MU-JHU has pursued rigorous epidemiological and clinical trial research to improve the health of Ugandans. With an early focus on perinatal HIV, MU-JHU has followed a logical progression of HIV and TB prevention and care.
It has now expanded its scope to include other health issues affecting women and infants. This includes growth and neurodevelopment, bone health, birth defects surveillance and characterisation of bacterial infections with a pathway to vaccine trials.
Together with Johns Hopkins University as a Clinical Trials Unit (CTU), MU-JHU as a Clinical Trials Site has participated in many multi-site National Institutes of Health (NIH) supported clinical trials addressing;
MU-JHU works in close partnership with:
Study population: Children living with HIV , 2-12years
Principal Investigator: Dr. Maxensia Owor
Study Coordinator: Dr. Joselyne Nansimbe
Duration: Ongoing
Study population: Adolescents living with HIV
Principal Investigator: Dr. Maxensia Owor
Study Coordinator: Dr. Hajira Kataikire
Study Population:
Pregnant women (aged ≥18 years) with confirmed HIV-1 infection and at 14-28 weeks’ gestation
Duration: 48 months
Objective: To compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.
Principal Investigator: Dr. Deo Wabwire
Study Coordinator: Dr. Enid Kabugho
Duration: Ongoing
Study population: Pregnant Adolescents and Young Women, 16-24years old
Principal Investigator: Dr. Clemensia Nakabiito
Study Coordinator: Dr. Joel Maena
Duration:
13 years
Objectives:
– To select a dolutegravir dose for chronic dosing; to determine the safety and tolerability of the dose,
– To evaluate the steady-state pharmacokinetics of dolutegravir in combination with other antiretrovirals
– To determine the dose of dolutegravir that achieves the targeted C24h and AUC0-24 PK parameters in the population.
Principal Investigator: Dr. Maxensia Owor
Study Coordinator: Dr Grace Ahimbisibwe
Duration:
5 years
Study Population:High-Risk,
– Cohort 1: Infants aged ≤ 48 hours of birth born to women with HIV infection who did not receive any antiretrovirals (ARVs) during pregnancy and ART-Started,
– Cohort 2: Infants ≤ 10 days of age with documented in utero HIV infection who initiated antiretroviral therapy (ART) outside of the study within 48 hours of birth
– Mothers of infants in both cohorts
Objectives:
Primary Objective:
To assess HIV remission (remission is defined as having no confirmed plasma HIV RNA LOD for 48 weeks following ART cessation) among HIV-infected neonates who initiate ART within 48 hours of birth.
Secondary Objectives:
– To assess the safety of very early ART in neonates.
– To assess the PK of NVP in neonates and young infants in order to determine the NVP dose needed to maintain NVP concentrations between 3,000 and 10,000 ng/mL required for HIV treatment.
– To describe LPV exposures when dosed with NVP in neonates and young infants.
– To assess the relationship between time to reach confirmed plasma HIV RNA < LOD and achievement of the virologic and immunologic criteria for ART cessation among infants who have no evidence of viral rebound.
– To assess the extent of HIV persistence in infants who achieve HIV remission.
– To evaluate immune activation and host and viral determinants, including maternal factors and HIV-specific immune responses, associated with HIV remission.
Principal Investigator: Dr. Maxensia Owor
Study Coordinator: Dr. Phionah Kibalama
Study Leads
Dr Carolyne Onyango- Makumbi
Dr. Deo Wabwire
Duration:
2021- 2022
Principal Investigator: Dr. Deo Wabwire
Study Coordinator: Dr. Jovita Kansiime
Duration: 2017- 2024
Study population: Pregnant mothers, over 18 years
Principal Investigator: Dr Clemensia Nakabiito
Study Coordinator: Dr. Phionah Kibalama
Duration: 1 year
Study population: Mother-infant pairs, breastfeeding mothers, above 18 years old
Principal Investigator: Dr Brenda Gati
Study Coordinator: Dr. Phionah Kibalama
Duration:1 year
Study Population: Heterosexual couples above 18 years
Principal Investigator: Juliane Etima
Study Coordinator- Doreen Kemigisha
Duration: 2 years
Study population: 16-24 year old Adolescent girls and young women
Principal Investigator: Dr Carolyne Akello
Study Coordinator: Dr Rita Nakalega
Duration: 2015-2018
Study Population: Former ASPIRE and Former HOPE study participants
Principal Investigator: Juliana Etima
Study Coordinator: Dr. Carolyne Akello
Duration: 2016-2018
Study population: Former ASPIRE study participants, 18 and above
Principal Investigator:Dr. Brenda Gati
Study Coordinator: Dr Carolyne Akello
Duration: 3 years
Study population: High risk women, 18- 45 years
Principal Investigator: Dr Flavia Matovu Kiweewa
Study Coordinator: Dr Brenda Gati Mirembe
Duration: 2009- 2021
Study population: Pregnant women from VOICE and ASPIRE Studies
Principal Investigator: Dr. Kenneth Kintu
Study Coordinator: Dr. Kenneth Kintu
Duration: 10 years
Study population: VOICE and ASPIRE study participants who have seroconverted
Principal Investigator: Dr. Clemensia Nakabiito
Study Coordinator: Dr. Carolyne Akello
Duration: 1 year
Study population: Former VOICE study participants
Principal Investigator: Dr Clemensia Nakabiito
Study Coordinator: Dr. Carolyne Akello
Duration: 2009- 2011
Study population: VOICE study participants taking tablets
Principal Investigator: Dr. Clemensia Nakabiito
Study Coordinator: Dr. Brenda Gati
Duration: 4 years
Study population: High risk women, 18- 45years
Principal Investigator: Dr. Clemensia Nakabiito
Study Coordinator: Dr. Kenneth Kintu
Duration: 1 year
Study population: Women, 18 years and above
Principal Investigator: Dr. Clemensia Nakabiito
Study Coordinator: Dr Flavia Matovu Kiweewa
Duration: Ongoing
Study population: HPTN-084 participants
Principal Investigator: Juliane Etima
Study Coordinator: Doreen Kemigisha
Duration: Ongoing
Study Population: High risk women, 18 years and above
Investigator of Records: Dr. Clemensia Nakabiito
Study Coordinator: Dr. Sheila Bamwenyana
Duration: Ongoing
Study Population: High risk women, 18 years and above
Investigator of Records: Dr. Clemensia Nakabiito
Study Coordinator: Dr. Sheila Bamwenyana
Duration: 2 years
Study Population: High risk adolescent 16-17 years
Principal Investigator: Dr. Brenda Gati
Study Coordinator: Dr. Betty Kamira
Duration:
60 months
Study Population:
18 years and older adults with pulmonary MDR-TB who has started MDR-TB treatment within the past 90 days, who has one or more household contacts and gives site staff permission to call and visit the household contacts.
Objective:
To compare how safe and effective 26 weeks of Delamanid (DLM), a medicine used to treat TB, is versus 26 weeks of isoniazid (INH), a standard medicine to treat or prevent TB, for preventing infection with TB (latent TB) or confirmed or probable active infection with TB among participants with HIV or an immune system problem not from HIV like cancer, latent TB infection and young children below the age of 5 years.
Principal Investigator:
Dr. Eric Wobudeya
Study Coordinator:
Dr. Hellen Kaganzi
Duration:
14 months
Study population:
Adults who are living with HIV or have another condition that has been associated with increased risk of developing severe COVID-19 illness. Examples of such conditions include pregnancy, diabetes, obesity, heart or kidney disease, and cancer.
Objectives:
– To know how many doses of vaccine are needed for protection against COVID-19 for adults living with HIV or other health conditions that may put them at risk for severe COVID-19.
– To know if people who have already had COVID-19 (and likely have some immunity) need as many vaccine doses as other people to obtain strong protection from reinfection.
Principal Investigator:
Dr. Deo Wabwire
Study Coordinator:
Dr. Joel Maena
Duration:
1st July 21-30th April 23
Study population:
Adults 18 years of age and older.
Principal Investigator:
Dr. Deo Wabwire
Study Coordinator:
Dr. Jovita Kansiime
Duration:
5th July 2021 – 4th July 2022
Study Population:
Women and Infants
Principal Investigator:
Dr. Kirsty Le Doare
Duration:
Feb 2022 – May 2022
Study Population:
Women and Infants
Principal Investigator:
Dr. Lillian Wambuzi
Site Investigator:
Dr. Lillian Wambuzi
Study Coodinator:
Dr. Patience Atuhaire
Study population: Sexually active, HIV negative, cisgender women, aged 16 to 30 years from African sites.
Site Investigator:
Dr. Brenda Gati
Study Coordinator:
Dr. Enid Kabugho
This study aimed to test the effectiveness of a behavioral intervention aimed at preventing the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk of acquiring HIV and dying.
Population :15 Years to 49 Years
Duration: February 2013- May 2016
Duration:
1st September 2020- 3rd August 2025
Study Population:
Infants
Principal Investigator:
Dr. Linda Barlow- Mosha
Duration:
9th October 2019-31st December 2023
Investigator of Record:
Dr. Grace Ahimbisibwe
Study Population:
Young people
This study aims to find out whether treating children and young people living with HIV with two anti-HIV medicines, Dolutegravir (DTG) and Lamivudine (3TC), is safe and as effective as dolutegravir-based treatment with three anti-HIV medicines.
Study Population:
Young people
Duration:
4years
Principal Investigator:
Prof. Philippa Musoke
Trial Manager:
Dr. Grace Ahimbisibwe
– To describe the sero-epidemiology of COVID-19 among pregnant women across five countries in Africa
– To assess the risk of COVID-19 to newborn infants born to women with COVID-19 and determine potential routes of MTC transmission
– To determine the clinical course and pregnancy outcomes of women with COVID-19 during pregnancy
– To determine the presence and duration of viral excretion in various mother and baby samples (serum, throat and nasal swabs, vaginal swab, urine stool, placental swab and biopsies and breastmilk)
– To assess the immune responses to SARS-CoV-2 in pregnant women and their babies
– To work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population
Duration:
21/10/20-30/04/22
Study Population:
Women and Infants
Principal Investigator:
Dr. Kirsty Le Doare
Duration:
1st February 2021-30th Mar 2022
Study Population:
Children (2-15yrs)
Principal Investigator:
Dr. Linda Barlow
Duration:
22/10/20-30/12/21
Study Population:
Mother and Paediatrics
Principal Investigator:
Dr. Philippa Musoke
Study Population:
Adolescent girls and young women
Duration:
6 years
Objective:
Project activities aimed at evaluating the efficacy of Lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing the risk of HIV infection relative to the background HIV incidence in adolescent girls and young women
Principal Investigator :
Dr. Flavia Matovu Kiweewa
Study Coordinator:
Dr. Edrine Kalule
Duration:
4 month
Study Population:
Adolescent girls and young women aged 16-25 years who are at risk of HIV especially those employed in the entertainment industry or at fishing sites, working in commercial sex parlors or on streets and those who identify themselves as commercial sex workers.
Principal Investigator:
Dr. Flavia Matovu Kiweewa
Study Coordinator:
Dr. Zubair Lukyamuzi
Duration:
1st July 2019- 30th June 2022
Principal Investigator :
Juliane Etima
Duration:
3 years
Objective:
IMPOWER 22 is studying a new monthly PrEP pill called islatravir—a small, powerful pill that could make protection against HIV much simpler. It looks very promising based on animal studies and is safe and well-tolerated in human studies. The next step is to see if it prevents HIV infection in humans. The IMPOWER 22 study will compare the efficacy and safety of monthly islatravir to daily emtricitabine/tenofovir among cisgender women.
Principal Investigator:
Dr. Brenda Gati
Study Coordinator:
Dr. Enid Kabugho
Duration:
1st August 2020-31st December 2022
Principal Investigator :
Dr. Linda Barlow- Mosha
Duration:
5 years
Study Population:
HIV infected and un-infected women aged 18-35 years attending the public and non for profit non governmental health facilities.
Objectives:
– To determine the combined effect of HIV, DMPA, and TDF initiation on BMD.
– To determine the effect of TDF initiation on BMD among DMPA users.
– To determine whether BMD loss with TDF ART initiation over a 2 year follow up period is greater with DMPA use.
Principal Investigator:
Dr. Flavia Matovu Kiweewa
Study Coordinator:
Esther Isingel
Duration
2018- 2023
Principal Investigator:
Dr. Flavia Matovu Kiweewa
Study Coordinator:
Dr Patience Atuhaire
Duration: 3rd December 2019- 6th June 2023
Objective:
The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).
Study population:
20 – 40 year old HIV-infected non pregnant women
Principal Investigator:
Dr. Flavia Matvovu Kiweewa
Study Coordinator:
Esther Isingel
Duration:
1st February 2022 -31st July 2022
Principal Investigator:
Dr. Flavia Matovu Kiweewa
Duration: 5 year
Study Population: 600 children in Malawi and Uganda. At MU-JHU, 60 HIV infected (HIV+) 120 HIV exposed uninfected 120 HIV (HEU) unexposed (HUU) children.
Main Objective:
To adapt and validate Brain Powered Games (BPG), a computerized cognitive rehabilitation therapy (CCRT) program as a neurocognitive assessment for Sub-Saharan African school-age children suffering from neurological insults such as neurotropic infections
Principal Investigator:
Dr. Lillian Wambuzi Ogwang
Study Coordinator:
Monica Okumbe Lyagoba
Duration:
5 years
Population:
1200 HIV exposed uninfected (HEU) children in Uganda and Malawi. 600 at MUJHU
Objective:
To evaluate whether prolonged antiretroviral (ARV) exposure among HEU infants in Malawi and Uganda will be associated with any negative late developmental, neuropsychological, neurologic, physical growth or hematologic consequences
Study Population:
HIV Exposed Uninfected, HUU Unexposed Uninfected children at least 5 yrs of age and older from the PROMISE ND study
Principal Investigator:
Dr. Lillian Wambuzi Ogwang
Study Coordinator:
Mai Nakitende
Official Title: A phase III randomised open trial comparing 4 vs 6 months treatment in children (+/- HIV) with smear-negative non-severe TB in Africa and India
Study Population:
• Age 0-16 years, weight ≥ 3kg
• No known drug resistance
• Clinical decision to treat with 1st line Rx
• Symptomatic but non-severe TB
• Smear-negative on respiratory samples
• GeneXpert positive allowed
• Not treated for TB in previous 2 years
• Known HIV infection status
Coordinator Investigator:
Dr. Eric Wobudeya
Study Coordinator:
Dr. Robert Mboizi
Study Population:
Children aged below 15 years seeking care at the district hospital and primary health care centres of selected districts.
Duration:
2019-2022
Objectives:
1. To assess the impact on childhood TB case detection of decentralizing an innovative childhood TB diagnostic approach
2. To compare the efficiency, feasibility and acceptability of two decentralization strategies
Coordinator Investigator:
Dr. Eric Wobudeya
Study Coordinator:
Dr. Gerald Bright Businge
Objectives:
his trial aims to answer two questions. Firstly, for children presenting with TBM (a form of tuberculosis that affects the lining of the brain) who are given a shorter and more intensified treatment for their TBM, is this treatment as effective as the standard treatment in preventing TBM-related deaths?
Secondly, if in addition to the anti-TB treatment, the children are given aspirin for the first 2 months after diagnosis, does this prevent long-term neurological disability in these children?
Duration:
1st October 2018 – 30th September 2022
Study Population:
Children under 15 years and over 28 days of age with TBM disease (a form of tuberculosis that affects the lining of the brain), with or without HIV infection
Principal Investigator:
Dr. Eric Wobudeya
Co-Investigator:
Prof. Philippa Musoke
Duration:
14th February 2022-13th February 2023
Study Population:
Children
Investigators:
Dr. Sabrina Kitaka
Dr. Eric Wobudeya
Duration:
2015 – 2026
Study population:
All births in Kawempe, Lubaga, Mengo and Nsambya hospitals. Annual estimate of 48,000
Main Objectives:
1.To establish a surveillance system for major external birth defects among all live and still births delivered or registered as born at four major hospitals ( Kawempe, Lubaga, Mengo and Nsambya) in Kampala Uganda.
2. To describe the risk factors associated with major external birth defects among newborns
3.To explore the parents’/caregivers’, health workers’ and community health extension workers’ perceptions, experiences and meanings attached to major external birth defects
Principal Investigator:
Prof. Philippa Musoke
Co-Principal Investigator:
Dr. Linda Barlow-Mosha
Study Coordinator / Program Manager:
Dr. Daniel Mwanja Mumpe
Duration:
5 years
Population:
Patients needing a transfusion based on a hemoglobin of less than 7 g/dL or clinical judgment of attending physician following the national guidelines, and meeting other inclusion/exclusion criteria.
Main Objectives:
To determine the effectiveness of Mirasol-pathogen reduction technology (PRT) in preventing transfusion-transmitted infections (TTIs) through fresh whole blood, to evaluate the dependability, quality, reproducibility, ease of operation, and sustainability of Mirasol PRT, and to assess the health and economic impact of TTIs in Uganda with implications for the value of the Mirasol PRT system.
Principal Investigator (JHU):
Prof. Aaron Tobian
Principal Investigator (MU-JHU):
Dr. Irene Lubega
Co-Principal Investigator / Program Manager:
Dr. Ronnie Kasirye
Study Coordinator:
Dr. Hellen Musana
Duration:
2years
Objective:
1. To describe the safety and tolerability of GBS6 when administered at ≥ 27 0/7 to ≤ 35 6/7 weeks’ gestation to pregnant women, with and without HIV, aged ≥ 18 to ≤ 40 years of age and their infants..
2. To assess the safety of GBS6 in infants born to HIV positive and negative women who were vaccinated during pregnancy.
3. To describe the immunogenicity of GBS6 when administered to pregnant women with and without HIV.
4. To describe GBS-specific antibody levels in infants born to women vaccinated with GBS6 during pregnancy.
5. To assess placental transfer of GBS-specific antibodies from pregnant women vaccinated with GBS6 to their infants.
Study Population:
Mother/ baby pairs
Principal Investigator:
Dr Musa Sekikubo
Program Manger:
Dr. Robert Mboizi
Study Coordinators : Dr Gerald Bright Businge & Dr Alexander Amone
Duration:
2years
Objective:
Component 1:
To establish obstetric and neonatal outcomes of all women and their babies among mother-infant pairs presenting for care at Kawempe hospital.
Component 2:
To actively establish obstetric and infant outcomes of women and their infants among women enrolled at Kawempe hospital in their first or second trimester of pregnancy.
Study Population:
Mother and Infants
Principal Investigator:
Dr Musa Sekikubo
Program Manger:
Dr. Robert Mboizi
Duration:
18 months
Objective:
Safety: To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in women living with HIV and women without HIV and their new-born babies from vaccination up to delivery/birth.
Immunological:
To compare the transfer rate of vaccine- specific immunoglobulin G (IgG) antibody concentrations from the mother to the baby at birth in women living with HIV with the transfer rate in women without HIV.
Study Population:
Mother/baby pairs
Principal Investigator:
Dr Musa Sekikubo
Program Manger:
Dr. Robert Mboizi
The aim is to conduct a rapid assessment gap analysis and stakeholder mapping for safety monitoring of vaccines used in pregnancy and potential for use of Electronic Medical Record (EMR) for sentinel site surveillance in Uganda for post licensure studies as well as current tetanus and COVID-19 vaccination. The results of the assessment will inform areas of focus for establishment of robust safety surveillance of novel maternal vaccination and vaccines that maybe administered during pregnancy in pandemic
situations in the country.
Duration:
18 months
Objective:
Map stakeholders involved in regulation, policy setting, collection and reporting of adverse
events following maternal vaccination and their linkages
Understand the existing methods, tools, and information flow for collecting and flow of
adverse event following maternal vaccination
Mapping of current Electronic Health Record and registries roll-out and how they interface
with national drug safety reporting system especially in relation to maternal vaccination
To understand the Community views, and perceptions on vaccination and reporting of AE
during maternal immunization.
Study Population:
Mother/baby pairs
Principal Investigator: Dr Victoria Nambasa
Co-Investigator: Prof Kirsty Le Doare
Program Manager: Dr Robert Mboizi
Study coordinator: Anthony Ssebagereka
Duration:
01/09/19-30/09/24
Study Population:
Mother and Infants
Principal Investigator:
Dr. Kirsty Le Doare
Program Manger:
Dr. Robert Mboizi
Project Lead:
Dr. Mary Kyohere
Duration:
6 months
Study Population:
Infants
Program Manager:
Dr. Mary Kyohere
Principal Investigators:
Dr. Kirsty Le Doare
Dr. Philippa Musoke
Duration:
01st June 2019- 31st May 2020
Study Population:
Infants
Principal Investigator:
Dr. Philippa Musoke
For more information, contact us at partnerships@mujhu.org