Dennis Buwembo Rogers
ID: UNCST-2021-R011765
|
QUALITY OF SELF-CARE FOR OLDER (AGED 60 YEARS AND ABOVE) PEOPLE WITH DEMENTIA IN WAKISO DISTRICT, UGANDA. CAREGIVER PERCEPTIONS, AND EFFECTS OF A PSYCHOEDUCATION INTERVENTION ON QUALITY OF SELF-CARE.
REFNo: HS2958ES
To determine the effect of a remotely delivered psychoeducation intervention for caregivers of older people with dementia on the quality of self-care.,To explore the perception, caregivers of older people with dementia have towards quality of self-care.,To measure the quality of self-care for older people with dementia in Wakiso district, Uganda.,To Improve quality of self-care provided to older people with dementia through use of a remotely delivered psychoeducation intervention of caregivers of older people with dementia in Wakiso, district Uganda.,
|
Wakiso, Kiwenda
|
Uganda |
2023-09-19 7:51:22 |
2026-09-19 |
71 |
Caregivers of older people diagnosed with dementia, 18-70 years, both female and males, all tribes as applicable |
Brain Health Training Program |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Dennis Ssesanga Ernest
ID: UNCST-2023-R008022
|
EFFECT OF MHEALTH COMMUNICATION ON STIGMA AND RETENTION IN CARE AMONG YOUTH LIVING WITH HIV AND LINKED TO CARE IN UGANDA.
REFNo: SS2215ES
1. To explore the effect of mhealth communication on stigma among youth living with HIV and linked to care in Uganda.
2. To systematically develop and evaluate an mHealth intervention on stigma and retention in care among youth living with HIV and linked to care in Uganda.
3. To investigate the determinants of stigma and retention in care among youth living with HIV and linked to care in Uganda.
4. To determine the effect of mhealth communication on retention in care among youth living with HIV and linked to care in Uganda.
|
Kampala, Nsambya
Kampala, Mulago
Jinja,
Jinja,
|
Uganda |
2023-12-19 11:26:33 |
2026-12-19 |
142 |
Participants will include voluntary consented and assented HIV-positive patients aged 15-24 years, who communicate in English, Lusoga or Luganda. Clinical |
Uganda Virus Research Institute |
Social Science and Humanities |
Clinical Trial |
Degree Award |
|
Deo Wabwire Ogema
ID: UNCST-2021-R013932
|
COVPN 3008: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0 16 May 2021
REFNo: HS1659ES
The primary objectives are:
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
•To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Secondary objectives are to evaluate the following:
•Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
•Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)
The exploratory objectives are to evaluate:
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
•Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
•Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
•Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial
|
Kampala, Mulago 1
|
Uganda |
2021-08-20 |
2024-08-20 |
14,000 across all sites, about 500 from Uganda |
The study population will include
1.Adults aged 40 years or more with at least one co-morbid factor associated with severe COVID 19
2.People living with HIV who are 18 years and above
Pregnant women aged 18 years and above |
South African Medical Research Council (SAMRC) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Deo Wabwire Ogema
ID: UNCST-2021-R013932
|
A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB) Version 2.0, Dated 21 Mar 2024
REFNo: HS5088ES
Primary objectives
(i)To compare Mycobacterial Growth in Tube (MGIT) liquid culture Time to Positivity (TTP) slope over the first 6 weeks of treatment for each experimental treatment arm to the standard of care (SOC) arm.
(ii)To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8weeks of treatment for each experimental treatment arm to the SOC arm.
Secondary Objectives
i)To compare time to stable culture conversion by MGIT liquid culture by week 8
for each experimental treatment arm to the SOC arm.
ii)To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for
each experimental treatment arm to the SOC arm.
iii) To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for
each experimental treatment arm to the SOC arm.
iv) To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26
weeks of treatment for each experimental treatment arm to the SOC arm.
v) To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.
vi) To compare a composite of efficacy and safety outcomes using a risk-benefit
approach for each experimental treatment arm to the SOC arm.
vii) To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.
viii) To compare durable cure by 52 weeks after treatment initiation in each
experimental treatment arm to the SOC arm.
|
Kampala, Mulago
|
Uganda |
2024-11-13 18:02:04 |
2027-11-13 |
315 participants |
Participants will be individuals (male and female) with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years.
Pregnant women will be excluded from the study. |
US National Institute of Allergy and Infectious Diseases. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Esther Cathlyn Atukunda
ID: UNCST-2022-R009265
|
Evaluating Healthy Families PrEP: an intervention to promote PrEP use during periconception, pregnancy and postpartum periods for women in rural Uganda
REFNo: HS6117ES
1. Adapt Healthy Families-PrEP (HF-PrEP) to community clinics in Mbarara and Sheema Districts, Uganda to include postpartum women guided by our conceptual framework and the Consolidated Framework for Implementation Research (CFIR
2. Test Healthy Families-PrEP intervention effectiveness in a cluster-randomized control trial in Ugandan community health centers (HCs)
3. Determine incremental cost-per-person participating in Healthy Families-PrEP and estimate cost-effectiveness per incident HIV infection averted among women and their infants.
|
Mbarara, All parishes
Sheema, All parishes
|
Uganda |
2025-07-09 16:14:46 |
2028-07-09 |
approximately 700 women |
There will be two groups of participants engaged for these studies:
1) women ages 18-45 years, in periconception, pregnant, and postpartum periods seeking health services from the community health centers
2) healthcare providers, administrators, and Ministry of Health officials
|
National Institute of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Esther Buregyeya
ID: UNCST-2020-R014116
|
Secondary distribution of HIV self-testing by Female Sex Workers, pre-exposure prophylaxis (PrEP) starter packs and brief counseling to promote PrEP initiation and persistence among high-risk men in Uganda
REFNo: HS4891ES
Determine acceptability, feasibility, and safety of the intervention, and preliminary estimates of the potential for the intervention, compared to the control, to promote PrEP initiation, adherence, and persistence among male clients,Conduct an initial (stage 1a) small pilot of the intervention and refine it in preparation for the stage 1b pilot trial,Create the proposed Kayungirizi intervention to promote PrEP initiation and persistence among male clients of FSW through qualitative research informing adaptation and integration of components of local models and aspects of evidence-based interventions,Our overall hypothesis is that secondary distribution of HIVST by FSW to their male clients as an entry point to generate demand for PrEP, followed by an FSW-led intervention to address ongoing structural, interpersonal, and individual-level barriers (convenience, confidentiality/stigma, flexibility) will promote PrEP initiation, adherence, and persistence among male clients. ,
|
Kampala, Bwaise
Kampala, Bwaise
|
Uganda |
2024-10-31 17:21:44 |
2027-10-31 |
140 |
Both male clients of Female Sex Workers (FSW) and the FSW
Age 18+ |
National institute of health (NIH) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
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.
|
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 |
|
Namulema Edith
ID:
|
Feasibility of using Continuous Positive Airway Pressure via the ‘LeVe CPAP System’ among Children with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A mixed methods study
REFNo: HS2478ES
1) To assess the acceptability of the LeVe CPAP system to deliver continuous positive airway pressure among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.
2) To assess the safety of LeVe CPAP system among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.
|
Kampala, 1
|
Uganda |
2022-11-09 13:49:10 |
2025-11-09 |
40 |
Paediatric patients of Age > 1 month with hypoxemic respiratory failure and caretakers admitted at the paediatric ward. |
Leeds University |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Edwin Nuwagira
ID: UNCST-2021-R013488
|
EFFICACY AND TOLERABILITY OF SHORT-COURSE INTERMITTENT INTRAVENOUS LIPOSOMAL AMPHOTERICIN B VERSUS ORAL POSACONAZOLE FOR CHRONIC PULMONARY ASPERGILLOSIS: A PHASE IIA, PROSPECTIVE, MULTI-CENTRE, RANDOMIZED, CONTROLLED, OPEN-LABEL, FEASIBILITY TRIAL
REFNo: HS6400ES
5. Assess recruitment and retention of patients with CPA on a trial to inform design and sample size for a definitive efficacy trial.,4. To assess adherence to posaconazole therapy,3. To evaluate the utility of different trial endpoints (change in Aspergillus IgG antibody titer, radiological improvement, step test and weight) across groups.,2. To compare 12-month all-cause mortality in each arm,1. To measure emergence of isolates of Aspergillus with resistance/reduced susceptibility to posaconazole in both arms. ,1. Compare the efficacy and tolerability of 1) short course, high dose of intravenous liposomal amphotericin B, 2) short course, high dose of intravenous liposomal amphotericin B followed by daily posaconazole, or 3) posaconazole alone for the treatment of CPA for 6 months.,
|
Mbarara, Medical cell
Gulu, Medical cell
Kampala, Salama road
|
Uganda |
2025-08-26 13:48:03 |
2028-08-26 |
120 |
Adults, age > or = to 18 years
All Ugandan tribes living in Ankole/Kigezi sub region
Both women and men |
Fungal Infection Trust |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
|
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.
|
Hoima, Kahora Division
Wakiso, Wkiso
Lira, Lira city
Buikwe, Buikwe
Mayuge, Mayuge
Kampala, Kampala
|
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 |
|
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).
|
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 |
|
Nanyonga Elizabeth Monica
ID: UNCST-2025-R018232
|
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REFNo: SIR516ES
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|
|
Uganda |
2025-05-27 9:30:38 |
2028-05-27 |
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Engineering and Technology |
Clinical Trial |
Non-degree Award |
|
Emmy Okello
ID: UNCST-2020-R009792
|
Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial
REFNo: HS1865ES
RIC will reduce the rates of all-cause death and early post-myocardial heart failure by approximately 25% when compared to sham control.,The RIC-AFRICA trial will investigate the effect of RIC in STEMI patients on the rates of all-cause death and early post-MI heart failure (pre-discharge HF and hospitalisation for HF at 30 days post-MI,) when compared to sham control,
|
,
Kampala, MULAGO
|
Uganda |
2022-02-01 |
2025-02-01 |
1500 |
Participants will be recruited from the Uganda Heart Institute and other nearby
state and private hospitals with STEMI care with in Uganda and other
collaborating sites in Sub-Saharan countries
|
Mancherje-Potash Foundation, USA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
EVA NATUKUNDA
ID: UNCST-2020-R014330
|
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
REFNo: HS4706ES
To provide Continued Access to Study Drug to Participants Who Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
|
Kampala, lubowa
|
Uganda |
2024-09-25 12:50:13 |
2027-09-25 |
86 |
5 to 18 years |
Gilead sciences |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Esther Atukunda Cathyln
ID: UNCST-2019-R001701
|
Integration of a patient-centered mobile health intervention (Support-Moms) into routine antenatal care to improve maternal health in Uganda.
REFNo: HS3366ES
Evaluate the cost and cost-effectiveness of implementing Support-Moms intervention into routine care and implications for sustainability,Evaluate intervention implementation using the Proctor framework and plan for future scale-up per the Consolidated Framework for Implementation Research ,Test the effectiveness of the Support-Moms intervention in a randomized controlled trial,
|
|
Uganda |
2023-11-13 12:57:49 |
2026-11-13 |
824 |
We will include individuals who: 1) are in the first trimester of pregnancy who have not yet presented for ANC, 2) reside in the catchment area of a study HC, 3) are emancipated minors and adults aged ≥ 18 years, 4) report access to a cell phone with reception in their home, 5) are able to identify at least two social supporters living within the study districts, and 6) are able to provide consent. |
National Institutes of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Etheldreda Nakimuli-Mpungu
ID: UNCST-2020-R014808
|
Tele-Psychotherapy for Youth using Mobile Phones during Covid-19 Pandemic
REFNo: HS2106ES
1. We aim to conduct online and community-based participatory qualitative research to obtain information on the potential usefulness of individual tele-support psychotherapy in addressing depression during the Covid-19 pandemic.
2. We will compare the effectiveness of individual tele-support psychotherapy (TSP) delivered by trained lay counsellors in combination with standard mental health services (SMHS) for depression with use of SMHS alone.
3. We aim to compare the effects of TSP combined with SMHS and SMHS alone on other psychosocial variables including self-esteem, anxiety, alcohol and substance use, social support, stigma, number of disability days, asset possession, poverty indices, and cost-effectiveness measures.
4. To conduct a process evaluation of trial activities informed by Linnan and Steckler’s process evaluation frameworks to specifically determine indicators of feasibility, acceptability, fidelity, and to explore causal mediating processes and contextual influences
5. We will also explore whether or not the effects of TSP and SMHS are moderated by alcohol and drug use.
6. We shall explore whether the strength of a therapeutic relationship will mediate the effects of TSP and SMHS on depression
|
Kampala, Makerere
Kampala, Kamwokya Parish
Kampala, Naguru Ii Parish or Go down
|
Uganda |
2022-04-21 |
2025-04-21 |
300 |
To be eligible for the study, each participant must be 15-30 years old, diagnosed with significant depression symptoms assessed with the self reporting questionnaire, residing in Naguru Go-down and Kamwokya slums, or Makerere University campus. |
USAID (DIV) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eugene Ruzagira
ID: UNCST-2023-R008282
|
A phase Ib study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague in Uganda
REFNo: HS2387ES
Primary
To investigate safety and tolerability of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine in healthy African adults aged 18 to 49 residing in Uganda, when given as one or two dose(s) intramuscularly with different prime-boost intervals
Secondary
To determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals.
Tertiary
Exploratory immunogenicity assays to determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals.
|
Masaka, KATWE
|
Uganda |
2022-09-12 18:28:42 |
2025-09-12 |
36 |
Healthy male or female African adults aged 18-49 years, inclusive. Inclusion and exclusion criteria are as follows:
Inclusion Criteria
• Willing and able to give informed consent for participation in the trial.
• Male or female aged between 18-49 years inclusive at enrolment (first vaccination visit, V1)
• In good health as determined by
o Medical history (as determined by verbal medical history)
o Physical examination
o Clinical judgment of the investigators
• Female participants of childbearing potential must be willing to ensure that they use effective contraception during the trial and for 3 months after the last vaccination.
• Female participants of childbearing potential must have a negative pregnancy test on the day(s) of screening and vaccination.
• Able to attend the scheduled visits and to comply with all study procedures
• Agrees to refrain from donating blood for the duration of the trial
• Clinically acceptable baseline screening results (includes vital signs, physical examination, urinalysis, and laboratory results)
• In the Investigator’s opinion, is able and willing to comply with all trial requirements.
Exclusion Criteria
The participant may not be enrolled in the study if any of the following apply:
• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• History of significant organ/system disease that could interfere with trial conduct or completion. This includes a known history of significant disease in the following:
o Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death
o Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease
o Endocrine disorders such as diabetes mellitus and Addison’s disease
o Significant renal or bladder disease
o Biliary tract disease
o Gastro-intestinal disease such as inflammatory bowel disease, major abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)
o Neurological disease such as seizures and myasthenia gravis
o Haematological problems such as coagulation problems or anaemia (haemoglobin < 12.5g/dL for females and < 13.5 g/dL and for males)
o Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
o Psychiatric illness requiring hospitalisation or depression if severity is deemed clinically significant by the study Investigators
o Known or suspected drug and/or alcohol misuse
o Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ
• Any other significant disease or disorder which, in the opinion of the Investigator, could:
o Put the participant at risk because of participation in the trial
o Influence the result of the trial
o Impair the participant’s ability to participate in the trial
• History of allergy to a vaccine or any component of the vaccines used in this study
• History of anaphylaxis
• Have any known or suspected impairment or alteration of immune function, resulting from, for example:
o Congenital or acquired immunodeficiency
o Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
o Autoimmune disease
o Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months).
• Receipt of immunoglobulins or any blood product transfusion within 3 months prior to enrolment
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
• Weight <50kg or a body mass index (BMI) greater than 35kg/m2.
• Known history of previous occurrence of disease caused by Y. pestis or receipt of a vaccine against plague
• Current active participation in another research study involving an investigational product (including receipt of an IMP within last 30 days) or where involvement in this study could impact the results
• It is not in the best interest of the volunteer to participate in the trial, in the opinion of the Investigator.
|
University of Oxford |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eugene Ruzagira
ID: UNCST-2023-R008282
|
Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV Control in Sub-Saharan Africa: A pragmatic Phase 3 Open-label Randomized Controlled Trial.
REFNo: HS2475ES
Primary objective:
To demonstrate the non-inferior efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long acting (LA) plus rilpivirine (RPV) LA compared with continuation of first-line oral ART over 12 months in people living with HIV (PLHIV) with a history of, or at risk of, sub-optimal HIV control.
Secondary objectives:
1) To demonstrate the antiviral activity and the impact on retention in HIV care of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care.
2) To demonstrate the immunological activity of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care. This will be measured through change in CD4+ T cell count and incidence of HIV disease progression.
3) To evaluate the safety and tolerability of switching to Q2M CAB LA + RPV LA compared to continuation of oral ART.
4) To assess genotypic viral resistance in participants experiencing protocol-defined confirmed virological failure (plasma HIV-1 RNA >200 c/ml) and its impact on future treatment options including proportion who resuppress on dolutegravir.
5) To evaluate the effect of Q2M CAB LA + RPV LA on health-related quality of live, treatment satisfaction and treatment adherence. To describe cost-effectiveness and acceptability of the regimen.
|
Kampala, NOT APPLICABLE
Wakiso, Entebbe
Western Region, Fort Portal
|
Uganda |
2022-11-02 17:27:11 |
2025-11-02 |
540 |
Age: Adults 18 years and above
Gender: Any
Source: HIV clinics in Uganda (MRC/UVRI & LSHTM Entebbe, Infectious Diseases Institute Kampala, Joint Clinical Research Centre clinics in Fort Portal and Lubowa)
Method of recruitment: Pre-screening of clinic database to identify potentially eligible participants who are counselled about the study and invited to be screened. Only adults who are eligible after the screening period are randomized.
|
London School of Hygiene and Tropical Medicine |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eugene Ruzagira
ID: UNCST-2023-R008282
|
A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-MTM in African children living with HIV.
REFNo: HS2496ES
Primary objective
a) To assess the safety and reactogenicity profile of the malaria vaccine candidate
R21/Matrix-MTM in 5-36-month-old African children living with HIV
Secondary objectives
a) To assess the humoral immunogenicity of R21/Matrix- MTM in 5-36-month-old African
children, comparing children living with HIV with HIV negative children
b) To assess the impact of vaccination on HIV reservoir
c) To assess whether increasing age and nadir CD4 count are associated with
immunogenicity of R21/Matrix-MTM in 5-36- month-old African children living with
HIV
Tertiary objectives
a) To assess the immunogenicity profile of R21/Matrix-MTM in 5- 36-month-old African
children, comparing children living with HIV with HIV negative children
|
Wakiso, Central
|
Uganda |
2022-10-20 18:13:49 |
2025-10-20 |
120 |
120 Children aged 5-36 months will be recruited to the trial. HIV positive children will be recruited from Pediatric HIV care centers within Kampala and Wakiso districts while HIV
negative children will be recruited from Entebbe hospital and primary health care centers that provide immunisation and growth monitoring services within Kampala and Wakiso districts.
100 children with confirmed HIV infection will be recruited to group 1 and 20 children without
HIV will be recruited to group 2.
|
The Serum Institute of India Pvt Ltd |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eugene Ruzagira
ID: UNCST-2023-R008282
|
Implementing oral (event-driven and daily) and long-acting Pre-exposure
prophylaxis (PrEP) in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)
REFNo: HS4366ES
Overall Objective
To assess effectiveness and implementation of long-acting cabotegravir (CAB-LA) and oral Truvada (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice.
|
Masaka, Masaka
|
Uganda |
2024-07-02 15:08:06 |
2027-07-02 |
400 mobile men. |
HIV negative men aged 18+ years in South
Africa and Uganda. Men who are mobile for work, and in the past 6-months have travelled for work or to find work and spent at least one night away from home for work-related purposes. Men male at birth, able and willing to provide informed consent and willing to have an HIV test. |
MRC/UVRI &LSHTM Uganda Research Unit |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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