The results of the study indicate that increasing use of standards could translate into improvements in time, costs, and overall approval rates. The study also observed an uptake in the use of eClinical technologies that could potentially create efficiencies and streamline operational processes.

Complementary feeding is crucial for improving child survival and promoting growth and development, particularly among HIV-exposed children who have higher risk of morbidity and mortality than their un-exposed peers. This prospective study employed an infant and child feeding index (ICFI) to measure complementary feeding and determine its association with nutritional status among 2092 HIV-exposed infants followed from 6 to 24 months of age in Dar es Salaam, Tanzania. The ICFI measured both quality and quantity of complementary feeding, including current breastfeeding status, food consistency, dietary diversity scores (DDS), food group frequency score, and meal frequency. The ICFI score ranged from 0 to 9; the median score was 6 (Inter-Quartile Range, IQR = 4–7). After adjusting for potential confounders, high ICFI scores were associated with reduced risk of stunting (high vs. low tertile hazard ratio, HR: 0.72; 95% confidence interval, CI: 0.57, 0.91; P< 0.01) and underweight (high vs. low tertile HR: 0.79; 95% CI: 0.61, 1.02; P= 0.07). Low DDS were associated with higher risk of stunting (low vs. high tertile HR: 1.59; 95% CI: 1.23, 2.07; P< 0.01) and underweight (low vs. high tertile HR: 1.48; 95% CI: 1.12, 1.96; P = 0.01). In this setting, high DDS and ICFI scores were protective of stunting and underweight. We recommend for nutrition programs in low-income countries to emphasize educating HIV-exposed children’s caregivers on the importance of dietary diversity and optimal complementary feeding to improve nutritional status in this important subpopulation.

Objective-To examine the association between complementary feeding (CF) and risks of diarrhea and acute respiratory infection (ARI) among HIV-exposed infants aged 6-24 months.Design-We prospectively employed an Infant and Child Feeding Index (ICFI) to measure CF practices (breastfeeding status, food consistency, dietary diversity, food group frequency and meal frequency). We determined the association of ICFI and each of its components with the risk of diarrhea and ARI. Generalized estimating equations (GEE) were used to estimate the relative risks for morbidity episodes. Setting-Dar es Salaam, Tanzania.Subjects-2092 HIV-exposed infants followed from 6 months of age to 24 months of age. Authors Contributions: PK: analysis plan, data analysis, interpretation of analysis results, and writing this article; CD, KPM, DS, WWF (Principal Investigator): contributed to the study design of the original trial of multivitamins study, the present study being a secondary analysis of data collected in the trial of multivitamins; EL, EH, DS, WWF: provided statistical guidance in data analysis; RK, RRK: study design, data collection and daily management of the field study; SA: contributed to the study implementation in the field, in the laboratory. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptResults-The ICFI score ranged from 0 to 9; the median score was 6 (Inter-Quartile Range; IQR=4, 7 Conclusions-In this setting, low ICFI, dietary diversity and food consistency scores were likely associated with increased risk of diarrhea and acute respiratory infection among HIVexposed infants.

No abstract