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Research

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.

National Institutes of Health (NIH) supported clinical 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;

  • Prevention of mother-to-child transmission of HIV
  • Paediatric and adolescent HIV treatment trials
  • Primary HIV prevention trials using Anti-Retroviral (ARV) based Pre Exposure
  • Prophylaxis (PrEP) among high-risk women with the International Maternal
  • Paediatric Adolescent Clinical Trials Network ( IMPAACT)
  • Microbicides Trials Network (MTN)
  • HIV Prevention Trials Network (HPTN)
  • Aids Clinical Trials Group (ACTG) networks
Close partnerships

MU-JHU works in close partnership with:

  • Uganda’s Ministry of Health (MOH)
  • Mulago National Referral Hospital
  • Makerere University College of Health Sciences
  • The departments of Obstetrics and Gynaecology; Paediatrics and Child Health; and Microbiology at Makerere University
  • School of Medicine
  • Kawempe National Referral Hospital
  • St. Francis Nsambya Hospital
  • Mengo Hospital
  • Uganda Martyrs’ Hospital Lubaga
  • Mityana Hospital
  • Infectious Diseases Institute
  • Uganda Medical Research Council
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Our Studies

Network Studies

14 Active Studies
International Maternal Pediatric Adolescent AIDS Clinical Trials Network
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IMPAACT 2009
  • 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.
  • Principal Investigator: Dr. Clemensia Nakabiito
IMPAACT 2017
  • 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.
  • Principal Investigator: Dr. Maxensia Owor
IMPAACT CHASE
  • Insulin-like Growth Factor /Growth Hormone Axis Alterations and Stunting in HIV Exposed Uninfected Children from the 1077BF/P1084s study.
  • Principal Investigator: Brenda Kakayi
IMPAACT P1093
  • 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.
  • Principal Investigator: Dr. Maxensia Owor
IMPAACT T015
  • NICHD International and Domestic Pediatric and Maternal HIV and Other High Priority Infectious Diseases Data Coordinating Center.
  • Principal Investigator: Dr. Clemensia Nakabiito
Microbicide Trials Network
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MTN 042
  • Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring (VR) and Oral TRUVADA Use in Pregnancy.
  • Principal Investigator: Dr. Clemensia Nakabiito
HIV Prevention Trials Network
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HPTN 111
  • Uptake of HIV testing and preventative care among heterosexual men attending barber shops in Uganda.
  • Principal Investigator: Dr. Zubair Lukyamuzi
HPTN 084
  • A Phase 3 Open-Label Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women.
  • Principal Investigator- Dr. Clemensia Nakabiito
HPTN 084-01
  • Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Females.
HPTN 084-2
  • Qualitative HPTN substudy of HPTN 084 trial to assess factors related to maternal adherence and attitudes toward use of long-acting agents.
2023 HPTN SCHOLARS GRANT
  • Exploring correlations between contraceptive use and PrEP adherence to inform integrated service delivery among young women in Southern Africa: a secondary analysis from HPTN-082.
  • Principal Investigator: Dr. Phionah Kibalama Ssemambo
HIV Prevention and Care interventions for Youth in Uganda (HIP-CY) Study
  • Using Implementation Science To Understand And Design Stakeholder Informed Innovative Interventions To Improve Youth HIV Prevention And Care Continuums In Rural And Urban Uganda
  • Principal Investigator: Prof. Philippa Musoke
AIDS Clinical Trials Group Network
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ACTG Mentorship Award
  • Hospitalization rates and associated factors among HIV-infected adults aged > 40 years on lifetime antiretroviral therapy.
PHOENIx MDR-TB
  • Protecting Households On Exposure to Newly Diagnosed Index Multidrug Resistant Tuberculosis Patients
  • Principal Investigator- Dr. Eric Wobudeya
COVID-19 Prevention Network
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CoVPN 3005
  • Phase III study to assess the efficacy, safety, and immunogenicity of SARS-CoV-2 Vaccines.
CoVPN 3008
  • Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.

Non-Network Studies

18 Active Studies
PMTCT Studies
Reservoir
  • Deciphering Molecular Mechanisms of HIV Latency Reversal in Perinatal Infections with Single Cell Transcriptomics
M1-Dart
  • The overall goal of this study is to determine the impact of ART regimen on i) weight gain and body fat distribution, ii) appetite, and iii) metabolic pathways in pregnant and postpartum women living with HIV and paired HEU infants.
Women's Health Studies
PreVent” (PREvention of malaria in pregnancy using Video-based Education to eNhance opTimal malaria preventive therapy knowledge and uptake)
PREVENT Study
  • To effectively prevent adverse maternal and foetal outcomes related malaria in pregnancy, there is need to optimally comply and adhere to stipulated dosing of efficacious malaria preventive treatment using cotrimoxazole and sulphadoxine-pyrimethamine  for HIV infected and HIV negative pregnant women respectively.  Complying and adhering to these interventions is reported to be suboptimal and thus the goal of our application is to develop a video-based-educational intervention to improve and enhance implementation of the malaria preventive interventions. Our intervention aims at addressing knowledge deficits on malaria prevention strategies particularly among pregnant women in Uganda and other low resource setting.
INSIGHT
  • Phase 3 development of the Islatravir (EFdA) monthly oral formulation
Paediatric studies
SNIP-Africa
  • Research network to implement trials in sub-Saharan Africa (SSA), for improved treatment of childhood infection in an era of increased antimicrobial resistance (AMR).
D3 Clinical Trial
  • 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. Principal Investigator- Prof. Philippa Musoke
ODYSSEY (PENTA 50)
  • 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. Principal Investigator- Prof. Philippa Musoke
ODYSSEY (PENTA 50)
  • 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. Principal Investigator- Prof. Philippa Musoke
Cobicistat_GSI Clinical Study
  • A Phase 2/3, Study Evaluating Pharmacokinetics, Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) in HIV-1 Infected, Virologically Suppressed Pediatric Participants. Principal Investigator- Dr. Flavia Matovu Kiweewa
Adolescent studies
Young Generation Alive Survey
  • A cross-sectional survey assessing knowledge, behaviors, and career aspirations of HIV+ and HIV perinatally exposed adolescents and young people. Principal Investigator- Juliane Etima
PURPOSE 1 study
  • Evaluating the efficacy of Lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing the risk of HIV infection in adolescent girls and young women.
  • Principal Investigator- Dr. Flavia Matovu Kiweewa
Bone Health Studies
Pelvic Floor Disorders (PFD)
  • Evaluation of pelvic floor disorders in parous Ugandan women Principal Investigator- Dr. Flavia Matovu Kiweewa
Maternal Bone Health Study (MBHS)
  • Determining Bone Loss and Bone Mineral Density Recovery Following Repeat Pregnancy/Lactation Among HIV women on ART. Principal Investigator- Dr. Flavia Matovu Kiweewa
BONE STAR
  • A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women. Principal Investigator- Dr. Flavia Matovu Kiweewa
Neurodevelopment Studies
Brain Powered Games (BPG)
  • BPG evaluations of HIV infected, HIV exposed uninfected infants and the HIV uninfected group of infants. Principal Investigator- Dr. Lillian Wambuzi
BPG Supplement
  • Culture-specific neurodevelopmental assessment of HIV-affected children. Principal Investigator- Dr. Lillian Wambuzi
TB Treatment and Prevention Studies
Paediatric Post TB lung function evaluation in Ugandan children
  • Factors associated with Lung Function after Completed Pulmonary Tuberculosis Treatment in Ugandan Children: A cross-sectional comparative study. Principal Investigator- Dr. Eric Wobudeya
Surveillance Studies
Birth Defects Study
  • Hospital –Based Birth Defects surveillance in Kampala, Uganda. Principal Investigator- Prof. Philippa Musoke
Treatment Technology Study
MERIT Study
  • A Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Other Transfusion Transmitted Infections. Principal Investigator- Dr. Irene Lubega
Vaccine Related Studies
Prevention of invasive Group B Streptococcus disease in young infants: a pathway for the evaluation & licensure of an investigational maternal GBS vaccine
Prepare Consortium (GBS Vaccine Studies)
  • PREPARE WP2 PREPARE WP4 Principal Investigator- Dr. Musa Sekikubo

Past Studies

International Maternal Pediatric Adolescent AIDS Clinical Trials Network
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IMPAACT
  • P1104: Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected Participants of P1060 and HIV-Uninfected Controls
  • IMPAACT 2009: 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
  • IMPAACT 2010 / VESTED: 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
  • P1026S / PK in Pregnancy: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
  • P1060 / NNRTI-Based vs. PI-Based ART in Infants Exposed/Not Exposed to NVP for PMTCT: Phase II, Parallel, Randomized Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single-Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission
  • P1068S / Parasitemia And Clinical Malaria In Children On Protease-Inhibitor-Based Therapy: P1060 Substudy Comparing Differences in Malaria Parasitemia by Real-Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART
  • P1070 / EFV in HIV-infected and HIV/TB Co-infected Subjects: Dose Finding and Pharmacogenetic Study of EFV in HIV-Infected and HIV/TB Co-infected Infants & Children >=3 months to <36 Months of Age
  • P1078 / TB APPRISE: TB Ante vs. Postpartum Prevention with INH in HIV Seropositive mothers and their Exposed infants: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-infected Women in High TB Incidence Settings
  • P1079 / PHARMACOLOGY OF ARTEMISININ-BASED ANTIMALARIAL THERAPY: Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy
  • P1084s / Maternal Infant TDF Toxicity Safety: Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of PROMISE Protocol: Promoting Maternal and Infant Survival Everywhere
  • P1092: Phase IV Evaluation of the Steady State Pharmacokinetics of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1 Infected Children
  • P1093 / PK, Safety, Tolerability and Antiviral Activity of Dolutegravir: 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
  • 1077BF / PROMISE 1077BF:Breastfeeding Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere
Microbicide Trials Network
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Microbicide Trials Network
  • MTN-001
  • MTN-003
  • MTN-003B
  • MTN-003D
  • MTN-015
  • MTN-016
  • MTN-018
  • MTN-018B
  • MTN-018C
  • MTN-019
  • MTN-020
  • MTN-025
  • MTN-032
  • MTN-034
  • MTN-041
  • MTN-042B
  • MTN-043
  • MTN-045
HIV Prevention Trials Network
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The HIV Prevention and Treatment Network
  • HIVNET 012
  • HPTN 046
  • HPTN 027
PMTCT Studies
PMTCT Studies
  • PEPFAR PROMOTE Study: Effects of long-term antiretroviral therapy in reproductive-age women in sub-Saharan Africa ( a multi-country observational cohort study)
  • PROMOTA Study
  • CD PROMOTE Study (Re-calibration of quantitative and contextual factors to predict child cognitive deficits in HIV exposed children in the PROMISE/PROMOTE study cohorts)
Vaccine Related Studies
Vaccine Related Studies
  • NeoObs - Observational study (Neo-Obs-001) to collect clinical and microbiological information on presumed and confirmed serious bacterial infections in neonates
  • PROGRESS - Seroepidemiology of Maternally derived antibody against Group B Streptococcus (GBS) in preparation for GBS vaccine studies
  • DTAP- Pertussis vaccine in HIV infected & uninfected pregnant women
  • PREPARE- GBS Vaccine preparedness & phase II trials
  • IMPRINT
TB Treatment and Prevention Studies
TB Treatment and Prevention Studies
  • SHINE: TB Treatment shortening trial for minimal tuberculosis using new WHO-recommended dosages in African and Indian HIV+ and HIV- children (Global Health Trials Team)
  • UNITAID-SPEED: 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
  • TB SURE: 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)

For more information, contact us at  partnerships@mujhu.org