Research Article Challenges in Assessing Outcomes among Infants of Pregnant HIV-Positive Women Receiving ART in Uganda Barbara Castelnuovo, Frank Mubiru, Ivan Kalule, Shadia Nakalema, and Agnes Kiragga Infectious Diseases Institute, Makerere University, Kampala, Uganda Correspondence should be addressed to Barbara Castelnuovo; bcastelnuovo@idi.co.ug Received 6 July 2017; Revised 24 August 2017; Accepted 27 August 2017; Published 7 December 2017 Academic Editor: David Katzenstein Copyright © 2017 Barbara Castelnuovo et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Since 2012, the WHO recommends lifelong ART with TDF+FTC/3TC+EFV for all HIV-positive pregnant and breastfeeding women (Option B-plus). In this analysis we describe the proportion of early and late transmission in mothers with high retention in Kampala, Uganda. We included 700 pregnant women from January 2012 to August 2014 with a follow-up extended to August 2016; the median age was 31 years (IQR: 26–35), 36.3% in WHO stage 3/4; median CD4 count was 447 cells/L (IQR: 301–651) and 73.3% were already on ART for a median time of 28 (IQR: 10–57) months; 52% infants were male and median weight was 3.2Kg (IQR: 2.5–3.5). Five hundred and sixty-fve (80.7%) infants had at least one test for HIV; 22 (3.1%) infants died, all with unknown serostatus; 3 tested positive at week 6 and one additional at months 12 and 18. Two of the mothers of the 4 HIV-positive infants were ART-na¨ ıve at the time of pregnancy. We report very low documented HIV transmission comparable with those reported in clinical trials settings; however, demonstrating the efcacy of Option B-plus in terms of averted transmission in routine settings is challenging since high proportion of infants do not have documented HIV tests. 1. Introduction Since 2012 the WHO recommends immediate start of life- long ART as a combination of TDF+FTC/3TC+EFV for all HIV-positive pregnant and breastfeeding women, a practice known as Option B-plus, in order to reduce mother to child transmission (MTCT) [1]. In the PROMISE trial the estimates of HIV MTCT at ages of 6, 9, and 12 months were 0.3%, 0.5%, and 0.6% [2], well below the UNAIDS set target for MTCT transmission rated of less than 5% [3]. However, currently there is paucity of data to evaluate the true efcacy of this strategy in routine settings. Program data of exposed infants whose mothers were enrolled into Option B-plus and who tested for HIV infection from Kenya [4] and Malawi [5] show a transmission rate of 2.8% and 5.9%, respectively. In this study we explored the feasibility of reporting the efcacy of Option B-plus in averting HIV transmission in a care setting with a high retention from enrolment to 18 months postpartum [6]. 2. Methods 2.1. Study Setting and Population. Te Infectious Diseases Institute (IDI), Makerere University, is an HIV centre of excellence [7] in Kampala, Uganda, with over 8,000 HIV- positive individuals receiving care. Since 2012 all pregnant women are seen in an integrated HIV-antenatal care clinic where they receive ART under Option B-Plus and they are educated about obstetric practices and breastfeeding options [6]. Postpartum, the women are instructed to attend the visits with their infants at the clinic Mother Baby Care Point. Infant feeding options are explained to the mother, with exclusive breastfeeding for the frst 6 months followed by exclusive replacement feeding being the preferred option. Exposed infants receive daily nevirapine from birth until 6 weeks of age and are tested for HIV by DNA PCR at week 6 and month 12 using Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay, and at month 18 by serial rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold to prompt early infant diagnosis. Hindawi AIDS Research and Treatment Volume 2017, Article ID 3202737, 4 pages https://doi.org/10.1155/2017/3202737