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
Consortiums
Our Studies
Network Studies
International Maternal Pediatric Adolescent AIDS Clinical Trials Network
Principal Investigator - Dr. Eric Wobudeya
IMPAACT 2003B – PHOENIx MDR TB Study
A Phase III, open label, multi-center trial with a cluster- randomized superiority design (eligible contacts in the same household are a cluster), to compare the efficacy and safety of 26 weeks of delamanid versus 26 weeks of isoniazid for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts of multidrug-resistant tuberculosis (MDR) TB patients.
Principal Investigator- Dr. Maxensia Owor
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 2017 Rollover Study
A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-acting Combination Therapy.
Principal Investigator- Dr. Clemensia Nakabiito
IMPAACT 2036
Phase I/II LA CAB + Rilpivirine children 2-12 yrs. Uganda sites halted lack of drug access post-trial
Principal Investigator- Dr. Patience Atuhaire
2024 IMPAACT Early Career Investigator program
TORCHES and relation to Preterm Delivery and Low birth weight among pregnant women living with HIV and their babies in the IMPAACT 1077BF trials
Principal Investigator- Brenda Kakayi
2023 IMPAACT Scholar Grant
Insulin-like Growth factor/growth hormone axis alterations and Stunting in HIV exposed Uninfected Children from 1077BF/P1084s study
Principal Investigator- Dr. Grace Ahimbisibwe
2025 IMPAACT ECI Award
Assessing the Effects of Immune Suppression of Pregnancy on the HIV Latent Reservoir in African Women with HIV Participating in P1078
Principal Investigator-Dr Denis Kimbugwe
2025 IMPAACT ECI Award
Systemic inflammation in pregnant and postpartum mothers with HIV and their children: relationship with child growth (utilizing data from IMPAACT 1077BF and 1077FF)
HIV Prevention Trials Network
Principal Investigator- Dr. Zubair Lukyamuzi
HPTN 111- TRIM Study
Uptake of HIV testing and preventative care among heterosexual men attending barber shops in Uganda
Principal Investigator- Dr. Phiona Kibalama Ssemambo
2023 HPTN Scholar 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. Rita Nakalega
2023 HPTN Scholar Grant
Exploring the correlates of non-disclosure of HIV-Positive status in the population cohort at 2 years in the HPTN 071 (Pop ART) HIV prevention trial.
AIDS Clinical Trials Group Network
Principal Investigator- Dr. Ronnie Kasirye
ACTG Mentorship Award
Hospitalization Rates and Associated Factors Among Older Adults with HIV.
Non-Network Studies
PMTCT Studies
Principal Investigator- Prof. Philippa Musoke
Reservoir
Deciphering Molecular Mechanisms of HIV Latency Reversal in Perinatal Infections with Single Cell Transcriptomics
Women's Health Studies
Principal Investigator- Dr. Brenda Gati
CUPID Study (Couples United in HIV Prevention & Informed Decisions)
An implementation science project building on the success of the CATALYST Project, which expanded PrEP options for women, including oral PrEP, long-acting PrEP, and the vaginal ring
- 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.
Principal Investigator- Dr. Rita Nakalega
PREVENT
- 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.
Principal Investigator- Dr. Flavia Matovu Kiweewa
M1DART
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.
Principal Investigator- Dr. Catherine Nakaye
DROP-D Study - UJMT Fogarty Global Health Fellowship Program
Feasibility, Acceptability, and persistence of community drug shop-based HIV self-testing and oral PrEP delivery among Women at risk of HIV in Kitebi, Kampala (DROP-D)
Paediatric studies
Principal Investigator- Dr. Flavia Matovu Kiweewa
Cobicistat (NCI/1/2)
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants” of HIV infection
Principal Investigator- Prof. Philippa Musoke
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- Dr. Grace Ahimbisibwe
Odyssey - Youth Trial Board
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.
Adolescent studies
Principal Investigator- Dr. Flavia Matovu Kiweewa
MSD EXPrESSIVE PrEP Study
Evaluate the safety and efficacy of oral MK-8527 once-monthly pill for HIV prevention in adolescent girls and young women
Principal Investigator- Prof. Philippa Musoke
PATCH3
Implementation Science PrEP in at risk adolescents; and ART adherence intervention
Principal Investigator- Dr. Flavia Matovu Kiweewa
PURPOSE 1
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 in a study entitled: A Phase 3, double-blinded, multi-center, randomized study to evaluate safety and efficacy of twice yearly long-acting subcutaneous lenacapavir, and daily oral emtricitabine/ tenofovir alafenamide for Pre-exposure prophylaxis in adolescent girls and young women at risk of HIV infection, shortly known as “PURPOSE 1”study.
Bone Health Studies
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 on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate based Anti-Retroviral Therapy.
Principal Investigator- Dr. Flavia Matovu Kiweewa
Promote RO1 (DXA)
Determining Bone Loss and Bone Mineral Density Recovery Following Repeat Pregnancy/Lactation Among HIV women of ART
Neurodevelopment Studies
Investigators- Dr. Lillian Wambuzi and Juliane Etima
Eye Tracking Pilot Study
TB Treatment and Prevention Studies
Principal Investigator- Dr. Deo Wabwire
RAD-TB study
A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
Treatment Technology Study
Principal Investagator- Brenda Kakayi
REVIVE Trial
A randomized double blinded, placebo controlled, multicenter trial of azythromycin prophylaxis for advanced HIV disease
Vaccine Related Studies
Principal Investigator- Dr. Musa Sekikubo
BoostMe
Earlier prime-BOOST schedule to improve MEasles protection in high-burden settings
Principal Investigator- Dr. Musa Sekikubo
PROTECT WP4
Safety and immunogenicity trial GBS6 in pregnant women HIV+ and neg, and their infants.
Principal Investigators- Dr. Musa Sekikubo
MINERVAX Phase 2
Trial of two doses of Group B Streptococcus vaccine (GBS-NN/NN2) in HIV+ and neg pregnant women
Past Studies
International Maternal Pediatric Adolescent AIDS Clinical Trials Network
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
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
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
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
PREPARE
- GBS Vaccine preparedness & phase II trials
IMPRINT- Public Engagement Project
- Increasing maternal immunisation awareness by working with women influencers in Kawempe Division, Uganda
WOMANPower
- The safety and imMunogeNicity of combined Pertussis-cOntaining vaccine (Tdap) for HIV-infected pregnant WomEn and their newboRns - A Randomized Clinical Trial
MINERVAX
- 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.
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
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