Therapy for HIVInfected Adults in Uganda The SHARE Trial JAYNE BYAKIKATUSIIME PHD AFRICA EVIDENCE SUMMIT 07 APRIL 2021 Presentation Outline Background to the study Study methods Results Conclusions and recommendations ID: 918939
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Task Shifting for Initiation and Monitoring of AntiretroviralTherapy for HIV-Infected Adults in Uganda: The SHARE Trial
JAYNE BYAKIKA-TUSIIME, PHDAFRICA EVIDENCE SUMMIT07 APRIL 2021
Slide2Presentation Outline
Background to the studyStudy methodsResults
Conclusions and recommendations
Slide3Background
SSA is home to 2/3 of PLHIVSSA has the lowest rates of physicians per capita
UNAIDS strategy to end the AIDS epidemic by 2030
WHO ‘s “Treat All” recommendation
Prevalence of HIV in Uganda is 6.2%
Uganda adopted the “Treat All” recommendation
Task shifting a recommended to address workforce shortages
Slide4Methods: Study design
Study design: A parallel, unblinded RCT using a noninferiority designStudy population: HIV-infected, ART-naive, and clinically stable adults (>=18 years) eligible for ARTStudy setting: HIV treatment clinics at 8 public regional referral hospitals in Uganda
Slide5Methods: Sample size calculation
878 individuals per armNull hypothesis: the nurse arm was inferior to the clinician arm
Used a noninferiority margin of 6%
Slide6Methods: Randomization
Used simple randomization with an allocation probability of 0.5 per armOffice generation of the randomization code
Slide7Methods: HIV Care models and patient follow up
Baseline viral load, ARTMonthly clinic visits scheduled for 1 yearLaboratory tests conducted at 6 and 12 months post-ART initiation
Slide8Data Analysis Plan
The primary study outcome was a composite end point of any of the following examined at 6 and 12 months post ART initiation: All-cause mortalityVirological failure
Toxicity failure
LTFU at 12 months post-ART initiation
Slide9Statistical Methods
Intention-to-treat (ITT) and per-protocol (PP) analyses doneComparison of proportionsIncidence and time to event analysis was performed
Slide10Results: Participant flow
Slide11Slide12Slide13Site-adjusted risk difference for end points and 97.5% CIs between nurse arm and clinician arm at 12 months
Slide14Kaplan–Meier survival from composite events
Time to first event was about 9 days in clinician arm and 14 days in nurse arm. Event included death, LTFU, and toxicity
Slide15Conclusion and Recommendations
Nurses are not inferior to clinicians in initiating and monitoring ART in HIV-infected stable adultsTask shifting to trained nurses is a viable means to increase access to ART
Need to develop a formal task-shifting policy in MOH
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