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
|
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
|
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).
|
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
|
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.
|
Kampala, Naguru
|
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 |
|
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 |
|
ELIZABETH NALINTYA
ID: UNCST-2021-R012882
|
Long title: A community-based Phase III, cluster randomized trial of point-of-care CD4 testing and enhanced screening and prophylaxis in advanced HIV disease
Short title: An enhanced package of care to reduce mortality in advanced HIV disease
REFNo: HS1605ES
Primary Objectives:
1. To assess 24-week survival with retention in care in persons with advanced HIV disease (CD4<200 cells/µL) with point-of-care CD4 testing compared to standard flow cytometry
2. To assess 24-week survival with retention in care with an enhanced diagnostic OI screening and prophylaxis strategy compared to standard WHO package of care in persons with advanced HIV disease
Secondary Objectives:
1. To determine incidence of OIs
2. To measure adverse events with enhanced prophylaxis regimens
3. To assess tolerability and adherence of enhanced prophylaxis regimens
4. To determine incidence and cause of hospitalization for persons with advanced HIV disease
5. To determine cause of death for persons with advanced HIV disease
6. To determine HIV outcomes of viral suppression in persons with advanced HIV disease.
7. Measure cost, cost-effectiveness, and budgetary impact of the CD4 testing strategies, and OI screening and prophylaxis strategies.
|
Kampala,
Wakiso,
|
Uganda |
2021-09-21 |
2024-09-21 |
2400 |
• Age >18 years
• CD4<200 cells/µL
• Ability and willingness to give informed consent for the enhanced package of care arm.
|
INFECTIOUS DISEASES INSTITUTE |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Achilles Katamba
ID: UNCST-2019-R000540
|
Human-Centred Design and Communities of Practice to Improve Delivery of Home based Tuberculosis Contact Investigation in Uganda
REFNo: HS1720ES
General Objective:
The study aims to assess the effectiveness of an enhanced intervention strategy for implementing TB contact investigation relative to usual care.
Specific Objectives:
1.To compare the implementation, effectiveness, and public health impact of TB
contact investigation delivered via an enhanced intervention strategy vs. the usual
care strategy in a stepped-wedge, cluster-randomized implementation trial.
2.To identify implementation processes and contextual factors that influence the
effectiveness of the intervention strategy for TB contact investigation.
3.To compare the costs and epidemiological impact of the intervention and usual care strategies for TB contact investigation.
|
Masaka, Ndejje
Masaka, Masaka
Butambala, Goombe
Wakiso, Wakiso
Wakiso, Ndejje
Kiboga, Kiboga
Mubende, Kasambya
Mubende, Mubende
Mityana, Mityana
Iganga, Iganga
Bugiri, Bugiri
Jinja, Jinja
Wakiso, Entebbe
Wakiso, Kasangati
Kayunga, Kayunga
Kayunga, Nagalama
|
Uganda |
2021-09-17 |
2024-09-17 |
1764 household and close contacts within approximately 2304 eligible index patient clusters over a 16-month period. |
Household and close contacts of index patients with active pulmonary TB |
National Institute of Allergy and Infectious Diseases (NIAID) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Martha Musyoka Mbenia
ID:
|
PREDICTORS OF ADVERSE FETO-MATERNAL OUTCOMES AMONG MOTHERS ADMITTED WITH ANTEPARTUM HEMORRHAGE AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: HS1450ES
To describe adverse outcomes and determine predictors of adverse feto-maternal outcomes in mothers with antepartum hemorrhage at Mbarara Regional Referral Hospital
|
Mbarara, Mbarara
|
Kenya |
2021-09-09 |
2024-09-09 |
107 |
All women of childbearing age presenting with antepartum hemorrhage at Mbarara Regional Referral Hospital |
Self. No conflict of interest anticipated |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Isaac Ssewanyana
ID: UNCST-2020-R014336
|
PERFORMANCE EVALUATION OF COVID-19 ANTIGEN RAPID DIAGNOSTIC TESTS
REFNo: HS1690ES
To determine the association of positive index test results with disease stage (days since symptom onset, e.g. acute, early, late), symptom severity and symptom severity.,To determine the diagnostic accuracy of SARS-CoV-2 Ag RDTs on a respiratory specimen (NP swab, OP swab, nasal swab, saliva), vs Cobas SARS-CoV-2 assay as performed in patients presenting with influenza-like illness.,
|
pakwach,
Kampala, Mulag0
Kampala, Kiruddu
Masaka, Masaka
Mbarara, Mbarara
|
Uganda |
2021-09-08 |
2024-09-08 |
5000 |
• Suspected COVID-19 cases ≥ 18 years of age presenting with symptoms at selected reginal and national referral hospitals in Uganda, will be enrolled for the study. These sites were chosen because they are the regional referral hospitals and register |
FIND, the global alliance for diagnostics |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2021-R013577
|
A clinical trial to assess the safety and immunogenicity of LNP-nCOV saRNA-02, a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19, in SARS-CoV-2 seronegative and seropositive Uganda population
REFNo: HS1641ES
Primary Objective:
• To compare the safety and immune responses for SARS-CoV-2 seronegative and seropositive individuals from two immunisations with LNP-nCOV saRNA-02 administered IM 4 weeks apart at one dose level in 42 participants age 18-45 years.
Exploratory Objectives:
• To characterise the humoral and cellular immune responses to LNP-nCOV saRNA-02 administered at one dose given at 0 weeks and 4 weeks for individuals seronegative and seropositive for SARS-CoV-2 antibodies
• To characterise the profile of class and sub-class of antibody responses
• To characterize infection induced immune responses in participants with naturally acquired infection who are also exposed to the vaccine
|
Masaka, Butego
|
Uganda |
2021-09-08 |
2024-09-08 |
42 |
The study will be conducted in healthy young adults as these individuals generate the most robust responses (18-45 years). Both male and female participants will be included and the trial site will attempt to keep an equal proportion, although the priorit |
The study is sponsored by Imperial College London, funded by the United Kingdom Engineering and Physical Sciences Research Council. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2021-R013577
|
A behavioural Science Research to Determine Factors that Facilitate Future Uptake of HIV Prevention Products and Multi-Purpose Prevention Technologies to Prevent HIV and Unwanted Pregnancy in Sub-Saharan Africa
Universally Accessible HIV Prevention Technologies for African Girls and Young Women through Knowledge Applied from Behavioural Economics (UPTAKE)
REFNo: HS1540ES
Multi-purpose Prevention Technologies (MPTs) to prevent HIV and unwanted pregnancy in Sub-Saharan Africa
i. To understand facilitators of and barriers to uptake and retention of injectable and implantable long acting pre-exposure prophylaxis (LA-PrEP) and MPT to inform product development, using formative behavioural research methods
ii. To design interventions to impact the uptake of new biomedical HIV prevention products, as part of a suite of self-care and self-screening products for sexual and reproductive health, using quantitative behavioural research methods
iii. To test the effectiveness of the alternate design/interventions and strategies, using marketed LA contraceptive products as proxies for LA HIV prevention products in development
iv. To estimate the cost of retention interventions and the cost effectiveness of products and delivery methods among adolescent girls and young women (AGYW) and female sex workers (FSWs) for prevention of pregnancy and/or HIV, using modelling
|
Kampala, NOT APPLICABLE
|
Uganda |
2021-08-31 |
2024-08-31 |
1190 |
Adolescent Girls and Young Women (AGYW) aged 15 to 24 years and Female Sex Workers (FSW) aged 15 to 45 years, Health Care Providers (HCP), and Policy Makers (PM) in Kampala, Uganda and Nairobi, Kenya.
Study Size and duration: Stage 1: 30 AGYW, 30 FSW, 10 |
International AIDS Vaccine Initiative, The Address, 11th Floor, Muthangari Drive, Nairobi, Kenya; T:+254.719.043.000 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
BRENDA GATI MIREMBE
ID: UNCST-2021-R013390
|
A Phase 3, Randomized, Active Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV 1 Infection.
REFNo: HS1631ES
Primary Objectives:
1. To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the
prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed
HIV-1 infection.
2. To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data
Secondary Objective
1. To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1
infection relative to the background rate.
|
Kampala,
Wakiso,
Mukono,
Mpigi,
Nakaseke,
Luweero,
Buikwe,
Jinja,
Gomba,
Butambala,
Kayunga,
|
Uganda |
2021-08-27 |
2024-08-27 |
Approximately 4,500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study po |
Cisgender female participants aged 16 to 45 years of age who are at high risk of acquiring HIV-1 infection. |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Jayne Ellis
ID: UNCST-2021-R013987
|
“Integrated management of cryptococcal and opportunistic infections to improve outcomes in advanced HIV disease (IMPROVE study)â€
REFNo: HS1607ES
1) To generate evidence on the safety (adverse events) and feasibility (adherence and tolerability) of 1HP (one month of isoniazid and rifapentine) for TB preventative therapy (TPT) amongst adults with HIV-associated cryptococcal meningitis.
2) To generate preliminary data on potential secondary benefits (reduced loss to follow-up, reduced active TB disease, reduced mortality due to TB) of early (inpatient initiation) 1HP TPT as compared to standard (outpatient initiation) 1HP TPT amongst adults with HIV-associated cryptococcal meningitis.
|
Kampala, Salaama
Mbarara, Mbarara
|
UK |
2021-08-25 |
2024-08-25 |
205 |
Adults (>18 years) with HIV-associated cryptococcal meningitis |
London School Hygiene and Tropical Medicine |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Peter Elyanu James
ID: UNCST-2021-R013210
|
CoVPN 3008- UBUNTU Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0, dated 16 May 2021. DAIDS Document ID # 38838.
REFNo: HS1642ES
Primary Objectives
The primary objectives of this study are to determine the following:
1. 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
2. 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
3. To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Secondary Objectives
The secondary objectives of this study are to evaluate the following:
1. 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
2. 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
3. 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
4. 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
5. Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
6. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
Exploratory Objectives
The exploratory objectives of this study are to evaluate the following:
1. 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
2. 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
3. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
4. 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
5. Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
6. Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial
|
Kampala, Mulago
Kampala, Kawaala
Kampala, Wankuluku
Kampala, Kisenyi
Kampala, Kisugu
Kampala, Kisugu
|
Uganda |
2021-08-24 |
2024-08-24 |
125 |
This study will be conducted in regions and populations where new more resistant variants of SARS-CoV-2 are highly prevalent. Prevalence of the new variants is known to result in reinfections, suggesting that a prior infection with the SARS-CoV-2 ancestra |
The study is sponsored by the South African Medical Research Council (SAMRC) and funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute of Health (NlH) of the United States of America. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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