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OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

Study acronym: OPTIMAH
StatusRecruiting
PhasePhase 4
Started2025-12-18
View on ClinicalTrials.gov ↗

Amendment history

2026-02-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12→confirmed 2025-12-18
Study sitesdetails revised at 2 of 2 sites
2025-10-29
minor
Study Status v3
Primary completion date2027-09→2027-12
Completion date2027-09→2027-12
Start date2025-09→2025-12
2025-08-26
minor
Study Status v2
Start date2025-07-15→2025-09
2025-07-20
minor
Study Status v1
Start date2025-06→2025-07-15
2025-05-02
minor
Original filing
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT06967519
Lead Sponsor Yale University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Malaria, Hiv
Enrollment 380 participants
Start Date 2025-12-18
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-04