Summary Background Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year. Methods In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal. We randomised mothers 1:1 to receive seasonally recommended trivalent inactivated influenza vaccine or saline placebo in blocks of eight, stratified by gestational age at enrolment (17–25 weeks vs 26–34 weeks). Women were eligible if they were married, 15–40 years of age, 17–34 weeks’ gestation at enrolment, and had not previously received any influenza vaccine that season. We collected serum samples before and after immunisation, and cord blood from a subset of women and infants. Staff masked to allocation made home visits every week from enrolment to 6 months after delivery. Midnasal swabs for respiratory virus PCR testing were collected during maternal acute febrile respiratory infections, and from infants with any respiratory symptom. We assessed vaccine immunogenicity, safety, and three primary outcomes: the incidence of maternal influenza-like illness in pregnancy and 0–180 days postpartum, the incidence of low birthweight (<2500 g), and the incidence of laboratory-confirmed infant influenza disease from 0 to 180 days. This trial is registered with ClinicalTrials.gov, number NCT01034254. Findings From April 25, 2011, to Sept 9, 2013, we enrolled 3693 women in two cohorts of 2090 (1041 assigned to placebo and 1049 to vaccine) and 1603 (805 assigned to placebo and 798 to vaccine), with 3646 liveborn infants (cohort 1, 999 in placebo group and 1010 in vaccine group; cohort 2, 805 in placebo group and 798 in vaccine group). Immunisation reduced maternal febrile influenza-like illness with an overall efficacy of 19% (95% CI 1 to 34) in the combined cohorts; 9% efficacy (−16 to 29) in the first cohort, and 36% efficacy (9 to 55) in the second cohort. For laboratory-confirmed influenza infections in infants aged 0–6 months, immunisation had an overall efficacy for the combined cohorts of 30% (95% CI 5 to 48); in the first cohort, the efficacy was 16% (−19 to 41), and in the second cohort it was 60% (26 to 88). Maternal immunisation reduced the rates of low birthweight by 15% (95% CI 3–25) in both cohorts combined. The rate of small for gestational age infants was not modified by immunisation. The number of adverse events was similar regardless of immunisation status. Miscarriage occurred in three (0·2%) participants in the placebo group versus five (0·3%) in the vaccine group, stillbirth occurred in 31 (1·7%) versus 33 (1·8%), and congenital defects occurred in 18 (1·0%) versus 20 (1·1%). Five women died in the placebo group and three died in the vaccine group. The number of infant deaths at age 0–6 months was similar in each group (50 in...

PurposeEvaluation of vitamin D (vD) status and risk factors for low vD among breastfeeding mother–infant dyads in a population at high risk for vD deficiency.Subjects and methodsWe measured serum 25-hydroxyvitamin D (25(OH)D) and parathyroid hormone at 1 month postpartum in 60 consecutive exclusively breastfeeding Arab mother–infant dyads enrolled in a high dose vD supplementation study to prevent vD deficiency in Doha, Qatar, (latitude 25°N) during summer months. Data were collected on demography, sun exposure, and vD supplementation. Comparison with a US cohort was evaluated. vD deficiency was defined as serum 25(OH)D <50 nmol/L and severe deficiency categorized as 25(OH)D <25 nmol/L in mothers and infants.ResultsMean maternal age was 29 years and 77% had college or university education. Maternal median 25(OH)D was 32.5 nmol/L and 78% were vD-deficient and 20% had 25(OH)D <25 nmol/L. Only 42% of mothers had reportedly taken vD supplements postpartum and median dietary vD intake (119 IU/day) and calcium (490 mg/day) were low. Maternal median sun index score (sun exposure [hours/week] × body surface area exposed while outdoors) was 0. Maternal 25(OH)D correlated with percent body surface area exposure while outdoors (rs=0.37, P=0.004). Infant median 25(OH)D was 20 nmol/L and 83% were deficient, while 58% had 25(OH)D <25 nmol/L. Infant 25(OH)D correlated with maternal levels (rs=0.41, P=0.001). None of the infants received vD supplement at 1 month of age and median sun index score was 0. Infant’s parathyroid hormone showed negative correlations with 25(OH)D (rs=−0.28, P=0.03). Sun exposure, vD supplementation rate, and vD status were lower in Doha than Cincinnati, US cohort.ConclusionvD deficiency is common in breastfeeding mother–infant dyads in this sunny environment and is associated with sun avoidance and low vD intake. We suggest corrective vD supplement of breastfeeding mothers and their infants, which should preferably start during pregnancy.

Purpose of Review HIV self-testing (HIVST) has the potential to expand access to and uptake of HIV pre-exposure prophylaxis (PrEP) delivery. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. Recent Findings After screening 1055 records, we included eight: three randomized trials and five values and preferences studies. None measured PrEP initiation. Most studies occurred in Sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly clinic visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly clinic visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. Summary HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.

Purpose: Sleep quality in relation to anatomic site among colorectal cancer (CRC) patients is not well understood, though discerning the relationship could contribute to improved survivorship care. Methods: We ascertained sleep quality (Pittsburgh Sleep Quality Index) and other personal characteristics within an ongoing population-based study of CRC patients identified through a cancer registry (N = 1453). Differences in sleep quality by CRC site were analyzed using chi-square and ANOVA tests. We used logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association of tumor site with sleep quality concerns, adjusting for patient attributes and time since diagnosis. Results: Sleeping problems were reported by 70% of CRC patients. Overall, participants with rectal (vs. colon) cancer were more likely (OR (95% CI)) to report general trouble sleeping (1.58 (1.19, 2.10)). Rectal cancer patients were also more likely than colon cancer patients to report changes in sleep patterns after cancer diagnosis (1.38 (1.05, 1.80)), and trouble sleeping specifically due to getting up to use the bathroom (1.53 (1.20, 1.96)) or pain (1.58 (1.15, 2.17)), but were less likely to report trouble sleeping specifically due to issues with breathing/coughing/snoring (0.51 (0.27, 0.99)). Conclusion: Overall, rectal cancer patients were more likely to have sleep complications compared to colon cancer patients. This suggests sleep-focused survivorship care may be adapted according to CRC site to ensure patients receive appropriate support.