PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
EClinicalMedicine
Abstract
Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in
partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including
uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an
existing HIV program.
Methods Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members
of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV.
The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain
mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6
months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent
couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and
cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was
registered at ClinicalTrials.gov, NCT03586128.
Findings From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics
in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During
the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6
months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within
90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis,
82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant
difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses.
Interpretation Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships
and did not improve the already high frequency of HIV viral suppression among partners living with HIV.
Description
Keywords
PrEP, Serodifferent couples, ART, Viral suppression, Stepped-wedge trial
Citation
Heffron, R., Muwonge, T. R., Thomas, K. K., Nambi, F., Nakabugo, L., Kibuuka, J., ... & Pisarski, E. (2022). PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial. EClinicalMedicine, 52, 101611. https://doi.org/10.1016/j. eclinm.2022.101611