Susan Nabadda
ID: UNCST-2020-R014331
|
CLINICAL PERFORMANCE EVALUATION (RETROSPECTIVE STUDY) OF THE STANDARD Q HIV/SYPHILIS/HBsAg TRIPLE TEST
REFNo: HS6651ES
Quantify the proportion of uninterpretable (Invalid) results to gauge operational feasibility based on the invalid rate.,Assess Inter-reader Variability among different operators to ensure consistency in test interpretation and hence reliability in real-world settings.,To assess the diagnostic accuracy of the STANDARD Q HIV/Syphilis/HBsAg Triple Test, a rapid chromatographic immunoassay for simultaneous detection of HIV-1/2 antibodies, syphilis (Treponema pallidum) antibodies, and hepatitis B surface antigen (HBsAg). ,
|
Kampala, National Health Laboratory and Diagnostic Service, Ministry of Health
|
Uganda |
2026-02-12 13:03:06 |
2029-02-12 |
Sample sizes for each disease analyte are calculated to achieve 95% confidence intervals with ±5% margin of error for sensitivity/specificity estimates. Clinical performance will follow the WHO TSS-1, TSS-6 and TSS-13 which require a sample size of up to 1000 samples; to achieve a pre-test clinical performance assessment of the HIV/Syphilis/HBsAg rapid diagnostic test kit, 50 samples of each disease analyte category will be used. |
Stored samples for 18 years and above for both males and females for all tribes will be considered. This retrospective study shall use archived samples from the CPHL biorepository with proof that at the time of sample collection, the source of the selected sample signed a broad consent indicating acceptance of storage for future research use of the remnant of their collected sample. Samples shall be selected from already known specific disease-characterized sets of positive and negative HIV, Syphilis and HBsAg. |
Department of National Health Laboratory and Diagnostic Service, Ministry of Health |
Medical and Health Sciences |
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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|
Christopher Turyatunga Bernard
ID: UNCST-2023-R006842
|
Drivers, profiling and drugs resistance effects, outcomes and cost-effectiveness of diagnostic and Syndromic interventions among urogenital discharging patients in southwestern Uganda
REFNo: HS3796ES
Establish the aetiology and sensitivity profile of urogenital discharges among patients in south western Uganda. ,5. Evaluate the Comparative cost effectiveness of diagnostic and Syndromic approaches in the management of patients with urogenital discharges in south western Uganda.,4. Compare the treatment outcomes between syndromic and diagnostic approaches in the management of patients with urogenital discharges in south western Uganda.,3. Determine the drivers of drugs resistance among patients with urogenital discharges in south western Uganda. ,2. Determine the effect of drugs’ resistance on the management of patients with urogenital discharges in south western Uganda.,This study is aimed at establishing the drivers, profiling and effect of drugs resistance, comparative treatment outcomes and cost-effectiveness of diagnostic and Syndromic interventions on patients with urogenital discharges in southwestern Uganda, and it is a parallel randomized intervention at STI clinics of Kabale and Mbarara Regional Referral Hospitals and Kisiizi Mission Hospital.,
|
|
Uganda |
2024-04-26 9:21:22 |
2027-04-26 |
476 |
Females and males Participants aged 15 to 60 years, with urethral and abnormal vaginal discharges void of HIV/AIDS, Diabetes Mellitus and pregnancy who have sought treatment more than once in the previous three months. |
MUST and STUDY Participants |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Catriona Waitt John
ID: UNCST-2019-R001068
|
Implementation of a "bundle of care" to improve anticoagulation control in patients receiving warfarin in Uganda and South Africa
REFNo: HS1422ES
Primary objective is to evaluate whether implementation of warfarin bundle improves time in therapeutic range
Secondary objectives are:
-To evaluate whether implementation of the warfarin bundle improves time to achieving a therapeutic INR
-Whether implementation of the warfarin bundle affects the occurrence of adverse events(death, bleeding and thrombotic events)
-whether staff find the interventions contained in the bundle acceptable
-To explore patients' experiences and acceptability of the package of care, and
-Whether the bundle represents good value for money
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Kampala, Salaama
Kampala, Mulago
|
UK |
2021-07-09 |
2024-07-09 |
444 |
Adult patients (18 years or older),male or female newly initiated on warfarin for the first time |
University of Liverpool |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Catriona Waitt John
ID: UNCST-2019-R001068
|
Drug Optimisation for LMICs in Pregnant HIV mothers and their INfants: temporary switch to CAB/RPV long acting injections in postpartum period
REFNo: HS5982ES
To characterise drug exposure in breast milk, and drug transfer to infants through breastfeeding, as well as infant drug elimination.
To characterise the elimination of CAB/RPV by describing PK profiles of IM CAB/RPV LA after last injection between 48 and 96 weeks.
To establish strategies on how to safely re-establish oral ART after discontinuation of IM CAB/RPV LA at 48 weeks and switch back to daily oral ART.
To explore early postpartum PK of CAB/RPV in maternal plasma and breastmilk.
To demonstrate antiviral activity and impact on retention in HIV care of temporarily switching to CAB/RPV LA compared with continuation of daily oral ART over 48 weeks.,
|
Kampala, Kampala
|
UK |
2025-09-17 13:21:16 |
2028-09-17 |
309 |
Consenting pregnant women living with HIV |
University of CapeTown |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Daniella Akellot
ID:
|
EVALUATION OF THE EFFECTIVENESS OF CLORPACTIN IN COMPARISON WITH OTHER WOUND DRESSING AGENTS USED AT SIGN SUPPORTED HOSPITALS IN UGANDA
REFNo: HS2769ES
To determine the effectiveness of Clorpactin in wound dressing at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor.,
|
Kumi, Booma South
Gulu, ForGod
|
Uganda |
2023-07-03 13:32:54 |
2026-07-03 |
546 patients |
Patients admitted at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor with surgical wound sepsis, infected open fractures, diabetic wounds, chronic osteomyelitis. |
SIGN Fracture Care International |
Medical and Health Sciences |
Clinical Trial |
Non-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 |
|
Daniella Ferguson
ID:
|
A Retrospective Analysis of Suramin Treatment forStage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (S1 TBR HAT) in Uganda and Malawi
REFNo: HS2582ES
Primary objectives
The primary objective is to determine whether standard of care treatment with suramin, as currently practiced in Uganda and Malawi, leads to better health outcomes in patients with S1 TBR HAT than observed in an untreated natural history cohort with source data from a published epidemiologic study.
Secondary objectives
The secondary objective is to evaluatethe safety and tolerability of suramin.
|
Kaberamaido, Lwala
|
South Africa |
2022-12-19 12:17:26 |
2025-12-19 |
150 -200 patients |
The study will include TBR HAT patients treated with suramin between 2000 and 2020 in Uganda and Malawi. The study will include all of the approximately 150 - 250 patients evaluated through chart review who are deemed eligible and have sufficient data. A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. |
PaxMedica, Inc. 303 South Broadway Suite 125 Tarrytown, NY |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
David Meya Bisagaya
ID: UNCST-2019-R000837
|
Platform Trial For Cryptococcal Meningitis - PLATFORM-CM
REFNo: HS2649ES
The purpose of this study is to know whether this oral form of amphotericin (MAT2203) is safe and effective in the treatment of people sick with cryptococcal meningitis.
|
Mbarara, Mbarara
Masaka, Masaka
Kampala, Kampala
|
Uganda |
2023-05-25 12:01:51 |
2026-05-25 |
270 |
Adult (18 years and above) males and females HIV-infected persons with cryptococcal meningitis. |
Matinas BioPharma Nanotechnologies, Inc. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
David Meya Bisagaya
ID: UNCST-2019-R000837
|
A Phase 2 Novel Antimicrobial Combination Therapy to Treat Tuberculous Meningitis
REFNo: HS5711ES
1. Assess the safety and efficacy of a novel anti-TB combination regimen with greater bactericidal activity than current standard of care (SOC) therapy
|
Kampala, all parishes
Mbarara, all parishes
|
Uganda |
2025-07-18 14:05:06 |
2028-07-18 |
150 |
All adults with TBM meningitis (definite, probable) with HIV, per the uniform TBM case definition. |
Meningitis Foundation |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Deborah Ojiambo
ID:
|
Efficacy of Group Activity Adherence Counselling (GAAC) for Adolescents with Unsuppressed HIV viral load at three large HIV clinics in Uganda: Randomized controlled trial
REFNo: SS805ES
1.To examine the barriers such as behavior problems and mental health problems to adherence experienced by adolescents living with HIV.
2.To evaluate the efficacy of GAAC in addressing barriers to adherence among adolescents living with HIV.
3.To assess whether GAAC is associated with viral load suppression, among adolescents living with HIV compared to Standard Service Provision (SSP)
|
Kampala, Mulago 1
Wakiso, Entebbe
|
Uganda |
2021-07-07 |
2024-07-07 |
300 |
The population for this study is school-going adolescents living with HIV (12-18 years) who received ART for at least 6 or more months at Mulago ISS, TASO Mulago, TASO Entebbe HIV clinics |
Makerere University Research and Innovation Fund (RIF) funded by Uganda government |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
Field Performance Evaluation of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in Uganda
REFNo: HS1606ES
Main objective
To evaluate the field performance of the m-PIMATM HIV-1/2 VL plasma VL in identifying virological failure (VF) in adults on ART. The performance will be compared to standard PCR assays used at UNHLs and UVRI.
2.3.2 Primary objectives
I). To evaluate the diagnostic accuracy using the sensitivity, specificity, NPV, PPV, FPR and FNR of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in comparison to a reference assay of HIV-1 RNA PCR in identifying HIV-VF at the WHO recommended threshold of 1000 copies/ml for HIV-1 infected.
II). To determine the operational characteristics of the m-PIMAâ„¢ HIV-1/2 VL plasma assay, such as ease of-use of the assay using the standardized system usability scale (SUS) by laboratory and no laboratory personnel
III). To determine changes in turn-around time and ease of clinic workflow integration.
IV).To determine acceptability of the m-PIMAâ„¢ HIV-1/2 VL plasma assay by the study participants
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Kampala, Kampala
Buikwe, Buikwe
Kayunga, Kayunga
Mpigi, Mpigi Town Council
|
Uganda |
2021-08-11 |
2024-08-11 |
403 participants |
-Adult ART patients who are ≥18 years old on ART for ≥ 6 months will be approached for study participation. Historical controls will be used to compare the time to initiation of intensive adherence counselling (IAC) between the m-PIMA and the standard |
- Abott Diagnostics |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
Performance evaluation of the CheckNOW™ HIV Self-Test study
REFNo: HS2170ES
1. To evaluate the performance (Sensitivity and specificity) of the CheckNOW™ HIV SELF TEST when compared to the Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination (reference testing) in the laboratory and the national testing algorithm.
2. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the professional users, when compared to the reference testing and the national testing algorithm.
3. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the lay users, when compared to the reference testing and the national testing algorithm.
4. To assess the accuracy of the lay user interpretation of the HIVST result. This will be compared with the interpretation by the RA.
5. To assess the usability of the CheckNOW™ HIV SELF TEST. The usability of the test will be evaluated by questionnaires completed by the study staff observers and by the lay users.
|
Kampala, Kampala
Kalungu, Kalungu
Kayunga, Kayunga
Mukono, Mukono
|
Uganda |
2022-04-01 |
2025-04-01 |
1000 |
Adults aged 18 years and above who are willing to have an HIV test. |
- Abott Diagnostics |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
Performance evaluation of the Determine™ HIV Early Detect 4th Generation HIV Rapid Diagnostic test
REFNo: HS2603ES
Primary Objectives:
1. To evaluate the Laboratory performance (Sensitivity and specificity) of the Determine™ HIV Early Detect
2. To assess the field performance of the Determine™ HIV Early Detect in parallel with the Determine™ HIV-1/2 test
Secondary Objective:
1. To assess the effectiveness of the Determine Early Detect to identify acute HIV infection among newly infected individuals
|
Buikwe, kawolo
Kampala, Kisenyi
Kampala, Naguru
Mityana, Mityana
Mukono, Mukono hospital
Wakiso, Wagagai
Wakiso, UVRI
Kayunga, Kayunga hospital
Kalungu, Nkozi hospital
Gomba, Gombe hospital
|
Uganda |
2022-12-23 18:06:59 |
2025-12-23 |
10,000 |
The study will enroll;
- Adults above 18 years of age
- Willing to have an HIV test.
- Eligible for testing as per the National HTS eligibility screening tool
- Documented
|
- Abott Diagnostics |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
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.
|
Gulu, Lacor hospital
Mbarara, Mbarara hospital
Tororo, AIC and TASO
Central Region, UVRI CLINIC
|
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 |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
Field Performance Evaluation of the TrinScreen™ HIV rapid test kit
REFNo: HS3878ES
1. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test, when compared to the national testing algorithm.
2. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test compared to the reference testing (Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination).
3. Estimate the proportion of inconclusive test results by Trinscreen™
|
Kampala, Naguru
Wakiso, kigongo
Gomba, mpigi
Kayunga, Kawolo
Mukono, Mukono
Mpigi, Nkozi
Wakiso, Mityana
Wakiso, wagagai
Kayunga, Kayunga
|
Uganda |
2024-03-14 12:38:09 |
2027-03-14 |
1550 |
- Adults above 18 years of age
- Willing to have an HIV test.
- Eligible for testing as per the National HIV testing service eligibility screening tool
- Documented co
|
Trinity Biotech Manufacturing Ltd |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
DAVID KITYA
ID: UNCST-2022-R009620
|
Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2500™) in Detecting Intracranial Hemorrhage in Patients Admitted to Mbarara Regional Referral Hospital
REFNo: HS4141ES
Use these findings to evaluate the InfraScanner 2500™\'s ability to accurately detect intracranial hemorrhages in darker-skinned populations within LMICs. ,Determine whether the InfraScanner 2500™ detects intracranial hemorrhage (ICH) with adequate precision relative to CT scans to be used as an effective triage tool to prioritize imaging and need for level of clinical monitoring in an African, LMIC population.,To demonstrate that the InfraScanner 2500™ is capable of detecting and ruling out intracranial hematomas at rates similar to CT scan in patients hospitalized at Mbarara Regional Referral Hospital who have sustained or are suspected to have sustained head trauma.,
|
Mbarara, Kamukuzi
|
Uganda |
2024-06-24 0:30:16 |
2027-06-24 |
180 |
12 years and above |
Duke Global Neurology Neurosurgery |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Denis Nansera
ID: UNCST-2024-R004002
|
Improving HIV testing among Children under five in Rural Uganda
REFNo: HS5829ES
The main objective of this study is to develop a traditional healer facilitated paediatric HIV testing program to improve access to paediatric HIV testing. To do this, we will first use qualitative study methods to determine factors that influence HIV testing among paediatric clients of TH and guide adaptation of the TH-facilitated HIV testing program for children. We will then implement a pilot study to evaluate offering paediatric HIV testing at traditional healer locations in southwestern Uganda.
|
|
Uganda |
2025-05-29 17:12:49 |
2028-05-29 |
465 |
Aim 1: Key stakeholders for Aim 1 will be defined as 1) adult caretakers of children ≤5 years old who receive care from TH in Mbarara District; 2) TH who care for more than 15 children under five each month; and 3) paediatric HIV clinicians from surrounding Health Centres III and IV. All participants will be 18 years or older, and able to provide informed consent. HIV clinicians must also have been in a patient-facing position (doctor, nurse, social worker, counsellor) for at least one year at the time of enrolment.
Aim 2: The study population will be ten TH with monthly volume of 15 children five years old or younger, and 200 children 18 months to 5 years of age who receive care from these TH practices in Mbarara District. Inclusion criteria for TH: aged 18 or older, consent to recruitment of children at their practice, agree with goals of the study and associated procedures, and agree to attend all study-related training. Exclusion criteria will be the same as in Aim 1 above. Inclusion criteria for children are: 18 months to 5 years old; have a parent or caregiver who can provide informed consent; not previously tested for HIV in the past three months; and not previously known to be HIV-infected. |
National Institute of Mental Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Dominik Biesalski
ID:
|
The Drivers, Effects and Measurement of Time Use Among the Urban Poor: Evidence from Uganda
REFNo: SS1674ES
Get insights into the time use patterns of urban workers and understand their effects on productivity and well-being.
|
Kampala, Kampala
|
Germany |
2023-05-11 14:41:00 |
2026-05-11 |
200 |
Workers who are older than 18 years old, both men and women of all tribes |
Private Enterprise Development in Low-Income Countries (PEDL) |
Social Science and Humanities |
Clinical Trial |
Degree Award |
|
Mohamed Farah Mohamud
ID: UNCST-2025-R016841
|
EFFECTIVENESS OF INTRAVENOUS PETHIDINE VERSUS INTRAVENOUS TRAMADOL FOR PERIOPERATIVE ANALGESIA IN UTERINE EVACUATION PROCEDURES AT JINJA REGIONAL REFERRAL HOSPITAL
REFNo: HS5960ES
1. To assess the effectiveness of intravenous pethidine versus intravenous tramadol for perioperative analgesia in uterine evacuation procedure at Jinja Regional Referral Hospital
2. To compare the secondary outcomes encountered among women administered with intravenous pethidine versus those with Intravenous Tramadol for perioperative analgesia in uterine evacuation procedures at Jinja Regional Referral Hospital
3. To compare the level of patient satisfaction with intravenous pethidine versus Intravenous tramadol in uterine evacuation procedures at Jinja Regional Referral Hospital
|
Jinja, rippon
|
Somalia |
2025-04-30 7:27:21 |
2028-04-30 |
170 |
t All adult women with an indication for uterine evacuation admitted on gynecology ward of Jinja Regional Referral Hospital |
selfsponser |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
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