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BACKGROUND: There has been limited research to date on the effects of food assistance provided to HIV-infected adults in resource-constrained settings with a high prevalence of malnutrition and chronic food insecurity. We compare antiretroviral therapy (ART) adherence, weight gain, and CD4+ lymphocyte count change among HIV-infected adults enrolled in a clinic-based food assistance program in Lusaka, Zambia versus a control group of non-recipients. METHODS: We conducted a cohort study incorporating interviewer-administered surveys and retrospective clinical data to compare ART patients receiving food assistance with a control group of non-recipients. Medication adherence was assessed using pharmacy dispensation records. We use propensity score matching to assess the effect of food assistance on outcome measures. RESULTS: After 6 months, food assistance recipients (n=145) had higher ART adherence compared to non-recipients (n=147, 98.3% versus 88.8%, respectively; p<0.01), but no significant effects were observed for weight or CD4+ lymphocyte count change. The improvement in adherence rates was greater for participants on ART for less than 230 days, and those with BMI<18.5 kg/m(2), a higher HIV disease stage, or a CD4+ lymphocyte count ≤ 350 cells/μl. CONCLUSIONS: Promoting optimal medication adherence among persons on ART is relevant to public health and the success of HIV control efforts. The provision of food assistance to HIV-infected adults on ART may have an incentivizing effect which can improve medication adherence, particularly among patients recently initiated on treatment and those with poor nutrition or advanced disease. The effects on body weight and immune reconstitution appear minimal.