CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

Results: We studied 500 children; the majority 381/500 (76.2%) initiated ART due to the new Test and Treat policy while 119/500 (23.8%) required ART based on the 2010 WHO guidelines. Children initiated based on the new policy had a median baseline CD4 count of 745 [551-1089] compared to 313 [77-558] for those initiated based on the 2010 WHO guidelines. Children initiated based on the new policy were less likely to develop malnutrition within the first 6 months of treatment OR 0.13 [95%CI 0.05; 0.30], were more likely to be adherent to ART OR 1.85 [95% CI 1.02; 3.29] and were also more likely to have viral suppression at 6 months OR 4.42 [95% CI 2.29; 8.53]. The rates of retention at 12 months were 99% for the Test and Treat group versus 85% for children initiated based on 2010 WHO guidelines. There were no other statistically significant differences between the two groups. Conclusions: The Test and Treat model of treatment is viable for resource limited settings with demonstrated favorable treatment outcomes. 843 48-Week Outcomes of African Children Starting ART at CD4 >500With Streamlined Care Florence Mwangwa 1 ; DianeV. Havlir 2 ;Vivek Jain 2 ; Dathan Byonanebye 3 ; Dalsone Kwarisiima 4 ;Tamara Clark 2 ; Edwin Charlebois 2 ; Maya Petersen 5 ; Moses R. Kamya;Theodore D. Ruel 2 1 Infectious Diseases Rsr Collab, Kampala, Uganda; 2 Univ of California San Francisco, San Francisco, CA, USA; 3 Makerere Univ Coll of Hlth Scis, Kampala, Uganda; 4 Makerere Univ-Univ of California San Francisco Rsr Collab, Kampala, Uganda; 5 Univ of California Berkeley, Berkeley, CA, USA Background: With global guidelines shifting to universal antiretroviral therapy (ART) for HIV+ children, strategies are needed to scale-up ART efficiently while ensuring good clinical outcomes. Data on children initiating ART at high CD4 counts are particularly limited. We evaluated retention in care, viral suppression, and safety in asymptomatic HIV+ children starting ART at CD4 >500 cells/μl in rural African clinics using a streamlined ART delivery system. Methods: In 16 rural Ugandan and Kenyan clinics, HIV+ adults and children were offered ART (SEARCH Study, NCT:01864603) in 2013-15. We studied children 2-14 years old who initiated ART with CD4 >500 cells/μl and were ineligible for ART by country guidelines. Streamlined care included: (1) nurse-driven triage and visits focused on symptom-based ART toxicity screening, (2) on-site nurse referral of complex cases to a physician, (3) a patient-centered care system, fostering a welcoming/ supportive environment, (4) viral load (VL) measurement and structured VL counseling, (5) provision of 3 months’ ART refills, and (6) appointment reminders and patient tracking. Patients had visits at baseline, 4, 12, then every 12 weeks. VL and basic safety laboratory tests were assessed at baseline, 24 and 48 weeks. Results: Overall, 77 HIV+ children initiated ART. Median age was 8 years (IQR 6-11), 56%were female, and 34%were orphans frommother/father/both. No prior + HIV test was reported by 43/77(56%). At baseline, children had a median VL of 14,851 copies/ml (IQR 1,651-66,479) and a median CD4 count of 847 cells/μl (IQR 659-1,103). Overall, 74/77(96%) of children were retained at week 48. Two children withdrew consent when they moved out of the study area and one because the parent declined ART. One child was last seen at enrollment, another at 12 weeks. There were no deaths. Overall, 3/77 (4%) patients had grade III or IV clinical adverse events, including thrombocytopenia(III), and neutropenia (III) and rash(IV). One patient each switched from nevirapine and abacavir due to rash. Viral suppression was achieved in 62/68 (91%) children tested at 48 weeks (see table). Conclusions: HIV+ children 2-14 years old with CD4 >500 cells/μl receiving ART in rural African clinics employing streamlined ART delivery had 94% retention in care at 48 weeks with 91% viral suppression among those tested. This suggests that as nations adopt universal ART, streamlined nurse-driven care systems can safely and effectively deliver ART to HIV+ children.

844 Family Clinic Day RCT in Uganda: Child Antiretroviral Therapy Retention and Adherence

Justin C. Graves 1 ; Christine J. Schellack 2 ; Margaret L. Prust 1 ; Esther Mirembe 2 ; Marta R. Prescott 1 ; Betty Mirembe 2 ; Ivan Lukabwe 3 ; Barbara Asire 3 ; Peter Elyanu 3 ; Sarah Moberley 4 1 Clinton Hlth Access Initiative, Boston, MA, USA; 2 Clinton Hlth Access Initiative, Kampala, Uganda; 3 Uganda Ministry of Hlth, Kampala, Uganda; 4 Clinton Hlth Access Initiative, Melbourne, Australia Background: Uganda recently adopted a test-and-treat policy for HIV patients 15 years or younger. But despite increased eligibility, low retention rates among pediatric and adolescent antiretroviral therapy (ART) initiates could severely limit the impact of this new policy. This evaluation tested the impact of the Family Clinic Day (FCD) program, a facility based family-centered appointment scheduling and health education intervention. Methods: We conducted a clustered randomized controlled trial for 6 months, from October 2014 to March 2015. Forty-six facilities were stratified by implementing partner and facility type and randomly assigned to the control arm receiving standard practice of care or the intervention are receiving FCD. Retrospective data collection of ART registers

Poster Abstracts

occurred after study completion in May 2015. Outcome indicators for paediatric and adolescent patients included the proportion retained in care and the proportion adherent to their appointment schedule. Six focus group discussions (FGD) were conducted with FCD participants and 17 interviews with health workers were conducted to understand perspectives on FCD successes and challenges. Results: A total of 4,715 pediatric and adolescent patient records were collected, of which 2,679 (n=1,319 from control facilities and 1,360 from intervention facilities) were eligible for inclusion. The FCD did not improve retention (adjusted odds ratio [aOR] 1.11; 90% CI 0.63 – 1.97, p=0.75), but as shown in figure 1, was associated with improved adherence to appointment schedule (aOR 1.64; 90% CI 1.27 – 2.11, p<0.01). Qualitative findings suggested that FCD patients benefited from the health education and increased psychosocial support. Health workers identified few challenges with FCD implementation, but broader challenges in ART care delivery may be impacting the ability of health facilities to implement FCD. Conclusions: FCD scale-up in Uganda would likely produce improvements to adherence following an increase in knowledge based on health education, peer support and adherence to appointments. Broad challenges facing ART clinics, such as under-staffing and poor filing systems, should be addressed in order to maximize the impact of programs such as FCD.

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CROI 2016