Following children with and without HIV to study malaria treatment over time
Follows children with and without HIV to compare malaria treatments.
Plain-language title generated from the registry record
Registry title: OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Key facts
- Where
- Kampala, UgandaSee the 2 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT06967519, who can take part
Where in Uganda
- Baylor- UgandaKampala, UgandaTaking people
- Infectious Disease Research Collaboration (IDRC)Kampala, UgandaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT06967519
- Record updated
- 4 February 2026
- Original description
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.Read full original descriptionShow less
OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
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.
Inclusion: 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 (all sites); For Children and adolescents living with HIV; Confirmed HIV infection; On DTG-based regimen for ≥14 days; For HIV-uninfected children - documentation of HIV-negative status by at least 1 assay.
Exclusion: Receipt of known CYP interacting drugs at enrolment (except HAART) - see list of disallowed medications; Prior intolerance to AL or AS-AQ (for those in Busia only); Concurrent enrolment in another research study; Significant comorbidities such as malignancy, active TB, chronic/active hepatitis B/C, diabetes, severe acute malnutrition, mitochondrial disorders; Pregnancy at enrolment (testing done at enrollment for all those of child-bearing age); Anemia defined by hemocue (Hb < 7.0) at the time of enrolment; Signs of uncomplicated or severe malaria at the time of enrollment.