-19 years living with HIV attending care at either Kisenyi or Kitebi health centers. Both male and female will be considered. |
Behavioral social science research grant |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Damalie Nalwanga
ID: UNCST-2021-R013217
|
SEVERE PNEUMONIA IN CHILDREN: THE ABILITY OF BODY COMPOSITION TO PREDICT SURVIVAL, AND THE EFFECT OF NUTRITIONAL SUPPLEMENTATION ON OUTCOMES
REFNo: HS1719ES
4. To determine the effect of a nutritional intervention (RUTF) on clinical outcomes (post discharge mortality, re-admission, and occurrence of severe acute malnutrition) of children hospitalized for severe pneumonia.,3. To determine the effect of a nutritional intervention (RUTF) on fat and muscle mass in children hospitalised for severe pneumonia.,2. To compare the ability of various muscle and fat mass indices to predict survival in children hospitalised for severe pneumonia.,1. To describe the role of nutritional status on outcomes following hospitalization for severe pneumonia among children.,To describe the relationship between muscle and fat mass and survival, and determine the role of nutritional supplementation on fat and muscle mass, and on treatment outcomes of children hospitalized for severe pneumonia,
|
,
Jinja,
Mbale,
Soroti,
|
Uganda |
2021-10-20 |
2024-10-20 |
450 |
Children aged 6 months to 12 years hospitalized for severe pneumonia. |
Self Sponsored |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Susan Adakun
ID:
|
Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non Inferiority Randomized Controlled Trial
REFNo: HS1796ES
Primary Objectives
1. To determine if adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) is non-inferior to that among patients on Directly Observed Therapy (DOT)
Secondary objectives
1. To determine the correlation between serum MDR-TB drug concentrations and adherence as measured by MEMS technology
2. To compare treatment outcomes between MDR-TB patients on self-administered therapy and DOT
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Kampala, Mulago
Lira,
Mbarara,
|
Uganda |
2021-10-20 |
2024-10-20 |
164 |
Age of study Population: 8 years and above
Gender of study population: Both male and female
Persons of any and all tribes are eligible for study participation as long as they fit the eligibility criteria |
Janssen Global Public Health, a division of Janssen Pharmaceutica NV, under grant number 1550786 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
|
Uganda Paediatric and Adolescent HIV Cohort on Antiretroviral Therapy: Study Protocol (UP-ART)
REFNo: HS1699ES
The objectives of this study are to:
1) Describe the characteristics of children and adolescents living with HIV receiving paediatric care in the participating centres and coverage of ART
2) Describe the uptake of new antiretroviral drugs such as DTG across age groups and regions
3) Assess the effectiveness and safety of new antiretroviral drugs such as DTG, including viral suppression, incidence of adverse events, serious adverse events and discontinuation of drug
4) Assess broader clinical outcomes including retention in care, mortality, disease progression, immune response, viral suppression, overall and by age and treatment regimen/treatment history
5) Assess (i) the prevalence of HIV drug resistance among children/adolescents start of treatment and the impact on treatment response, and (ii) among those who experiencing virological failure on DTG to describe the risk of accumulation of drug resistance (see sub-study Section 4).
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Hoima, Kahora Division
Lira, Lira
Wakiso, Wakiso
|
Uganda |
2021-10-14 |
2024-10-14 |
3000 |
All children/adolescents attending HIV care at the participating clinics will be invited to join the study |
the International AIDS Society, the World Health Organisation, University College London capacity strengthening grant and UNICEF (grant and in-kind support). |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Fred Ssewamala
ID: UNCST-2020-R014060
|
Youth Health SMS: Using mobile technology to prevent HIV and related Youth Health problems: Sexual health, Mental health, and Substance use in southwest Uganda
REFNo: SS969ES
This study will result in the development of one of the first mobile phone-based interventions for Adolescents and Young Adults (AYA) in East Africa that begins to address the co-morbid HIV risk factors of sexual health, mental health, and alcohol use. AYA is a developmental period associated with the increased importance of peers, increased technology use, increased mobility, initiation of sex, emergence of mental health disorders (if at risk), and initiation of alcohol use. Consequently, AYA is a critical time for preventive interventions. Poor mental health and alcohol abuse are associated with increased risk for HIV infection. Thus, the proposed research will attempt to address these areas concurrently.
The proposed research will evaluate if adapting and updating the existing free and nationally available text message and interactive voice recognition (IVR) service included in *161 that was initially developed by FHI 360. Our work will test and tailor messages for AYA to disseminate pre-exposure prophylaxis (PrEP) information and pilot specific mental health and hazardous alcohol use screens. Symptomatic AYA will be referred to behavioral health counselors for further assessment and treatment as needed. AYA today rely heavily on mobile phones for information and services, thus we believe the proposed intervention could be applied and adapted across the region, and potentially in other under-resourced settings.
We will conduct formative research to evaluate and adapt an existing text-message and interactive voice recognition (IVR) platform. We will then pilot the new menus and examine if using this platform promotes HIV prevention (pre-exposure prophylaxis (PrEP), HIV testing, safer sexual behaviors) and increases mental health and alcohol use screening and linkage to counselors as needed for adolescents and young adults (AYA) in a rural Ugandan region with high HIV seroprevalence and limited resources.
2. State the study objective(s) and research question(s)
Aim 1: To adapt an evidence-based mobile phone-delivered sexual health program, to include PrEP information and deliver mental health and alcohol use assessments with the goal of increasing screening and referral, as well as linkage to counselors for AYA at HIV risk.
Aim 2: Evaluate through a pilot RCT (N=126 AYA, 15-19 years) intervention (a) acceptability and feasibility, and (b) impact on uptake of HIV prevention strategies, as well as screening and linkage to mental health and alcohol use school-based counselors.
|
Masaka, Kimaanya
Kalungu, Kabukunge
|
Uganda |
2021-10-12 |
2024-10-12 |
164 |
There will be two phases to the study. The first will be approximately three months and include 24 male and female AYA (15-19) years. The second phase will include 140 male and female (15-19 years). |
National Institute of Mental Health (NIMH) |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Christine Wiltshire Sekaggya
ID: UNCST-2019-R000578
|
Clinical Predictors of 3-Months Isoniazid Rifapentine (3HP)- Related Adverse Drug Reactions (ADR) During Tuberculosis Preventive Therapy
(PAnDoRA-3HP study)
REFNo: HS1582ES
Primary Objectives
1.To describe the safety profile of 3HP among people receiving tuberculosis preventive therapy.
2.To describe the effect of adverse drug reactions on tuberculosis preventive therapy completion rates
Secondary Objective
1.To describe the pharmacokinetic and pharmacogenomic determinants of ADRs among people receiving tuberculosis preventive therapy in Uganda
2.To determine the efficacy of 3HP when used for tuberculosis preventive therapy.
|
Kampala, Mulago III
Kampala, Kisenyi
Kampala, Kasubi
Kampala, Nakawa I
Jinja, Magwa
Mubende, Mubende Town Council
|
Uganda |
2021-10-04 |
2024-10-04 |
614 |
Patients will be included in the study if they meet the following inclusion criteria:
1. Individuals of any age who have been initiated on TPT using the isoniazid/rifapentine regimen according to standard of care
2. Both PLWHIV and HIV-uninfected indivi |
National Institution of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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|
Joseph Lutaakome
ID: UNCST-2020-R008323
|
An International Multicenter, Randomized, Double-Blind, PlaceboControlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
REFNo: HS1715ES
Primary Objective
Primary objective: Among outpatients with recently diagnosed SARS-CoV-2 infection to compare the safety and efficacy of a single infusion of hIVIG (pooled for the 2 hIVIG
products) versus placebo, each given with SOC, on clinical status after seven days. Two hypotheses will be tested to address this primary objective, which compares the primary endpoint among two study populations: 1) participants where neutralizing MAb was not specified as part of SOC treatment (stratum 1, see Section 6.1 Overall Study Design); and 2) all randomized participants (stratum 1 and stratum 2 combined). hIVIG will be considered superior to placebo if either of the two hypotheses are rejected.
Secondary Objectives and Endpoints
Secondary objectives, including subgroup analyses and safety outcomes, will be addressed for all randomized participants and for those in stratum 1 and 2 separately.
Secondary Endpoints
The clinical status as classified on the ordinal outcome scale will be assessed with a number of additional analyses comparing hIVIG (pooled for the 2 hIVIG products) with placebo, among the overall study population as well as for the key subgroup of those not receiving anti-SARS-CoV-2 monoclonal antibodies as part of SOC (stratum 1), including:
1. All-cause hospitalization or death through 28 days.
2. All-cause mortality through 28 days.
3. Significant disease progression through 28 days, using a time to event analysis with outcome defined by fulfilling criteria for category 4 or 5 on the ordinal scale.
4. Distribution of ordinal scale outcome at Day 4, 14, and 28.
5. The proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry
|
|
Uganda |
2021-10-04 |
2024-10-04 |
A sample size for this phase 3 trial of 820 participants is planned, which would consist of at least 656 participants in stratum 1. |
In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria prior to randomization:
i. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an
ii. immunosuppressed condition.
|
The study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, through their contract organization Leidos. There is a subcontract between the University of Minnesota (the Sponsor) and the MRC CTU at UCL. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Lukia Namaganda Hamid
ID:
|
Malnutrition as a probable predictor of mortality in cerebral palsy (CP), and the effect of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and adolescents with CP in the Iganga, Mayuge and Bugweri rural districts of eastern Uganda
REFNo: HS1427ES
Specific Objectives:
1. To assess mortality and whether malnutrition is one of the predictors among a population based sample of children and adolescents with cerebral palsy the Iganga Mayuge-Health and Demographic Surveillance Site (IM-HDSS), Uganda
2. To assess the difference in the change in nutritional status in 2015 and 2019 among children with CP compared to their age and sex matched controls without CP at the IM-HDSS, Uganda.
3. To explore positive and negative nutrition practices among caregivers of well-nourished and under-nourished children with cerebral palsy respectively at the IM-HDSS, Uganda.
4. To determine the difference in the effectiveness of the positive deviance strategy and parent facilitator trainings on CP child and adolescent malnutrition and caregiving within the Iganga, Mayuge and Bugweri districts, Uganda.
|
Iganga,
Mayuge,
|
Uganda |
2021-09-29 |
2024-09-29 |
126 for the RCT |
Caregivers of children and adolscents with Cerebral aged 2-21 years old |
Cerebral Palsy in Uganda Project (CURIE), Makerere University School of Public Health, Department of Epidemiology and Biostatistics |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Isaac Ssewanyana
ID: UNCST-2020-R014336
|
Evaluation of the performance of the Salmonella Biolineâ„¢ typhi IgG/IgM Fast test in a near-patient testing environment, including evaluation of usability
REFNo: HS1700ES
To evaluate the usability of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in the near-patient environment using a questionnaire based survey. ,To establish the performance of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in a near-patient setting compared to the performance in a professional lab (i.e. Central Public Health Laboratory) using venous whole blood samples. ,
|
pakwach,
Kampala, Kiruddu
Kampala, kisenyi
|
Uganda |
2021-09-29 |
2024-09-29 |
80 |
• Male and female patients above 18 years seeking treatment from selected health units who are able to give consent to the study meeting the selection criteria. |
ABBOTT KOREA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Isaac Ssewanyana
ID: UNCST-2020-R014336
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COMPARISON OF PERFORMANCE OF CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA TEST DEVICE/ TEST REF: ISY-U402 AND CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA RAPID TEST STRIP) REF: ISY-U401
USING SD BIOLINE VERSION 3.0 AS A REFERENCE
REFNo: HS1643ES
The objective of this evaluation is to demonstrate the equivalence of capillary (fingerprick) whole blood and venous whole blood on the Syphilis Ultra test device/ Test strip (Whole Blood/Serum/ Plasma) and strip.
2.4 Exploratory Objectives
• To determine the diagnostic accuracy of the Syphilis Ultra test device/ Test (Whole Blood/Serum/ Plasma) and strip.
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Kampala, Naguru
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Uganda |
2021-09-23 |
2024-09-23 |
100 |
3.1 Subject Population
Patients attending the Sexually Transmitted Diseases clinic (STD) at China Friendship Regional referral Hospital Uganda will be enrolled for the study. Patients attending this clinic are referrals from other units presenting with s |
Ministry of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
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Transitioning children to Optimal Regimens of Paediatric Dolutegravir (TORPEDO) in Uganda
REFNo: HS1596ES
the primary objective for the study is to assess patients’/ caregivers’ preference for a paediatric DTG regimen over their previous regimen, when transitioned from another regimen.
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Hoima, Kahora Division
Wakiso, Wkiso
Lira, Lira city
Buikwe, Buikwe
Mayuge, Mayuge
Kampala, Kampala
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Uganda |
2021-09-22 |
2024-09-22 |
approximately 4,000 children and adolescents |
0-19 years |
Clinton Health Access Initiative |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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