Actively Recruiting
OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Led by Yale University · Updated on 2026-02-04
380
Participants Needed
2
Research Sites
101 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A longitudinal study with four parallel cohorts with each participant followed for 2 years: two cohorts in Busia (high malaria transmission site) and two cohorts in Kampala (low malaria transmission). Each site will have a cohort of children living with HIV (CLHIV) and HIV- uninfected children and will be age-matched, enrolled in parallel, and followed for two years. All children will be enrolled without malaria infection, as determined by a negative blood smear at baseline.
CONDITIONS
Official Title
OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agreement to come to the clinic for all follow-up evaluations
- Provision of informed consent and assent (as appropriate)
- Residency within approximately 30 km of the study clinic
- Negative blood smear for malaria at baseline
- For children living with HIV: confirmed HIV infection
- For children living with HIV: on a dolutegravir-based regimen for at least 14 days
- For HIV-uninfected children: documented HIV-negative status by at least one assay
You will not qualify if you...
- Significant comorbidities such as malignancy, active tuberculosis, chronic or active hepatitis B or C, diabetes, severe acute malnutrition, or mitochondrial disorders
- Receiving known CYP interacting drugs at enrollment (except HAART)
- Anemia with hemoglobin less than 7.0 at enrollment
- Signs of uncomplicated or severe malaria at enrollment
- Prior intolerance to artemether-lumefantrine or artesunate-amodiaquine (for those in Busia only)
- Pregnancy at enrollment
- Concurrent enrollment in another research study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Baylor- Uganda
Kampala, Uganda
Actively Recruiting
2
Infectious Disease Research Collaboration (IDRC)
Kampala, Uganda
Actively Recruiting
Research Team
S
Sunil Parikh, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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