Grace Ndeezi
ID: UNCST-2019-R001802
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Nutritional management of growth faltering in infants aged under six months. Study protocol for an individually randomised trial
REFNo: HS2766ES
To determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.
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Iganga,
Iganga,
Iganga,
Iganga,
Iganga,
Mayuge,
Mayuge,
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Uganda |
2023-04-26 11:15:23 |
2026-04-26 |
900 infants |
Pregnant women (and adolescents) aged 15 to 45 years. Their babies will be enrolled at birth for a nutritional intervention. Both female and male babies will be enrolled. There will be no exclusion based on tribe as long as they comprehend English and Lusoga. |
World Health Organisation |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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ELIZABETH ASIGE
ID:
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THE IMPACT AND COST-EFFECTIVENESS OF A COMMUNITY-BASED
PROGRAM FOR CHILDREN WITH CEREBRAL PALSY AND THEIR CAREGIVERS AND
THE STAKEHOLDERS IN UGANDA.
REFNo: HS1979ES
1. To examine the impact of a community-based program on children with CP reported frequency of participation in the home, school, and community activities.
2. To assess the impact of a community-based training program on improving caregiver knowledge regarding CP and reducing caregiver stress.
3. To determine the impact of a communication and advocacy program in broadening stakeholders’ knowledge, attitude and practices regarding childhood disability and inclusion.
4. To determine the cost-effectiveness of a community-based program on children with CP, their caregivers, and the stakeholders in relation to costs and benefits.
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Iganga, Iganga
Mayuge, Mayuge
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Uganda |
2023-04-20 21:15:22 |
2026-04-20 |
100 participants- 50 in the study group and 50 in the control group |
The study population will comprise children and youth with cerebral palsy aged 2-22 years, both male and female, and their primary caregivers of any tribe living in the study communities plus the community stakeholders |
Prof. Hans Forssberg -Karolinska Institutet Astrid Lindgren Children’s Hospital 17176, Stockholm Sweden |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
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Beatrice Onyango Ekesa
ID:
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Bio-efficacy of Pro-Vitamin A-rich banana to improve vitamin A status among children in Uganda living in an area with a high burden of inflammation
REFNo: HS2721ES
3. Establish the stability of retinol isotopes on DSS at room temperature in the determination of TBS of vitamin A.,2. Assess the effect of inflammation and nutritional status on vitamin A absorption and TBS assessment among school-aged Ugandan children.,1. Determine the bio-efficacy of carotenoids in Pro-Vitamin A rich bananas in improving TBS in children aged 6-14years.,This study will determine the bio-efficacy of carotenoids in Pro-Vitamin A-rich banana-based diets and their potential in improving the vitamin A body stores by the RID technique among school-going children aged 6-14years living in Tororo district, an area with a high burden of inflammation.,
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Tororo, Aturukuk
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Kenya |
2023-04-19 12:44:24 |
2026-04-19 |
110 |
The study will be conducted among school going children aged 6-14 years because the school setting facilitates the feeding trial and monitoring, and the age group forms the youngest group available in an organised setting that can easily be engaged for a long period. In addition, this age group is not involved in the current national vitamin A supplementation programs. |
International Atomic Energy Agency (IAEA) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Pontiano Kaleebu
ID: UNCST-2020-R019901
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Field Evaluation of National HIV Testing Services Algorithm
REFNo: HS2701ES
Main Objective
To determine the appropriate HIV rapid test algorithm to be used in Uganda considering the new kits on the market.
Specific objectives
1. To assess specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV) of the rapid HIV tests on the market in Uganda and come up with best RDT algorithm.
2. To identify an algorithm that will best identify acute HIV infections
3. To determine the inter-observer and inter-lab agreement in HIV diagnosis using evaluated RDTs.
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Gulu, Lacor hospital
Mbarara, Mbarara hospital
Tororo, AIC and TASO
Central Region, UVRI CLINIC
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Uganda |
2023-04-12 15:44:58 |
2026-04-12 |
3500 |
Adults aged 18 years and above who would have come for an HIV test |
The Global Fund |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Francis Ssali
ID: UNCST-2021-R012134
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Protocol A5394: “Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV” Version 1.0, May 27, 2022
REFNo: HS2647ES
1.2 Primary Objectives
1.2.1 To assess the safety and tolerability of treatment with SLGN administered once weekly by mouth for 24 weeks.
1.2.2 To determine the proportion of participants with ≥1 log10 IU/mL decline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24.
1.3 Secondary Objectives
1.3.1 To determine the proportion of participants with ≥1 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.
1.3.2 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg after SLGN treatment at Week 24.
1.3.3 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.
1.3.4 To evaluate the proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up.
1.3.5 To evaluate changes in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 after SLGN initiation and, separately, among the placebo recipients.
1.3.6 To determine the proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study, by study arm.
1.3.7 To determine the proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study, by study arm.
1.3.8 To determine the proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study, by study arm.
1.3.9 To evaluate levels of circulating cytokines, including IFN-gamma, IL-12p40, IL-1RA, and CD163 at entry, 24 hours post-first study drug dose, Weeks 4, 12, 24, 36, and 48, by study arm.
1.3.10 To determine whether administration of SLGN will perturb HIV latency as measured by an increase in HIV transcription.
1.3.11 To determine whether administration of SLGN will decrease the size of the latent reservoir, as measured by the change in amount of cell-associated unspliced HIV RNA, HIV DNA, replication-competent and/or intact virus at Weeks 2, 4, 24, and 48.
1.4 Exploratory Objectives
1.4.1 To define the pharmacokinetic (PK) profile and PK-pharmacodynamic (PD) associations of SLGN in people with both HIV and CHB taking suppressive antiviral therapy for both viruses.
1.4.2 To explore if SLGN and antiretroviral (ARV) PK are altered when administered together.
1.4.3 To evaluate participants’ adherence by using several tools, including self-report, directly observed therapy (DOT), and drug concentrations.
1.4.4 To compare quantitative changes in experimental measures of HBV antiviral efficacy (including HBV RNA, hepatitis B core related antigen [HBcrAg], qHBeAg, and low positive HBsAg measured with a high sensitivity qHBsAg assay [LLOQ of 0.05 IU/mL]) and measure changes in large, medium, and small HBsAg isoforms from baseline during and after treatment.
1.4.5 To determine the immunological effects of SLGN on circulating immune signaling by performing single cell RNA sequencing using peripheral blood mononuclear cells (PBMCs) and evaluating HIV-specific T-cell responses.
1.4.6 To determine the effects on circulating immune cells, including cellular phenotypes and T and B-cell responses.
1.4.7 To determine whether administration of SLGN will affect levels of circulating cytokines, including TNF-alpha, IL-12, IL18, IP-10, ISG15, IL-21, Fas Ligand, and TRAIL.
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Kampala, Seguku
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Uganda |
2023-04-12 14:38:49 |
2026-04-12 |
The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if replacements are needed for key analyses. |
Participants with both (1) HIV and chronic hepatitis B (CHB) on suppressive effective antiviral therapy for HIV (ART) and HBV for ≥5 years immediately prior to study entry and (2) screening quantitative hepatitis B surface antigen (qHBsAg) >1000 IU/mL, and without evidence of advanced liver fibrosis or cirrhosis. Enrollment of women (female sex assigned at birth) is encouraged, and the study will set an enrollment goal of at least 14 women. The study is expected to enroll participants in North America, South America, Africa, and Asia. For the first 9 months, enrollment will be capped at 24 participants at US sites and 24 participants at non-US sites. After 9 months, enrollment will be open to all sites without regional caps
The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if r
eplacements are needed for key analyses.
There are no Uganda specific differences.
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National Institute of Allergy and Infectious Diseases, Gilead Sciences, Inc. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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