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Streamlining Antiretroviral Therapy Uptake: A Stepped-Wedge Cluster Randomized Trial
Gideon Amanyire1; Fred Collins Semitala1; Jennifer Namusobya1; Richard Katuramu2; Leatitia Kampiire2; Jeanna Wallenta3; David V. Glidden3; Moses R. Kamya1; Diane V. Havlir3; Elvin H. Geng3
1Makerere Univ Coll of Hlth Scis, Kampala, Uganda;2Infectious Diseases Rsr Collab, Kampala, Uganda;3Univ of California San Francisco, San Francisco, CA, USA
In Africa, uptake of antiretroviral therapy (ART), even among clinically-eligible patients presenting for care, is often sub-optimal. Common reasons include sluggish diffusion of contemporary evidence about risks of delay (especially among symptomatic patients); overnight CD4 processing and therefore inefficient determination of treatment eligibility; and multiple pre-treatment adherence counseling norms.
We designed an intervention targeting prevalent barriers to ART uptake comprised of opinion-leader led teaching and coaching about risks of delayed initiation; introduction of a point-of-care CD4 testing platform (Alere PIMA); a revised counseling approach without mandatory multiple pre-initiation sessions and quantitative clinic feedback on ART initiation rates. We randomized twenty clinics in southwestern Uganda operated by the Ministry of Health and supported by a Ugandan NGO to the intervention in groups of five every six months. We evaluated all treatment eligible adults for ART initiation and a random sample for HIV RNA suppression one year after ART eligibility (defined as < 200 copies/mL). Mixed-effects logistic regression with a normal random effect for site and a fixed effect for intervention was used to estimate probability of ART initiation.
Among 12,024 treatment eligible patients with a median CD4 level of 310/µl (IQR: 179-424), 79.6% met the primary outcome of ART initiation two weeks after eligibility in the intervention condition vs. 37.7% in the control condition (risk difference (RD): 41.9%, 95% CI: 40.1%-43.8%, p<0.0001) (Figure). Same-day ART initiation rose from 18.3% to 70.8% (RD: 52.5%, 95% CI: 50.7%-54.3%, p<0.0001). Among 414 patients randomly selected for HIV RNA measurement, when missing HIV RNA were counted as failure, 65.6% in the intervention were suppressed vs. 57.7% in the control (RD: 7.9%, 95% CI: -4.2% to 20.0%, p=0.20). Among the 335 patients (81%) in whom HIV RNA was successfully obtained, suppression was 86.2% in intervention and 70.6% in control condition (RD=15.6%, 95% CI: 4.4%-26.7%, p=0.0078).
A multi-component intervention targeting health care worker behavior doubled the probability of ART initiation 14 days after eligibility and improved HIV RNA suppression among those successfully measured. Implementation interventions can achieve rapid gains in the effectiveness and efficiency of real-world ART delivery systems and close gaps in the cascade of care.