CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

Methods: Quarterly supervision includes collection of verified ART cohort reports from all sites. This data is entered into a central database at MOH to create the Quarterly HIV Program Reports. We analyzed this site-level data to describe annual program performance 1 year before and 4 years after introduction of Option B+. Results: Within 4 years, the number of active ART sites increased from 303 to 714, and the proportion of antenatal clinics providing ART services increased from 37% in June 2012 to 98% in June 2015. The percent of ART sites which were rural (55% to 73%), health centers (47% to 69%) or enrolling fewer than 50 new ART patients per quarter (52% to 73%) all increased from 2011 to 2015. Total annual ART initiations (73,805 to 107,181), ART initiations among pregnant women (4,850 to 25,851) and patient transfers between sites (16,978 to 26,514) all increased as a result of decentralization. Between July 2014 and June 2015, 94% of sites enrolled both Option B+ and general ART patients. ART coverage among known HIV-infected pregnant women increased from 22% to 95%. The proportion of sites with 12 month retention >80% declined from 56% in the year prior to Option B+ to 49% four years after. In June 2015, 7% of sites were scored as ‘in need of urgent clinical mentoring’, compared to 22% in June 2012. Conclusions: In Malawi, full decentralization of ART and integration with PMTCT successfully led to a rapid increase in patients initiating ART and ART coverage among pregnant women. Integration was evident in the high proportion of sites enrolling both Option B+ and general ART patients . Through quarterly supervision, service delivery models and service quality at sites improved over time. Routine service data are known to underestimate ART retention by about 10% due to unrecorded patient transfers or visits. Actual 12 month retention has remained stable or decreased slightly. 790 Optimizing PMTCT Outcomes in Rural North-Central Nigeria: A Cluster-Randomized Study Muktar H. Aliyu 1 ; Meridith Blevins 1 ; Carolyn M. Audet 1 ; Marcia Kalish 1 ; Mary Lou Lindegren 1 ; Usman I. Gebi 1 ; Obinna Onwujekwe 2 ; Bryan E. Shepherd 1 ; C.WilliamWester 1 ; Sten H. Vermund 1 1 Vanderbilt Inst for Global Hlth, Nashville, TN, USA; 2 Univ of Nigeria, Enugu, Nigeria Background: Antiretroviral therapy (ART) and retention in care are essential for prevention of mother-to-child HIV transmission (PMTCT). In a randomized trial, we assessed the impact of a family-focused, integrated PMTCT care package on maternal ART initiation, post-partummother-infant pair retention and infant HIV infection. Methods: We pair-matched 12 sites, randomizing clinic-pairs to intervention vs. control (SOC) arms. Standard-of-care (SOC) services included: group provision of health information; opt-out HIV testing with same-day results; infant feeding counseling; referral to hub centers for CD4/treatment initiation; home-based care services; infant prophylaxis and early infant diagnosis. Intervention sites received SOC plus (a) Point-of-care CD4+cell count testing; (b) de-evolution of decentralized PMTCT tasks to trained lower-cadre providers; (c) integrated mother-infant care; and (d) active male partner and community involvement. A generalized linear mixed effects model with random effect for matched clinic-pairs was used to determine intervention effects for maternal ART initiation and retention of mother–infant pairs at 6- and 12-weeks postpartum. Results: We enrolled 369 participants (n=172, intervention; n= 197, SOCl). Participants were comparable across arms for marital status, time of HIV diagnosis, and distance to facility. Enrolment median CD4+ cell count was higher in intervention mothers than in SOC (424 cells/μL (IQR: 268-606) vs. 314 cells/μL (IQR: 245-406), p<0.001). Most participants were WHO clinical stage 1 (98%), of high functional status (working/ambulatory, 99%), and delivered vaginally (96%). After adjusting for age, education, travel time to facility, employment, maternal ethnicity, and time of HIV diagnosis, intervention mothers were significantly more likely to initiate ART than SOC (Relative Risk, RR [95% Confidence Interval, CI]= 3.3 [1.4-7.8]). Mother-infant pairs in the intervention arm had comparatively higher likelihood than SOC arm pairs of being retained in care at 6- and 12-weeks postpartum (RR=9.1 [5.2-15.9] and 10.3 [5.4-19.7], respectively). At the 12 week visit, 2.4% (95% CI: 0.9-6.3%) of infants tested HIV-positive in the intervention arm vs. 7.3% (95% CI: 3.3-15.6%) in the control arm. Conclusions: This integrated, family-focused service package improved maternal ART uptake and retention and reduced infant HIV infection.

Figure: Cumulative incidence of infant HIV infection during the first 12 weeks by trial arm in 12 rural sites, Niger state, Nigeria

Poster Abstracts

791 Randomized Trial of a Lay Counselor-Led Combination Intervention for PMTCT Retention

Ruby N. Fayorsey 1 ; Duncan Chege 2 ; Chunhui wang 1 ;William Reidy 1 ; Zach Peters 1 ; MartinW. Sirengo 3 ; Masila Syengo 2 ; ChrisotinW. Barasa 4 ; Mark Hawken 4 ; Elaine J. Abrams 1 1 ICAP, Columbia Univ Mailman Sch of PH, New York, NY, USA; 2 ICAP at Coulmbia Univ, Nairobi, Kenya; 3 Natl AIDS and STI Control Prog, Nairobi, Kenya; 4 ICAP at Columbia Univ, Nairobi, Kenya Background: Despite simplification of prevention of mother-to-transmission (PMTCT) services, retention of HIV positive (HIV+) mothers and infants across the PMTCT-pediatric care continuum remains problematic. A variety of interventions have been proposed to improve retention but rigorous assessment of their efficacy to improve maternal and child outcomes are scarce. Methods: The Maternal-Infant Retention for Health (MIR4Health) study was conducted at 10 PMTCT sites in Nyanza, Kenya, between Sept 2013 –Sept 2015, to evaluate the effectiveness of a combination package of lay counselor administrated evidence-based interventions (Active Patient Follow-up/APFU) compared with the Standard of Care (SOC) on mother-infant retention. HIV+ pregnant women starting antenatal care were randomized to APFU (lay counselor administered individualized health education, home visits, phone and short message service appointment reminders, physical tracing immediately after missed clinic visits, and individualized retention and adherence support) vs. routine PMTCT/postnatal HIV care as per national guidelines. Retention of mother-infant pairs was defined as documented clinic attendance of mother and infant at 6 months (mos) postpartum± 3 mos. Intent-to-treat analysis was used to assess the difference in retention between arms. Further analysis was done excluding women with pregnancy complications, neonatal/infant death, and transfer-out to compare lost-to-follow-up (LTFU). Results: 340 HIV+ pregnant women were randomized to APFU (170) or SOC (170): 106 (31%) were known HIV+ (58 APFU, 48 SOC arms); median gestational age 24 weeks (IQR 17-28); median CD4+ 426 cells/mm 3 (IQR 274-601). A total of 142 (83.5%) APFU women had a documented live birth vs. 130 (76.5%) SOC women ( p =0.10). At 6 mos postpartum, 130 mother-infant pairs were retained in the APFU arm vs. 112 the SOC arm. APFU subjects were 16%more likely to be retained at 6 mos postpartum compared to SOC (RR=1.16, 95% CI: 1.01-1.33; p=0.03). After excluding pregnancy complications, transfers and neonatal/infant deaths, 10.3% of the APFU arm and 18.8% of the SOC armwere LTFU (RR=0.55, 95%CI: 0.30-0.99; p=0.04). There were 3 infants testing HIV DNA PCR positive in the APFU arm and 6 in the SOC arm ( p =0.25). Conclusions: Engaging lay workers to provide a combination package of evidence-based interventions improved retention and reduced loss to follow-up among mother-infant pairs in a high prevalence community in Nyanza, Kenya.

330

CROI 2016