PROMOTE Nutrition

Role of Nutrition in HIV Treatment Outcomes in Pregnant Women and Children

Malnutrition is pervasive in sub-Saharan Africa, and addressing malnutrition and food insecurity is a critical component of any sustainable HIV prevention and treatment program. Malnutrition, particularly micronutrient deficiencies, may worsen the clinical course of HIV infection and is associated with increased risk of death. Baseline malnutrition is associated with worse clinical response to ART initiation. Moreover, food insecurity – the socioeconomic force behind malnutrition – is associated with decreased adherence to antiretroviral therapy (ART), lower baseline CD4 count and increased mortality. Ultimately, PEPFAR will be most successful when issues of malnutrition are integrated into the framework of caring for those infected with and affected by HIV living in urban and rural sub-Saharan African communities.

Within the context of two PEPFAR-supported pediatric ART and prevention of mother-to-child transmission (PMTCT) clinics associated with our NICHD sponsored program project in rural Uganda, we propose to evaluate the nutritional status of program participants, identify factors which increase the risk of nutritional deficiency and subsequent poor clinical outcomes, correlate levels of malnutrition and ART pharmacokinetic exposure and response, and pilot a nutritional supplementation strategy tailored to routine practice in resource limited settings. Our research will begin to fill significant gaps in knowledge of the role of nutritional status and response to ART in HIV(+) pregnant and breastfeeding women and children.

The specific aims of this study are:

Aim 1: Nutritional Assessment and Predictors of Poor ART Response. Utilizing standardized nutritional assessment measures, we will evaluate the nutritional status of 300 children (50 HIV+ on ART, 50 HIV+ at ART initiation, 100 HIV- born to HIV+ women, and 100 HIV- unexposed) and 200 pregnant and breastfeeding women (100 HIV+ on ART and 100 HIV-). Among those with HIV, we will compare measures of HIV RNA, CD4 cell counts, and percentage at baseline and prospectively over six months to identify nutrition-related predictors of poor virologic and immunologic response to ART.

Aim 2: Correlation of Nutritional Status and ART Drug Levels. In a subset of 90 children on ART [30 on lopinavir/ritonavir (LPV/rit), 30 on efavirenz (EFV) (≥3 yrs. of age) and 30 on nevirapine (NVP) (<3 yrs. of age)] chosen across strata of levels of malnutrition, we will evaluate the correlation between nutritional status and ART drug exposure measured by pharmacokinetic sampling. Likewise, we will perform pharmacokinetic evaluation among 30 HIV+ pregnant women at 30-34 weeks gestation and at 12 weeks post-partum and identify correlations with measures of nutritional status.

Aim 3: Integrating Nutritional Assessment, Counseling, and Supplementation. We will pilot and evaluate an integrated nutritional assessment, counseling and supplementation strategy for patients on or initiating ART tailored to routine practice in pediatric ART and PMTCT clinics. We will evaluate the feasibility and acceptability of this intervention from both provider and patient perspectives and generate estimates of its impact on patient nutritional status and HIV outcomes which will be used to design larger studies.