Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.

BACKGROUND: Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmilk versus infant Nevirapine prophylaxis (iNVP) on somatic growth of HEUs in the randomized PROMISE trial. METHODS AND FINDINGS: We randomized 2431 mothers with HIV and their 2444 HEUs from six African countries and India 6-14 days after delivery to mART or iNVP for prevention of breastmilk HIV transmission. The mART regimen contained tenofovir/emtricitabine (99%) plus lopinavir/ritonavir. Infant growth parameters were compared at postnatal week 10, 26, 74 and 104 using World Health Organization (WHO) z-scores for length-for-age (LAZ), weight-for-age (WAZ), and head circumference-for-age (HCAZ). Week 26 LAZ was the primary endpoint measure. Student T-tests compared mean LAZ, WAZ, and HCAZ; estimated mean and 95% confidence interval (CI) are presented. Maternal and infant baseline characteristics were comparable between study arms. The estimated median breastfeeding duration was 70 weeks. After a mean follow-up of 88 weeks, mean LAZ and WAZ were below the WHO reference population mean at all timepoints, whereas mean HCAZ was not. The mART and iNVP arms did not differ for the primary outcome measure of LAZ at week 26 (p-value = 0.39; estimated mean difference (95%CI) of -0.05 (-0.18, 0.07)) or any of the other secondary growth outcome measures or timepoints (all p-values≥0.16). Secondary analyses of the primary outcome measure adjusting for week 0 LAZ and other covariates did not change these results (all p-values≥0.09). However, infants assigned to mART were more likely to have stunting compared to iNVP infants at week 26 (odds ratio (95% CI): 1.28 (1.05, 1.57)). CONCLUSIONS: In HEUs, growth effects from postnatal exposure to mART compared to iNVP were comparable for measures on length, weight and head circumference with no clinically relevant differences between the groups. Despite breastfeeding into the second year of life, length and weight were below reference population means at all ages in both arms. Further investment is needed to optimize postnatal growth of infants born to women with HIV. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT01061151.

Patient costs for paediatric hospital admissions in Tanzania: a neglected burden?

OBJECTIVE: Tanzania has a policy of free provision of inpatient care for young children in order to promote timely access and thus reduce the current levels of mortality. However, little is known about out-of-pocket costs that may be incurred by families in seeking care for sick children. We conducted this study to identify the magnitude of these costs in relation to family income. METHODS: Five hundred and ten caretakers were interviewed on the day of discharge of their child from 11 hospitals in north-east Tanzania. Caretakers were asked to report expenditure related to hospitalization in various categories and family wealth was assessed through reported expenditure in the previous month. RESULTS: Food (mean US$2.2, median US$1.6), transport (mean US$1.7, median US$0) and medicines (mean US$1.0, median US$0.4) were the leading categories of expenditure, and overall the mean out-of-pocket expenditure was US$5.5 (median US$3.7) per admission. Mean out-of-pocket expenditure was more than 1.5 times higher for households in the highest monthly expenditure quintile compared with those in the lowest. However, this differential was reversed when expenditure was considered as a proportion of family expenditure in the previous month; for the lowest quintile, families spent more than three-quarters of their total monthly expenditure on a single paediatric admission. CONCLUSION: Out-of-pocket expenditure on child hospitalization places a considerable burden on poor families. Our findings justify a closer scrutiny of how this expenditure could be reduced, particularly through the provision of adequate food for both children and caretakers and through reducing stock-outs of essential medicines.