Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
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Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Performance evaluation of the CheckNOW™ HIV Self-Test study
REFNo: HS2170ES

1. To evaluate the performance (Sensitivity and specificity) of the CheckNOW™ HIV SELF TEST when compared to the Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination (reference testing) in the laboratory and the national testing algorithm.

2. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the professional users, when compared to the reference testing and the national testing algorithm.

3. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the lay users, when compared to the reference testing and the national testing algorithm.

4. To assess the accuracy of the lay user interpretation of the HIVST result. This will be compared with the interpretation by the RA.
5. To assess the usability of the CheckNOW™ HIV SELF TEST. The usability of the test will be evaluated by questionnaires completed by the study staff observers and by the lay users.



Kampala, Kampala
Kalungu, Kalungu
Kayunga, Kayunga
Mukono, Mukono
 Uganda 2022-04-01 2025-04-01 1000 Adults aged 18 years and above who are willing to have an HIV test. - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Suubi4Stronger Families: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting among Families in Uganda
REFNo: SS1205ES

The study examines the mechanisms by which economic empowerment (EE) and family strengthening (FS) interventions targeting social, familial and context-specific drivers affect childhood behavioral health.

Specific aims of the study are:

Aim 1: Examine the impact of EE only, MFG-based FS only, and combined EE+MFG-based FS on children’s DBD symptoms and behavioral functioning.

Aim 2: Test the influence of EE only, MFG-based FS only, and combined EE+MFG-based FS on family financial stability (e.g., food and housing stability, material assets, savings), parenting and protective family
processes (e.g., family organization, caregiver/child interaction, cohesion, support) and perceptions related to
help seeking (e.g., stigma) on CBH and functioning; and assess whether these change mechanism mediate intervention effects on DBD symptoms and behavioral functioning, and explore moderation by context specific moderators of intervention effects.

Aim 3: Qualitatively examine participants’ experiences with each intervention arm.
 Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Bukulula
 Uganda 2022-03-30 2025-03-30 900 A total of 900 primary-school-going children (ages 10-14 at enrollment) in upper primary (the last 3 year of primary school: P5-P7), both male and female will be enrolled and followed for three school-academic terms(12 months). To avoid stigma that surro National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
SIMON ARUNGA
ID: UNCST-2021-R013498
 Cluster randomised controlled trial of a complex intervention package to reduce blindness from severe microbial keratitis in Uganda.
REFNo: HS1814ES

To determine if a complex intervention package delivered at the Primary Health Centres (PHCs) including early recognition, prompt chlorhexidine 0.2% treatment and rapid referral can result in reduced rates of blindness from severe MK at three months
 Ntungamo, All parishes
Isingiro, All parishes
 Uganda 2022-03-21 2025-03-21 Participants Individuals with corneal abrasions and corneal infection (microbial keratitis) presenting at the cluster primary health centres in these two districts in South Western Uganda will be elig All individuals aged 18 and above, of all sexes in the two districts London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Johanna  Blomgren
ID: UNCST-2021-R012309
 MIDWIZE - Strengthening midwives to implement and sustain quality improvements to optimise maternity care: A longitudinal observational study in Uganda
REFNo: HS1885ES

This PhD project aims to explore how midwives can take the lead in implementing or enhancing QI components within maternal health care in Uganda. The overall goal of this project is to improve the health of women and newborns. The way to achieve this is through enhancing the quality of care by capacitating midwives. Sub-study 1 - Co-creating and developing the intervention and the implementation Specific objectives: To explore multisectoral stakeholders' perspectives and ideas on how to strengthen midwives' capacity to implement QI components. To explore which QI components the midwives will implement or enhance. Sub-study 2 - Implementation and evaluating the sustainability of the implementation Specific objectives: -To measure the uptake of evidence-based QI components when midwives lead, organise and provide enhanced intra- and postpartum care. -To measure the long-term sustainability of the midwives' QI projects. Sub-study 3 – Process evaluation Specific objective: To evaluate the process of strengthening midwives' capacity to implement QIs in maternal care.
 Kampala,
Sweden 2022-03-21 2025-03-21 668 Study 1 Midwives at Naguru hospital, women and their relatives, other professionals and managers, multisectoral stakeholders (professional association, education, policymakers) Study 2 Pregnant women above 18 years in the uptake area. However, dependin Karolinska Institutet Medical and Health Sciences Clinical Trial Degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A Randomized, Observer-Blind, Phase 2 Clinical Trial of COVAC-2 in Generally Healthy Adults
REFNo: HS2124ES

Primary Objective:
• To evaluate the safety and tolerability of the COVAC-2 vaccine (25 ?g dosing of S1 antigen) in generally healthy adults ages 18+.
Secondary Objectives:
• To determine spike-binding and pseudovirus neutralizing antibody responses against the Wuhan strain of SARS-CoV-2 induced by COVAC-2; and
• To determine a cellular immune response induced by COVAC-2.
Exploratory Objectives:
• To determine Receptor-Binding Domain (RBD)-binding antibody responses induced by COVAC-2; and
• To determine the neutralizing antibody response induced by COVAC-2 against one or more Variant(s) of Concern (VOC) and/or Variant(s) of Interest (VOI).


Wakiso, NOT APPLICABLE
Mbarara, NOT APPLICABLE
Masaka, NOT APPLICABLE
 Uganda 2022-03-21 2025-03-21 300 The target population for this Phase 2 study is generally healthy adults of diverse gender ? 18 years of age. The target indication for the candidate COVAC-2 vaccine is adults because they are a population that experiences significant age-related COVID-19 The study is funded by the Government of Canada through the University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO). Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 Exposure-Response Evaluation of IV Artesunate in Children with Severe Malaria
REFNo: HS2027ES

Primary:
• To determine the relationship between dihydroartemisinin (DHA) exposures following intravenous dosing and markers of physiologic dysfunction associated with severe malaria
Secondary:
• To determine the relationship between DHA exposures and time to hospital discharge
• To determine the relationship between DHA exposures and parasite clearance associated with treatment of severe malaria.
Exploratory:
• To determine the relationship between DHA exposures and neurodevelopmental outcomes associated with treatment of severe malaria outcomes and explore predictors that may affect this relationship
• To evaluate the role of parasite clearance as a mediator of the relationship between DHA exposures and markers of physiologic dysfunction associated with severe malaria
• To develop a score comprised of markers of physiologic dysfunction and describe its relationship to clinical outcomes
• To assess P. falciparum infections for artemisinin resistance

Tororo, central division
 Uganda 2022-03-14 2025-03-14 100 Children with severe malaria who are 6 months to 14 years of age living in or near Tororo District, Uganda VTEU Contract HHSN2722013000221 Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Ngonzi
ID: UNCST-2019-R001579
 Automated visual evaluation and geospatial mapping for cervical cancer screening optimization in sub-Saharan Africa (AVE-Map)
REFNo: HS2069ES

3. To use AVE and geospatial analysis to scale up cervical cancer screening in Uganda ,2. To determine access to cervical cancer screening and referral pathways in Uganda ,1. To validate and expand use of AVE for cervical cancer screening in SSA ,We aim to leverage and develop data science expertise at our sites to first optimize and then combine AVE-based screening by health workers at peripheral health facilities with geospatial-analysis and needs-driven assessment to inform scale-up of cervical cancer screening in Uganda ,
 ,
Mbarara, Kakoba
 Uganda 2022-02-28 2025-02-28 2000 Females aged 25 years and above NATIONAL INSTITUTE OF HEALTH Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 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
REFNo: HS1991ES

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.

 Kampala, Kawempe
Kampala, Kisenyi
Uganda 2022-02-11 2025-02-11 300 pregnant women aged 18 to 40 years at gestation age of ? 27 0/7 to ?35 6/7 weeks. St George’s, University of London Cranmer Terrace SW17 0RE Medical and Health Sciences Clinical Trial Non-degree Award
Aisha Nanyiti
ID: UNCST-2021-R013489
 A Randomized Control Trial (RCT) on the Adoption of Liquefied Petroleum Gas (LPG) Cooking Technology among Fast Food (Chapati) Vendors in Uganda
REFNo: SS1017ES

This study seeks to establish the impact of hire purchase schemes and health and safety information on adoption of LPG cookstoves by chapati vendors.

This study will achieve the following specific objectives:
1) The impact of learning from LPG use in grace period before purchase armotisation on adoption of LPG cookstoves by chapati vendors for their businesses and households.
2) The impact of hire purchase on adoption of LPG cookstoves by chapati vendors for their businesses and households.
3) The impact of information on safety and health benefits of LPG on adoption of LPG cookstoves by chapati vendors for their businesses and households.
4) The impact of peer learning from other vendors using LPG cookstoves on adoption of LPG cookstoves by chapati vendors for their businesses and households.
 Kampala,
Uganda 2022-02-10 2025-02-10 210 chapatti vendors; they are mainly males of age range in 18-45 years from all districts of Uganda. Environment for Development Initiative Social Science and Humanities Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Effectiveness of a community health worker delivered care intervention for hypertension control in Uganda: a stepped wedge, cluster randomized control trial.
REFNo: HS1917ES

To assess the effectiveness of a CHW-delivered intervention for hypertension control in Uganda.,
 Nakaseke, Kigegge, Bulwadda, Mifunya, Kyamutakasa, Kasambya, Kasagga, North Ward. East Ward. Namilali, Kivule Central Ward
 Uganda 2022-02-10 2025-02-10 900 Hypertensive patients, 18 years and above, attending Nakaseke hospital or Life Care NCD clinics, and residing either in Nakaseke town council, Nakaseke Subcounty or Kasangombe. Else Kroner Fresenius Stiftung Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes among Adolescents Living with HIV in Uganda
REFNo: SS1166ES

Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome); and adherence to HIV treatment (keeping appointments, pharmacy refills, pill counts), and retention in care (secondary outcome).

Aim 2: Examine the effect of M-Suubi on Stigma (internalized anticipated, and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation.

Aim 3: Assess the cost and cost-effectiveness of each intervention condition.

Aim 4: Qualitatively examine: a) participants’ experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators’ attitudes towards ALHIV and experiences with GED-HIVSR, and program/policy implementation post-training.

Aim 5: Conduct formative work (focus group discussions) to understand the needs of depressed ALHIV.

 Masaka, Kimaanya
Kalungu, Bukulula
Rakai, Kakuuto TC
Lyantonde, Lyantonde TC
Bukomansimbi, Butenga
Lwengo, Lwengo
 Uganda 2022-02-04 2025-02-04 840 dyads The target populations for this study will be ALHIV, their caregivers (N=840 child-caregiver dyads), and administrators attending 42 boarding schools in the greater Masaka region. Participants will be included in the study if they meet the following inclu National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Emmy Okello
ID: UNCST-2020-R009792
 Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial
REFNo: HS1865ES

RIC will reduce the rates of all-cause death and early post-myocardial heart failure by approximately 25% when compared to sham control.,The RIC-AFRICA trial will investigate the effect of RIC in STEMI patients on the rates of all-cause death and early post-MI heart failure (pre-discharge HF and hospitalisation for HF at 30 days post-MI,) when compared to sham control,
 ,
Kampala, MULAGO
 Uganda 2022-02-01 2025-02-01 1500 Participants will be recruited from the Uganda Heart Institute and other nearby state and private hospitals with STEMI care with in Uganda and other collaborating sites in Sub-Saharan countries Mancherje-Potash Foundation, USA Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
 Safety and Efficacy of COVIDEX™ Therapy in Management of adult Covid-19 Patients in Uganda: A randomized double-blind placebo controlled adaptive phase 2 B clinical trial.
REFNo: HS2041ES

3. To determine the plasma concentration of berberine in COVID-19 patients receiving COVIDEX. ,2. To determine the efficacy of COVIDEXTm for treatment of COVID-19 among adults in Uganda.,To determine the efficacy of COVIDEXTm for treatment of COVID-19 among adults in Uganda.,To validate the safety and determine the efficacy of COVIDEXTm therapy for treatment of COVID-19 in adult Ugandans. ,
 Mbarara, kakoba
Kampala, mulago 1
 Uganda 2022-01-25 2025-01-25 584 Participants who are categorized as mild score 2 (limitation of activities), moderately ill COVID-19 patients score 3 (Hospitalized with no oxygen therapy), score 4(Hospitalized with oxygen by mask or nasal prongs) and hospitalized severe disease score 5 JENA HERBALS LTD, MINISTRY OF HEALTH UGANDA Medical and Health Sciences Clinical Trial Non-degree Award
Susanne Guidetti Gittel Eleonora
ID: UNCST-2021-R012422
 Participation in everyday life - A randomized controlled trial of mobile phone-supported and family-centred rehabilitation after stroke in Uganda
REFNo: HS1528ES

General objective (Overall aim)
To implement and evaluate the effects a mobile phone supported and family-centred rehabilitation intervention F@ce 2.0 aiming to enable performance in daily activities and participation in everyday life among persons who have had a stroke and their family members both in urban (Kampala and its surroundings) and rural (Greater Masaka) areas.

Specific objectives
• To describe the perceived impact of stroke and perceived participation in everyday life in a sample of people with stroke in rural Uganda. (Study 1)
• To evaluate the effects of F@ce in comparison with ordinary rehabilitation among persons with stroke in urban and rural Uganda regarding a) self-efficacy b) perceived performance and participation in everyday activities c) independence in ADL, d) healthcare utilization and e)their families´ perceived participation in everyday activities.(Study 2)
• To explore and describe the experiences of people with stroke and family members of participating in the F@ce (Study 3)
• To evaluate the implementation process of F@ce and to gain knowledge on the mechanisms of impact as well as the contextual factors that might influence the implementation process and its outcome. (Study 4)
• To determine the cost of delivering the F@ce intervention in comparison with the usual rehabilitation (Study 5)

 Kampala,
Masaka,
Iganga,
Sweden 2022-01-19 2025-01-19 174 The sample size will accommodate for an attrition rate of 10%, based on our pilot study in Uganda, therefore will require the inclusion of a total of 174 participants with stroke, 15 health professionals and 15 caregivers (family members). The study will The Swedish Research Council Medical and Health Sciences Clinical Trial Non-degree Award
Maria NAKACHWA
ID:
Mobile Telephone Communication and Utilization of Antenatal Care Services During Pregnancy. A Case Study of Kyotera and Rakai Districts- Uganda
REFNo: HS1957ES

d. To develop a model for the prediction of ANC uptake when mobile telephone communication is used.,c. To evaluate effects of patient factors in the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts , Uganda.,b. To assess patient factors influencing mobile telephone communication among expectant mothers in Kyotera and Rakai Districts, Uganda.,a. To examine effects of mobile telephone communication on the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts, Uganda.,
 Rakai, Kitente
 Uganda 2022-01-12 2025-01-12 2214 THE STUDY POPULATION CONSTITUTES OF EXPECTANT MOTHERS AGED 15 TO 49 YEARS RESIDING IN KYOTERA AND RAKAI DISTRICTS FROM ALL THE TRIBES IN THESE COMMUNITIES. SELF SPONDORED Medical and Health Sciences Clinical Trial Degree Award
David Lubogo
ID: UNCST-2020-R014473
 Metabolic Syndrome among Females of Reproductive age in Wakiso district, Central Uganda: Risk factors and Effectiveness of a Community based Nutrition Education Intervention
REFNo: HS1281ES

General objective: To investigate the prevalence of, and factors associated with metabolic syndrome (MetS) and evaluate the effect of a community based nutrition education intervention among females of reproductive age with MetS in Wakiso district, Central Uganda in order to contribute information for the design of interventions for MetS.
Specific objectives
1. To determine the prevalence of, and factors associated with Metabolic Syndrome.
2. To determine optimal WC cut off points for MetS.
3. To determine the effectiveness of a 12 -week community-based nutrition education and counseling intervention for metabolic syndrome on selected cardiovascular outcomes (BP), biochemical outcomes (HDL, TGS, blood sugar), anthropometric measures (WC, weight), behavioral outcomes (dietary intake, physical activity), and on knowledge as an outcome.
4. To explore the female and health care provider perceptions/perspectives towards the nutrition promotion intervention on MetS among female of reproductive age in South Central Uganda.

 Wakiso,
Wakiso,
Uganda 2021-12-28 2024-12-28 840 Females aged 15- 49 years in Wakiso district. Strengthening Education and Training Capacity in Sexual and Reproductive Health and Rights in Uganda (SET-SRHR) and the Government of Uganda Medical and Health Sciences Clinical Trial Degree Award
JIM ARINAITWE
ID: UNCST-2021-R012572
 Quit4Life: Adapting and Evaluating a Phone-Based Tobacco Uses Cessation Program for People Living with HIV in Uganda and Zambia.
REFNo: HS1762ES

The goal of the study is to adapt and evaluate the efficacy of a phone-based tobacco cessation intervention for PLWH in Uganda and Zambia in five years. The primary objective of the study is to promote smoking cessation among HIV infected persons. Specifically, 1) adapt a standard short message service (SMS) for tobacco cessation program, 2) Nicotine Replacement Therapy, 3) compare the efficacy of our SMS-based program tailored to meet the needs of PLWH (Quit4Life+) to the current standard of care.
Arua, Adumi HCIV, Omugo HCIV and River Oli HCIV
Moroto, Loputuk HCIII, Nadunget HCIII and Tapac HCIII
 Uganda 2021-12-28 2024-12-28 Total Sample size is 800 with 400 from Uganda and 400 from Zambia The study will include males and females of consenting age attending HIV services at Health III, IV, District/Regional Referral Hospitals National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
JULIET MWANGA-AMUMPAIRE
ID: UNCST-2022-R009420
 An open-label, multicentre, randomized, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19
REFNo: HS1789ES

Primary objective: to compare the efficacy of alternative treatment strategies versus control on the risk of progression to severe respiratory disease
The secondary objectives are:
 To compare the safety of each study arm to control, up to Day 21 of follow-up
 To compare the rate of hospitalizations due to COVID-19 in each study arm versus control
 To compare the time to hospitalization due to COVID-19 in each study arm versus control
 To compare the rate of hospitalizations for other reason than Covid-19 in each study arm versus control
 To compare the disease-free rate in each study arm versus control
 To compare the death rate in each study arm versus control
 To compare time to worsening of SpO2 < 93in each study arm versus control
 To compare the capacity to prevent severe progression between study arms
 To identify risk factors for severe progression
 To assess efficacy in sub-groups of patients e.g. with pre-existing conditions/co-morbidities, by age group, sex, BMI, timeframe between onset of symptoms and randomization.

 Mbarara, Mbarara Medical Cell
 Uganda 2021-12-07 2024-12-07 175 1. Male or female patients, 2. Adult’s  18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology or validated antigenic test Drugs for Neglected Diseases Initiative (DNDi) Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 PURPOSE 1: GS-US-412-5624/ A Phase 3, Double-Blinded, Multicenter, 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. Version 2.0, dated 10 March 2021.
REFNo: HS1920ES

1. Primary Objectives i) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection. ii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection. 2. Secondary Objectives/ end points i) To compare the efficacy of LEN with F/TDF for HIV PrEP in AGYW at risk of HIV infection. ii) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection in participants adherent to LEN. iii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection in participants adherent to F/TAF. iv) To compare the efficacy of F/TAF with F/TDF for HIV PrEP in AGYW at risk of HIV infection. v) To evaluate the safety and tolerability of LEN, F/TAF, and F/TDF for HIV PrEP in AGYW at risk of HIV infection. vi) To evaluate the safety and tolerability of LEN and F/TAF for HIV PrEP in AGYW ≥ 16 to < 18 years of age who have sex with male partners and are at risk for HIV infection. 3. Exploratory objectives i) To assess the adherence rate to LEN as assessed by on-time LEN injection ii) To assess LEN plasma levels iii) To assess the adherence rate to F/TAF and F/TDF using intracellular TFV-DP levels in DBS. iv) To evaluate the acceptability of a once every 26 weeks LEN injection for HIV PrEP in AGYW at risk of HIV infection. v) To assess LEN plasma levels during pregnancy. vi) To explore concentrations of hormonal contraceptives in LEN participants.
Mityana, Mityana
Hoima, Hoima county
Masaka, Masaka
Kalangala, Kalangala
 Uganda 2021-11-25 2024-11-25 The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a randomized blinded study (Randomized Phase). The Incidence Phase of the study will remain open until the backg Cisgender AGYW who have sex with male partners, at risk for HIV infection ≥ 16 to ≤ 25 years of age. Gilead Sciences Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Kamya Moses
ID: UNCST-2020-R014203
 Enhancing immunity to malaria in young children with effective chemoprevention
REFNo: HS1763ES

To compare the incidence of malaria from 4 weeks to 4 years of age among children born to mothers randomized to receive intermittent preventative therapy in pregnancy (IPTp) with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP.

To compare the incidence of malaria from 2-4 years of age among children randomized to receive IPT in childhood (IPTc) with monthly DP from 8 weeks to 1 year of age vs. monthly DP from 8 weeks to 2 year of age vs. no IPTc.

To compare innate and adaptive effector and regulatory responses between children randomized to different IPT arms.

Busia, Masafu
 Uganda 2021-11-24 2024-11-24 924 HIV-uninfected infants Children both male and female, 4 weeks to 4 years of age, resident of Busia District Division of Microbiology and Infectious Diseases (DMID) Medical and Health Sciences Clinical Trial Non-degree Award
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