CROI 2016 Abstract eBook

Abstract Listing

Oral Abstracts

Methods: 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. Results: 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). Conclusions: 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.

Oral Abstracts

113LB A Randomized Trial to Accelerate HIV Care and ART Initiation Following HIV Diagnosis Christopher Hoffmann 1 ;Tonderai Mabuto 2 ; Sibuse Ginindza 2 ; Katherine L. Fielding 3 ; Griffiths Kubeka 2 ; David Dowdy 4 ; Gavin Churchyard 5 ; Salome Charalambous 5 1 Johns Hopkins Univ Sch of Med, Baltimore, MD, USA; 2 Aurum Inst, Johannesburg, South Africa; 3 London Sch of Hygiene & Trop Med, London, UK; 4 Johns Hopkins Univ Bloomberg School of Public Hlth, Baltimore, MD, USA; 5 The Aurum Inst, Johannesburg, South Africa Background: There is substantial attrition from HIV testing to initiation of care and antiretroviral therapy (ART). We tested three strategies to accelerate entry-into-care and ART initiation after testing positive at mobile HIV counselling and testing (HCT) units deployed in communities and workplaces in South Africa. Methods: We conducted an unmasked individually randomized pragmatic trial. Following enrollment, participants were allocated equally into four arms: standard of care (SOC), point-of-care CD4 (POC CD4), POC CD4 plus strengths based care facilitation (CF), or POC CD4 plus transport reimbursement. Randomization was stratified by urban/rural status. POC CD4 count testing was accompanied by standardized counseling. CF consisted of five standardized sessions along with text messaging and ad hoc communication. Transport reimbursement was provided via cell phone transfer or at grocery stores. We assessed outcomes by self-report and by clinical documentation and calculated hazard ratios using Cox regression adjusted for randomization stratum. Here we present final results for the primary outcome of 90 day entry-into-care and a secondary outcome of 180 day ART initiation. Results: We enrolled 2,558 participants, of whom 160 were excluded after randomization. Of the remaining 2398 participants, 1497 (62%) were women, the median age was 33 (IQR: 27, 41) years, and the median CD4 + T-cell count (in arms offering POC CD4) was 427 cells/mm 3 (IQR: 287, 595). During the first 90 days following enrollment, 1,236 (52%) participants self-reported entry into care, with no difference by arm (Table). Overall, 764 (32%) participants had documented entry-into-care within 90 days to any of 90 clinics, and 371 (15%) had documented ART initiation within 180 days, with the POC CD4 + CF arm showing significant improvement relative to SOC (HR 1.4, p=0.002 and HR 1.4, p=0.02 for 90 day entry and 180 day ART, respectively). Conclusions: POC CD4, with or without transport reimbursement or care facilitation, did not improve self-reported 90-day entry into HIV care. POC CD4 with strengths-based care facilitation did increase the secondary outcomes of clinically documented entry-into-care and ART initiation by 40%. While care facilitation could improve the HIV care continuum in South Africa, community and clinic-level strategies are likely also needed to achieve substantial increases in initiation of care and ART.

44

CROI 2016