Randomized controlled trial of a community-based intervention on HIV and nutritional outcomes at 6 months among women living with HIV/AIDS in rural India

OBJECTIVE:To assess the impact of nurse-led Asha (Accredited Social Health Activist)-support behavioral and nutritional intervention among women living with HIV/AIDS (WLH/A) in rural India. DESIGN:Cluster randomized controlled trial. METHODS:Sixteen Primary Health Centers serving WLH/A in Andhra Pradesh were grouped into four regional clusters that were randomly allocated into one of four arms. All four groups included Asha-support and consisted ofAsha-support only (control group); nutrition education; nutrition supplementation; and the combination of supplementation and education. Differences between baseline and 6-month follow-up for key physiological outcomes (BMI, CD4 cell count) were analyzed using factorial mixed models that accounted for geographic clustering. RESULTS:At 6 months, all groups improved CD4 cell countAsha only [mean difference score (D) = 343.97, standard deviation (SD) = 106.94], nutrition education (D = 356.15, SD = 0.69), nutrition supplement (D = 469.66, SD = 116.0), and nutrition supplement and education (D = 530.82, SD = 128.56). In multivariable models, Asha-support and nutrition, and Asha-support and nutrition supplement interventions demonstrated independent significant improvements in CD4 cell count; the interaction term was significant [estimate = 529.9; 95% confidence interval (CI) 512.0, 547.8; P = 0.006]. BMI also increased for all groupsAsha only (D = 0.95, SD = 0.82), Asha and nutrition education (D = 1.28, SD = 0.53), Asha and nutrition supplement (D = 2.38, SD = 0.60), nutrition supplement, and nutrition supplement and education (D = 2.72, SD = 0.84). Nutrition supplementation and nutrition education demonstrated independent effects on BMI; the interaction term was not significant (estimate = 0.27; 95% CI = 2.5, 2.7; P = 0.80). CONCLUSION:Interventions supported by community workers were efficacious at improving physiological outcomes and may be beneficial at meeting critical healthcare needs of vulnerable WLH/A in India.