Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

Study population: Children living with HIV , 2-12years

Principal Investigator: Dr. Maxensia Owor

Study Coordinator: Dr. Joselyne Nansimbe

Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents.

Duration: Ongoing

Study population: Adolescents living with HIV

Principal Investigator: Dr. Maxensia Owor

Study Coordinator: Dr. Hajira Kataikire

Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants.

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

Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants.

Duration: Ongoing

Study population: Pregnant Adolescents and Young Women, 16-24years old

Principal Investigator: Dr. Clemensia Nakabiito

Study Coordinator: Dr. Joel Maena

Phase I/II Multi-center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents.

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

Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study.

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

Studying TB Ante vs. Postpartum Prevention with INH in HIV Seropositive mothers and their Exposed infants

Study Leads
Dr Carolyne Onyango- Makumbi
Dr. Deo Wabwire

Studying the Breast milk reservoir: The role of Viral load and cell associated virus in risk of breast milk transmission and ARV drug levels in breast milk among transmitters compared to non-transmitters.

Duration:
2021- 2022

Pharmacokinetic Properties of Antiretroviral Drugs during Pregnancy.

Principal Investigator: Dr. Deo Wabwire

Study Coordinator: Dr. Jovita Kansiime

MTN-042 is a Phase 3b, open-label, multi-site, randomized trial designed to assess the safety, adherence, and acceptability profiles of the dapivirine Varginal Ring and Truvada (FTC/TDF) oral tablet when used during pregnancy

Duration: 2017- 2024

Study population: Pregnant mothers, over 18 years

Principal Investigator: Dr Clemensia Nakabiito

Study Coordinator: Dr. Phionah Kibalama

MTN-043 was a Phase 3B, open-label, randomized, multi-site, mother-infant pair PK study designed to assess the safety, pharmacokinetics, adherence, and acceptability of the dapivirine Varginal Ring, inserted every 4-weeks, and once-daily Truvada tablet used by women from sub-Saharan countries during breastfeeding.

Duration: 1 year

Study population: Mother-infant pairs, breastfeeding mothers, above 18 years old

Principal Investigator: Dr Brenda Gati

Study Coordinator: Dr. Phionah Kibalama

MTN-045 was a cross-sectional study that will utilize questionnaires, including a Discrete-Choice Experiment (DCE) and joint decision task, to assess couples’ preferences related to dual purpose prevent (DPP) products that could be used to prevent unintended pregnancies and HIV infection.

Duration:1 year

Study Population: Heterosexual couples above 18 years

Principal Investigator: Juliane Etima

Study Coordinator- Doreen Kemigisha

MTN-041 was a multi-site qualitative acceptability study that utilized focus group discussions and in-depth interviews to explore the attitudes of community members and key informants from the community about the use of a Dapivirine Vaginal Ring or oral PrEP (FTC/TDF) during pregnancy and breastfeeding.

Safety and Adherence to a Vaginal Dapivirine ring vs Oral TDF/FTC in female Adolescent

Duration: 2 years

Study population: 16-24 year old Adolescent girls and young women

Principal Investigator: Dr Carolyne Akello

Study Coordinator: Dr Rita Nakalega

MTN-032 was an exploratory study primarily designed to identify factors that may have affected participant adherence to study product in MTN-020 (ASPIRE) and MTN-025 (HOPE).

Duration: 2015-2018

Study Population: Former ASPIRE and Former HOPE study participants

Principal Investigator: Juliana Etima

Study Coordinator: Dr. Carolyne Akello

MTN-025, the HIV Open-label Prevention Extension (HOPE) trial, was a multi-site, open-label, Phase 3B trial. Eligible HIV-uninfected former ASPIRE participants were offered a silicone elastomer VR containing 25 mg of dapivirine.

Duration: 2016-2018

Study population: Former ASPIRE study participants, 18 and above

Principal Investigator:Dr. Brenda Gati

Study Coordinator: Dr Carolyne Akello

MTN-020, or ASPIRE (A Study to Prevent Infection with a Ring for Extended Use), was a Phase III study to determine whether a vaginal ring containing the ARV drug dapivirine is a safe and effective method for protecting against the sexual transmission of HIV when used by women for a month at a time.

Duration: 3 years

Study population: High risk women, 18- 45 years
Principal Investigator: Dr Flavia Matovu Kiweewa

Study Coordinator: Dr Brenda Gati Mirembe

MTN-016 or EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) was an observational study and data registry designed to understand the effects, if any, the use of ARV-based HIV prevention products may have on pregnancy and infant outcomes.

Duration: 2009- 2021

Study population: Pregnant women from VOICE and ASPIRE Studies

Principal Investigator: Dr. Kenneth Kintu

Study Coordinator: Dr. Kenneth Kintu

MTN-015 was a multi-site, prospective, observational cohort study of women following HIV-1 seroconversion in microbicide trials of ARV-based microbicides or oral pre-exposure prophylaxis (PrEP).

Duration: 10 years

Study population: VOICE and ASPIRE study participants who have seroconverted

Principal Investigator: Dr. Clemensia Nakabiito

Study Coordinator: Dr. Carolyne Akello

VOICE D (MTN-003D) was a behavioral sub-study of VOICE that aimed to understand women’s actual and reported use of study products and sexual behavior during their participation in VOICE.

Duration: 1 year

Study population: Former VOICE study participants

Principal Investigator: Dr Clemensia Nakabiito

Study Coordinator: Dr. Carolyne Akello

The BMD Substudy was an observational substudy of VOICE designed to assess the impact of oral TDF and oral FTC/TDF on bone mineral density.

Duration: 2009- 2011

Study population: VOICE study participants taking tablets

Principal Investigator: Dr. Clemensia Nakabiito

Study Coordinator: Dr. Brenda Gati

VOICE was a Phase 2B, multi-site, five-arm, randomized, controlled trial. A total of 5029 women were randomized to five study arms in a 1:1:1: 1:1 ratio. Secondary objectives focused on adherence/behavioral factors, HIV-1 drug resistance (among those who become HIV-infected during the study), pharmacokinetic parameters, and the potential for delayed seroconversion during an off-product period scheduled at the end of study participation.

Duration: 4 years

Study population: High risk women, 18- 45years

Principal Investigator: Dr. Clemensia Nakabiito

Study Coordinator: Dr. Kenneth Kintu

MTN-001 was a Phase II trial that looked at how tenofovir is absorbed in the body as either an oral tablet or a vaginal gel, as well as women’s preferences for and ability to adhere to the daily regimens of each approach.

Duration: 1 year

Study population: Women, 18 years and above

Principal Investigator: Dr. Clemensia Nakabiito

Study Coordinator: Dr Flavia Matovu Kiweewa

Qualitative study:
Acceptability of injectable Cabotegravir versus daily oral tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) for PrEP.

Duration: Ongoing

Study population: HPTN-084 participants

Principal Investigator: Juliane Etima

Study Coordinator: Doreen Kemigisha

PrEP study long-acting Cabotegravir injectable vs Truvada.

Duration: Ongoing

Study Population: High risk women, 18 years and above

Investigator of Records: Dr. Clemensia Nakabiito

Study Coordinator: Dr. Sheila Bamwenyana

PrEP study long-acting Cabotegravir injectable vs Truvada.

Duration: Ongoing

Study Population: High risk women, 18 years and above

Investigator of Records: Dr. Clemensia Nakabiito

Study Coordinator: Dr. Sheila Bamwenyana

Open Label of Long-Acting Cabotegravir ( CAB LA) in Adolescents.

Duration: 2 years

Study Population: High risk adolescent 16-17 years

Principal Investigator: Dr. Brenda Gati

Study Coordinator: Dr. Betty Kamira

Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding

A Phase I, randomized, double blind, placebo-controlled trial to evaluate the safety and immunogenicity of ALVAC-HIV vCP1521 in infants born to HIV-1 infected women in Uganda

A Phase IIB Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates

This trial is in household contacts (HHC) at high risk for developing multidrug resistant tuberculosis (MDR-TB) which is an infection that does not get better with standard treatment for tuberculosis.

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

Multi-Center, Randomized, Efficacy Study of COVID-9 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

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

Phase 3, SARS-CoV-2 VAT00008 Sanofi A parallel-group, Phase III, multi-stage, modified double-blind, multiarmed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older.

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

Incidence and risk factors for COVID-19 amongst pregnant and lactating women and their infants in Uganda

Duration:
5th July 2021 – 4th July 2022

Study Population:
Women and Infants

Principal Investigator:
Dr. Kirsty Le Doare

Primary goal of the project is to determine the prevalence of Covid-19 antibody in HIV-infected women and their children and correlate with maternal and pediatric demographics and outcomes.

Duration:
Feb 2022 – May 2022

Study Population:
Women and Infants

Principal Investigator:
Dr. Lillian Wambuzi

Re-calibration of quantitative and contextual factors to predict child cognitive deficits in HIV exposed children in the PROMISE/PROMOTE study cohorts

PROMOTing Adherence to life-long ART
Cross-cultural translation, adaptation and validation of the AIDS Clinical Trials Group (ACTG) adherence questionnaire and evaluation of two modes of delivery in Uganda; a sub-study nested within the PROMOTE longitudinal cohort study

The PROMOTE study aimed to measure long-term antiretroviral treatment (ART) safety and adherence; compare HIV disease progression; assess subsequent adverse pregnancy outcomes; evaluate effect of ART exposure on growth and development in HIV-exposed uninfected children; and assess long-term survival of mothers and children.

Site Investigator:
Dr. Lillian Wambuzi

Study Coodinator:
Dr. Patience Atuhaire

A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women.

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

Primary HIV Prevention in Pregnant and Lactating Ugandan Women.

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

Objective
Deciphering Molecular Mechanisms of HIV Latency Reversal in Perinatal Infections with Single Cell Transcriptomics

Duration:
1st September 2020- 3rd August 2025

Study Population:
Infants

Principal Investigator:
Dr. Linda Barlow- Mosha

A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART.

Duration:
9th October 2019-31st December 2023

Investigator of Record:
Dr. Grace Ahimbisibwe

This is a substudy of ODYSSEY being conducted in Uganda, UK, Zimbabwe and South Africa to look at the involvement of young people in Clinical Trials.

Study Population:
Young people

A randomised non-inferiority trial with nested PK to assess DTG/3TC fixed dose formulations for the maintenance of virological suppression in children with HIV infection aged 2 to <15 years old.

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

Objective

– 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

Grant aims to prospectively recruit children in Uganda, Zambia, & Zimbabwe who are presenting with symptoms of central nervous system infection, but do not have TBM, as controls for a diagnostic sub-study within the TBM SURE treatment trial.

Duration:
1st February 2021-30th Mar 2022

Study Population:
Children (2-15yrs)

Principal Investigator:
Dr. Linda Barlow

Clinical Characteristics and Outcomes of Adult Patients Infected With SARS-CoV-2 in Africa

Duration:
22/10/20-30/12/21

Study Population:
Mother and Paediatrics

Principal Investigator:
Dr. Philippa Musoke

Title:
A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long- Acting Subcutaneous Lenacapavir, and Daily Oral Emitricitabine / Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection.

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

Official Title: Using Recency Assays to estimate incident HIV infections among Adolescent Girls and Young Women in Hoima and Mityana/Mubende Districts, Uganda

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

Reaching out to children infected and affected with HIV through their communities.

Duration:
1st July 2019- 30th June 2022

Principal Investigator :
Juliane Etima

Test the efficacy and safety of once-a-month Islatravir drug on high risk Cis-gender women in Sub-Saharan Africa Primary target audience: HIV negative at high risk Cisgender women, 16-45 years old Focus: The safety and efficacy of once a month HIV prevention treatment drug called Islatravir

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

Adapting the STARx Transition Readiness Questionaire for Uganda Young People Living with HIV/ AIDs (PLHIV) and their Parents

Duration:
1st August 2020-31st December 2022

Principal Investigator :
Dr. Linda Barlow- Mosha

Bone Mineral Density in a Cohort of Young Adult Women Using Depo-Provera and Tenofovir, Kampala, Uganda.

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

Determining Bone Loss and Bone Mineral Density Recovery Following Repeat Pregnancy/Lactation Among HIV women of ART an R01 study

Duration
2018- 2023

Principal Investigator:
Dr. Flavia Matovu Kiweewa

Study Coordinator:
Dr Patience Atuhaire

Official Title: Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate Based Anti-Retroviral Therapy

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

Evaluation of pelvic floor disorders in parous Ugandan women

Duration:
1st February 2022 -31st July 2022

Principal Investigator:
Dr. Flavia Matovu Kiweewa

Official Title: Culture-Specific Neurodevelopmental Assessment of HIV-Affected Children

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

Official Title:
Developmental, Neuropsychological and Physical Growth Outcomes among HIV Exposed Uninfected Infants who are exposed to antiretroviral drugs

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

SHINE Trial is the first Phase III paediatric RCT to evaluate whether the standard 6 months of treatment can be reduced to 4 months in children with smear-negative non-severe (minimal) TB

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

Evaluation of an early tuberculosis detection strategy in children with severe pneumonia. Validation of diagnostic tools and algorithms in HIV-infected and severely malnourished children with presumptive tuberculosis.

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

RCT of 6-month intensified anti-TB treatment versus 12-month WHO standard anti-TB treatment, for children with TB Meningitis (TBM) (Global Health Trials Team)

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

Building the foundations for improving diagnosis of TB meningitis in children

Duration:
14th February 2022-13th February 2023

Study Population:
Children

Investigators:
Dr. Sabrina Kitaka
Dr. Eric Wobudeya

Hospital-based birth defects surveillance in Kampala, Uganda

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

Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Other Transfusion Transmitted Infections.

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

A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants.

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

Maternal, neonatal and infant outcomes at Kawempe National Referral Hospital
Prevention of invasive Group B Streptococcus disease in young infants: a pathway for the evaluation & licensure of an investigational maternal GBS vaccine

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

A multi-Centre, randomised, placebo controlled, double-blind, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine (GBS-NN/NN2) in women who are pregnant and living with HIV and women who are pregnant and do not have HIV.

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

Study Title: Landscape Assessment To Understand Maternal Vaccine Pharmacovigilance In Uganda.

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

Prevention of invasive Group B Streptococcus disease in young infants: a pathway for the evaluation & licensure of an investigational maternal GBS vaccine

Duration:
01/09/19-30/09/24

Study Population:
Mother and Infants

Principal Investigator:
Dr. Kirsty Le Doare

Program Manger:
Dr. Robert Mboizi

Our project aimed to increase awareness of maternal immunisation in the ten parishes surrounding a maternal health specialty, Kawempe National Referral Hospital, in Uganda. Our primary target audience were pregnant women and women of child-bearing age and their influencers. The focus was on community education emphasizing the benefits and dispelling myths and misconceptions of maternal vaccines; using these to trace and refer women who default on the maternal immunisation schedule. Using mixed methods of health promotion, the project leveraged various media channels including mobile films at community level, radio messaging, and women influencers’ support groups.

Project Lead:
Dr. Mary Kyohere

Duration:
6 months

The safety and imMunogeNicity of combined Pertussis-cOntaining vaccine (Tdap) for HIV-infected pregnant WomEn and their newboRns – A Randomized Clinical Trial (WoMANPOWER)

Study Population:
Infants

Program Manager:
Dr. Mary Kyohere

Project aims to develop methodology and generate key immunologival background data to enable the first human GBS challenge studies.

Principal Investigators:
Dr. Kirsty Le Doare
Dr. Philippa Musoke

Duration:
01st June 2019- 31st May 2020

Multi-centre observational study (Neo-Obs-001) to collect clinical and microbiological information on presumed and confirmed serious bacterial infections in neonates

Study Population:
Infants

Principal Investigator:
Dr. Philippa Musoke

Seroepidemiology of Maternally derived antibody against Group B Streptococcus (GBS) in preparation for GBS vaccine studies